Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02129205
Previous Study | Return to List | Next Study

A Dose Escalation Study of PF-06650808 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: NCT02129205
Recruitment Status : Terminated (The study was terminated due to a change in sponsor prioritization.)
First Posted : May 2, 2014
Results First Posted : March 29, 2019
Last Update Posted : March 29, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Neoplasms
Breast Cancer
Intervention Drug: PF-06650808
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PF-06650808 0.2 mg/kg (Part 1) PF-06650808 0.4 mg/kg (Part 1) PF-06650808 0.8 mg/kg (Part 1) PF-06650808 1.6 mg/kg (Part 1) PF-06650808 2.0 mg/kg (Part 1) PF-06650808 2.4 mg/kg (Part 1) PF-06650808 3.0 mg/kg (Part 1) PF-06650808 3.6 mg/kg (Part 1) PF-06650808 4.68 mg/kg (Part 1) PF-06650808 2.4mg/kg (Part 2)
Hide Arm/Group Description PF-06650808 0.2 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. PF-06650808 0.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. PF-06650808 0.8 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the maximum tolerated dose (MTD). The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study.
Period Title: Overall Study
Started 2 2 2 2 7 11 6 6 2 0
Completed 1 2 2 2 4 7 2 4 0 0
Not Completed 1 0 0 0 3 4 4 2 2 0
Reason Not Completed
Withdrawal by Subject             0             0             0             0             1             1             1             0             1             0
Other             1             0             0             0             2             3             3             2             1             0
Arm/Group Title PF-06650808 0.2 mg/kg (Part 1) PF-06650808 0.4 mg/kg (Part 1) PF-06650808 0.8 mg/kg (Part 1) PF-06650808 1.6 mg/kg (Part 1) PF-06650808 2.0 mg/kg (Part 1) PF-06650808 2.4 mg/kg (Part 1) PF-06650808 3.0 mg/kg (Part 1) PF-06650808 3.6 mg/kg (Part 1) PF-06650808 4.68 mg/kg (Part 1) PF-06650808 2.4 mg/kg (Part 2) Total
Hide Arm/Group Description PF-06650808 0.2 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. PF-06650808 0.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. PF-06650808 0.8 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the MTD. The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study. Total of all reporting groups
Overall Number of Baseline Participants 2 2 2 2 7 11 6 6 2 0 40
Hide Baseline Analysis Population Description
Baseline analysis population included all participants who received at least 1 dose of study treatment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2 participants 2 participants 2 participants 2 participants 7 participants 11 participants 6 participants 6 participants 2 participants 0 participants 40 participants
56.5  (6.4) 69.5  (3.5) 55  (24) 49.5  (2.1) 51.9  (14.7) 59.9  (9.8) 59.3  (13.8) 60.8  (4.7) 42  (28.3) 57.2  (12.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 2 participants 2 participants 2 participants 7 participants 11 participants 6 participants 6 participants 2 participants 0 participants 40 participants
Female
1
  50.0%
2
 100.0%
2
 100.0%
1
  50.0%
7
 100.0%
11
 100.0%
3
  50.0%
6
 100.0%
2
 100.0%
0
35
  87.5%
Male
1
  50.0%
0
   0.0%
0
   0.0%
1
  50.0%
0
   0.0%
0
   0.0%
3
  50.0%
0
   0.0%
0
   0.0%
0
5
  12.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2 participants 2 participants 2 participants 2 participants 7 participants 11 participants 6 participants 6 participants 2 participants 0 participants 40 participants
White 2 1 2 2 6 8 5 4 2 32
Black 0 0 0 0 1 1 1 1 0 4
Asian 0 1 0 0 0 2 0 1 0 4
1.Primary Outcome
Title Number of Participants With Dose-limiting Toxicities (DLT) (Part 1)
Hide Description Severity of AEs (adverse events ) was graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. For the purpose of dose escalation, any of the following AEs which were not considered related to disease progression occurring in the first cycle of treatment (21 days) were classified as DLTs: 1) Hematologic: Grade 4 neutropenia lasting >7 days; Febrile neutropenia; 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/mm3 regardless of duration. 2) Non hematologic: Grade>=3 toxicities except those that had not been maximally treated; Delayed by more than 2 weeks in receiving the next scheduled cycle due to persisting toxicities not attributable to disease progression. 3) clinically important or persistent toxicities may have been considered a DLT following review by the Sponsor and the investigators.
Time Frame Day 1 up to Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set was used, which included all enrolled participants who received at least one dose of study medication.
Arm/Group Title PF-06650808 0.2 mg/kg (Part 1) PF-06650808 0.4 mg/kg (Part 1) PF-06650808 0.8 mg/kg (Part 1) PF-06650808 1.6 mg/kg (Part 1) PF-06650808 2.0 mg/kg (Part 1) PF-06650808 2.4 mg/kg (Part 1) PF-06650808 3.0 mg/kg (Part 1) PF-06650808 3.6 mg/kg (Part 1) PF-06650808 4.68 mg/kg (Part 1)
Hide Arm/Group Description:
PF-06650808 0.2 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 0.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 0.8 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
Overall Number of Participants Analyzed 2 2 2 2 7 11 6 6 2
Measure Type: Count of Participants
Unit of Measure: Participants
Yes
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
3
  27.3%
2
  33.3%
1
  16.7%
2
 100.0%
No
2
 100.0%
2
 100.0%
2
 100.0%
2
 100.0%
7
 100.0%
8
  72.7%
4
  66.7%
5
  83.3%
0
   0.0%
2.Primary Outcome
Title Percentage of Participants With Objective Response (Part 1 and Part 2)
Hide Description Assessment of response was made using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. A participant achieved complete response (CR) if both target and non-target lesions achieved CR, no new lesions; achieved partial response (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. The overall objective response was defined as confirmed CR and PR.
Time Frame Day 1 and every 6 weeks until disease progression, unacceptable toxicity, or up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who received at least 1 dose of study medication and had both baseline and at least 1 post-baseline tumor assessments. The study was prematurely terminated prior to the start of dose expansion phase (Part 2).
Arm/Group Title PF-06650808 0.2 mg/kg (Part 1) PF-06650808 0.4 mg/kg (Part 1) PF-06650808 0.8 mg/kg (Part 1) PF-06650808 1.6 mg/kg (Part 1) PF-06650808 2.0 mg/kg (Part 1) PF-06650808 2.4 mg/kg (Part 1) PF-06650808 3.0 mg/kg (Part 1) PF-06650808 3.6 mg/kg (Part 1) PF-06650808 4.68 mg/kg (Part 1) PF-06650808 2.4 mg/kg (Part 2)
Hide Arm/Group Description:
PF-06650808 0.2 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 0.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 0.8 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the MTD. The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study.
Overall Number of Participants Analyzed 2 2 1 2 6 7 4 5 2 0
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
0
(0.0 to 84.2)
0
(0.0 to 84.2)
0
(0.0 to 97.5)
0
(0.0 to 84.2)
16.7
(0.4 to 64.1)
14.3
(0.4 to 57.9)
0
(0.0 to 60.2)
20.0
(0.5 to 71.6)
0
(0.0 to 84.2)
3.Secondary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Part 1 and Part 2)
Hide Description AE was defined as any untoward medical occurrence in a clinical investigation participant administered a product or medical device, regardless of the causal relationship to study treatment. Treatment-emergent AEs (TEAEs) were defined as AEs which occurred for the first time during the effective duration of treatment or AEs that increased in severity during treatment. Serious AEs (SAEs) were defined as any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or caused prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduction normal life functions). AEs included SAEs and non-serious AEs. Causality to study treatment was determined by the investigator. Severity was graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set was used, which included all enrolled participants who received at least one dose of study medication. The study was prematurely terminated prior to the start of dose expansion phase (Part 2).
Arm/Group Title PF-06650808 0.2 mg/kg (Part 1) PF-06650808 0.4 mg/kg (Part 1) PF-06650808 0.8 mg/kg (Part 1) PF-06650808 1.6 mg/kg (Part 1) PF-06650808 2.0 mg/kg (Part 1) PF-06650808 2.4 mg/kg (Part 1) PF-06650808 3.0 mg/kg (Part 1) PF-06650808 3.6 mg/kg (Part 1) PF-06650808 4.68 mg/kg (Part 1) PF-06650808 2.4 mg/kg (Part 2)
Hide Arm/Group Description:
PF-06650808 0.2 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 0.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 0.8 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the MTD. The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study.
