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A Study Of PF-06647263 In Patients With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02078752
Recruitment Status : Terminated (The study was terminated due to a change in sponsor prioritization.)
First Posted : March 5, 2014
Results First Posted : April 29, 2019
Last Update Posted : April 29, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Neoplasms
Triple-Negative Breast Cancer
Intervention Drug: PF-06647263
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PF-06647263 0.01 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg Q3W (Part 1) PF-06647263 0.02 mg/kg QW (Part 1) PF-06647263 0.03 mg/kg Q3W (Part 1) PF-06647263 0.05 mg/kg Q3W (Part 1) PF-06647263 0.075 mg/kg Q3W (Part 1) PF-06647263 0.1 mg/kg Q3W (Part 1) PF-06647263 0.134 mg/kg Q3W (Part 1) PF-06647263 0.015 mg/kg QW (Part 2)
Hide Arm/Group Description Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated. Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated. Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated. Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated. Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated. Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated. Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated. Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated. Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated. Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Period Title: Overall Study
Started 3 13 2 7 3 9 3 6 2 12
Completed 1 6 1 5 2 5 1 3 2 2
Not Completed 2 7 1 2 1 4 2 3 0 10
Reason Not Completed
Death             0             3             0             0             0             1             0             1             0             4
Lost to Follow-up             1             0             0             1             0             0             0             0             0             0
Withdrawal by Subject             1             1             1             1             0             3             2             1             0             1
Other             0             3             0             0             1             0             0             1             0             0
Study terminated by sponsor             0             0             0             0             0             0             0             0             0             5
Arm/Group Title PF-06647263 0.01 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg Q3W (Part 1) PF-06647263 0.02 mg/kg QW (Part 1) PF-06647263 0.03 mg/kg Q3W (Part 1) PF-06647263 0.05 mg/kg Q3W (Part 1) PF-06647263 0.075 mg/kg Q3W (Part 1) PF-06647263 0.1 mg/kg Q3W (Part 1) PF-06647263 0.134 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg QW (Part 2) Total
Hide Arm/Group Description Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated. Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated. Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated. Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated. Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated. Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated. Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated. Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated. Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated. Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study. Total of all reporting groups
Overall Number of Baseline Participants 3 13 2 7 3 9 3 6 2 12 60
Hide Baseline Analysis Population Description
Baseline analysis population included all participants who received at least 1 dose of study treatment.
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 13 participants 2 participants 7 participants 3 participants 9 participants 3 participants 6 participants 2 participants 12 participants 60 participants
18-44
0
   0.0%
2
  15.4%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  50.0%
1
   8.3%
4
   6.7%
45-64
2
  66.7%
4
  30.8%
2
 100.0%
6
  85.7%
3
 100.0%
9
 100.0%
1
  33.3%
3
  50.0%
0
   0.0%
8
  66.7%
38
  63.3%
>=65
1
  33.3%
7
  53.8%
0
   0.0%
1
  14.3%
0
   0.0%
0
   0.0%
2
  66.7%
3
  50.0%
1
  50.0%
3
  25.0%
18
  30.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 13 participants 2 participants 7 participants 3 participants 9 participants 3 participants 6 participants 2 participants 12 participants 60 participants
Female
3
 100.0%
12
  92.3%
2
 100.0%
7
 100.0%
3
 100.0%
7
  77.8%
2
  66.7%
4
  66.7%
2
 100.0%
12
 100.0%
54
  90.0%
Male
0
   0.0%
1
   7.7%
0
   0.0%
0
   0.0%
0
   0.0%
2
  22.2%
1
  33.3%
2
  33.3%
0
   0.0%
0
   0.0%
6
  10.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 13 participants 2 participants 7 participants 3 participants 9 participants 3 participants 6 participants 2 participants 12 participants 60 participants
White
2
  66.7%
11
  84.6%
1
  50.0%
6
  85.7%
3
 100.0%
5
  55.6%
2
  66.7%
6
 100.0%
2
 100.0%
10
  83.3%
48
  80.0%
Black
1
  33.3%
2
  15.4%
1
  50.0%
1
  14.3%
0
   0.0%
1
  11.1%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
6
  10.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  11.1%
0
   0.0%
0
   0.0%
0
   0.0%
2
  16.7%
3
   5.0%
Other
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  11.1%
1
  33.3%
0
   0.0%
0
   0.0%
0
   0.0%
2
   3.3%
Unspecified
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  11.1%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.7%
1.Primary Outcome
Title Number of Participants With Dose Limiting Toxicities (DLTs) (Part 1)
Hide Description DLTs were defined as any of the following adverse events (AEs) which were not considered related to disease progression occurring in the first cycle of treatment:(1)Hematologic: grade 4 neutropenia lasting >7 days; febrile neutropenia (defined as neutropenia >=Grade 3 and a single body temperature >38.3°C or a sustained temperature of >=38°C for more than 1 hour); grade >=3 neutropenia with infection; any grade thrombocytopenia associated with clinically significant or life threatening bleeding; grade 4 thrombocytopenia >=72 hours or platelets <=10,000/mm^3 regardless of duration. (2)Non- hematologic: bilirubin increase >=2 × upper limit of normal (ULN) and not related to disease progression or other known cause; all other Grade >=3 toxicities, except those that had not been maximally treated (eg, nausea, vomiting, diarrhea); delay by more than 2 weeks in receiving the next scheduled cycle due to persisting toxicities not attributable to disease progression.
Time Frame Baseline up to Cycle 2 Day 1 (22 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis set included all enrolled participants who received at least 1 dose of PF-06647263.
Arm/Group Title PF-06647263 0.01 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg Q3W (Part 1) PF-06647263 0.02 mg/kg QW (Part 1) PF-06647263 0.03 mg/kg Q3W (Part 1) PF-06647263 0.05 mg/kg Q3W (Part 1) PF-06647263 0.075 mg/kg Q3W (Part 1) PF-06647263 0.1 mg/kg Q3W (Part 1) PF-06647263 0.134 mg/kg Q3W (Part 1)
Hide Arm/Group Description:
Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Overall Number of Participants Analyzed 3 13 2 7 3 9 3 6 2
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
1
   7.7%
0
   0.0%
1
  14.3%
0
   0.0%
2
  22.2%
0
   0.0%
2
  33.3%
2
 100.0%
2.Primary Outcome
Title Percentage of Participants With Objective Response (Part 2)
Hide Description Objective response rate (ORR) refers to percentage of participants who achieved complete response (CR) or partial response (PR) determined by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1. A participant achieved CR if both target and non-target lesions achieved CR, no new lesions; achieved PR if target lesions achieved CR or PR, non-target lesions were assessed as non-CR/non-PD (progressive disease), indeterminate or missing, and no new lesions. For target lesions, CR: complete disappearance of all target lesions except nodal disease (target nodes must decrease to normal size); PR: >= 30% decrease under baseline of the sum of diameters of all target measurable lesions. For non-target lesions, CR: disappearance of all non-target lesions and normalization of tumor marker levels and all lymph nodes must be normal in size; non-CR/non-PD: persistence of any non-target lesions and/or tumor marker level above the normal limits.
Time Frame Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis set included all treated participants in Part 2 with measurable disease at baseline.
Arm/Group Title PF-06647263 0.015 mg/kg QW (Part 2)
Hide Arm/Group Description:
Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Overall Number of Participants Analyzed 12
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
8.3
(0.2 to 38.5)
3.Secondary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (AEs) (All Causality, All Cycles)
Hide Description An AE was any untoward medical occurrence in a clinical investigation patient administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Any events occurring following start of treatment or increasing in severity were counted as treatment-emergent.
Time Frame Baseline up to 28 days after the last treatment administration (Approximately 13 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all enrolled participants who received at least 1 dose of PF-06647263.
Arm/Group Title PF-06647263 0.01 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg Q3W (Part 1) PF-06647263 0.02 mg/kg QW (Part 1) PF-06647263 0.03 mg/kg Q3W (Part 1) PF-06647263 0.05 mg/kg Q3W (Part 1) PF-06647263 0.075 mg/kg Q3W (Part 1) PF-06647263 0.1 mg/kg Q3W (Part 1) PF-06647263 0.134 mg/kg Q3W (Part 1) PF-06647263 0.015 mg/kg QW (Part 2)
Hide Arm/Group Description:
Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Overall Number of Participants Analyzed 3 13 2 7 3 9 3 6 2 12
Measure Type: Count of Participants
Unit of Measure: Participants
3
 100.0%
13
 100.0%
2
 100.0%
7
 100.0%
3
 100.0%
9
 100.0%
3
 100.0%
6
 100.0%
2
 100.0%
12
 100.0%
4.Secondary Outcome
Title Number of Participants With Treatment-Emergent AEs (Treatment-related, All Cycles)
Hide Description An AE was any untoward medical occurrence in a clinical investigation patient administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Any events occurring following start of treatment or increasing in severity were counted as treatment-emergent.
Time Frame Baseline up to 28 days after the last treatment administration (Approximately 13 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all enrolled participants who received at least 1 dose of PF-06647263.
Arm/Group Title PF-06647263 0.01 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg Q3W (Part 1) PF-06647263 0.02 mg/kg QW (Part 1) PF-06647263 0.03 mg/kg Q3W (Part 1) PF-06647263 0.05 mg/kg Q3W (Part 1) PF-06647263 0.075 mg/kg Q3W (Part 1) PF-06647263 0.1 mg/kg Q3W (Part 1) PF-06647263 0.134 mg/kg Q3W (Part 1) PF-06647263 0.015 mg/kg QW (Part 2)
Hide Arm/Group Description:
Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Overall Number of Participants Analyzed 3 13 2 7 3 9 3 6 2 12
Measure Type: Number
Unit of Measure: Participants
3 11 2 7 3 9 3 5 2 8
5.Secondary Outcome
Title Number of Participants With Treatment-Emergent Serious Adverse Events (SAEs) (All Causality, All Cycles)
Hide Description A SAE was any untoward medical occurrence at any dose that: resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect. Any events occurring following start of treatment or increasing in severity were counted as treatment-emergent.
Time Frame Baseline up to 28 days after the last treatment administration (Approximately 13 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all enrolled participants who received at least 1 dose of PF-06647263.
Arm/Group Title PF-06647263 0.01 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg Q3W (Part 1) PF-06647263 0.02 mg/kg QW (Part 1) PF-06647263 0.03 mg/kg Q3W (Part 1) PF-06647263 0.05 mg/kg Q3W (Part 1) PF-06647263 0.075 mg/kg Q3W (Part 1) PF-06647263 0.1 mg/kg Q3W (Part 1) PF-06647263 0.134 mg/kg Q3W (Part 1) PF-06647263 0.015 mg/kg QW (Part 2)
Hide Arm/Group Description:
Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Overall Number of Participants Analyzed 3 13 2 7 3 9 3 6 2 12
Measure Type: Number
Unit of Measure: Participants
1 6 0 0 1 1 1 3 1 4
6.Secondary Outcome
Title Number of Participants With Treatment-Emergent SAEs (Treatment-related, All Cycles)
Hide Description A SAE was any untoward medical occurrence at any dose that: resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect. Any events occurring following start of treatment or increasing in severity were counted as treatment-emergent.
Time Frame Baseline up to 28 days after the last treatment administration (Approximately 13 months)
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Hide Analysis Population Description
The safety analysis set included all enrolled participants who received at least 1 dose of PF-06647263.
Arm/Group Title PF-06647263 0.01 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg Q3W (Part 1) PF-06647263 0.02 mg/kg QW (Part 1) PF-06647263 0.03 mg/kg Q3W (Part 1) PF-06647263 0.05 mg/kg Q3W (Part 1) PF-06647263 0.075 mg/kg Q3W (Part 1) PF-06647263 0.1 mg/kg Q3W (Part 1) PF-06647263 0.134 mg/kg Q3W (Part 1) PF-06647263 0.015 mg/kg QW (Part 2)
Hide Arm/Group Description:
Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Overall Number of Participants Analyzed 3 13 2 7 3 9 3 6 2 12
Measure Type: Number
Unit of Measure: Participants
0 1 0 0 0 0 1 0 1 1
7.Secondary Outcome
Title Number of Participants With Vital Signs Abnormalities
Hide Description Following parameters were analyzed for examination of vital signs: sitting systolic and diastolic blood pressure (SBP & DBP), and sitting pulse rate. The abnormal criteria were: (1) minimum SBP <90mmHg; (2) SBP change from baseline, maximum decrease >=30mmHg or maximum increase >=30mmHg; (3) minimum DBP <50mmHg; (4) DBP change from baseline, maximum decrease >=20mmHg or maximum increase >=20mmHg; (5) minimum supine pulse rate <40 BPM or maximum supine pulse rate >120 BPM.
Time Frame Baseline, Days 1, 8, 15 of each cycle, and post treatment period. (Approximately 13 months)
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Hide Analysis Population Description
The safety analysis set included all enrolled participants who received at least 1 dose of PF-06647263.
Arm/Group Title PF-06647263 0.01 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg Q3W (Part 1) PF-06647263 0.02 mg/kg QW (Part 1) PF-06647263 0.03 mg/kg Q3W (Part 1) PF-06647263 0.05 mg/kg Q3W (Part 1) PF-06647263 0.075 mg/kg Q3W (Part 1) PF-06647263 0.1 mg/kg Q3W (Part 1) PF-06647263 0.134 mg/kg Q3W (Part 1) PF-06647263 0.015 mg/kg QW (Part 2)
Hide Arm/Group Description:
Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Overall Number of Participants Analyzed 3 13 2 7 3 9 3 6 2 12
Measure Type: Count of Participants
Unit of Measure: Participants
Sitting systolic blood pressure (SBP) <90
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  11.1%
1
  33.3%
1
  16.7%
0
   0.0%
1
   8.3%
Sitting diastolic blood pressure (DBP) <50
1
  33.3%
0
   0.0%
0
   0.0%
3
  42.9%
0
   0.0%
1
  11.1%
1
  33.3%
2
  33.3%
0
   0.0%
0
   0.0%
Sitting pulse rate <40
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sitting pulse rate >120
1
  33.3%
1
   7.7%
0
   0.0%
0
   0.0%
1
  33.3%
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
1
   8.3%
Max increase from baseline in sitting SBP >=30
0
   0.0%
0
   0.0%
0
   0.0%
1
  14.3%
1
  33.3%
0
   0.0%
0
   0.0%
1
  16.7%
0
   0.0%
1
   8.3%
Max increase from baseline in sitting DBP >=20
0
   0.0%
1
   7.7%
0
   0.0%
1
  14.3%
1
  33.3%
0
   0.0%
0
   0.0%
1
  16.7%
0
   0.0%
2
  16.7%
Max decrease from baseline in sitting SBP >=30
1
  33.3%
5
  38.5%
2
 100.0%
2
  28.6%
1
  33.3%
1
  11.1%
2
  66.7%
2
  33.3%
1
  50.0%
0
   0.0%
Max decrease from baseline in sitting DBP >=20
1
  33.3%
3
  23.1%
1
  50.0%
1
  14.3%
0
   0.0%
1
  11.1%
2
  66.7%
2
  33.3%
1
  50.0%
0
   0.0%
8.Secondary Outcome
Title Area Under the Serum Concentration-time Profile From Time 0 to the 504-hour Time Point (AUC504) of PF-06647263
Hide Description AUC504 was determined by linear/log trapezoidal method. AUC504 analysis only applied to QW groups.
Time Frame Cycle 1 Day 1: predose, 1, 4, 24, 72 hrs postdose, Cycle 1 Days 8 and 15: predose, 1 and 72 hrs postdose, up to Cycle 2 Day 1 predose (504 hr).
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was defined as all enrolled patients treated who had sufficient information to estimate AUC504.
Arm/Group Title PF-06647263 0.01 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg QW (Part 1) PF-06647263 0.02 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg QW (Part 2)
Hide Arm/Group Description:
Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Overall Number of Participants Analyzed 3 10 6 8
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*hr/mL
2299
(41%)
2777
(26%)
3958
(45%)
3414
(23%)
9.Secondary Outcome
Title Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of PF-06647263
Hide Description Tau is dosing interval, where tau=168 hours for the QW dosing and 504-hour for the Q3W dosing. AUC tau was determined by linear/log trapezoidal method. In time frame, C=cycle, D=day.
Time Frame QW: C1D1: predose, 1,4,24,72 hrs postdose, C1D8 & 15: predose, 1 & 72 hrs postdose, up to C2D1 predose. Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.
Hide Outcome Measure Data
Hide Analysis Population Description
"Number of Participants Analyzed" represents the number of participants who were enrolled and received at least 1 dose of PF-06647263. "Number Analyzed" represents the number of participants contributing to the PK parameter summary statistics at that time point.
Arm/Group Title PF-06647263 0.01 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg Q3W (Part 1) PF-06647263 0.02 mg/kg QW (Part 1) PF-06647263 0.03 mg/kg Q3W (Part 1) PF-06647263 0.05 mg/kg Q3W (Part 1) PF-06647263 0.075 mg/kg Q3W (Part 1) PF-06647263 0.1 mg/kg Q3W (Part 1) PF-06647263 0.134 mg/kg Q3W (Part 1) PF-06647263 0.015 mg/kg QW (Part 2)
Hide Arm/Group Description:
Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Overall Number of Participants Analyzed 3 13 2 7 3 9 3 6 2 12
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*hr/mL
Cycle 1 Day 1 Number Analyzed 3 participants 11 participants 2 participants 6 participants 3 participants 5 participants 3 participants 4 participants 2 participants 12 participants
594.1
(38%)
544.8
(28%)
NA [1] 
(NA%)
1056
(31%)
1246
(56%)
3475
(36%)
6023
(35%)
6363
(18%)
NA [2] 
(NA%)
669.9
(31%)
Cycle 1 Day 15 Number Analyzed 3 participants 9 participants 0 participants 2 participants 0 participants 0 participants 0 participants 0 participants 0 participants 8 participants
927.8
(33%)
1166
(37%)
NA [3] 
(NA%)
1274
(30%)
Cycle 4 Day 1 Number Analyzed 0 participants 0 participants 0 participants 0 participants 2 participants 3 participants 1 participants 1 participants 0 participants 0 participants
NA [4] 
(NA%)
4617
(42%)
NA [5] 
(NA%)
NA [6] 
(NA%)
[1]

