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A Study of PF-05082566 In Combination With Mogamulizumab 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: NCT02444793
Recruitment Status : Terminated (The study was terminated due to marginal efficacy and change in sponsor prioritization. The combination had a manageable safety profile.)
First Posted : May 14, 2015
Results First Posted : February 15, 2019
Last Update Posted : February 27, 2019
Sponsor:
Collaborator:
Kyowa Kirin Co., Ltd.
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Masking: None (Open Label);   Primary Purpose: Treatment
Condition Advanced/Metastatic Solid Tumors
Interventions Drug: PF-05082566
Drug: KW-0761
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 100 mg + Mogamulizumab 1 mg/kg PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg
Hide Arm/Group Description PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
Period Title: Overall Study
Started 11 6 4 3
Completed 0 0 0 0
Not Completed 11 6 4 3
Reason Not Completed
Lost to Follow-up             2             2             0             0
Death             0             3             0             0
Other             0             0             2             0
Objective progression or relapse             9             1             2             3
Arm/Group Title PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 100 mg + Mogamulizumab 1 mg/kg PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg Total
Hide Arm/Group Description PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. Total of all reporting groups
Overall Number of Baseline Participants 11 6 4 3 24
Hide Baseline Analysis Population Description
Included all enrolled participants who received at least 1 dose of study treatment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 6 participants 4 participants 3 participants 24 participants
61.5  (4.9) 66.2  (8.6) 67.8  (4.0) 62.7  (8.7) 63.9  (6.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 6 participants 4 participants 3 participants 24 participants
Female
1
   9.1%
1
  16.7%
2
  50.0%
1
  33.3%
5
  20.8%
Male
10
  90.9%
5
  83.3%
2
  50.0%
2
  66.7%
19
  79.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 6 participants 4 participants 3 participants 24 participants
White
9
  81.8%
6
 100.0%
3
  75.0%
1
  33.3%
19
  79.2%
Black
2
  18.2%
0
   0.0%
1
  25.0%
1
  33.3%
4
  16.7%
Other
0
   0.0%
0
   0.0%
0
   0.0%
1
  33.3%
1
   4.2%
1.Primary Outcome
Title Number of Participants With Dose Limiting Toxicities (DLT)
Hide Description DLTs was defined as any of the following adverse events (AEs) according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 at first 2 Cycles. Hematologic: (1) Grade 4 neutropenia lasting >7 days; (2) Febrile neutropenia, defined as absolute neutrophil count (ANC) <1000/mm3 with a single temperature of >38.3 degrees C (101 degrees F) or a sustained temperature of >=38 degrees C (100.4 degrees F) for more than 1 hour; (3) Grade >=3 neutropenic infection; (4) Grade >=3 thrombocytopenia with bleeding; (5) Grade 4 thrombocytopenia. Non-Hematologic: (1) Grade >=3 non laboratory toxicities (excluding infusion reactions), except those that had not been maximally treated (eg, nausea, vomiting, diarrhea); (2) Grade >=3 laboratory abnormalities (other than aspartate aminotransferase [AST]/alanine aminotransferase [ALT]) if: Medical intervention was required to treat the participant, or The abnormality led to hospitalization; (3) Grade 4 AST and ALT increase.
Time Frame First 2 Cycles (28 days in each cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who were eligible for the study and received study treatment.
Arm/Group Title PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 100 mg + Mogamulizumab 1 mg/kg PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg
Hide Arm/Group Description:
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
Overall Number of Participants Analyzed 11 6 4 3
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2.Secondary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (All Causalities)
Hide Description An AE was any untoward medical occurrence in a participant administered a product or medical device without regard to possibility of causal relationship. 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 prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduction normal life functions); resulted in congenital anomaly/birth defect. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study treatment. AEs were graded by the investigator according to NCI CTCAE version 4.03 (Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE). AEs included non-serious AEs and SAEs.
Time Frame Day 1 up to 60 days after last dose of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least 1 dose of study treatment.
Arm/Group Title PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 100 mg + Mogamulizumab 1 mg/kg PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg
Hide Arm/Group Description:
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
Overall Number of Participants Analyzed 11 6 4 3
Measure Type: Count of Participants
Unit of Measure: Participants
AEs
11
 100.0%
6
 100.0%
4
 100.0%
3
 100.0%
SAEs
3
  27.3%
3
  50.0%
2
  50.0%
2
  66.7%
Grade 3 or 4
2
  18.2%
3
  50.0%
2
  50.0%
1
  33.3%
Grade 5
0
   0.0%
2
  33.3%
0
   0.0%
0
   0.0%
3.Secondary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (PF-05082566 Related)
Hide Description An AE was any untoward medical occurrence in a participant administered a product or medical device has a causal relationship with PF-05082566. 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 prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduction normal life functions); resulted in congenital anomaly/birth defect. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study treatment. AEs were graded by the investigator according to NCI CTCAE version 4.03 (Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE). AEs included non-serious AEs and SAEs.