Overall Number of Participants Analyzed 2 2 2 2 7 11 6 6 2 0
Measure Type: Count of Participants
Unit of Measure: Participants
All causalities AE Grade 1
0
   0.0%
0
   0.0%
1
  50.0%
0
   0.0%
1
  14.3%
0
   0.0%
1
  16.7%
0
   0.0%
0
   0.0%
All causalities AE Grade 2
2
 100.0%
1
  50.0%
1
  50.0%
2
 100.0%
1
  14.3%
2
  18.2%
1
  16.7%
1
  16.7%
0
   0.0%
All causalities AE Grade 3
0
   0.0%
1
  50.0%
0
   0.0%
0
   0.0%
5
  71.4%
8
  72.7%
2
  33.3%
4
  66.7%
1
  50.0%
All causalities AE Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
  33.3%
1
  16.7%
1
  50.0%
All causalities AE Grade 5
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   9.1%
0
   0.0%
0
   0.0%
0
   0.0%
All causalities SAE Grade 1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  14.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
All causalities SAE Grade 2
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%
All causalities SAE Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
  18.2%
1
  16.7%
2
  33.3%
1
  50.0%
All causalities SAE Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
  33.3%
1
  16.7%
1
  50.0%
All causalities SAE Grade 5
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   9.1%
0
   0.0%
0
   0.0%
0
   0.0%
Treatment related AE Grade 1
1
  50.0%
2
 100.0%
1
  50.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
0
   0.0%
0
   0.0%
Treatment related AE Grade 2
0
   0.0%
0
   0.0%
0
   0.0%
1
  50.0%
2
  28.6%
4
  36.4%
1
  16.7%
1
  16.7%
0
   0.0%
Treatment related AE Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
4
  57.1%
6
  54.5%
3
  50.0%
4
  66.7%
1
  50.0%
Treatment related AE Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
1
  16.7%
1
  50.0%
Treatment related AE Grade 5
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%
Treatment related SAE Grade 1
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%
Treatment related SAE Grade 2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
0
   0.0%
0
   0.0%
Treatment related SAE Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   9.1%
1
  16.7%
1
  16.7%
1
  50.0%
Treatment related SAE Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
1
  16.7%
1
  50.0%
Treatment related SAE Grade 5
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%
4.Secondary Outcome
Title Number of Participants With Laboratory Abnormalities Without Regard to Baseline (Hematology) (Part 1 and Part 2)
Hide Description Hematology evaluation included hemoglobin, platelets, white blood cell, absolute neutrophils, absolute lymphocytes, absolute monocytes, absolute eosinophils and absolute basophils. The participants who experienced laboratory test abnormalities were determined by investigators.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set was used, which included all enrolled participants who received at least one dose of study medication. The study was prematurely terminated prior to the start of dose expansion phase (Part 2).
Arm/Group Title PF-06650808 0.2 mg/kg (Part 1) PF-06650808 0.4 mg/kg (Part 1) PF-06650808 0.8 mg/kg (Part 1) PF-06650808 1.6 mg/kg (Part 1) PF-06650808 2.0 mg/kg (Part 1) PF-06650808 2.4 mg/kg (Part 1) PF-06650808 3.0 mg/kg (Part 1) PF-06650808 3.6 mg/kg (Part 1) PF-06650808 4.68 mg/kg (Part 1) PF-06650808 2.4 mg/kg (Part 2)
Hide Arm/Group Description:
PF-06650808 0.2 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 0.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 0.8 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the MTD. The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study.
Overall Number of Participants Analyzed 2 2 2 2 7 11 6 6 2 0
Measure Type: Count of Participants
Unit of Measure: Participants
Anemia
1
  50.0%
2
 100.0%
2
 100.0%
1
  50.0%
4
  57.1%
6
  54.5%
5
  83.3%
3
  50.0%
2
 100.0%
Hemoglobin increased
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%
Lymphocyte count increased
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%
Lymphopenia
2
 100.0%
1
  50.0%
2
 100.0%
1
  50.0%
4
  57.1%
9
  81.8%
4
  66.7%
4
  66.7%
2
 100.0%
Neutrophils count decreased
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%
Patelets count decreased
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%
White blood cells decreased
0
   0.0%
0
   0.0%
1
  50.0%
0
   0.0%
1
  14.3%
3
  27.3%
1
  16.7%
0
   0.0%
0
   0.0%
5.Secondary Outcome
Title Number of Participants With Laboratory Abnormalities Without Regard to Baseline (Chemistries) (Part 1 and Part 2)
Hide Description Chemistry evaluation included alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, sodium, potassium, magnesium, chloride, calcium, total bilirubin, blood urea nitrogen (BUN) or urea, creatinine, uric acid, glucose (non-fasted), albumin, phosphorus, bicarbonate or carbon dioxide, total protein and lactate dehydrogenase. The participants who experienced laboratory test abnormalities were determined by investigators.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set was used, which included all enrolled participants who received at least one dose of study medication. The study was prematurely terminated prior to the start of dose expansion phase (Part 2).
Arm/Group Title PF-06650808 0.2 mg/kg (Part 1) PF-06650808 0.4 mg/kg (Part 1) PF-06650808 0.8 mg/kg (Part 1) PF-06650808 1.6 mg/kg (Part 1) PF-06650808 2.0 mg/kg (Part 1) PF-06650808 2.4 mg/kg (Part 1) PF-06650808 3.0 mg/kg (Part 1) PF-06650808 3.6 mg/kg (Part 1) PF-06650808 4.68 mg/kg (Part 1) PF-06650808 2.4 mg/kg (Part 2)
Hide Arm/Group Description:
PF-06650808 0.2 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 0.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 0.8 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the MTD. The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study.
Overall Number of Participants Analyzed 2 2 2 2 7 11 6 6 2 0
Measure Type: Count of Participants
Unit of Measure: Participants
Alanine aminotransferase (ALT) increased
0
   0.0%
1
  50.0%
1
  50.0%
0
   0.0%
3
  42.9%
0
   0.0%
0
   0.0%
0
   0.0%
1
  50.0%
Alkaline phosphatase increased
1
  50.0%
0
   0.0%
1
  50.0%
1
  50.0%
4
  57.1%
3
  27.3%
2
  33.3%
1
  16.7%
1
  50.0%
Aspartate aminotransferase (AST) increased
0
   0.0%
1
  50.0%
1
  50.0%
0
   0.0%
4
  57.1%
4
  36.4%
0
   0.0%
1
  16.7%
1
  50.0%
Bilirubin (Total) increased
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%
Creatinine increased
1
  50.0%
1
  50.0%
1
  50.0%
0
   0.0%
0
   0.0%
1
   9.1%
0
   0.0%
1
  16.7%
0
   0.0%
Hypercalcemia
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%
Hyperglycemia
0
   0.0%
1
  50.0%
1
  50.0%
2
 100.0%
2
  28.6%
4
  36.4%
5
  83.3%
3
  50.0%
0
   0.0%
Hyperkalemia
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%
Hypermagnesemia
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%
Hypernatremia
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%
Hypoalbuminemia
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  14.3%
4
  36.4%
2
  33.3%
1
  16.7%
1
  50.0%
Hypocalcemia
1
  50.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  14.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hypoglycemia
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%
Hypokalemia
1
  50.0%
0
   0.0%
0
   0.0%
1
  50.0%
1
  14.3%
1
   9.1%
0
   0.0%
0
   0.0%
0
   0.0%
Hypomagnesemia
1
  50.0%
0
   0.0%
1
  50.0%
0
   0.0%
2
  28.6%
2
  18.2%
3
  50.0%
0
   0.0%
1
  50.0%
Hyponatremia
1
  50.0%
1
  50.0%
0
   0.0%
0
   0.0%
2
  28.6%
3
  27.3%
1
  16.7%
2
  33.3%
0
   0.0%
Hypophosphatemia
1
  50.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
0
   0.0%
1
  50.0%
6.Secondary Outcome
Title Number of Participants With Laboratory Abnormalities Without Regard to Baseline (Urinalysis) (Part 1 and Part 2)
Hide Description Urinalysis included urine protein. Microscopic analyses were performed if dipstick was abnormal. The participants who experienced laboratory test abnormalities were determined by investigators.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set was used, which included all enrolled participants who received at least one dose of study medication. The study was prematurely terminated prior to the start of dose expansion phase (Part 2).