Individual values are reported when fewer than 3 participants had report able parameter values.

Individual values were :458 and 1360

[2]

Individual values are reported when fewer than 3 participants had report able parameter values.

Individual values were 8060 and 13400

[3]

Individual values are reported when fewer than 3 participants had report able parameter values.

Individual values were 1370 and 1570

[4]

Individual values are reported when fewer than 3 participants had report able parameter values.

Individual values were 1800 and 1900.

[5]

Individual values are reported when fewer than 3 participants had report able parameter values.

The individual value was 10200.

[6]

Individual values are reported when fewer than 3 participants had report able parameter values.

The individual value was 6820.

10.Secondary Outcome
Title Maximum Observed Serum Concentration (Cmax) of PF-06647263
Hide Description Maximum observed serum concentration Cmax was determined directly from data. In time frame, C=cycle, D=day.
Time Frame QW: C1D1: predose, 1,4,24,72 hrs postdose, C1D8 & 15: predose, 1 & 72 hrs postdose, up to C2D1 predose. Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.
Hide Outcome Measure Data
Hide Analysis Population Description
"Number of Participants Analyzed" represents the number of participants who were enrolled and received at least 1 dose of PF-06647263. "Number Analyzed" represents the number of participants contributing to the PK parameter summary statistics at that time point.
Arm/Group Title PF-06647263 0.01 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg Q3W (Part 1) PF-06647263 0.02 mg/kg QW (Part 1) PF-06647263 0.03 mg/kg Q3W (Part 1) PF-06647263 0.05 mg/kg Q3W (Part 1) PF-06647263 0.075 mg/kg Q3W (Part 1) PF-06647263 0.1 mg/kg Q3W (Part 1) PF-06647263 0.134 mg/kg Q3W (Part 1) PF-06647263 0.015 mg/kg QW (Part 2)
Hide Arm/Group Description:
Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Overall Number of Participants Analyzed 3 13 2 7 3 9 3 6 2 12
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
Cycle 1 Day 1 Number Analyzed 3 participants 13 participants 2 participants 7 participants 3 participants 9 participants 3 participants 6 participants 2 participants 12 participants
12.64
(20%)
11.96
(26%)
NA [1] 
(NA%)
22.63
(24%)
25.41
(60%)
58.25
(40%)
84.40
(38%)
101.6
(34%)
NA [2] 
(NA%)
16.86
(29%)
Cycle 1 Day 15 Number Analyzed 3 participants 12 participants 0 participants 4 participants 0 participants 0 participants 0 participants 0 participants 0 participants 12 participants
11.86
(33%)
13.73
(47%)
27.45
(48%)
17.84
(25%)
Cycle 4 Day 1 Number Analyzed 0 participants 0 participants 0 participants 0 participants 2 participants 3 participants 2 participants 2 participants 0 participants 0 participants
NA [3] 
(NA%)
41.98
(16%)
NA [4] 
(NA%)
NA [5] 
(NA%)
[1]

Individual values are reported when fewer than 3 participants had report able parameter values.