Time Frame Day 1 up to 60 days after last dose of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least 1 dose of study treatment.
Arm/Group Title PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 100 mg + Mogamulizumab 1 mg/kg PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg
Hide Arm/Group Description:
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
Overall Number of Participants Analyzed 11 6 4 3
Measure Type: Count of Participants
Unit of Measure: Participants
AEs
7
  63.6%
6
 100.0%
3
  75.0%
3
 100.0%
SAEs
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 3 or 4 AEs
0
   0.0%
2
  33.3%
0
   0.0%
0
   0.0%
Grade 5 AEs
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
4.Secondary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (Mogamulizumab Related)
Hide Description An AE was any untoward medical occurrence in a participant administered a product or medical device has a causal relationship with Mogamulizumab. 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 prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduction normal life functions); resulted in congenital anomaly/birth defect. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study treatment. AEs were graded by the investigator according to NCI CTCAE version 4.03 (Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE). AEs included non-serious AEs and SAEs.
Time Frame Day 1 up tp 60 days after last dose of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least 1 dose of study treatment.
Arm/Group Title PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 100 mg + Mogamulizumab 1 mg/kg PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg
Hide Arm/Group Description:
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
Overall Number of Participants Analyzed 11 6 4 3
Measure Type: Count of Participants
Unit of Measure: Participants
AEs
7
  63.6%
6
 100.0%
4
 100.0%
3
 100.0%
SAEs
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 3 or 4 AEs
0
   0.0%
2
  33.3%
0
   0.0%
0
   0.0%
Grade 5 AEs
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
5.Secondary Outcome
Title Number of Participants With Hematology Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4
Hide Description The hematology laboratory tests include: Anemia, Hemoglobin increased, Lymphocyte count increased, Lymphopenia, Neutrophils (absolute), Platelets, White blood cells.
Time Frame Screening (within 28 days prior to registration) up to 28 days (+7 days) after the last dose of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least 1 dose of study treatment.
Arm/Group Title PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 100 mg + Mogamulizumab 1 mg/kg PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg
Hide Arm/Group Description:
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
Overall Number of Participants Analyzed 11 6 4 3
Measure Type: Count of Participants
Unit of Measure: Participants
Anemia
1
   9.1%
1
  16.7%
0
   0.0%
0
   0.0%
Hemoglobin increased
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%
Lymphopenia
6
  54.5%
0
   0.0%
2
  50.0%
0
   0.0%
Neutrophils (absolute)
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Platelets
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White blood cells
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
6.Secondary Outcome
Title Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4
Hide Description The chemistry laboratory tests included: Alanine aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Lactate Dehydrogenase, Sodium, Potassium, Magnesium, Total Calcium, Phosphorus or Phosphate, Total bilirubin, Creatinine or creatinine clearance, Albumin, Total proteins, Uric Acid, BUN or Urea, Immunoglobulin G, Glucose (fasted).
Time Frame Screening (within 28 days prior to registration) up to 28 days (+7 days) after the last dose of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least 1 dose of study treatment.
Arm/Group Title PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 100 mg + Mogamulizumab 1 mg/kg PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg
Hide Arm/Group Description:
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
Overall Number of Participants Analyzed 11 6 4 3
Measure Type: Count of Participants
Unit of Measure: Participants
ALT
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Alkaline phosphatase
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
AST
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Bilirubin (total)
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Creatinine
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hypercalcemia
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hyperglycemia
1
   9.1%
1
  16.7%
1
  25.0%
0
   0.0%
Hyperkalemia
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%
Hypernatremia
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%
Hypocalcemia
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%
Hypokalemia
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hypomagnesemia
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hyponatremia
1
   9.1%
0
   0.0%
0
   0.0%
0
   0.0%
Hypophosphatemia
1
   9.1%
1
  16.7%
0
   0.0%
0
   0.0%
7.Secondary Outcome
Title Number of Participants With Clinical Significant Observations in Vital Signs
Hide Description Blood pressure (BP) and pulse rate were recorded in supine or sitting position.
Time Frame Screening (within 28 days prior to registration) up to 28 days (+7 days) after the last dose of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least 1 dose of study treatment.