Arm/Group Title PF-06650808 0.2 mg/kg (Part 1) PF-06650808 0.4 mg/kg (Part 1) PF-06650808 0.8 mg/kg (Part 1) PF-06650808 1.6 mg/kg (Part 1) PF-06650808 2.0 mg/kg (Part 1) PF-06650808 2.4 mg/kg (Part 1) PF-06650808 3.0 mg/kg (Part 1) PF-06650808 3.6 mg/kg (Part 1) PF-06650808 4.68 mg/kg (Part 1) PF-06650808 2.4 mg/kg (Part 2)
Hide Arm/Group Description:
PF-06650808 0.2 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 0.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 0.8 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the MTD. The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study.
Overall Number of Participants Analyzed 2 2 2 2 6 10 5 6 1 0
Measure Type: Count of Participants
Unit of Measure: Participants
1
  50.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
7.Secondary Outcome
Title Number of Participants With Vital Signs Meeting Categorical Summarization Criteria (Part 1 and Part 2)
Hide Description Vital Signs tests included systolic and diastolic blood pressure (BP) and pulse rate of seated supine and standing . Vital signs categorical summarization criteria were 1), supine and standing BP: systolic (SBP) greater than or equal to (>=) 30 millimeters of mercury (mm Hg) change from baseline, systolic less than (<) 90 mm Hg; diastolic BP (DBP) >=20 mm Hg change from baseline, diastolic <50 mm Hg; 2), supine and standing pulse rate <40 or greater than (>) 120 beats per minute (bpm).
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set was used, which included all enrolled participants who received at least one dose of study medication. The study was prematurely terminated prior to the start of dose expansion phase (Part 2).
Arm/Group Title PF-06650808 0.2 mg/kg (Part 1) PF-06650808 0.4 mg/kg (Part 1) PF-06650808 0.8 mg/kg (Part 1) PF-06650808 1.6 mg/kg (Part 1) PF-06650808 2.0 mg/kg (Part 1) PF-06650808 2.4 mg/kg (Part 1) PF-06650808 3.0 mg/kg (Part 1) PF-06650808 3.6 mg/kg (Part 1) PF-06650808 4.68 mg/kg (Part 1) PF-06650808 2.4 mg/kg (Part 2)
Hide Arm/Group Description:
PF-06650808 0.2 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 0.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 0.8 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the MTD. The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study.
Overall Number of Participants Analyzed 2 2 2 2 7 9 6 6 2 0
Measure Type: Count of Participants
Unit of Measure: Participants
Sitting Systolic BP < 90 mmHg Number Analyzed 2 participants 2 participants 2 participants 2 participants 7 participants 9 participants 6 participants 6 participants 2 participants 0 participants
0
   0.0%
1
  50.0%
1
  50.0%
0
   0.0%
1
  14.3%
0
   0.0%
1
  16.7%
0
   0.0%
0
   0.0%
Sitting Diastolic BP < 50 mmHg Number Analyzed 2 participants 2 participants 2 participants 2 participants 7 participants 9 participants 6 participants 6 participants 2 participants 0 participants
0
   0.0%
1
  50.0%
1
  50.0%
0
   0.0%
1
  14.3%
1
  11.1%
0
   0.0%
0
   0.0%
0
   0.0%
Sitting Pulse Rate < 40 BPM Number Analyzed 2 participants 2 participants 2 participants 2 participants 7 participants 9 participants 6 participants 6 participants 2 participants 0 participants
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 BPM Number Analyzed 2 participants 2 participants 2 participants 2 participants 7 participants 9 participants 6 participants 6 participants 2 participants 0 participants
0
   0.0%
0
   0.0%
1
  50.0%
0
   0.0%
1
  14.3%
0
   0.0%
1
  16.7%
2
  33.3%
0
   0.0%
Supine Systolic BP < 90 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants 0 participants 0 participants 0 participants 0 participants
0
   0.0%
Supine Diastolic BP < 50 mmHg Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants 0 participants 0 participants 0 participants 0 participants
0
   0.0%
Supine Pulse Rate < 40 BPM Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants 0 participants 0 participants 0 participants 0 participants
0
   0.0%
Supine Pulse Rate > 120 BPM Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants 0 participants 0 participants 0 participants 0 participants
0
   0.0%
Systolic BP < 90 mmHg Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 3 participants 1 participants 0 participants 0 participants 0 participants
1
  33.3%
0
   0.0%
Diastolic BP < 50 mmHg Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 3 participants 1 participants 0 participants 0 participants 0 participants
1
  33.3%
0
   0.0%
Pulse Rate < 40 BPM Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 3 participants 1 participants 0 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
Pulse Rate > 120 BPM Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 3 participants 1 participants 0 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
Increase: Sitting Systolic BP >= 30 mmHg Number Analyzed 2 participants 2 participants 2 participants 2 participants 7 participants 8 participants 6 participants 6 participants 2 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
  28.6%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Increase: Sitting Diastolic BP >= 20 mmHg Number Analyzed 2 participants 2 participants 2 participants 2 participants 7 participants 8 participants 6 participants 6 participants 2 participants 0 participants
0
   0.0%
0
   0.0%
1
  50.0%
0
   0.0%
1
  14.3%
3
  37.5%
2
  33.3%
4
  66.7%
0
   0.0%
Increase: Systolic BP >= 30 mmHg Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 3 participants 0 participants 0 participants 0 participants 0 participants
0
   0.0%
Increase: Diastolic BP >= 20 mmHg Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 3 participants 0 participants 0 participants 0 participants 0 participants
0
   0.0%
Decrease: Sitting Systolic BP >= 30 mmHg Number Analyzed 2 participants 2 participants 2 participants 2 participants 7 participants 8 participants 6 participants 6 participants 2 participants 0 participants
0
   0.0%
1
  50.0%
0
   0.0%
0
   0.0%
2
  28.6%
1
  12.5%
2
  33.3%
1
  16.7%
0
   0.0%
Decrease: Sitting Diastolic BP >= 20 mmHg Number Analyzed 2 participants 2 participants 2 participants 2 participants 7 participants 8 participants 6 participants 6 participants 2 participants 0 participants
0
   0.0%
1
  50.0%
1
  50.0%
0
   0.0%
2
  28.6%
2
  25.0%
0
   0.0%
1
  16.7%
0
   0.0%
Decrease: Systolic BP >= 30 mmHg Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 3 participants 0 participants 0 participants 0 participants 0 participants
1
  33.3%
Decrease: Diastolic BP >= 20 mmHg Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 3 participants 0 participants 0 participants 0 participants 0 participants
2
  66.7%
8.Secondary Outcome
Title Maximum Observed Serum Concentration (Cmax) (Part 1 and Part 2)
Hide Description Maximum observed serum concentration (Cmax) of ADC (PF-06650808), total antibody (PF-06460005) and unconjugated payload (PF-06380101) were observed directly from data. PF-06650808 is comprised of an antibody (PF-06460005) and a cytotoxic agent (PF-06380101).
Time Frame Pre-dose, 1, 4 and 24 hours post-dose, Days 4, 8 and 15 in Cycle 1 and Cycle 4
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. The study was prematurely terminated prior to the start of dose expansion phase (Part 2).
Arm/Group Title PF-06650808 0.2 mg/kg (Part 1) PF-06650808 0.4 mg/kg (Part 1) PF-06650808 0.8 mg/kg (Part 1) PF-06650808 1.6 mg/kg (Part 1) PF-06650808 2.0 mg/kg (Part 1) PF-06650808 2.4 mg/kg (Part 1) PF-06650808 3.0 mg/kg (Part 1) PF-06650808 3.6 mg/kg (Part 1) PF-06650808 4.68 mg/kg (Part 1) PF-06650808 2.4 mg/kg (Part 2)
Hide Arm/Group Description:
PF-06650808 0.2 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 0.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 0.8 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the MTD. The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study.