Individual values were 12.8 and 21.8.

[2]

Individual values are reported when fewer than 3 participants had report able parameter values.

Individual values were 131 and 154.

[3]

Individual values are reported when fewer than 3 participants had report able parameter values.

Individual values were 21.2 and 18.1.

[4]

Individual values are reported when fewer than 3 participants had report able parameter values.

Individual values were 47.7 and 80.9.

[5]

Individual values are reported when fewer than 3 participants had report able parameter values.

Individual values were 67.7 and 43.8.

11.Secondary Outcome
Title Time for Cmax (Tmax) of PF-06647963
Hide Description Tmax was determined directly from data as time of first occurrence. In time frame, C=cycle, D=day.
Time Frame QW: C1D1: predose, 1,4,24,72 hrs postdose, C1D8 & 15: predose, 1 & 72 hrs postdose, up to C2D1 predose. Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.
Hide Outcome Measure Data
Hide Analysis Population Description
"Number of Participants Analyzed" represents the number of participants who were enrolled and received at least 1 dose of PF-06647263. "Number Analyzed" represents the number of participants contributing to the PK parameter summary statistics at that time point.
Arm/Group Title PF-06647263 0.01 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg Q3W (Part 1) PF-06647263 0.02 mg/kg QW (Part 1) PF-06647263 0.03 mg/kg Q3W (Part 1) PF-06647263 0.05 mg/kg Q3W (Part 1) PF-06647263 0.075 mg/kg Q3W (Part 1) PF-06647263 0.1 mg/kg Q3W (Part 1) PF-06647263 0.134 mg/kg Q3W (Part 1) PF-06647263 0.015 mg/kg QW (Part 2)
Hide Arm/Group Description:
Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Overall Number of Participants Analyzed 3 13 2 7 3 9 3 6 2 12
Median (Full Range)
Unit of Measure: hr
Cycle 1 Day 1 Number Analyzed 3 participants 13 participants 2 participants 7 participants 3 participants 9 participants 3 participants 6 participants 2 participants 12 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 4.00)
2.52
(1.00 to 4.03)
1.00
(1.00 to 4.00)
1.00
(1.00 to 1.05)
1.00
(0.85 to 4.00)
3.97
(1.05 to 4.05)
1.05
(1.00 to 1.12)
1.03
(1.02 to 1.03)
1.00
(1.00 to 4.00)
Cycle 1 Day 15 Number Analyzed 3 participants 12 participants 0 participants 4 participants 0 participants 0 participants 0 participants 0 participants 0 participants 12 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Cycle 4 Day 1 Number Analyzed 0 participants 0 participants 0 participants 0 participants 2 participants 3 participants 2 participants 2 participants 0 participants 0 participants
2.55
(1.00 to 4.10)
1.08
(1.00 to 4.00)
2.60
(1.07 to 4.13)
1.56
(1.05 to 2.07)
12.Secondary Outcome
Title Clearance (CL) of PF-06647263
Hide Description For single dose, CL was determined by Dose/AUCinf while for multiple dose, CL was determined by Dose/AUCtau. AUCinf was the area under the serum concentration-time profile from time 0 extrapolated to infinite time. In time frame, C=cycle, D=day.
Time Frame QW: C1D15: predose, 1 & 72 hrs postdose, up to C2D1 predose. Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.
Hide Outcome Measure Data
Hide Analysis Population Description
"Number of Participants Analyzed" represents the number of participants who were enrolled and received at least 1 dose of PF-06647263. "Number Analyzed" represents the number of participants contributing to the PK parameter summary statistics at that time point.
Arm/Group Title PF-06647263 0.01 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg Q3W (Part 1) PF-06647263 0.02 mg/kg QW (Part 1) PF-06647263 0.03 mg/kg Q3W (Part 1) PF-06647263 0.05 mg/kg Q3W (Part 1) PF-06647263 0.075 mg/kg Q3W (Part 1) PF-06647263 0.1 mg/kg Q3W (Part 1) PF-06647263 0.134 mg/kg Q3W (Part 1) PF-06647263 0.015 mg/kg QW (Part 2)
Hide Arm/Group Description:
Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Overall Number of Participants Analyzed 3 13 2 7 3 9 3 6 2 12
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: L/hr
Cycle 1 Day 1 Number Analyzed 0 participants 0 participants 1 participants 0 participants 3 participants 7 participants 3 participants 5 participants 2 participants 0 participants
NA [1] 
(NA%)
1.547
(33%)
1.108
(24%)
0.9244
(43%)
0.9219
(39%)
NA [2] 
(NA%)
Cycle 1 Day 15 Number Analyzed 3 participants 9 participants 0 participants 2 participants 0 participants 0 participants 0 participants 0 participants 0 participants 8 participants
0.7932
(15%)
0.9454
(31%)
NA [3] 
(NA%)
0.8451
(27%)
Cycle 4 Day 1 Number Analyzed 0 participants 0 participants 0 participants 0 participants 2 participants 3 participants 1 participants 1 participants 0 participants 0 participants
NA [4] 
(NA%)
0.6904
(36%)
NA [5] 
(NA%)
NA [6] 
(NA%)
[1]

Individual values are reported when fewer than 3 participants had report able parameter values.

The individual value was 0.938.

[2]

Individual values are reported when fewer than 3 participants had report able parameter values.

Individual values were 1.06 and 0.807.

[3]

Individual values are reported when fewer than 3 participants had report able parameter values.

Individual values were 0.699 and 0.868.

[4]

Individual values are reported when fewer than 3 participants had report able parameter values.

Individual values were 0.944 and 1.47.

[5]

Individual values are reported when fewer than 3 participants had report able parameter values.

The individual value was 0.441.

[6]

Individual values are reported when fewer than 3 participants had report able parameter values.

The individual value was 0.601.

13.Secondary Outcome
Title Volume of Distribution at Steady State (Vss) of PF-06647263
Hide Description Vss was determined by CL × MRT (mean residence time). MRT=[AUMCtau +tau(AUCinf-AUCtau)]/AUCtau. AUMCtau was the area under the first moment curve derived using the linear/log trapezoidal method. In time frame, C=cycle, D=day.
Time Frame QW: C1D15: predose, 1 & 72 hrs postdose, up to C2D1 predose. Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.
Hide Outcome Measure Data
Hide Analysis Population Description
"Number of Participants Analyzed" represents the number of participants who were enrolled and received at least 1 dose of PF-06647263. "Number Analyzed" represents the number of participants contributing to the PK parameter summary statistics at that time point.
Arm/Group Title PF-06647263 0.01 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg Q3W (Part 1) PF-06647263 0.02 mg/kg QW (Part 1) PF-06647263 0.03 mg/kg Q3W (Part 1) PF-06647263 0.05 mg/kg Q3W (Part 1) PF-06647263 0.075 mg/kg Q3W (Part 1) PF-06647263 0.1 mg/kg Q3W (Part 1) PF-06647263 0.134 mg/kg Q3W (Part 1) PF-06647263 0.015 mg/kg QW (Part 2)
Hide Arm/Group Description:
Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Overall Number of Participants Analyzed 3 13 2 7 3 9 3 6 2 12
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: L
Cycle 1 Day 1 Number Analyzed 0 participants 0 participants 1 participants 0 participants 3 participants 7 participants 3 participants 5 participants 2 participants 0 participants
NA [1] 
(NA%)
162.7
(44%)
114.8
(20%)
134.0
(49%)
116.5
(56%)
NA [2] 
(NA%)
Cycle 1 Day 15 Number Analyzed 3 participants 6 participants 0 participants 1 participants 0 participants 0 participants 0 participants 0 participants 0 participants 7 participants
84.01
(28%)
102.3
(49%)
NA [3] 
(NA%)
72.31
(21%)
Cycle 4 Day 1 Number Analyzed 0 participants 0 participants 0 participants 0 participants 2 participants 3 participants 2 participants 2 participants 0 participants 0 participants
NA [4] 
(NA%)
105.7
(18%)
NA [5] 
(NA%)
NA [6] 
(NA%)
[1]

Individual values are reported when fewer than 3 participants had report able parameter values.

The individual value was 116.

[2]

Individual values are reported when fewer than 3 participants had report able parameter values.

The individual value were 128 and 159.

[3]

Individual values are reported when fewer than 3 participants had report able parameter values.

The individual value was 96.1.

[4]

Individual values are reported when fewer than 3 participants had report able parameter values.

Individual values were 123 and 187.

[5]
Individual values are reported when fewer than 3 participants had report able parameter values. One of the individual values was 84.6. The other was not reported because CL value did not meet reporting criteria.
[6]
Individual values are reported when fewer than 3 participants had report able parameter values. One of the individual values was 109. The other was not reported because CL value did not meet reporting criteria.
14.Secondary Outcome
Title Terminal Serum Half-life (t1/2) of PF-06647263
Hide Description T1/2 was determined by loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log linear concentration-time curve. The t1/2 analysis only applied to Q3W group. In time frame, C=cycle, D=day.
Time Frame Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.
Hide Outcome Measure Data
Hide Analysis Population Description
"Number of Participants Analyzed" represents the number of participants who were enrolled and received at least 1 dose of PF-06647263. "Number Analyzed" represents the number of participants contributing to the PK parameter summary statistics at that time point.
Arm/Group Title PF-06647263 0.015 mg/kg Q3W (Part 1) PF-06647263 0.03 mg/kg Q3W (Part 1) PF-06647263 0.05 mg/kg Q3W (Part 1) PF-06647263 0.075 mg/kg Q3W (Part 1) PF-06647263 0.1 mg/kg Q3W (Part 1) PF-06647263 0.134 mg/kg Q3W (Part 1)
Hide Arm/Group Description:
Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Overall Number of Participants Analyzed 2 3 9 3 6 2
Mean (Standard Deviation)
Unit of Measure: day
Cycle 1 Day 1 Number Analyzed 1 participants 3 participants 7 participants 3 participants 5 participants 2 participants
NA [1]   (NA) 4.403  (0.593) 3.541  (0.756) 5.353  (0.542) 4.336  (1.02) NA [2]   (NA)
Cycle 4 Day 1 Number Analyzed 0 participants 2 participants 3 participants 2 participants 2 participants 0 participants
NA [3]   (NA) 5.100  (1.56) NA [4]   (NA) NA [5]   (NA)
[1]

Individual values are reported when fewer than 3 participants had report able parameter values..