Arm/Group Title PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 100 mg + Mogamulizumab 1 mg/kg PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg
Hide Arm/Group Description:
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
Overall Number of Participants Analyzed 11 6 4 3
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
8.Secondary Outcome
Title Number of Participants With Significant Changes From Baseline in Physical Examination
Hide Description Physical examination included an examination of major body systems, including general, head, ears, eyes, nose, mouth, throat, neck, lungs, heart, abdomen, musculoskeletal, lymph nodes, neurological and external genitalia. Significant changes from baseline were reported in each category.
Time Frame Cycle 2 Day 1; End of the treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least 1 dose of study treatment. Number analyzed was the number of participants at the given category.
Arm/Group Title PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 100 mg + Mogamulizumab 1 mg/kg PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg
Hide Arm/Group Description:
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
Overall Number of Participants Analyzed 11 6 4 3
Measure Type: Count of Participants
Unit of Measure: Participants
Cycle 2 Day 1 Number Analyzed 11 participants 5 participants 3 participants 3 participants
1
   9.1%
1
  20.0%
1
  33.3%
0
   0.0%
End of Treatment Number Analyzed 10 participants 4 participants 2 participants 3 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
9.Secondary Outcome
Title Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Shift to Grades 2, 3, 4 or 5
Hide Description ECOG performance status was classified as 5 grades: 0 (Fully active, able to carry on all predisease performance without restriction); 1 (Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, ie, light house work, office work); 2 (Ambulatory and capable of all self care but unable to carry out any work activities. Up and about more than 50% of waking hours); 3 (Capable of only limited self care, confined to bed or chair more than 50% of waking hours); 4 (Completely disabled. Cannot carry on any self care. Totally confined to bed or chair); 5 (Death). On-study shifts to ECOG performance statuses of 2, 3, 4 or 5 were reported.
Time Frame Screening (within 28 days prior to registration) up to 28 days (+7 days) after the last dose of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least 1 dose of study treatment.
Arm/Group Title PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 100 mg + Mogamulizumab 1 mg/kg PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg
Hide Arm/Group Description:
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
Overall Number of Participants Analyzed 11 6 4 3
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
10.Secondary Outcome
Title Maximum Observed Serum Concentration (Cmax) of PF-05082566-Cycle 5
Hide Description Maximum Observed Serum Concentration (Cmax) was observed directly from the data.
Time Frame Cycle 5: Day 1 at pre-dose, at the end of PF-05082566 infusion, and at 2, 6, 168 hours (Day 8) and 336 hours (Day 15) after the start of PF-05082566 infusion.
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest.
Arm/Group Title PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 100 mg + Mogamulizumab 1 mg/kg PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg
Hide Arm/Group Description:
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
Overall Number of Participants Analyzed 2 1 0 2
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: μg/mL
18.71 [1] 
(NA%)
27.80 [1] 
(NA%)
105.7 [1] 
(NA%)
[1]
fewer than 3 participants had reportable parameter values
11.Secondary Outcome
Title Dose Normalized Cmax of PF-05082566-Cycle 5
Hide Description Dose normalized Cmax was calculated by Cmax / Dose
Time Frame Cycle 5: Day 1 at pre-dose, at the end of PF-05082566 infusion, and at 2, 6, 168 hours (Day 8) and 336 hours (Day 15) after the start of PF-05082566 infusion.
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest.
Arm/Group Title PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 100 mg + Mogamulizumab 1 mg/kg PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg
Hide Arm/Group Description:
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
Overall Number of Participants Analyzed 2 1 0 2
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: µg/mL/mg/kg
15.61 [1] 
(NA%)
25.60 [1] 
(NA%)
21.13 [1] 
(NA%)
[1]
fewer than 3 participants had reportable parameter values
12.Secondary Outcome
Title Cmax of Mogamulizumab-Cycles 1 and 5
Hide Description Maximum Observed Serum Concentration (Cmax) was observed directly from the data.
Time Frame Cycle 1: pre-dose and at the end of mogamulizumab infusion on Days 1, 8, 15 and 22; Cycle 5: Pre-dose, at the end of mogamulizumab infusion, and at 6 hours, 168 hours (Day 8) after the start of the mogamulizumab infusion; Pre-dose on Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest.
Arm/Group Title PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 100 mg + Mogamulizumab 1 mg/kg PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg
Hide Arm/Group Description:
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
Overall Number of Participants Analyzed 11 5 4 3
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: μg/mL
Cycle 1 Number Analyzed 11 participants 5 participants 4 participants 3 participants
18.78
(19%)
19.73
(32%)
19.77
(16%)
19.82
(19%)
Cycle 5 Number Analyzed 2 participants 1 participants 0 participants 2 participants
31.05 [1] 
(NA%)
31.90 [1] 
(NA%)
32.62 [1] 
(NA%)
[1]
fewer than 3 participants had reportable parameter values
13.Secondary Outcome
Title Pre-dose Concentration During Multiple Dosing (Ctrough) of PF-05082566-Cycle 5
Hide Description Pre-dose Concentration during Multiple Dosing (Ctrough) was observed directly from data
Time Frame Cycle 5: Day 1 at pre-dose, at the end of PF-05082566 infusion, and at 2, 6, 168 hours (Day 8) and 336 hours (Day 15) after the start of PF-05082566 infusion.