Overall Number of Participants Analyzed 2 2 2 2 7 11 6 6 2 0
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
Serum PF-06650808 (ADC)_Cycle 1 Number Analyzed 2 participants 2 participants 2 participants 2 participants 7 participants 11 participants 6 participants 6 participants 2 participants 0 participants
NA [1] 
(NA%)
NA [2] 
(NA%)
NA [3] 
(NA%)
NA [4] 
(NA%)
59440
(33%)
54220
(29%)
76480
(27%)
71390
(38%)
NA [5] 
(NA%)
Serum PF-06460005 (Total Antibody)_Cycle 1 Number Analyzed 2 participants 2 participants 2 participants 2 participants 7 participants 11 participants 6 participants 6 participants 2 participants 0 participants
NA [6] 
(NA%)
NA [7] 
(NA%)
NA [8] 
(NA%)
NA [9] 
(NA%)
48840
(29%)
54120
(17%)
93530
(53%)
65810
(35%)
NA [10] 
(NA%)
Serum PF-06380101 (Unconjugated Payload)_Cycle 1 Number Analyzed 2 participants 2 participants 2 participants 2 participants 7 participants 11 participants 6 participants 6 participants 2 participants 0 participants
NA [11] 
(NA%)
NA [12] 
(NA%)
NA [13] 
(NA%)
NA [14] 
(NA%)
6.495
(75%)
5.916
(81%)
10.680
(30%)
9.060
(82%)
NA [15] 
(NA%)
Serum PF-06650808 (ADC)_Cycle 4 Number Analyzed 0 participants 1 participants 1 participants 2 participants 4 participants 4 participants 0 participants 2 participants 0 participants 0 participants
NA [16] 
(NA%)
NA [17] 
(NA%)
NA [18] 
(NA%)
46240
(12%)
43910
(17%)
NA [19] 
(NA%)
Serum PF-06460005 (Total Antibody)_Cycle 4 Number Analyzed 0 participants 1 participants 1 participants 2 participants 4 participants 4 participants 0 participants 2 participants 0 participants 0 participants
NA [20] 
(NA%)
NA [21] 
(NA%)
NA [22] 
(NA%)
41610
(34%)
50640
(23%)
NA [23] 
(NA%)
Serum PF-06380101 (Unconjugated Payload)_Cycle 4 Number Analyzed 0 participants 1 participants 1 participants 2 participants 4 participants 4 participants 0 participants 2 participants 0 participants 0 participants
NA [24] 
(NA%)
NA [25] 
(NA%)
NA [26] 
(NA%)
4.518
(78%)
4.081
(54%)
NA [27] 
(NA%)
[1]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 6200 and 4290 ng/mL, respectively.
[2]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 11000 and 8030 ng/mL, respectively.
[3]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 18100 and 19400 ng/mL, respectively.
[4]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values.Individual participant values are 34600 and 34900 ng/mL, respectively.
[5]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values.Individual participant values are 141000 and 92200 ng/mL, respectively
[6]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values.Individual participant values are 5000 and 3690 ng/mL, respectively.
[7]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values.Individual participant values are 8920 and 7860 ng/mL, respectively.
[8]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values.Individual participant values are 21600 and 17700 ng/mL, respectively.
[9]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 30800 and 26800 ng/mL, respectively.
[10]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values.Individual participant values are 99600 and 62400 ng/mL, respectively.
[11]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 0.735 and 0.627 ng/mL, respectively.
[12]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 1.180 and 0.536 ng/mL, respectively.
[13]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 2.530 and 2.900 ng/mL, respectively.
[14]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 2.430 and 6.450 ng/mL, respectively.
[15]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 26.100 and 14.400 ng/mL, respectively.
[16]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values is 11400 ng/mL.
[17]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values is 18200 ng/mL.
[18]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 36700 and 38100 ng/mL, respectively.
[19]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 36100 and 64900 ng/mL, respectively.
[20]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values is 9920 ng/mL.
[21]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values is 11900 ng/mL.
[22]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 35100 and 51500 ng/mL, respectively.
[23]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 62400 and 108000 ng/mL, respectively.
[24]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values is 1.200 ng/mL.
[25]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values is 2.180 ng/mL.
[26]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 2.220 and 4.730 ng/mL, respectively.
[27]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 2.800 and 15.700 ng/mL, respectively.
9.Secondary Outcome
Title Time to Reach Maximum Observed Serum Concentration (Tmax) (Part 1 and Part 2)
Hide Description Tmax of ADC (PF-06650808), total antibody (PF-06460005) and unconjugated payload (PF-06380101) were observed directly from data as time of first occurrence.
Time Frame Pre-dose, 1, 4 and 24 hours post-dose, Days 4, 8 and 15 in Cycle 1 and Cycle 4
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. The study was prematurely terminated prior to the start of dose expansion phase (Part 2).
Arm/Group Title PF-06650808 0.2 mg/kg (Part 1) PF-06650808 0.4 mg/kg (Part 1) PF-06650808 0.8 mg/kg (Part 1) PF-06650808 1.6 mg/kg (Part 1) PF-06650808 2.0 mg/kg (Part 1) PF-06650808 2.4 mg/kg (Part 1) PF-06650808 3.0 mg/kg (Part 1) PF-06650808 3.6 mg/kg (Part 1) PF-06650808 4.68 mg/kg (Part 1) PF-06650808 2.4 mg/kg (Part 2)
Hide Arm/Group Description:
PF-06650808 0.2 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 0.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 0.8 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the MTD. The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study.
Overall Number of Participants Analyzed 2 2 2 2 7 11 6 6 2 0
Median (Full Range)
Unit of Measure: hr
Serum PF-06650808 (ADC)_Cycle 1 Number Analyzed 2 participants 2 participants 2 participants 2 participants 7 participants 11 participants 6 participants 6 participants 2 participants 0 participants
0.967
(0.950 to 0.983)
0.974
(0.917 to 1.03)
0.967
(0.967 to 0.967)
1.01
(0.983 to 1.03)
0.967
(0.917 to 1.08)
1.03
(0.933 to 4.05)
1.06
(0.967 to 4.00)
1.04
(0.917 to 4.08)
1.45
(1.15 to 1.75)
Serum PF-06460005 (Total Antibody)_Cycle 1 Number Analyzed 2 participants 2 participants 2 participants 2 participants 7 participants 11 participants 6 participants 6 participants 2 participants 0 participants
0.967
(0.950 to 0.983)
0.974
(0.917 to 1.03)
0.967
(0.967 to 0.967)
1.01
(0.983 to 1.03)
1.08
(0.917 to 4.02)
1.02
(0.933 to 3.98)
1.04
(0.967 to 4.00)
1.04
(0.950 to 4.08)
1.45
(1.15 to 1.75)
Serum PF-06380101 (Unconjugated Payload)_Cycle 1 Number Analyzed 2 participants 2 participants 2 participants 2 participants 7 participants 11 participants 6 participants 6 participants 2 participants 0 participants
25.3
(25.2 to 25.4)
24.6
(23.4 to 25.8)
48.5
(24.8 to 72.1)
24.6
(23.8 to 25.4)
24.0
(22.1 to 71.6)
24.3
(23.0 to 72.3)
57.9
(23.1 to 75.9)
69.1
(22.4 to 73.0)
47.7
(23.8 to 71.6)
Serum PF-06650808 (ADC)_Cycle 4 Number Analyzed 0 participants 1 participants 1 participants 2 participants 4 participants 4 participants 0 participants 2 participants 0 participants 0 participants
0.917
(0.917 to 0.917)
0.917
(0.917 to 0.917)
1.00
(0.900 to 1.10)
2.34
(0.933 to 5.00)
1.03
(0.917 to 1.07)
2.47
(0.933 to 4.00)
Serum PF-06460005 (Total Antibody)_Cycle 4 Number Analyzed 0 participants 1 participants 1 participants 2 participants 4 participants 4 participants 0 participants 2 participants 0 participants 0 participants
0.917
(0.917 to 0.917)
0.917
(0.917 to 0.917)
2.55
(1.10 to 4.00)
1.00
(0.933 to 1.05)
1.05
(0.917 to 22.1)
0.925
(0.917 to 0.933)
Serum PF-06380101 (Unconjugated Payload)_Cycle 4 Number Analyzed 0 participants 1 participants 1 participants 2 participants 4 participants 4 participants 0 participants 2 participants 0 participants 0 participants
23.4
(23.4 to 23.4)
24.6
(24.6 to 24.6)
13.5
(4.00 to 23.0)
23.5
(21.9 to 25.2)
46.4
(5.00 to 70.0)
23.6
(23.1 to 24.0)
10.Secondary Outcome
Title Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) (Part 1 and Part 2)
Hide Description Tau refers to the dosing interval, and it equals to 504 hours (3 weeks) of ADC (PF-06650808), total antibody (PF-06460005) and unconjugated payload (PF-06380101) were determined using linear/log trapezoidal method.
Time Frame Pre-dose, 1, 4 and 24 hours post-dose, Days 4, 8 and 15 in Cycle 1 and Cycle 4
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. The study was prematurely terminated prior to the start of dose expansion phase (Part 2).