The individual value was 4.76.

[2]

Individual values are reported when fewer than 3 participants had report able parameter values.

The individual value were 5.16 and 5.28.

[3]

Individual values are reported when fewer than 3 participants had report able parameter values.

Individual values were 4.16 and 4.22.

[4]

Individual values are reported when fewer than 3 participants had report able parameter values.

Individual values were 4.93 and 5.79.

[5]

Individual values are reported when fewer than 3 participants had report able parameter values.

Individual values were 4.77 and 6.07.

15.Secondary Outcome
Title AUC504 of Total Antibody
Hide Description AUC504 was determined by linear/log trapezoidal method. AUC504 analysis only applied to QW groups. PF-06647263 is an antibody-drug conjugate (ADC) which comprises total antibody (PF-06523432) and unconjugated payload ( CL-184538).
Time Frame Cycle 1 Day 1: predose, 1, 4, 24, 72 hrs postdose, Cycle 1 Days 8 and 15: predose, 1 and 72 hrs postdose, up to Cycle 2 Day 1 predose (504 hr).
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was defined as all enrolled patients treated who had sufficient information to estimate AUC504.
Arm/Group Title PF-06647263 0.01 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg QW (Part 1) PF-06647263 0.02 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg QW (Part 2)
Hide Arm/Group Description:
Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Overall Number of Participants Analyzed 3 11 4 8
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*hr/mL
50080
(38%)
64190
(26%)
91730
(19%)
74250
(40%)
16.Secondary Outcome
Title AUCtau of Total Antibody
Hide Description Tau is dosing interval, where tau=168 hours for the QW dosing and 504-hour for the Q3W dosing. AUC tau was determined by linear/log trapezoidal method. PF-06647263 is an antibody-drug conjugate (ADC) which comprises total antibody (PF-06523432) and unconjugated payload ( CL-184538). In time frame, C=cycle, D=day.
Time Frame QW: C1D1: predose, 1,4,24,72 hrs postdose, C1D8 & 15: predose, 1 & 72 hrs postdose, up to C2D1 predose. Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.
Hide Outcome Measure Data
Hide Analysis Population Description
"Number of Participants Analyzed" represents the number of participants who were enrolled and received at least 1 dose of PF-06647263. "Number Analyzed" represents the number of participants contributing to the PK parameter summary statistics at that time point.
Arm/Group Title PF-06647263 0.01 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg Q3W (Part 1) PF-06647263 0.02 mg/kg QW (Part 1) PF-06647263 0.03 mg/kg Q3W (Part 1) PF-06647263 0.05 mg/kg Q3W (Part 1) PF-06647263 0.075 mg/kg Q3W (Part 1) PF-06647263 0.1 mg/kg Q3W (Part 1) PF-06647263 0.134 mg/kg Q3W (Part 1) PF-06647263 0.015 mg/kg QW (Part 2)
Hide Arm/Group Description:
Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Overall Number of Participants Analyzed 3 13 2 7 3 9 3 6 2 12
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*hr/mL
Cycle 1 Day 1 Number Analyzed 3 participants 11 participants 2 participants 6 participants 3 participants 5 participants 3 participants 4 participants 2 participants 11 participants
12140
(29%)
11780
(32%)
NA [1] 
(NA%)
18900
(26%)
38330
(63%)
81710
(45%)
173000
(39%)
164400
(22%)
NA [2] 
(NA%)
13950
(29%)
Cycle 1 Day 15 Number Analyzed 3 participants 10 participants 0 participants 2 participants 0 participants 0 participants 0 participants 0 participants 0 participants 7 participants
21620
(30%)
29740
(33%)
NA [3] 
(NA%)
32760
(39%)
Cycle 4 Day 1 Number Analyzed 0 participants 0 participants 0 participants 0 participants 2 participants 3 participants 1 participants 1 participants 0 participants 0 participants
NA [4] 
(NA%)
155800
(62%)
NA [5] 
(NA%)
NA [6] 
(NA%)
[1]

Individual values are reported when fewer than 3 participants had report able parameter values.

Individual values were 10500 and 38500.

[2]

Individual values are reported when fewer than 3 participants had report able parameter values.

Individual values were 191000 and 419000.

[3]

Individual values are reported when fewer than 3 participants had report able parameter values.

Individual values were 35100 and 35300.

[4]

Individual values are reported when fewer than 3 participants had report able parameter values.

Individual values were 61500 and 95900.

[5]

Individual values are reported when fewer than 3 participants had report able parameter values.

The individual value was 398000.

[6]

Individual values are reported when fewer than 3 participants had report able parameter values.

The individual value was 265000.

17.Secondary Outcome
Title Cmax of Total Antibody
Hide Description Cmax was determined directly from data. PF-06647263 is an antibody-drug conjugate (ADC) which comprises total antibody (PF-06523432) and unconjugated payload ( CL-184538). In time frame, C=cycle, D=day.
Time Frame QW: C1D1: predose, 1,4,24,72 hrs postdose, C1D8 & 15: predose, 1 & 72 hrs postdose, up to C2D1 predose. Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.
Hide Outcome Measure Data
Hide Analysis Population Description
"Number of Participants Analyzed" represents the number of participants who were enrolled and received at least 1 dose of PF-06647263. "Number Analyzed" represents the number of participants contributing to the PK parameter summary statistics at that time point.
Arm/Group Title PF-06647263 0.01 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg Q3W (Part 1) PF-06647263 0.02 mg/kg QW (Part 1) PF-06647263 0.03 mg/kg Q3W (Part 1) PF-06647263 0.05 mg/kg Q3W (Part 1) PF-06647263 0.075 mg/kg Q3W (Part 1) PF-06647263 0.1 mg/kg Q3W (Part 1) PF-06647263 0.134 mg/kg Q3W (Part 1) PF-06647263 0.015 mg/kg QW (Part 2)
Hide Arm/Group Description:
Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Overall Number of Participants Analyzed 3 13 2 7 3 9 3 6 2 12
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
Cycle 1 Day 1 Number Analyzed 3 participants 13 participants 2 participants 7 participants 3 participants 8 participants 3 participants 6 participants 2 participants 11 participants
209.1
(23%)
187.7
(23%)
NA [1] 
(NA%)
357.2
(20%)
482.9
(52%)
865.9
(32%)
1475
(45%)
1622
(32%)
NA [2] 
(NA%)
265.3
(27%)
Cycle 1 Day 15 Number Analyzed 3 participants 12 participants 0 participants 4 participants 0 participants 0 participants 0 participants 0 participants 0 participants 11 participants
229.6
(25%)
282.7
(32%)
506.5
(44%)
305
(32%)
Cycle 4 Day 1 Number Analyzed 0 participants 0 participants 0 participants 0 participants 2 participants 3 participants 2 participants 2 participants 0 participants 0 participants
NA [3] 
(NA%)
813
(32%)
NA [4] 
(NA%)
NA [5] 
(NA%)
[1]

Individual values are reported when fewer than 3 participants had report able parameter values.

Individual values were 240 and 424.

[2]

Individual values are reported when fewer than 3 participants had report able parameter values.

Individual values were 2120 and 2860.

[3]

Individual values are reported when fewer than 3 participants had report able parameter values.

Individual values were 419 and 462.

[4]

Individual values are reported when fewer than 3 participants had report able parameter values.

Individual values were 1170 and 1830.

[5]

Individual values are reported when fewer than 3 participants had report able parameter values.

Individual values were 1080 and 1320.