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest.
Arm/Group Title PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 100 mg + Mogamulizumab 1 mg/kg PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg
Hide Arm/Group Description:
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
Overall Number of Participants Analyzed 1 1 0 2
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: μg/mL
1.300 [1] 
(NA%)
1.160 [1] 
(NA%)
3.464 [1] 
(NA%)
[1]
fewer than 3 participants had reportable parameter values
14.Secondary Outcome
Title Ctrough of Mogamulizumab- Cycle 5
Hide Description Pre-dose Concentration during Multiple Dosing (Ctrough) was observed directly from data.
Time Frame Cycle 5: Pre-dose, at the end of mogamulizumab infusion, and at 6 hours, 168 hours (Day 8) after the start of the mogamulizumab infusion; Pre-dose on Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest.
Arm/Group Title PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 100 mg + Mogamulizumab 1 mg/kg PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg
Hide Arm/Group Description:
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
Overall Number of Participants Analyzed 2 1 0 2
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: μg/mL
15.45 [1] 
(NA%)
9.040 [1] 
(NA%)
15.99 [1] 
(NA%)
[1]
fewer than 3 participants had reportable parameter values
15.Secondary Outcome
Title Time for Cmax (Tmax) of PF-05082566-Cycle 5
Hide Description Time for Cmax (Tmax) was observed directly from the data.
Time Frame Cycle 5: Day 1 at pre-dose, at the end of PF-05082566 infusion, and at 2, 6, 168 hours (Day 8) and 336 hours (Day 15) after the start of PF-05082566 infusion.
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest.
Arm/Group Title PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 100 mg + Mogamulizumab 1 mg/kg PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg
Hide Arm/Group Description:
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
Overall Number of Participants Analyzed 2 1 0 2
Median (Full Range)
Unit of Measure: hour
2.02
(2.00 to 2.03)
6.00
(6.00 to 6.00)
1.08
(1.00 to 1.25)
16.Secondary Outcome
Title Time of Last Measurable Concentration (Tlast) of PF-05082566-Cycle 5
Hide Description Time of last measurable concentration was observed directly from data.
Time Frame Cycle 5: Day 1 at pre-dose, at the end of PF-05082566 infusion, and at 2, 6, 168 hours (Day 8) and 336 hours (Day 15) after the start of PF-05082566 infusion.
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest.
Arm/Group Title PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 100 mg + Mogamulizumab 1 mg/kg PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg
Hide Arm/Group Description:
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
Overall Number of Participants Analyzed 2 1 0 2
Median (Full Range)
Unit of Measure: hour
336
(335 to 336)
309
(309 to 309)
97.6
(25.1 to 170)
17.Secondary Outcome
Title Tmax of Mogamulizumab-Cycles 1 and 5
Hide Description Time for Cmax (Tmax) was observed directly from the data.
Time Frame Cycle 1: pre-dose and at the end of mogamulizumab infusion on Days 1, 8, 15 and 22; Cycle 5: Pre-dose, at the end of mogamulizumab infusion, and at 6 hours, 168 hours (Day 8) after the start of the mogamulizumab infusion; Pre-dose on Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest.
Arm/Group Title PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 100 mg + Mogamulizumab 1 mg/kg PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg
Hide Arm/Group Description:
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
Overall Number of Participants Analyzed 11 5 4 3
Median (Full Range)
Unit of Measure: hour
Cycle 1 Number Analyzed 11 participants 5 participants 4 participants 3 participants
1.28
(1.00 to 5.50)
1.30
(1.10 to 2.25)
1.24
(1.15 to 4.58)
1.03
(0.917 to 1.18)
Cycle 5 Number Analyzed 2 participants 1 participants 0 participants 2 participants
13.5
(4.52 to 22.4)
1.05
(1.05 to 1.05)
1.05
(1.02 to 1.07)
18.Secondary Outcome
Title Tlast of Mogamulizumab-Cycles 1 and 5
Hide Description Time of last measurable concentration was observed directly from the data.
Time Frame Cycle 1: pre-dose and at the end of mogamulizumab infusion on Days 1, 8, 15 and 22; Cycle 5: Pre-dose, at the end of mogamulizumab infusion, and at 6 hours, 168 hours (Day 8) after the start of the mogamulizumab infusion; Pre-dose on Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest.