Arm/Group Title PF-06650808 0.2 mg/kg (Part 1) PF-06650808 0.4 mg/kg (Part 1) PF-06650808 0.8 mg/kg (Part 1) PF-06650808 1.6 mg/kg (Part 1) PF-06650808 2.0 mg/kg (Part 1) PF-06650808 2.4 mg/kg (Part 1) PF-06650808 3.0 mg/kg (Part 1) PF-06650808 3.6 mg/kg (Part 1) PF-06650808 4.68 mg/kg (Part 1) PF-06650808 2.4 mg/kg (Part 2)
Hide Arm/Group Description:
PF-06650808 0.2 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 0.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 0.8 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the MTD. The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study.
Overall Number of Participants Analyzed 2 2 2 2 6 11 5 5 1 0
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*hr/mL
Serum PF-06650808 (ADC)_Cycle 1 Number Analyzed 2 participants 2 participants 2 participants 2 participants 6 participants 11 participants 5 participants 5 participants 1 participants 0 participants
NA [1] 
(NA%)
NA [2] 
(NA%)
NA [3] 
(NA%)
NA [4] 
(NA%)
1786000
(17%)
2147000
(33%)
3659000
(31%)
2956000
(39%)
NA [5] 
(NA%)
Serum PF-06460005 (Total Antibody)_Cycle 1 Number Analyzed 1 participants 2 participants 1 participants 2 participants 6 participants 10 participants 5 participants 5 participants 1 participants 0 participants
NA [6] 
(NA%)
NA [7] 
(NA%)
NA [8] 
(NA%)
NA [4] 
(NA%)
2385000
(24%)
3078000
(36%)
5116000
(31%)
3571000
(48%)
NA [9] 
(NA%)
Serum PF-06380101 (Unconjugated Payload)_Cycle 1 Number Analyzed 2 participants 1 participants 2 participants 2 participants 6 participants 9 participants 4 participants 5 participants 1 participants 0 participants
NA [10] 
(NA%)
NA [11] 
(NA%)
NA [12] 
(NA%)
NA [13] 
(NA%)
814.700
(96%)
671.500
(103%)
1307.000
(19%)
1082.000
(88%)
NA [14] 
(NA%)
Serum PF-06650808 (ADC)_Cycle 4 Number Analyzed 0 participants 1 participants 1 participants 2 participants 4 participants 4 participants 0 participants 2 participants 0 participants 0 participants
NA [15] 
(NA%)
NA [16] 
(NA%)
NA [17] 
(NA%)
1690000
(18%)
1899000
(31%)
NA [18] 
(NA%)
Serum PF-06460005 (Total Antibody)_Cycle 4 Number Analyzed 0 participants 1 participants 1 participants 2 participants 4 participants 3 participants 0 participants 2 participants 0 participants 0 participants
NA [19] 
(NA%)
NA [20] 
(NA%)
NA [21] 
(NA%)
2234000
(20%)
2901000
(33%)
NA [22] 
(NA%)
Serum PF-06380101 (Unconjugated Payload)_Cycle 4 Number Analyzed 0 participants 1 participants 1 participants 2 participants 4 participants 4 participants 0 participants 2 participants 0 participants 0 participants
NA [23] 
(NA%)
NA [24] 
(NA%)
NA [25] 
(NA%)
507.400
(90%)
486.600
(78%)
NA [26] 
(NA%)
[1]
Summary statistics were not presented if fewer than 3 partipants had reportable parameter values. Individual participant values are 156000 and 105000 ng.hr/mL, respectively.
[2]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 394000 and 255000 ng.hr/mL, respectively.
[3]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 515000 and 567000 ng.hr/mL, respectively.
[4]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 1290000 and 1070000 ng.hr/mL, respectively.
[5]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values is 4180000 ng.hr/mL.
[6]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 122000 ng.hr/mL.
[7]
Summary statistics were not presented if fewer than 3 particpants had reportable parameter values. Individual participant values are 371000 and 265000 ng.hr/mL, respectively.
[8]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 689000 ng.hr/mL.
[9]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values is 4270000 ng.hr/mL.
[10]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 76.300 and 46.600 ng.hr/mL, respectively.
[11]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 48.900 ng.hr/mL.
[12]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 291.000 and 228.000 ng.hr/mL, respectively.
[13]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 300.000 and 576.000 ng.hr/mL, respectively.
[14]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 2060.000 ng.hr/mL.
[15]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 365000 ng.hr/mL.
[16]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 578000 ng.hr/mL.
[17]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participants values are 1550000 and 1150000 ng.hr/mL, respectively.
[18]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 1400000 and 2600000 ng.hr/mL, respectively.
[19]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 399000 ng.hr/mL.
[20]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 593000 ng.hr/mL.
[21]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 2130000 and 1720000 ng.hr/mL, respectively.
[22]
Summary statistics were not presented if fewer than 3 participants reportable parameter values. Individual participant values are 3160000 and 6060000 ng.hr/mL, respectively.
[23]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 113.00 ng.hr/mL.
[24]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 186.000 ng.hr/mL.
[25]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 304.000 and 403.000 ng.hr/mL, respectively.
[26]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 273.000 and 2040.000 ng.hr/mL, respectively.
11.Secondary Outcome
Title Clearance (CL) (Part 1 and Part 2)
Hide Description Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. CL was calculated as dose/AUCinf, where AUCinf was the area under the serum concentration-time profile from time 0 extrapolated to infinite time. CL was only for PF-06650808 (ADC) and Cycle 1.
Time Frame Pre-dose, 1, 4 and 24 hours post-dose, Days 4, 8 and 15 in Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. The study was prematurely terminated prior to the start of dose expansion phase (Part 2).
Arm/Group Title PF-06650808 0.2 mg/kg (Part 1) PF-06650808 0.4 mg/kg (Part 1) PF-06650808 0.8 mg/kg (Part 1) PF-06650808 1.6 mg/kg (Part 1) PF-06650808 2.0 mg/kg (Part 1) PF-06650808 2.4 mg/kg (Part 1) PF-06650808 3.0 mg/kg (Part 1) PF-06650808 3.6 mg/kg (Part 1) PF-06650808 4.68 mg/kg (Part 1) PF-06650808 2.4 mg/kg (Part 2)
Hide Arm/Group Description:
PF-06650808 0.2 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 0.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 0.8 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the MTD. The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study.
Overall Number of Participants Analyzed 2 2 2 2 6 11 5 5 1 0
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: L/hr
NA [1] 
(NA%)
NA [2] 
(NA%)
NA [3] 
(NA%)
NA [4] 
(NA%)
0.08368
(25%)
0.07545
(26%)
0.07924
(30%)
0.07517
(38%)
NA [5] 
(NA%)
[1]
Summary statistics were not presented if fewer than 3 partipants had reportable parameter values. Individual participant values are 0.118 and 0.143 L/hr, respectively.
[2]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 0.0798 and 0.0808 L/hr, respectively.
[3]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 0.106 and 0.0703 L/hr, respectively.
[4]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 0.0894 and 0.124 L/hr, respectively.
[5]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 0.0947 L/hr.
12.Secondary Outcome
Title Volume of Distribution at Steady State (Vss) (Part 1 and Part 2)
Hide Description Vss was calculated as dose/(AUCinf × kel), where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Vss was only for PF-06650808 (ADC) and Cycle 1.
Time Frame Pre-dose, 1, 4 and 24 hours post-dose, Days 4, 8 and 15 in Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. The study was prematurely terminated prior to the start of dose expansion phase (Part 2).
Arm/Group Title PF-06650808 0.2 mg/kg (Part 1) PF-06650808 0.4 mg/kg (Part 1) PF-06650808 0.8 mg/kg (Part 1) PF-06650808 1.6 mg/kg (Part 1) PF-06650808 2.0 mg/kg (Part 1) PF-06650808 2.4 mg/kg (Part 1) PF-06650808 3.0 mg/kg (Part 1) PF-06650808 3.6 mg/kg (Part 1) PF-06650808 4.68 mg/kg (Part 1) PF-06650808 2.4 mg/kg (Part 2)
Hide Arm/Group Description:
PF-06650808 0.2 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 0.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 0.8 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the MTD. The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study.
Overall Number of Participants Analyzed 2 2 2 2 6 11 5 5 1 0
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: L
NA [1] 
(NA%)
NA [2] 
(NA%)
NA [3] 
(NA%)
NA [4] 
(NA%)
3.428
(26%)
3.232
(28%)
3.800
(30%)
3.481
(36%)
NA [5] 
(NA%)
[1]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values.Individual participant values are 3.43 and 3.45 L, respectively.