18.Secondary Outcome
Title Tmax of Total Antibody
Hide Description Tmax was determined directly from data as time of first occurrence. PF-06647263 is an antibody-drug conjugate (ADC) which comprises total antibody (PF-06523432) and unconjugated payload ( CL-184538). In time frame, C=cycle, D=day.
Time Frame QW: C1D1: predose, 1,4,24,72 hrs postdose, C1D8 & 15: predose, 1 & 72 hrs postdose, up to C2D1 predose. Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.
Hide Outcome Measure Data
Hide Analysis Population Description
"Number of Participants Analyzed" represents the number of participants who were enrolled and received at least 1 dose of PF-06647263. "Number Analyzed" represents the number of participants contributing to the PK parameter summary statistics at that time point.
Arm/Group Title PF-06647263 0.01 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg Q3W (Part 1) PF-06647263 0.02 mg/kg QW (Part 1) PF-06647263 0.03 mg/kg Q3W (Part 1) PF-06647263 0.05 mg/kg Q3W (Part 1) PF-06647263 0.075 mg/kg Q3W (Part 1) PF-06647263 0.1 mg/kg Q3W (Part 1) PF-06647263 0.134 mg/kg Q3W (Part 1) PF-06647263 0.015 mg/kg QW (Part 2)
Hide Arm/Group Description:
Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Overall Number of Participants Analyzed 3 13 2 7 3 9 3 6 2 12
Median (Full Range)
Unit of Measure: hr
Cycle 1 Day 1 Number Analyzed 3 participants 13 participants 2 participants 7 participants 3 participants 8 participants 3 participants 6 participants 2 participants 11 participants
1.00
(1.00 to 4.00)
1.00
(1.00 to 4.00)
1.00
(1.00 to 1.00)
1.00
(1.00 to 4.00)
1.00
(1.00 to 1.05)
1.00
(0.850 to 4.00)
1.05
(1.05 to 4.05)
1.08
(1.00 to 4.00)
3.81
(3.62 to 4.00)
1.00
(1.00 to 4.00)
Cycle 1 Day 15 Number Analyzed 3 participants 12 participants 0 participants 4 participants 0 participants 0 participants 0 participants 0 participants 0 participants 11 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
1.00
(1.00 to 72.0)
Cycle 4 Day 1 Number Analyzed 0 participants 0 participants 0 participants 0 participants 2 participants 3 participants 2 participants 2 participants 0 participants 0 participants
2.55
(1.00 to 4.10)
1.08
(1.00 to 4.00)
2.60
(1.07 to 4.13)
2.55
(1.05 to 4.05)
19.Secondary Outcome
Title CL of Total Antibody
Hide Description For single dose, CL was determined by Dose/AUCinf while for multiple dose, CL was determined by Dose/AUCtau. PF-06647263 is an antibody-drug conjugate (ADC) which comprises total antibody (PF-06523432) and unconjugated payload ( CL-184538). In time frame, C=cycle, D=day.
Time Frame QW: C1D15: predose, 1 & 72 hrs postdose, up to C2D1 predose. Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.
Hide Outcome Measure Data
Hide Analysis Population Description
"Number of Participants Analyzed" represents the number of participants who were enrolled and received at least 1 dose of PF-06647263. "Number Analyzed" represents the number of participants contributing to the PK parameter summary statistics at that time point.
Arm/Group Title PF-06647263 0.01 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg Q3W (Part 1) PF-06647263 0.02 mg/kg QW (Part 1) PF-06647263 0.03 mg/kg Q3W (Part 1) PF-06647263 0.05 mg/kg Q3W (Part 1) PF-06647263 0.075 mg/kg Q3W (Part 1) PF-06647263 0.1 mg/kg Q3W (Part 1) PF-06647263 0.134 mg/kg Q3W (Part 1) PF-06647263 0.015 mg/kg QW (Part 2)
Hide Arm/Group Description:
Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Overall Number of Participants Analyzed 3 13 2 7 3 9 3 6 2 12
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: L/hr
Cycle 1 Day 1 Number Analyzed 0 participants 0 participants 1 participants 0 participants 3 participants 3 participants 1 participants 3 participants 0 participants 0 participants
NA [1] 
(NA%)
0.04455
(43%)
0.04947
(17%)
NA [2] 
(NA%)
0.03471
(33%)
Cycle 1 Day 15 Number Analyzed 3 participants 10 participants 0 participants 2 participants 0 participants 0 participants 0 participants 0 participants 0 participants 7 participants
0.03411
(5%)
0.03736
(35%)
NA [3] 
(NA%)
0.03447
(48%)
Cycle 4 Day 1 Number Analyzed 0 participants 0 participants 0 participants 0 participants 2 participants 3 participants 1 participants 1 participants 0 participants 0 participants
NA [4] 
(NA%)
0.02049
(45%)
NA [5] 
(NA%)
NA [6] 
(NA%)
[1]

Individual values are reported when fewer than 3 participants had report able parameter values.

The individual value was 0.107.

[2]

Individual values are reported when fewer than 3 participants had report able parameter values.

The individual value was 0.0419.

[3]

Individual values are reported when fewer than 3 participants had report able parameter values.

Individual values were 0.0312 and 0.0339.

[4]

Individual values are reported when fewer than 3 participants had report able parameter values.

Individual values were 0.0276 and 0.0292.

[5]

Individual values are reported when fewer than 3 participants had report able parameter values.

The individual value was 0.0113.

[6]

Individual values are reported when fewer than 3 participants had report able parameter values.

The individual value was 0.0155.

20.Secondary Outcome
Title Vss of Total Antibody
Hide Description Vss was determined by CL × MRT (mean residence time). MRT=[AUMCtau +tau(AUCinf-AUCtau)]/AUCtau. AUMCtau was the area under the first moment curve derived using the linear/log trapezoidal method. PF-06647263 is an antibody-drug conjugate (ADC) which comprises total antibody (PF-06523432) and unconjugated payload ( CL-184538). In time frame, C=cycle, D=day.
Time Frame QW: C1D15: predose, 1 & 72 hrs postdose, up to C2D1 predose. Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.
Hide Outcome Measure Data
Hide Analysis Population Description
"Number of Participants Analyzed" represents the number of participants who were enrolled and received at least 1 dose of PF-06647263. "Number Analyzed" represents the number of participants contributing to the PK parameter summary statistics at that time point.
Arm/Group Title PF-06647263 0.01 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg Q3W (Part 1) PF-06647263 0.02 mg/kg QW (Part 1) PF-06647263 0.03 mg/kg Q3W (Part 1) PF-06647263 0.05 mg/kg Q3W (Part 1) PF-06647263 0.075 mg/kg Q3W (Part 1) PF-06647263 0.1 mg/kg Q3W (Part 1) PF-06647263 0.134 mg/kg Q3W (Part 1) PF-06647263 0.015 mg/kg QW (Part 2)
Hide Arm/Group Description:
Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Overall Number of Participants Analyzed 3 13 2 7 3 9 3 6 2 12
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: L
Cycle 1 Day 1 Number Analyzed 0 participants 0 participants 1 participants 0 participants 3 participants 3 participants 1 participants 3 participants 0 participants 0 participants
NA [1] 
(NA%)
10.32
(32%)
10.96
(17%)
NA [2] 
(NA%)
8.074
(51%)
Cycle 1 Day 15 Number Analyzed 2 participants 2 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 2 participants
NA [3] 
(NA%)
NA [4] 
(NA%)
NA [5] 
(NA%)
Cycle 4 Day 1 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants 0 participants 0 participants 0 participants 0 participants
NA [6] 
(NA%)
[1]

Individual values are reported when fewer than 3 participants had report able parameter values.

The individual value was 6.30.

[2]

Individual values are reported when fewer than 3 participants had report able parameter values.

The individual value was 13.3.

[3]

Individual values are reported when fewer than 3 participants had report able parameter values.

Individual values were 4.82 and 5.19.

[4]

Individual values are reported when fewer than 3 participants had report able parameter values.

Individual values were 5.09 and 6.45.

[5]

Individual values are reported when fewer than 3 participants had report able parameter values..

Individual values were 3.87 and 4.06.

[6]

Individual values are reported when fewer than 3 participants had report able parameter values.

The individual value was 5.33.