Arm/Group Title PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 100 mg + Mogamulizumab 1 mg/kg PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg
Hide Arm/Group Description:
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
Overall Number of Participants Analyzed 11 5 4 3
Median (Full Range)
Unit of Measure: hour
Cycle 1 Number Analyzed 11 participants 5 participants 4 participants 3 participants
166
(164 to 285)
166
(163 to 214)
143
(22.4 to 194)
166
(166 to 171)
Cycle 5 Number Analyzed 2 participants 1 participants 0 participants 2 participants
335
(334 to 335)
308
(308 to 308)
107
(45.2 to 168)
19.Secondary Outcome
Title Area Under the Serum Concentration-time Profile From Time 0 to the Time of the Last Measurable Concentration (AUClast) of PF-05082566-Cycle 5
Hide Description AUClast was area under the serum concentration-time profile from time 0 to the time of the last measurable concentration (Clast), which was measured by Linear/Log trapezoidal method.
Time Frame Cycle 5: Day 1 at pre-dose, at the end of PF-05082566 infusion, and at 2, 6, 168 hours (Day 8) and 336 hours (Day 15) after the start of PF-05082566 infusion.
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest.
Arm/Group Title PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 100 mg + Mogamulizumab 1 mg/kg PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg
Hide Arm/Group Description:
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
Overall Number of Participants Analyzed 2 1 0 2
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: μg*hr/mL
1143 [1] 
(NA%)
2700 [1] 
(NA%)
3875 [1] 
(NA%)
[1]
fewer than 3 participants had reportable parameter values
20.Secondary Outcome
Title Dose Normalized AUClast of PF-05082566-Cycle 5
Hide Description Dose normalized AUClast was calculated by AUClast / Dose
Time Frame Cycle 5: Day 1 at pre-dose, at the end of PF-05082566 infusion, and at 2, 6, 168 hours (Day 8) and 336 hours (Day 15) after the start of PF-05082566 infusion.
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest.
Arm/Group Title PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 100 mg + Mogamulizumab 1 mg/kg PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg
Hide Arm/Group Description:
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
Overall Number of Participants Analyzed 2 1 0 2
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: µg•hr/mL/mg/kg
952.5 [1] 
(NA%)
2490 [1] 
(NA%)
773.0 [1] 
(NA%)
[1]
fewer than 3 participants had reportable parameter values
21.Secondary Outcome
Title AUClast of Mogamulizumab-Cycles 1 and 5
Hide Description AUClast was area under the serum concentration-time profile from time 0 to the time of the last measurable concentration (Clast), which was measured by Linear/Log trapezoidal method.
Time Frame Cycle 1: pre-dose and at the end of mogamulizumab infusion on Days 1, 8, 15 and 22; Cycle 5: Pre-dose, at the end of mogamulizumab infusion, and at 6 hours, 168 hours (Day 8) after the start of the mogamulizumab infusion; Pre-dose on Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest.
Arm/Group Title PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 100 mg + Mogamulizumab 1 mg/kg PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg
Hide Arm/Group Description:
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
Overall Number of Participants Analyzed 11 5 4 3
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: μg*hr/mL
Cycle 1 Number Analyzed 11 participants 5 participants 4 participants 3 participants
2001
(24%)
2182
(36%)
1382
(133%)
2126
(24%)
Cycle 5 Number Analyzed 2 participants 1 participants 0 participants 2 participants
6853 [1] 
(NA%)
5870 [1] 
(NA%)
2310 [1] 
(NA%)
[1]
fewer than 3 participants had reportable parameter values
22.Secondary Outcome
Title Area Under the Serum Concentration-time Profile From Time 0 to 168 Hours (AUC168) of Mogamulizumab-Cycle 1
Hide Description AUC168 was area under the serum concentration-time profile from time 0 to 168 hours post dose (Cycle 1 only where dosing was once a week), which was measured by Linear/Log trapezoidal method.
Time Frame Cycle 1: pre-dose and at the end of mogamulizumab infusion on Days 1, 8, 15 and 22
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest.
Arm/Group Title PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 100 mg + Mogamulizumab 1 mg/kg PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg
Hide Arm/Group Description:
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
Overall Number of Participants Analyzed 11 5 3 3
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: μg*hr/mL
1945
(25%)
2124
(33%)
2353
(14%)
2123
(24%)
23.Secondary Outcome
Title Area Under the Serum Concentration-time Profile From Time 0 to Time Tau (AUCtau) of Mogamulizumab-Cycle 5
Hide Description AUCtau was area under the serum concentration-time profile from time 0 to time tau, the dosing interval, where tau=336 hours
Time Frame Cycle 5: Pre-dose, at the end of mogamulizumab infusion, and at 6 hours, 168 hours (Day 8) after the start of the mogamulizumab infusion; Pre-dose on Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest.