[2]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values.Individual participant values are 2.71 and 2.87 L, respectively.
[3]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values.Individual participant values are 3.51 and 2.20 L, respectively.
[4]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values.Individual participant values are 3.39 and 3.81 L, respectively.
[5]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values.Individual participant values is 5.04.
13.Secondary Outcome
Title Terminal Elimination Half-Life (t1/2) (Part 1 and Part 2)
Hide Description Terminal elimination half-life was defined as the time measured for the serum concentration to decrease by one half, and calculated as loge(2)/kel.
Time Frame Pre-dose, 1, 4 and 24 hours post-dose, Days 4, 8 and 15 in Cycle 1 and Cycle 4
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. The study was prematurely terminated prior to the start of dose expansion phase (Part 2).
Arm/Group Title PF-06650808 0.2 mg/kg (Part 1) PF-06650808 0.4 mg/kg (Part 1) PF-06650808 0.8 mg/kg (Part 1) PF-06650808 1.6 mg/kg (Part 1) PF-06650808 2.0 mg/kg (Part 1) PF-06650808 2.4 mg/kg (Part 1) PF-06650808 3.0 mg/kg (Part 1) PF-06650808 3.6 mg/kg (Part 1) PF-06650808 4.68 mg/kg (Part 1) PF-06650808 2.4 mg/kg (Part 2)
Hide Arm/Group Description:
PF-06650808 0.2 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 0.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 0.8 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the MTD. The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study.
Overall Number of Participants Analyzed 2 2 2 2 6 11 5 5 1 0
Mean (Standard Deviation)
Unit of Measure: hr
Serum PF-06650808 (ADC)_Cycle 1 Number Analyzed 2 participants 2 participants 2 participants 2 participants 6 participants 11 participants 5 participants 5 participants 1 participants 0 participants
NA [1]   (NA) NA [2]   (NA) NA [3]   (NA) NA [4]   (NA) 29.52  (5.2320) 30.72  (5.0245) 35.12  (4.1282) 32.72  (5.1266) NA [5]   (NA)
Serum PF-06460005 (Total Antibody)_Cycle 1 Number Analyzed 1 participants 2 participants 1 participants 2 participants 6 participants 10 participants 5 participants 5 participants 1 participants 0 participants
NA [6]   (NA) NA [7]   (NA) NA [8]   (NA) NA [9]   (NA) 33.62  (3.4487) 40.93  (9.5650) 49.06  (13.670) 39.80  (9.2477) NA [10]   (NA)
Serum PF-06380101 (Unconjugated Payload)_Cycle 1 Number Analyzed 2 participants 1 participants 2 participants 2 participants 5 participants 9 participants 4 participants 5 participants 1 participants 0 participants
NA [11]   (NA) NA [12]   (NA) NA [13]   (NA) NA [14]   (NA) 53.06  (6.0260) 53.11  (8.5249) 59.18  (7.0486) 53.52  (3.4434) NA [15]   (NA)
Serum PF-06650808 (ADC)_Cycle 4 Number Analyzed 0 participants 1 participants 1 participants 2 participants 4 participants 4 participants 0 participants 2 participants 0 participants 0 participants
NA [16]   (NA) NA [17]   (NA) NA [18]   (NA) 28.50  (4.9349) 30.33  (4.0991) NA [19]   (NA)
Serum PF-06460005 (Total Antibody)_Cycle 4 Number Analyzed 0 participants 1 participants 1 participants 2 participants 4 participants 3 participants 0 participants 2 participants 0 participants 0 participants
NA [20]   (NA) NA [21]   (NA) NA [22]   (NA) 38.85  (3.7108) 40.80  (2.5060) NA [23]   (NA)
Serum PF-06380101 (Unconjugated Payload)_Cycle 4 Number Analyzed 0 participants 1 participants 1 participants 2 participants 4 participants 4 participants 0 participants 2 participants 0 participants 0 participants
NA [24]   (NA) NA [25]   (NA) NA [26]   (NA) 52.40  (7.9461) 53.83  (6.5961) NA [27]   (NA)
[1]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 20.4 and 16.8 hr, respectively.
[2]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 23.5 and 24.9 hr, respectively.
[3]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 21.4 and 20.7 hr, respectively.
[4]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 27.2 and 20.1 hr, respectively.
[5]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values is 40.8 hr.
[6]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values is 19.1 hr.
[7]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 28.7 and 28.7 hr, respectively.
[8]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values is 28.4 hr.
[9]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 37.0 and 26.7 hr, respectively.
[10]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values is 61.1 hr.
[11]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 45.2 and 26.5 hr, respectively.
[12]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values is 40.4 hr.
[13]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 50.3 and 39.9 hr, respectively.
[14]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 47.5 and 39.4 hr, respectively.
[15]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values is 71.8 hr.
[16]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values is 20.4 hr.
[17]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values is 18.5 hr.
[18]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 28.4 and 20.7 hr, respectively.
[19]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 30.8 and 35.8 hr, respectively.
[20]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values is 26.1 hr.
[21]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values is 24.6 hr.
[22]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 33.2 and 23.4 hr, respectively
[23]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 41.8 and 59.2 hr, respectively
[24]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values is 43.8 hr.
[25]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values is 38.8 hr.
[26]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 45.7 and 49.2 hr, respectively.
[27]
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 48.7 and 61.5 hr, respectively.
14.Secondary Outcome
Title Number of Participants With the Presence of Anti-PF-06650808 Antibodies (Part 1 and Part 2)
Hide Description Assays to assess for anti drug (anti PF-06650808) antibodies (ADA) were performed. Positive ADA: titer>=1.88.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who received at least 1 dose of study medication and had at least 1 post-dose ADA measurements. The study was prematurely terminated prior to the start of dose expansion phase (Part 2).
Arm/Group Title PF-06650808 0.2 mg/kg (Part 1) PF-06650808 0.8 mg/kg (Part 1) PF-06650808 0.4 mg/kg (Part 1) PF-06650808 1.6 mg/kg (Part 1) PF-06650808 2.0 mg/kg (Part 1) PF-06650808 2.4 mg/kg (Part 1) PF-06650808 3.0 mg/kg (Part 1) PF-06650808 3.6 mg/kg (Part 1) PF-06650808 4.68 mg/kg (Part 1) PF-06650808 2.4 mg/kg (Part 2)
Hide Arm/Group Description:
PF-06650808 0.2 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 0.8 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 0.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the MTD. The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study.
Overall Number of Participants Analyzed 2 2 2 2 7 11 6 6 2 0
Measure Type: Count of Participants
Unit of Measure: Participants
1
  50.0%
0
   0.0%
1
  50.0%
0
   0.0%
4
  57.1%
1
   9.1%
0
   0.0%
1
  16.7%
0
   0.0%
15.Secondary Outcome
Title Progression Free Survival and Overall Survival (Part 2)
Hide Description Progression Free Survival was defined as the time from Cycle 1 Day 1 (C1D1) to first documentation of disease progression or to death due to any cause, whichever occurs first. Overall survival was defined as the time from initial dose until death from any cause, and is measured in the intent to treat population.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The study was prematurely terminated prior to the start of dose expansion phase (Part 2).
Arm/Group Title PF-06650808 2.4 mg/kg (Part 2)
Hide Arm/Group Description:
Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the MTD. The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 3 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PF-06650808 0.2 mg/kg PF-06650808 0.4 mg/kg PF-06650808 0.8 mg/kg PF-06650808 1.6 mg/kg PF-06650808 2.0 mg/kg PF-06650808 2.4 mg/kg PF-06650808 3.0 mg/kg PF-06650808 3.6 mg/kg PF-06650808 4.68 mg/kg
Hide Arm/Group Description PF-06650808 0.2 mg/kg was administered on Day 1 of each 21 day cycle per the DAI as an IV infusion over approximately 60 minutes. PF-06650808 0.4 mg/kg was administered on Day 1 of each 21 day cycle per the DAI as an IV infusion over approximately 60 minutes. PF-06650808 0.8 mg/kg was administered on Day 1 of each 21 day cycle per the DAI as an IV infusion over approximately 60 minutes. PF-06650808 1.6 mg/kg was administered on Day 1 of each 21 day cycle per the DAI as an IV infusion over approximately 60 minutes. PF-06650808 2.0 mg/kg was administered on Day 1 of each 21 day cycle per the DAI as an IV infusion over approximately 60 minutes. PF-06650808 2.4 mg/kg was administered on Day 1 of each 21 day cycle per the DAI as an IV infusion over approximately 60 minutes. PF-06650808 3.0 mg/kg was administered on Day 1 of each 21 day cycle per the DAI as an IV infusion over approximately 60 minutes. PF-06650808 3.6 mg/kg was administered on Day 1 of each 21 day cycle per the DAI as an IV infusion over approximately 60 minutes. PF-06650808 4.68 mg/kg was administered on Day 1 of each 21 day cycle per the DAI as an IV infusion over approximately 60 minutes.