21.Secondary Outcome
Title t1/2 of Total Antibody
Hide Description T1/2 was determined by loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log linear concentration-time curve. The t1/2 analysis only applied to Q3W group. PF-06647263 is an antibody-drug conjugate (ADC) which comprises total antibody (PF-06523432) and unconjugated payload ( CL-184538). In time frame, C=cycle, D=day.
Time Frame Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.
Hide Outcome Measure Data
Hide Analysis Population Description
"Number of Participants Analyzed" represents the number of participants who were enrolled and received at least 1 dose of PF-06647263. "Number Analyzed" represents the number of participants contributing to the PK parameter summary statistics at that time point.
Arm/Group Title PF-06647263 0.015 mg/kg Q3W (Part 1) PF-06647263 0.03 mg/kg Q3W (Part 1) PF-06647263 0.05 mg/kg Q3W (Part 1) PF-06647263 0.075 mg/kg Q3W (Part 1) PF-06647263 0.1 mg/kg Q3W (Part 1) PF-06647263 0.134 mg/kg Q3W (Part 1)
Hide Arm/Group Description:
Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Overall Number of Participants Analyzed 2 3 9 3 6 2
Mean (Standard Deviation)
Unit of Measure: day
Cycle 1 Day 1 Number Analyzed 1 participants 3 participants 3 participants 1 participants 3 participants 0 participants
NA [1]   (NA) 7.860  (0.581) 7.587  (2.34) NA [2]   (NA) 7.713  (1.52)
Cycle 4 Day 1 Number Analyzed 0 participants 0 participants 1 participants 0 participants 0 participants 0 participants
NA [3]   (NA)
[1]
Fewer than 3 subjects had reportable parameter values. The individual value was 1.88.
[2]
Fewer than 3 subjects had reportable parameter values. The individual value was 10.1.
[3]
Fewer than 3 subjects had reportable parameter values. The individual value was 14.8.
22.Secondary Outcome
Title Cmax of Unconjugated Payload CL-184538
Hide Description Cmax was determined directly from data. PF-06647263 is an antibody-drug conjugate (ADC) which comprises total antibody (PF-06523432) and unconjugated payload ( CL-184538).
Time Frame Every Cycle: Days 1, 8, 15. up to end of treatment (Approximately 13 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis set was defined as enrolled patients who were analyzed for pharmacokinetics.
Arm/Group Title PF-06647263 0.01 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg Q3W (Part 1) PF-06647263 0.02 mg/kg QW (Part 1) PF-06647263 0.03 mg/kg Q3W (Part 1) PF-06647263 0.05 mg/kg Q3W (Part 1) PF-06647263 0.075 mg/kg Q3W (Part 1) PF-06647263 0.1 mg/kg Q3W (Part 1) PF-06647263 0.134 mg/kg Q3W (Part 1) PF-06647263 0.015 mg/kg QW (Part 2)
Hide Arm/Group Description:
Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Overall Number of Participants Analyzed 3 13 2 7 3 9 3 6 2 12
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
NA [1] 
(NA%)
NA [1] 
(NA%)
NA [1] 
(NA%)
NA [1] 
(NA%)
NA [1] 
(NA%)
NA [1] 
(NA%)
NA [1] 
(NA%)
NA [1] 
(NA%)
NA [1] 
(NA%)
NA [1] 
(NA%)
[1]
CL-184538 (unconjugated payload) serum exposure was low with the majority of samples below the limit of quantitation (0.0500 ng/mL).
23.Secondary Outcome
Title Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Hide Description Following parameters were analyzed for laboratory examination: hematology, blood chemistry, coagulation panel, urinalysis and pregnancy test.
Time Frame Baseline up to 7 days post end of treatment (Approximately 13 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all enrolled participants who received at least 1 dose of PF-06647263.
Arm/Group Title PF-06647263 0.01 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg Q3W (Part 1) PF-06647263 0.02 mg/kg QW (Part 1) PF-06647263 0.03 mg/kg Q3W (Part 1) PF-06647263 0.05 mg/kg Q3W (Part 1) PF-06647263 0.075 mg/kg Q3W (Part 1) PF-06647263 0.1 mg/kg Q3W (Part 1) PF-06647263 0.134 mg/kg Q3W (Part 1) PF-06647263 0.015 mg/kg QW (Part 2)
Hide Arm/Group Description:
Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Overall Number of Participants Analyzed 3 13 2 7 3 9 3 6 2 12
Measure Type: Count of Participants
Unit of Measure: Participants
2
  66.7%
12
  92.3%
2
 100.0%
7
 100.0%
3
 100.0%
9
 100.0%
3
 100.0%
6
 100.0%
2
 100.0%
11
  91.7%
24.Secondary Outcome
Title Number of Participants With Positive Antibodies for PF-06647263, Total Antibody (PF-06523432), and Unconjugated Payload (CL-184538)
Hide Description Positive was defined as: anti-drug antibody (ADA) titer >=1.88. In time frame, C=cycle, D=day.
Time Frame QW: C1:D1&D15; every other cycle: D1; end of treatment. Q3W:C1: D1&D15; Cycles 2 through 4: D1; every other cycle: D1; end of treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
"Number of Participants Analyzed" represents the number of participants who were enrolled and received at least 1 dose of PF-06647263. "Number Analyzed" represents the number of participants tested for that parameter.
Arm/Group Title PF-06647263 0.01 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg Q3W (Part 1) PF-06647263 0.02 mg/kg QW (Part 1) PF-06647263 0.03 mg/kg Q3W (Part 1) PF-06647263 0.05 mg/kg Q3W (Part 1) PF-06647263 0.075 mg/kg Q3W (Part 1) PF-06647263 0.1 mg/kg Q3W (Part 1) PF-06647263 0.134 mg/kg Q3W (Part 1) PF-06647263 0.015 mg/kg QW (Part 2)
Hide Arm/Group Description:
Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Overall Number of Participants Analyzed 3 13 2 7 3 9 3 6 2 12
Measure Type: Count of Participants
Unit of Measure: Participants
Positive Anti-PF-06647263 Number Analyzed 3 participants 13 participants 2 participants 7 participants 3 participants 9 participants 3 participants 6 participants 2 participants 12 participants
2
  66.7%
5
  38.5%
0
   0.0%
4
  57.1%
2
  66.7%
4
  44.4%
1
  33.3%
1
  16.7%
0
   0.0%
8
  66.7%
Positive Anti PF-06523432 Number Analyzed 2 participants 5 participants 0 participants 4 participants 2 participants 4 participants 1 participants 1 participants 0 participants 8 participants
0
   0.0%
3
  60.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  12.5%
Positive Anti CL-184538 Number Analyzed 2 participants 5 participants 0 participants 4 participants 2 participants 4 participants 1 participants 1 participants 0 participants 8 participants
2
 100.0%
5
 100.0%
2
  50.0%
2
 100.0%
4
 100.0%
1
 100.0%
0
   0.0%
6
  75.0%
25.Secondary Outcome
Title Number of Participants With Positive Neutralizing Anti PF-06647263 Antibody
Hide Description Positive was defined as: neutralizing antibody titer >=1.30. In time frame, C=cycle, D=day.
Time Frame QW: C1:D1&D15; every other cycle: D1; end of treatment. Q3W:C1: D1&D15; Cycles 2 through 4: D1; every other cycle: D1; end of treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis set included all participants who were treated and tested for that parameter.
Arm/Group Title PF-06647263 0.01 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg Q3W (Part 1) PF-06647263 0.02 mg/kg QW (Part 1) PF-06647263 0.03 mg/kg Q3W (Part 1) PF-06647263 0.05 mg/kg Q3W (Part 1) PF-06647263 0.075 mg/kg Q3W (Part 1) PF-06647263 0.1 mg/kg Q3W (Part 1) PF-06647263 0.134 mg/kg Q3W (Part 1) PF-06647263 0.015 mg/kg QW (Part 2)
Hide Arm/Group Description:
Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Overall Number of Participants Analyzed 2 5 0 4 2 4 1 1 0 8
Measure Type: Count of Participants
Unit of Measure: Participants
2
 100.0%
5
 100.0%
3
  75.0%
2
 100.0%
3
  75.0%
1
 100.0%
0
   0.0%
8
 100.0%
26.Secondary Outcome
Title Number of Participants With Treatment-Emergent and Treatment-Boosted Anti PF-06647263 Antibody
Hide Description Treatment-Emergent=Baseline negative with at least one positive ADA sample post-treatment. Treatment-Boosted=Baseline positive but endpoint titer (log10-scale titer) increases by at least 0.5 (representing 3-fold titer increase). In time frame, C=cycle, D=day.
Time Frame QW: C1:D1&D15; every other cycle: D1; end of treatment. Q3W:C1: D1&D15; Cycles 2 through 4: D1; every other cycle: D1; end of treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
"Number of Participants Analyzed" represents the number of participants who were enrolled and received at least 1 dose of PF-06647263. "Number Analyzed" represents the number of participants tested for that parameter.
Arm/Group Title PF-06647263 0.01 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg Q3W (Part 1) PF-06647263 0.02 mg/kg QW (Part 1) PF-06647263 0.03 mg/kg Q3W (Part 1) PF-06647263 0.05 mg/kg Q3W (Part 1) PF-06647263 0.075 mg/kg Q3W (Part 1) PF-06647263 0.1 mg/kg Q3W (Part 1) PF-06647263 0.134 mg/kg Q3W (Part 1) PF-06647263 0.015 mg/kg QW (Part 2)
Hide Arm/Group Description:
Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Overall Number of Participants Analyzed 3 13 2 7 3 9 3 6 2 12
Measure Type: Count of Participants
Unit of Measure: Participants
Treatment-emergent
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   8.3%
Treatment-boosted
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
27.Secondary Outcome
Title Percentage of Participants With Objective Response (Part 1)
Hide Description Objective response rate (ORR) refers to percentage of participants who achieved complete response (CR) or partial response (PR) determined by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1. A participant achieved CR if both target and non-target lesions achieved CR, no new lesions; achieved PR if target lesions achieved CR or PR, non-target lesions were assessed as non-CR/non-PD (progressive disease), indeterminate or missing, and no new lesions. For target lesions, CR: complete disappearance of all target lesions except nodal disease (target nodes must decrease to normal size); PR: >= 30% decrease under baseline of the sum of diameters of all target measurable lesions. For non-target lesions, CR: disappearance of all non-target lesions and normalization of tumor marker levels and all lymph nodes must be normal in size; non-CR/non-PD: persistence of any non-target lesions and/or tumor marker level above the normal limits.
Time Frame Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis set included treated participants with measurable disease at baseline.
Arm/Group Title PF-06647263 0.01 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg Q3W (Part 1) PF-06647263 0.02 mg/kg QW (Part 1) PF-06647263 0.03 mg/kg Q3W (Part 1) PF-06647263 0.05 mg/kg Q3W (Part 1) PF-06647263 0.075 mg/kg Q3W (Part 1) PF-06647263 0.1 mg/kg Q3W (Part 1) PF-06647263 0.134 mg/kg Q3W (Part 1)
Hide Arm/Group Description:
Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Overall Number of Participants Analyzed 2 11 1 6 3 7 3 6 2
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
0
(0.0 to 84.2)
9.1
(0.2 to 41.3)
0
(0.0 to 97.5)
16.7
(0.4 to 64.1)
0
(0.0 to 70.8)
14.3
(0.4 to 57.9)
66.7
(9.4 to 99.2)
0
(0.0 to 45.9)
0
(0.0 to 84.2)
28.Secondary Outcome
Title Percentage of Participants With Clinical Benefit Response
Hide Description Clinical Benefit Response (CBR) was defined as a CR, PR or stable disease (SD) ≥6 cycles. CR was defined as disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as the reference of baseline sum diameters. Stable disease was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (progressive disease: >=20% increase in the sum of diameters of target lesions and an absolute increase of >=5mm or appearance of >=1 new lesion), taking as reference the smallest sum diameters while on study.
Time Frame Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis set included the number of participants with measurable disease at baseline.
Arm/Group Title PF-06647263 0.01 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg Q3W (Part 1) PF-06647263 0.02 mg/kg QW (Part 1) PF-06647263 0.03 mg/kg Q3W (Part 1) PF-06647263 0.05 mg/kg Q3W (Part 1) PF-06647263 0.075 mg/kg Q3W (Part 1) PF-06647263 0.1 mg/kg Q3W (Part 1) PF-06647263 0.134 mg/kg Q3W (Part 1) PF-06647263 0.015 mg/kg QW (Part 2)
Hide Arm/Group Description:
Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Overall Number of Participants Analyzed 2 11 1 6 3 7 3 6 2 12
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
50.0
(1.3 to 98.7)
36.4
(10.9 to 69.2)
0
(0.0 to 97.5)
16.7
(0.4 to 64.1)
33.3
(0.8 to 90.6)
42.9
(9.9 to 81.6)
66.7
(9.4 to 99.2)
16.7
(0.4 to 64.1)
0
(0.0 to 84.2)
25.0
(5.5 to 57.2)
29.Secondary Outcome
Title Progression Free Survival
Hide Description The progression free survival (PFS) was defined as the time from Cycle 1 Day 1 to first documentation of disease progression or to death due to any cause, whichever occurred first. PFS was characterized by the estimate median time to event which was derived using Kaplan-Meier method.
Time Frame Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis set included the number of participants with event.
Arm/Group Title PF-06647263 0.01 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg Q3W (Part 1) PF-06647263 0.02 mg/kg QW (Part 1) PF-06647263 0.03 mg/kg Q3W (Part 1) PF-06647263 0.05 mg/kg Q3W (Part 1) PF-06647263 0.075 mg/kg Q3W (Part 1) PF-06647263 0.1 mg/kg Q3W (Part 1) PF-06647263 0.134 mg/kg Q3W (Part 1) PF-06647263 0.015 mg/kg QW (Part 2)
Hide Arm/Group Description:
Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Overall Number of Participants Analyzed 0 8 0 4 2 4 1 2 1 8
Median (95% Confidence Interval)
Unit of Measure: month
3.0
(1.4 to 7.1)
1.4
(0.6 to 8.3)
5.3
(1.9 to 5.3)
5.8
(1.9 to 7.3)
NA [1] 
(1.4 to NA)
2.8 [2] 
(0.6 to NA)
NA [1] 
(1.3 to NA)
1.4
(0.7 to 3.0)
[1]
With only one participant, we cannot calculate median or meaningful CI.
[2]
Only 33.3% (2/6) of the participants were with event. A 95% CI for the quantile is the set of all efficacy endpoint variable values satisfying the formula. In this group, only one variable value satisfied, so upper limit was not estimable.
30.Secondary Outcome
Title Overall Survival (OS)-Stratifying for EFNA4 Expression (Part 2)
Hide Description [Not Specified]
Time Frame Baseline up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
OS was not estimable since there were fewer number of participants with event.
Arm/Group Title PF-06647263 0.015 mg/kg QW (Part 2)
Hide Arm/Group Description:
Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Baseline up to 28 days after the last treatment administration (Approximately 13 months)
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
 