Arm/Group Title PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 100 mg + Mogamulizumab 1 mg/kg PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg
Hide Arm/Group Description:
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
Overall Number of Participants Analyzed 2 1 0 1
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: μg*hr/mL
6868 [1] 
(NA%)
6160 [1] 
(NA%)
6950 [1] 
(NA%)
[1]
fewer than 3 participants had reportable parameter values
24.Secondary Outcome
Title Clearance (CL) of Mogamulizumab-Cycle 5
Hide Description Clearance (CL) was measured by Dose / AUCtau
Time Frame Cycle 5: Pre-dose, at the end of mogamulizumab infusion, and at 6 hours, 168 hours (Day 8) after the start of the mogamulizumab infusion; Pre-dose on Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest.
Arm/Group Title PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 100 mg + Mogamulizumab 1 mg/kg PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg
Hide Arm/Group Description:
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
Overall Number of Participants Analyzed 2 1 0 1
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mL/hr/kg
0.146 [1] 
(NA%)
0.162 [1] 
(NA%)
0.144 [1] 
(NA%)
[1]
fewer than 3 participants had reportable parameter values
25.Secondary Outcome
Title Anti-Drug Antibody (ADA) Titer for PF-05082566
Hide Description Serum samples were assayed for ADA using a validated analytical method.
Time Frame Pre-dose on Day 1 of Cycles 1, 3, 5, 8, 12, 16, 20, 24 up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed was determined as participants with treatment-induced ADA.
Arm/Group Title PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 100 mg + Mogamulizumab 1 mg/kg PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg
Hide Arm/Group Description:
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
Overall Number of Participants Analyzed 7 3 1 2
Median (Inter-Quartile Range)
Unit of Measure: Titer
14.98
(12.31 to 16.31)
10.80
(6.23 to 10.92)
17.25 [1] 
(NA to NA)
8.03
(6.23 to 9.82)
[1]
Only 1 participant was positive for ADA
26.Secondary Outcome
Title Neutralizing Antibodies (NAb) Titers for PF-05082566
Hide Description ADA positive samples were further analyzed for NAb using a validated assay.
Time Frame Pre-dose on Day 1 of Cycles 1, 3, 5, 8, 12, 16, 20, 24 up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed was determined as participants with treatment-induced NAb.
Arm/Group Title PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 100 mg + Mogamulizumab 1 mg/kg PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg
Hide Arm/Group Description:
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
Overall Number of Participants Analyzed 7 2 1 1
Median (Inter-Quartile Range)
Unit of Measure: Titer
1.80
(1.56 to 1.86)
1.30
(1.30 to 1.30)
2.64 [1] 
(NA to NA)
1.30 [1] 
(NA to NA)
[1]
Only 1 participant was positive for NAb
27.Secondary Outcome
Title Anti-Drug Antibody (ADA) Titers for Mogamulizumab
Hide Description Serum samples were assayed for ADA using a validated analytical method.
Time Frame Pre-dose on Day 1 of Cycles 1, 3, 5, 8, 12, 16, 20, 24 up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed was determined as participants with treatment-induced ADA.
Arm/Group Title PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 100 mg + Mogamulizumab 1 mg/kg PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg
Hide Arm/Group Description:
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
Overall Number of Participants Analyzed 0 1 0 0
Median (Inter-Quartile Range)
Unit of Measure: Titer
1024 [1] 
(NA to NA)
[1]
Only 1 participant was positive for ADA
28.Secondary Outcome
Title Neutralizing Antibodies (NAb) Titers for Mogamulizumab
Hide Description ADA positive samples were further analyzed for NAb using a validated assay
Time Frame Pre-dose on Day 1 of Cycles 1, 3, 5, 8, 12, 16, 20, 24 up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed was determined as participants with treatment-induced NAb.
Arm/Group Title PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 100 mg + Mogamulizumab 1 mg/kg PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg
Hide Arm/Group Description:
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
29.Secondary Outcome
Title Number of Participants With Objective Response (OR) and Immune-related Objective Response (irOR)
Hide Description OR was defined as best overall response (BOR) of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1. Immune-related OR (irOR) was defined as immune-related BOR (irBOR) of immune-related CR (irCR) and immune-related PR (irPR) according to immune-related RECIST. CR: Complete disappearance of all target lesions with the exception of nodal disease; PR: Greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions.
Time Frame Every 8 weeks up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all enrolled participants.