All-Cause Mortality
PF-06650808 0.2 mg/kg PF-06650808 0.4 mg/kg PF-06650808 0.8 mg/kg PF-06650808 1.6 mg/kg PF-06650808 2.0 mg/kg PF-06650808 2.4 mg/kg PF-06650808 3.0 mg/kg PF-06650808 3.6 mg/kg PF-06650808 4.68 mg/kg
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   0/2 (0.00%)   0/2 (0.00%)   0/2 (0.00%)   0/2 (0.00%)   1/7 (14.29%)   1/11 (9.09%)   0/6 (0.00%)   0/6 (0.00%)   0/2 (0.00%) 
Hide Serious Adverse Events
PF-06650808 0.2 mg/kg PF-06650808 0.4 mg/kg PF-06650808 0.8 mg/kg PF-06650808 1.6 mg/kg PF-06650808 2.0 mg/kg PF-06650808 2.4 mg/kg PF-06650808 3.0 mg/kg PF-06650808 3.6 mg/kg PF-06650808 4.68 mg/kg
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   0/2 (0.00%)   0/2 (0.00%)   0/2 (0.00%)   0/2 (0.00%)   1/7 (14.29%)   3/11 (27.27%)   3/6 (50.00%)   3/6 (50.00%)   2/2 (100.00%) 
Blood and lymphatic system disorders                   
Anaemia * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/2 (0.00%) 
Febrile neutropenia * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  0/2 (0.00%) 
Neutropenia * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  2/2 (100.00%) 
Cardiac disorders                   
Acute myocardial infarction * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/2 (0.00%) 
Atrial fibrillation * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/11 (9.09%)  0/6 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Gastrointestinal disorders                   
Abdominal pain * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/2 (50.00%) 
Ascites * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/11 (9.09%)  0/6 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Diarrhoea * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/2 (0.00%) 
Enterocolitis * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/2 (50.00%) 
Nausea * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/2 (0.00%) 
Small intestinal obstruction * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/11 (9.09%)  0/6 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Vomiting * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/2 (0.00%) 
General disorders                   
Asthenia * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/2 (0.00%) 
Disease progression * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/11 (9.09%)  0/6 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Mucosal inflammation * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/2 (50.00%) 
Multiple organ dysfunction syndrome * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/2 (0.00%) 
Pyrexia * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  0/11 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/2 (0.00%) 
Infections and infestations                   
Upper respiratory tract infection * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/2 (0.00%) 
Urinary tract infection * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/11 (9.09%)  0/6 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Metabolism and nutrition disorders                   
Decreased appetite * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/2 (0.00%) 
Dehydration * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  0/2 (0.00%) 
Hyponatraemia * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/11 (9.09%)  1/6 (16.67%)  0/6 (0.00%)  0/2 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                   
Tumour pain * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/2 (0.00%) 
Nervous system disorders                   
Cerebrovascular accident * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/2 (0.00%) 
Encephalopathy * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/2 (0.00%) 
Psychiatric disorders                   
Mental status changes * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/2 (0.00%) 
Renal and urinary disorders                   
Acute kidney injury * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/2 (0.00%) 
Respiratory, thoracic and mediastinal disorders                   
Cough * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/2 (0.00%) 
Dyspnoea * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/2 (0.00%) 
Pleural effusion * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/11 (9.09%)  0/6 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Pulmonary embolism * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/2 (0.00%) 
Skin and subcutaneous tissue disorders                   
Rash macular * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/2 (50.00%) 
Vascular disorders                   
Deep vein thrombosis * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/2 (0.00%) 
Embolism * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/11 (9.09%)  0/6 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
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-06650808 0.2 mg/kg PF-06650808 0.4 mg/kg PF-06650808 0.8 mg/kg PF-06650808 1.6 mg/kg PF-06650808 2.0 mg/kg PF-06650808 2.4 mg/kg PF-06650808 3.0 mg/kg PF-06650808 3.6 mg/kg PF-06650808 4.68 mg/kg
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   2/2 (100.00%)   2/2 (100.00%)   2/2 (100.00%)   2/2 (100.00%)   7/7 (100.00%)   11/11 (100.00%)   6/6 (100.00%)   6/6 (100.00%)   2/2 (100.00%) 
Blood and lymphatic system disorders                   
Anaemia * 1  0/2 (0.00%)  0/2 (0.00%)  1/2 (50.00%)  0/2 (0.00%)  2/7 (28.57%)  3/11 (27.27%)  0/6 (0.00%)  2/6 (33.33%)  0/2 (0.00%) 
Leukopenia * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  1/11 (9.09%)  0/6 (0.00%)  0/6 (0.00%)  1/2 (50.00%) 
Neutropenia * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  2/11 (18.18%)  1/6 (16.67%)  1/6 (16.67%)  1/2 (50.00%) 
Thrombocytopenia * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/2 (0.00%) 
Cardiac disorders                   
Left ventricular dysfunction * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/11 (9.09%)  0/6 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Sinus tachycardia * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  1/11 (9.09%)  1/6 (16.67%)  1/6 (16.67%)  1/2 (50.00%) 
Tachycardia * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  1/11 (9.09%)  0/6 (0.00%)  1/6 (16.67%)  0/2 (0.00%) 
Endocrine disorders                   
Hypothyroidism * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/11 (9.09%)  0/6 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Eye disorders                   
Dry eye * 1  0/2 (0.00%)  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Foreign body sensation in eyes * 1  0/2 (0.00%)  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Vision blurred * 1  0/2 (0.00%)  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  0/11 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Gastrointestinal disorders                   
Abdominal distension * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  1/11 (9.09%)  0/6 (0.00%)  1/6 (16.67%)  0/2 (0.00%) 
Abdominal pain * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  2/11 (18.18%)  2/6 (33.33%)  3/6 (50.00%)  2/2 (100.00%) 
Cheilitis * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/2 (0.00%) 
Constipation * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  2/7 (28.57%)  4/11 (36.36%)  1/6 (16.67%)  3/6 (50.00%)  1/2 (50.00%) 
Diarrhoea * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  3/11 (27.27%)  1/6 (16.67%)  0/6 (0.00%)  1/2 (50.00%) 
Dyspepsia * 1  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  2/7 (28.57%)  2/11 (18.18%)  0/6 (0.00%)  0/6 (0.00%)  1/2 (50.00%) 
Dysphagia * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/11 (9.09%)  0/6 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Eructation * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  0/11 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Flatulence * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  0/11 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Gastrooesophageal reflux disease * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/11 (9.09%)  0/6 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Haematemesis * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/2 (50.00%) 
Ileus * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/2 (50.00%) 
Nausea * 1  1/2 (50.00%)  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  4/7 (57.14%)  5/11 (45.45%)  2/6 (33.33%)  1/6 (16.67%)  2/2 (100.00%) 
Rectal tenesmus * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/11 (9.09%)  0/6 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Retching * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/2 (0.00%) 
Stomatitis * 1  0/2 (0.00%)  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/11 (9.09%)  1/6 (16.67%)  0/6 (0.00%)  1/2 (50.00%) 
Vomiting * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  5/7 (71.43%)  2/11 (18.18%)  0/6 (0.00%)  0/6 (0.00%)  2/2 (100.00%) 
General disorders                   
Adverse drug reaction * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/2 (50.00%)  0/7 (0.00%)  0/11 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Asthenia * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/2 (0.00%) 
Chest discomfort * 1  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/2 (0.00%) 
Chest pain * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/2 (0.00%) 
Chills * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  1/11 (9.09%)  0/6 (0.00%)  0/6 (0.00%)  1/2 (50.00%) 
Fatigue * 1  0/2 (0.00%)  0/2 (0.00%)  1/2 (50.00%)  1/2 (50.00%)  3/7 (42.86%)  8/11 (72.73%)  3/6 (50.00%)  3/6 (50.00%)  0/2 (0.00%) 
Gait disturbance * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/11 (9.09%)  0/6 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Induration * 1  0/2 (0.00%)  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Malaise * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/11 (9.09%)  0/6 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Mucosal inflammation * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  2/2 (100.00%) 
Non-cardiac chest pain * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/2 (0.00%) 
Oedema peripheral * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  0/11 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/2 (0.00%) 
Pain * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  0/6 (0.00%)  3/6 (50.00%)  0/2 (0.00%) 