Arm/Group Title PF-06647263 0.01 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg Q3W (Part 1) PF-06647263 0.02 mg/kg QW (Part 1) PF-06647263 0.03 mg/kg Q3W (Part 1) PF-06647263 0.05 mg/kg Q3W (Part 1) PF-06647263 0.075 mg/kg Q3W (Part 1) PF-06647263 0.1 mg/kg Q3W (Part 1) PF-06647263 0.134 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg QW (Part 2)
Hide Arm/Group Description Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated. Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated. Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated. Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated. Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated. Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated. Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated. Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated. Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated. Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
All-Cause Mortality
PF-06647263 0.01 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg Q3W (Part 1) PF-06647263 0.02 mg/kg QW (Part 1) PF-06647263 0.03 mg/kg Q3W (Part 1) PF-06647263 0.05 mg/kg Q3W (Part 1) PF-06647263 0.075 mg/kg Q3W (Part 1) PF-06647263 0.1 mg/kg Q3W (Part 1) PF-06647263 0.134 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg QW (Part 2)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   4/13 (30.77%)   0/2 (0.00%)   0/7 (0.00%)   0/3 (0.00%)   1/9 (11.11%)   0/3 (0.00%)   1/6 (16.67%)   0/2 (0.00%)   1/12 (8.33%) 
Hide Serious Adverse Events
PF-06647263 0.01 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg Q3W (Part 1) PF-06647263 0.02 mg/kg QW (Part 1) PF-06647263 0.03 mg/kg Q3W (Part 1) PF-06647263 0.05 mg/kg Q3W (Part 1) PF-06647263 0.075 mg/kg Q3W (Part 1) PF-06647263 0.1 mg/kg Q3W (Part 1) PF-06647263 0.134 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg QW (Part 2)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/3 (33.33%)   6/13 (46.15%)   0/2 (0.00%)   0/7 (0.00%)   1/3 (33.33%)   1/9 (11.11%)   1/3 (33.33%)   3/6 (50.00%)   1/2 (50.00%)   4/12 (33.33%) 
Cardiac disorders                     
Atrial fibrillation * 1  0/3 (0.00%)  1/13 (7.69%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%)  0/12 (0.00%) 
Gastrointestinal disorders                     
Diarrhoea * 1  0/3 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/2 (0.00%)  0/12 (0.00%) 
Gastric fistula * 1  0/3 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/2 (0.00%)  0/12 (0.00%) 
Gastrointestinal haemorrhage * 1  0/3 (0.00%)  2/13 (15.38%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%)  0/12 (0.00%) 
Nausea * 1  0/3 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/2 (0.00%)  2/12 (16.67%) 
Oesophageal varices haemorrhage * 1  0/3 (0.00%)  1/13 (7.69%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%)  0/12 (0.00%) 
Small intestinal obstruction * 1  0/3 (0.00%)  1/13 (7.69%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%)  0/12 (0.00%) 
Upper gastrointestinal haemorrhage * 1  0/3 (0.00%)  1/13 (7.69%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%)  0/12 (0.00%) 
Vomiting * 1  0/3 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  1/2 (50.00%)  0/12 (0.00%) 
General disorders                     
Death * 1  0/3 (0.00%)  1/13 (7.69%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%)  0/12 (0.00%) 
Disease progression * 1  0/3 (0.00%)  1/13 (7.69%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  1/9 (11.11%)  0/3 (0.00%)  1/6 (16.67%)  0/2 (0.00%)  1/12 (8.33%) 
Pyrexia * 1  1/3 (33.33%)  0/13 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%)  0/12 (0.00%) 
Hepatobiliary disorders                     
Hyperbilirubinaemia * 1  0/3 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/9 (0.00%)  1/3 (33.33%)  0/6 (0.00%)  1/2 (50.00%)  0/12 (0.00%) 
Infections and infestations                     
Device related infection * 1  0/3 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  1/9 (11.11%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%)  0/12 (0.00%) 
Sepsis * 1  0/3 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/2 (0.00%)  0/12 (0.00%) 
Urinary tract infection * 1  0/3 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/9 (0.00%)  1/3 (33.33%)  0/6 (0.00%)  0/2 (0.00%)  1/12 (8.33%) 
Influenza * 1  0/3 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%)  1/12 (8.33%) 
Injury, poisoning and procedural complications                     
Fall * 1  0/3 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  1/9 (11.11%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%)  0/12 (0.00%) 
Metabolism and nutrition disorders                     
Dehydration * 1  0/3 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/3 (33.33%)  0/9 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%)  0/12 (0.00%) 
Nervous system disorders                     
Paraesthesia * 1  0/3 (0.00%)  1/13 (7.69%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%)  0/12 (0.00%) 
Respiratory, thoracic and mediastinal disorders                     
Dyspnoea * 1  0/3 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/2 (0.00%)  0/12 (0.00%) 
Pleural effusion * 1  0/3 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  1/9 (11.11%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%)  1/12 (8.33%) 
1
Term from vocabulary, MedDRA 20.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PF-06647263 0.01 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg Q3W (Part 1) PF-06647263 0.02 mg/kg QW (Part 1) PF-06647263 0.03 mg/kg Q3W (Part 1) PF-06647263 0.05 mg/kg Q3W (Part 1) PF-06647263 0.075 mg/kg Q3W (Part 1) PF-06647263 0.1 mg/kg Q3W (Part 1) PF-06647263 0.134 mg/kg QW (Part 1) PF-06647263 0.015 mg/kg QW (Part 2)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/3 (100.00%)   13/13 (100.00%)   2/2 (100.00%)   7/7 (100.00%)   3/3 (100.00%)   9/9 (100.00%)   3/3 (100.00%)   6/6 (100.00%)   2/2 (100.00%)   12/12 (100.00%) 
Blood and lymphatic system disorders                     
Anaemia * 1  0/3 (0.00%)  3/13 (23.08%)  0/2 (0.00%)  1/7 (14.29%)  2/3 (66.67%)  0/9 (0.00%)  0/3 (0.00%)  2/6 (33.33%)  0/2 (0.00%)  1/12 (8.33%) 
Leukocytosis * 1  0/3 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  1/9 (11.11%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%)  0/12 (0.00%) 
Leukopenia * 1  0/3 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  1/9 (11.11%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%)  0/12 (0.00%) 
Neutropenia * 1  0/3 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  1/9 (11.11%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%)  0/12 (0.00%) 
Splenic infarction * 1  1/3 (33.33%)  0/13 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%)  0/12 (0.00%) 
Splenomegaly * 1  0/3 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/2 (50.00%)  0/12 (0.00%) 
Thrombocytopenia * 1  1/3 (33.33%)  4/13 (30.77%)  0/2 (0.00%)  3/7 (42.86%)  2/3 (66.67%)  3/9 (33.33%)  1/3 (33.33%)  3/6 (50.00%)  2/2 (100.00%)  3/12 (25.00%) 
Cardiac disorders                     
Atrial fibrillation * 1  0/3 (0.00%)  1/13 (7.69%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%)  0/12 (0.00%) 
Palpitations * 1  0/3 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/3 (33.33%)  0/9 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%)  0/12 (0.00%) 
Tachycardia * 1  0/3 (0.00%)  1/13 (7.69%)  0/2 (0.00%)  0/7 (0.00%)  1/3 (33.33%)  0/9 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%)  0/12 (0.00%) 
Ear and labyrinth disorders                     
Ear pain * 1  0/3 (0.00%)  1/13 (7.69%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%)  0/12 (0.00%) 
Endocrine disorders                     
Hypothyroidism * 1  0/3 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%)  1/12 (8.33%) 
Eye disorders                     
Conjunctival haemorrhage * 1  0/3 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/3 (33.33%)  0/9 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%)  0/12 (0.00%) 
Dry eye * 1  1/3 (33.33%)  1/13 (7.69%)  0/2 (0.00%)  1/7 (14.29%)  0/3 (0.00%)  1/9 (11.11%)  1/3 (33.33%)  0/6 (0.00%)  0/2 (0.00%)  1/12 (8.33%) 
Eye discharge * 1  1/3 (33.33%)  0/13 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%)  0/12 (0.00%) 
Eye haemorrhage * 1  0/3 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/9 (0.00%)  1/3 (33.33%)  0/6 (0.00%)  0/2 (0.00%)  0/12 (0.00%) 
Eye irritation * 1  0/3 (0.00%)  1/13 (7.69%)  0/2 (0.00%)  1/7 (14.29%)  0/3 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%)  0/12 (0.00%) 
Eye pruritus * 1  0/3 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  1/9 (11.11%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%)  0/12 (0.00%) 
Eye symptom * 1  0/3 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/9 (0.00%)  1/3 (33.33%)  0/6 (0.00%)  0/2 (0.00%)  0/12 (0.00%) 
Iritis * 1  0/3 (0.00%)  1/13 (7.69%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%)  0/12 (0.00%) 
Lacrimation increased * 1  0/3 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  2/3 (66.67%)  1/9 (11.11%)  0/3 (0.00%)  1/6 (16.67%)  1/2 (50.00%)  0/12 (0.00%) 
Mydriasis * 1  0/3 (0.00%)  1/13 (7.69%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%)  0/12 (0.00%) 
Ocular hyperaemia * 1  0/3 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  1/9 (11.11%)  0/3 (0.00%)  0/6 (0.00%)  1/2 (50.00%)  0/12 (0.00%) 