Arm/Group Title PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 100 mg + Mogamulizumab 1 mg/kg PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg
Hide Arm/Group Description:
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
Overall Number of Participants Analyzed 11 6 4 3
Measure Type: Count of Participants
Unit of Measure: Participants
Objective Response
0
   0.0%
1
  16.7%
0
   0.0%
0
   0.0%
immune-related Objective Response
0
   0.0%
1
  16.7%
0
   0.0%
0
   0.0%
30.Secondary Outcome
Title Time to Response (TTR) and Immue-related Time to Response (irTTR)-Dose Expansion Portion
Hide Description TTR was defined, for participants with an OR, as the time from the date of first dose of study treatment to the first documentation of OR (CR or PR), which was subsequently confirmed. irTTR was defined, for participants with an irOR, as the time from the first dose of study treatment to the first documentation of irOR (irCR or irPR) which was subsequently confirmed. CR: Complete disappearance of all target lesions with the exception of nodal disease; PR: Greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions.
Time Frame Every 8 weeks up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
No participants were enrolled in the dose-expansion portion.
Arm/Group Title Dose Expansion Cohort
Hide Arm/Group Description:
Expansion cohorts of participants were to be enrolled to further study the safety, tolerability, PK/PD, and preliminary anti tumor activity for PF-05082566 in combination with mogamulizumab, as well as to study tumor associated biomarkers.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
31.Secondary Outcome
Title Duration of Response (DR) and Immune-related DR (irDR) -Dose Expansion Portion
Hide Description DR was defined, for participants with an OR, as the time from first documentation of OR (CR or PR) to the date of first documentation of objective progression disease (PD) or death due to any cause. irDR was defined, for participants with an irOR, as the time from the first documentation of irOR (irCR or irPR) to the date of first documentation of immune-related PD (irPD) (which was subsequently confirmed) or death due to any cause. CR: Complete disappearance of all target lesions with the exception of nodal disease; PR: Greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions; PD: 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm.
Time Frame Every 8 weeks from the first occurrence of CR or PR, until disease progression or death up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
No participants were enrolled in the dose-expansion portion.
Arm/Group Title Dose Expansion Cohort
Hide Arm/Group Description:
Expansion cohorts of participants were to be enrolled to further study the safety, tolerability, PK/PD, and preliminary anti tumor activity for PF-05082566 in combination with mogamulizumab, as well as to study tumor associated biomarkers.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
32.Secondary Outcome
Title Progression Free Survival (PFS) and Immune-related PFS (irPFS) - Dose Expansion Portion
Hide Description PFS was defined as the time from the date of first dose of study treatment to the date of the first documentation of PD or death due to any cause, whichever occurred first. irPFS was defined as the time from the first dose of study treatment to the date of first documentation of irPD (which was subsequently confirmed) or death due to any cause, whichever occurred first. PD:20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm.
Time Frame Every 8 weeks up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
No participants were enrolled in the dose-expansion portion.
Arm/Group Title Dose Expansion Cohort
Hide Arm/Group Description:
Expansion cohorts of participants were to be enrolled to further study the safety, tolerability, PK/PD, and preliminary anti tumor activity for PF-05082566 in combination with mogamulizumab, as well as to study tumor associated biomarkers.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Day 1 up to 60 days after last dose of study treatment
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 100 mg + Mogamulizumab 1 mg/kg PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg
Hide Arm/Group Description PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
All-Cause Mortality
PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 100 mg + Mogamulizumab 1 mg/kg PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   3/6 (50.00%)   0/4 (0.00%)   0/3 (0.00%) 