Peripheral swelling * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/2 (0.00%) 
Pyrexia * 1  0/2 (0.00%)  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  2/11 (18.18%)  0/6 (0.00%)  0/6 (0.00%)  2/2 (100.00%) 
Immune system disorders                   
Seasonal allergy * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/2 (0.00%) 
Infections and infestations                   
Candida infection * 1  0/2 (0.00%)  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  0/11 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Conjunctivitis * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  2/11 (18.18%)  0/6 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Cystitis * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/2 (0.00%) 
Folliculitis * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/2 (50.00%) 
Herpes zoster * 1  0/2 (0.00%)  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Lung infection * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/11 (9.09%)  0/6 (0.00%)  1/6 (16.67%)  0/2 (0.00%) 
Skin infection * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  0/11 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Injury, poisoning and procedural complications                   
Arthropod bite * 1  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Fall * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/2 (0.00%) 
Investigations                   
Activated partial thromboplastin time prolonged * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  1/11 (9.09%)  1/6 (16.67%)  1/6 (16.67%)  0/2 (0.00%) 
Alanine aminotransferase increased * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  1/11 (9.09%)  2/6 (33.33%)  0/6 (0.00%)  0/2 (0.00%) 
Aspartate aminotransferase increased * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  2/7 (28.57%)  1/11 (9.09%)  2/6 (33.33%)  0/6 (0.00%)  0/2 (0.00%) 
Blood alkaline phosphatase * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  0/11 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Blood alkaline phosphatase increased * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/11 (9.09%)  0/6 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Blood creatine increased * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  0/11 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Blood parathyroid hormone increased * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/2 (50.00%) 
Electrocardiogram QT prolonged * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  2/6 (33.33%)  0/6 (0.00%)  0/2 (0.00%) 
International normalised ratio increased * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  2/11 (18.18%)  0/6 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Lymphocyte count decreased * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  2/7 (28.57%)  2/11 (18.18%)  2/6 (33.33%)  1/6 (16.67%)  0/2 (0.00%) 
Neutrophil count decreased * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  1/11 (9.09%)  1/6 (16.67%)  1/6 (16.67%)  0/2 (0.00%) 
Platelet count decreased * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  0/11 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Weight decreased * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  2/11 (18.18%)  1/6 (16.67%)  1/6 (16.67%)  0/2 (0.00%) 
White blood cell count * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/2 (0.00%) 
White blood cell count decreased * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  2/7 (28.57%)  4/11 (36.36%)  2/6 (33.33%)  1/6 (16.67%)  0/2 (0.00%) 
White blood cell count increased * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/11 (9.09%)  0/6 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Metabolism and nutrition disorders                   
Decreased appetite * 1  1/2 (50.00%)  2/2 (100.00%)  0/2 (0.00%)  0/2 (0.00%)  4/7 (57.14%)  5/11 (45.45%)  6/6 (100.00%)  3/6 (50.00%)  2/2 (100.00%) 
Dehydration * 1  0/2 (0.00%)  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  4/11 (36.36%)  2/6 (33.33%)  1/6 (16.67%)  1/2 (50.00%) 
Hypercalcaemia * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/2 (0.00%) 
Hyperglycaemia * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  2/11 (18.18%)  2/6 (33.33%)  1/6 (16.67%)  0/2 (0.00%) 
Hyperuricaemia * 1  0/2 (0.00%)  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  2/7 (28.57%)  1/11 (9.09%)  0/6 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Hypoalbuminaemia * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  1/11 (9.09%)  1/6 (16.67%)  1/6 (16.67%)  0/2 (0.00%) 
Hypocalcaemia * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/11 (9.09%)  0/6 (0.00%)  1/6 (16.67%)  0/2 (0.00%) 
Hypoglycaemia * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/2 (0.00%) 
Hypokalaemia * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  3/7 (42.86%)  3/11 (27.27%)  1/6 (16.67%)  2/6 (33.33%)  1/2 (50.00%) 
Hypomagnesaemia * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  2/11 (18.18%)  2/6 (33.33%)  1/6 (16.67%)  1/2 (50.00%) 
Hyponatraemia * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  3/11 (27.27%)  1/6 (16.67%)  4/6 (66.67%)  0/2 (0.00%) 
Hypophosphataemia * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  2/11 (18.18%)  1/6 (16.67%)  1/6 (16.67%)  0/2 (0.00%) 
Musculoskeletal and connective tissue disorders                   
Arthralgia * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/2 (50.00%)  2/7 (28.57%)  2/11 (18.18%)  1/6 (16.67%)  1/6 (16.67%)  2/2 (100.00%) 
Back pain * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  0/11 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/2 (50.00%) 
Bone pain * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  2/7 (28.57%)  4/11 (36.36%)  0/6 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Muscle spasms * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  0/11 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Muscle tightness * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/2 (0.00%) 
Muscular weakness * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/11 (9.09%)  1/6 (16.67%)  0/6 (0.00%)  0/2 (0.00%) 
Musculoskeletal chest pain * 1  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  0/11 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Musculoskeletal discomfort * 1  0/2 (0.00%)  0/2 (0.00%)  1/2 (50.00%)  0/2 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Musculoskeletal pain * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/2 (0.00%) 
Myalgia * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/2 (50.00%)  1/7 (14.29%)  2/11 (18.18%)  2/6 (33.33%)  1/6 (16.67%)  1/2 (50.00%) 
Pain in extremity * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/2 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                   
Tumour pain * 1  0/2 (0.00%)  1/2 (50.00%)  1/2 (50.00%)  0/2 (0.00%)  0/7 (0.00%)  1/11 (9.09%)  0/6 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Nervous system disorders                   
Cognitive disorder * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/11 (9.09%)  0/6 (0.00%)  1/6 (16.67%)  1/2 (50.00%) 
Dizziness * 1  0/2 (0.00%)  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  2/7 (28.57%)  1/11 (9.09%)  0/6 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Dysgeusia * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  1/11 (9.09%)  1/6 (16.67%)  0/6 (0.00%)  0/2 (0.00%) 
Headache * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  3/7 (42.86%)  1/11 (9.09%)  1/6 (16.67%)  0/6 (0.00%)  0/2 (0.00%) 
Hypoaesthesia * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/11 (9.09%)  0/6 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Neuropathy peripheral * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  2/7 (28.57%)  0/11 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  0/2 (0.00%) 
Nystagmus * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  0/11 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Paraesthesia * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  0/11 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/2 (0.00%) 
Peripheral sensory neuropathy * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/11 (9.09%)  1/6 (16.67%)  1/6 (16.67%)  0/2 (0.00%) 
Restless legs syndrome * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  0/11 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Sedation * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/2 (0.00%) 
Psychiatric disorders                   
Anxiety * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/2 (50.00%) 
Confusional state * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/2 (0.00%) 
Delirium * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/11 (9.09%)  0/6 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Depression * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  2/11 (18.18%)  0/6 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Insomnia * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/2 (50.00%)  0/7 (0.00%)  3/11 (27.27%)  1/6 (16.67%)  1/6 (16.67%)  0/2 (0.00%) 
Restlessness * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  0/11 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Renal and urinary disorders                   
Haematuria * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/2 (0.00%) 
Pollakiuria * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/11 (9.09%)  0/6 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Proteinuria * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/2 (0.00%) 
Reproductive system and breast disorders                   
Breast pain * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/2 (0.00%) 
Menopausal symptoms * 1  0/2 (0.00%)  0/2 (0.00%)  1/2 (50.00%)  0/2 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Respiratory, thoracic and mediastinal disorders                   
Bronchospasm * 1  0/2 (0.00%)  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Cough * 1  0/2 (0.00%)  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  2/7 (28.57%)  1/11 (9.09%)  0/6 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Dysphonia * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  0/11 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Dyspnoea * 1  0/2 (0.00%)  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  4/11 (36.36%)  1/6 (16.67%)  0/6 (0.00%)  0/2 (0.00%)