Vision blurred * 1  0/3 (0.00%)  2/13 (15.38%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  1/9 (11.11%)  1/3 (33.33%)  0/6 (0.00%)  0/2 (0.00%)  0/12 (0.00%) 
Vitreous floaters * 1  0/3 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  1/9 (11.11%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%)  0/12 (0.00%) 
Cataract * 1  0/3 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%)  1/12 (8.33%) 
Diplopia * 1  0/3 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%)  1/12 (8.33%) 
Gastrointestinal disorders                     
Abdominal distension * 1  0/3 (0.00%)  1/13 (7.69%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  3/6 (50.00%)  0/2 (0.00%)  0/12 (0.00%) 
Abdominal pain * 1  2/3 (66.67%)  3/13 (23.08%)  0/2 (0.00%)  1/7 (14.29%)  2/3 (66.67%)  3/9 (33.33%)  1/3 (33.33%)  1/6 (16.67%)  2/2 (100.00%)  0/12 (0.00%) 
Abdominal pain upper * 1  1/3 (33.33%)  1/13 (7.69%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/9 (0.00%)  1/3 (33.33%)  0/6 (0.00%)  0/2 (0.00%)  1/12 (8.33%) 
Abdominal rigidity * 1  1/3 (33.33%)  0/13 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%)  0/12 (0.00%) 
Abdominal tenderness * 1  0/3 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  0/3 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%)  0/12 (0.00%) 
Aphthous ulcer * 1  1/3 (33.33%)  0/13 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  0/3 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/2 (0.00%)  0/12 (0.00%) 
Ascites * 1  0/3 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  2/2 (100.00%)  0/12 (0.00%) 
Buccal mucosal roughening * 1  0/3 (0.00%)  1/13 (7.69%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%)  0/12 (0.00%) 
Constipation * 1  1/3 (33.33%)  5/13 (38.46%)  0/2 (0.00%)  1/7 (14.29%)  0/3 (0.00%)  3/9 (33.33%)  1/3 (33.33%)  1/6 (16.67%)  1/2 (50.00%)  3/12 (25.00%) 
Diarrhoea * 1  3/3 (100.00%)  2/13 (15.38%)  0/2 (0.00%)  4/7 (57.14%)  2/3 (66.67%)  2/9 (22.22%)  1/3 (33.33%)  2/6 (33.33%)  1/2 (50.00%)  3/12 (25.00%) 
Dry mouth * 1  1/3 (33.33%)  0/13 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  0/3 (0.00%)  2/9 (22.22%)  1/3 (33.33%)  2/6 (33.33%)  1/2 (50.00%)  2/12 (16.67%) 
Dyspepsia * 1  0/3 (0.00%)  3/13 (23.08%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  2/9 (22.22%)  1/3 (33.33%)  0/6 (0.00%)  0/2 (0.00%)  0/12 (0.00%) 
Dysphagia * 1  0/3 (0.00%)  3/13 (23.08%)  0/2 (0.00%)  0/7 (0.00%)  1/3 (33.33%)  1/9 (11.11%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%)  2/12 (16.67%) 
Flatulence * 1  1/3 (33.33%)  0/13 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/3 (33.33%)  0/9 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%)  0/12 (0.00%) 
Gastritis * 1  0/3 (0.00%)  1/13 (7.69%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%)  0/12 (0.00%) 
Gastrointestinal pain * 1  0/3 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  1/9 (11.11%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%)  0/12 (0.00%) 
Gastrooesophageal reflux disease * 1  2/3 (66.67%)  0/13 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  1/9 (11.11%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%)  0/12 (0.00%) 
Gingival bleeding * 1  0/3 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  1/9 (11.11%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%)  0/12 (0.00%) 
Gingival discolouration * 1  0/3 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/9 (0.00%)  1/3 (33.33%)  0/6 (0.00%)  0/2 (0.00%)  0/12 (0.00%) 
Gingival disorder * 1  0/3 (0.00%)  2/13 (15.38%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%)  0/12 (0.00%) 
Haematemesis * 1  0/3 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/2 (50.00%)  0/12 (0.00%) 
Haematochezia * 1  0/3 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/2 (0.00%)  0/12 (0.00%) 
Haemorrhoids * 1  0/3 (0.00%)  1/13 (7.69%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/2 (0.00%)  0/12 (0.00%) 
Hypoaesthesia oral * 1  0/3 (0.00%)  1/13 (7.69%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%)  1/12 (8.33%) 
Large intestinal obstruction * 1  0/3 (0.00%)  1/13 (7.69%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%)  0/12 (0.00%) 
Mouth ulceration * 1  0/3 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  2/9 (22.22%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%)  0/12 (0.00%) 
Nausea * 1  2/3 (66.67%)  9/13 (69.23%)  2/2 (100.00%)  4/7 (57.14%)  3/3 (100.00%)  4/9 (44.44%)  3/3 (100.00%)  3/6 (50.00%)  2/2 (100.00%)  6/12 (50.00%) 
Oral disorder * 1  0/3 (0.00%)  1/13 (7.69%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/9 (0.00%)  1/3 (33.33%)  0/6 (0.00%)  0/2 (0.00%)  0/12 (0.00%) 
Oral dysaesthesia * 1  0/3 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/2 (0.00%)  0/12 (0.00%) 
Oral pain * 1  0/3 (0.00%)  3/13 (23.08%)  0/2 (0.00%)  0/7 (0.00%)  1/3 (33.33%)  0/9 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%)  0/12 (0.00%) 
Proctalgia * 1  0/3 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  1/9 (11.11%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%)  0/12 (0.00%) 
Proctitis * 1  0/3 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  1/9 (11.11%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%)  0/12 (0.00%) 
Rectal haemorrhage * 1  0/3 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  1/9 (11.11%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%)  0/12 (0.00%) 
Stomatitis * 1  1/3 (33.33%)  0/13 (0.00%)  1/2 (50.00%)  0/7 (0.00%)  1/3 (33.33%)  3/9 (33.33%)  1/3 (33.33%)  0/6 (0.00%)  1/2 (50.00%)  1/12 (8.33%) 
Tongue coated * 1  0/3 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/9 (0.00%)  1/3 (33.33%)  0/6 (0.00%)  0/2 (0.00%)  0/12 (0.00%) 
Tongue discolouration * 1  0/3 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  1/9 (11.11%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%)  0/12 (0.00%) 
Tongue ulceration * 1  0/3 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  1/9 (11.11%)  0/3 (0.00%)  1/6 (16.67%)  0/2 (0.00%)  0/12 (0.00%) 
Vomiting * 1  2/3 (66.67%)  7/13 (53.85%)  1/2 (50.00%)  4/7 (57.14%)  1/3 (33.33%)  2/9 (22.22%)  1/3 (33.33%)  2/6 (33.33%)  1/2 (50.00%)  6/12 (50.00%) 
General disorders                     
Application site erosion * 1  0/3 (0.00%)  1/13 (7.69%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%)  0/12 (0.00%) 
Asthenia * 1  0/3 (0.00%)  3/13 (23.08%)  0/2 (0.00%)  1/7 (14.29%)  0/3 (0.00%)  1/9 (11.11%)  0/3 (0.00%)  1/6 (16.67%)  0/2 (0.00%)  4/12 (33.33%) 
Catheter site erythema * 1  0/3 (0.00%)  1/13 (7.69%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%)  0/12 (0.00%) 
Catheter site pain * 1  0/3 (0.00%)  1/13 (7.69%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%)  0/12 (0.00%) 
Catheter site related reaction * 1  0/3 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/9 (0.00%)  1/3 (33.33%)  0/6 (0.00%)  0/2 (0.00%)  0/12 (0.00%) 
Chest discomfort * 1  1/3 (33.33%)  0/13 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%)  0/12 (0.00%) 
Chills * 1  1/3 (33.33%)  0/13 (0.00%)  1/2 (50.00%)  0/7 (0.00%)  0/3 (0.00%)  1/9 (11.11%)  1/3 (33.33%)  1/6 (16.67%)  0/2 (0.00%)  0/12 (0.00%) 
Early satiety * 1  0/3 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  1/9 (11.11%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%)  0/12 (0.00%) 
Face oedema * 1  0/3 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/3 (33.33%)  0/9 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%)  1/12 (8.33%) 
Fatigue * 1  2/3 (66.67%)  10/13 (76.92%)  1/2 (50.00%)  5/7 (71.43%)  2/3 (66.67%)  6/9 (66.67%)  3/3 (100.00%)  4/6 (66.67%)  2/2 (100.00%)  5/12 (41.67%) 
Gait disturbance * 1  0/3 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  0/3 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%)  0/12 (0.00%) 
Generalised oedema * 1  0/3 (0.00%)  1/13 (7.69%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%)  1/12 (8.33%) 
Malaise * 1  0/3 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/3 (33.33%)  0/9 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%)  0/12 (0.00%) 
Mucosal inflammation * 1  1/3 (33.33%)  5/13 (38.46%)  0/2 (0.00%)  3/7 (42.86%)  1/3 (33.33%)  2/9 (22.22%)  1/3 (33.33%)  2/6 (33.33%)  1/2 (50.00%)  7/12 (58.33%) 
Non-cardiac chest pain * 1  0/3 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  1/9 (11.11%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%)  0/12 (0.00%) 
Oedema * 1  0/3 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/2 (0.00%)  0/12 (0.00%) 
Oedema peripheral * 1  0/3 (0.00%)  4/13 (30.77%)  0/2 (0.00%)  0/7 (0.00%)  1/3 (33.33%)  1/9 (11.11%)  1/3 (33.33%)  3/6 (50.00%)  1/2 (50.00%)  3/12 (25.00%) 
Pain * 1  0/3 (0.00%)  0/13 (0.00%)  1/2 (50.00%)  0/7 (0.00%)  0/3 (0.00%)  1/9 (11.11%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%)  1/12 (8.33%) 
Pyrexia * 1  2/3 (66.67%)  3/13 (23.08%)  0/2 (0.00%)  0/7 (0.00%)  2/3 (66.67%)  1/9 (11.11%)  2/3 (66.67%)  0/6 (0.00%)  1/2 (50.00%)  2/12 (16.67%) 
Temperature intolerance * 1  0/3 (0.00%)  1/13 (7.69%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%)  0/12 (0.00%) 
Axillary pain * 1  0/3 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%)  2/12 (16.67%) 
Feeling abnormal * 1  0/3 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%)  1/12 (8.33%) 
Localised oedema * 1  0/3 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%)  1/12 (8.33%) 
Hepatobiliary disorders                     
Hepatic congestion&nb