Hide Serious Adverse Events
PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 100 mg + Mogamulizumab 1 mg/kg PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/11 (27.27%)   3/6 (50.00%)   2/4 (50.00%)   2/3 (66.67%) 
Gastrointestinal disorders         
Abdominal pain * 1  1/11 (9.09%)  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%) 
General disorders         
Disease progression * 1  0/11 (0.00%)  1/6 (16.67%)  0/4 (0.00%)  0/3 (0.00%) 
Pyrexia * 1  0/11 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  1/3 (33.33%) 
Infections and infestations         
Clostridium difficile colitis * 1  1/11 (9.09%)  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%) 
Pneumonia * 1  1/11 (9.09%)  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%) 
Salmonellosis * 1  0/11 (0.00%)  0/6 (0.00%)  1/4 (25.00%)  0/3 (0.00%) 
Sepsis * 1  0/11 (0.00%)  1/6 (16.67%)  0/4 (0.00%)  0/3 (0.00%) 
Metabolism and nutrition disorders         
Dehydration * 1  1/11 (9.09%)  0/6 (0.00%)  0/4 (0.00%)  1/3 (33.33%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Malignant neoplasm progression * 1  0/11 (0.00%)  1/6 (16.67%)  0/4 (0.00%)  0/3 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Dyspnoea * 1  0/11 (0.00%)  0/6 (0.00%)  1/4 (25.00%)  0/3 (0.00%) 
Vascular disorders         
Embolism * 1  0/11 (0.00%)  0/6 (0.00%)  1/4 (25.00%)  0/3 (0.00%) 
Haemorrhage * 1  1/11 (9.09%)  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%) 
1
Term from vocabulary, MedDRA 20.1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 100 mg + Mogamulizumab 1 mg/kg PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   11/11 (100.00%)   6/6 (100.00%)   4/4 (100.00%)   3/3 (100.00%) 
Blood and lymphatic system disorders         
Anaemia * 1  1/11 (9.09%)  3/6 (50.00%)  0/4 (0.00%)  0/3 (0.00%) 
Thrombocytopenia * 1  0/11 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  1/3 (33.33%) 
Cardiac disorders         
Pericardial effusion * 1  0/11 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  1/3 (33.33%) 
Tachycardia * 1  1/11 (9.09%)  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%) 
Eye disorders         
Erythema of eyelid * 1  0/11 (0.00%)  1/6 (16.67%)  0/4 (0.00%)  0/3 (0.00%) 
Vision blurred * 1  1/11 (9.09%)  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%) 
Gastrointestinal disorders         
Abdominal pain * 1  0/11 (0.00%)  1/6 (16.67%)  0/4 (0.00%)  0/3 (0.00%) 
Abdominal pain lower * 1  1/11 (9.09%)  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%) 
Constipation * 1  1/11 (9.09%)  1/6 (16.67%)  1/4 (25.00%)  2/3 (66.67%) 
Diarrhoea * 1  1/11 (9.09%)  3/6 (50.00%)  2/4 (50.00%)  0/3 (0.00%) 
Dry mouth * 1  0/11 (0.00%)  0/6 (0.00%)  1/4 (25.00%)  0/3 (0.00%) 
Gastrointestinal disorder * 1  0/11 (0.00%)  1/6 (16.67%)  0/4 (0.00%)  0/3 (0.00%) 
Nausea * 1  1/11 (9.09%)  1/6 (16.67%)  2/4 (50.00%)  0/3 (0.00%) 
Rectal haemorrhage * 1  0/11 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  1/3 (33.33%) 
Stomatitis * 1  0/11 (0.00%)  1/6 (16.67%)  0/4 (0.00%)  0/3 (0.00%) 
Vomiting * 1  1/11 (9.09%)  1/6 (16.67%)  0/4 (0.00%)  0/3 (0.00%) 
General disorders         
Chest pain * 1  0/11 (0.00%)  0/6 (0.00%)  1/4 (25.00%)  0/3 (0.00%) 
Chills * 1  1/11 (9.09%)  1/6 (16.67%)  1/4 (25.00%)  0/3 (0.00%) 
Face oedema * 1  0/11 (0.00%)  0/6 (0.00%)  1/4 (25.00%)  0/3 (0.00%) 
Fatigue * 1  2/11 (18.18%)  5/6 (83.33%)  2/4 (50.00%)  2/3 (66.67%) 
Malaise * 1  0/11 (0.00%)  1/6 (16.67%)  1/4 (25.00%)  0/3 (0.00%) 
Oedema peripheral * 1  0/11 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  1/3 (33.33%) 
Pyrexia * 1  1/11 (9.09%)  2/6 (33.33%)  0/4 (0.00%)  1/3 (33.33%) 
Temperature intolerance * 1  1/11 (9.09%)  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%) 
Immune system disorders         
Hypersensitivity * 1  0/11 (0.00%)  0/6 (0.00%)  1/4 (25.00%)  0/3 (0.00%) 
Infections and infestations         
Genital herpes * 1  0/11 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  1/3 (33.33%) 
Otitis media * 1  0/11 (0.00%)  0/6 (0.00%)  1/4 (25.00%)  0/3 (0.00%) 
Pneumonia * 1  0/11 (0.00%)  1/6 (16.67%)  0/4 (0.00%)  0/3 (0.00%) 
Respiratory tract infection * 1  1/11 (9.09%)  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%) 
Upper respiratory tract infection * 1  0/11 (0.00%)  2/6 (33.33%)  0/4 (0.00%)  0/3 (0.00%) 
Urinary tract infection * 1  0/11 (0.00%)  1/6 (16.67%)  0/4 (0.00%)  0/3 (0.00%) 
Viral upper respiratory tract infection * 1  0/11 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  1/3 (33.33%) 
Injury, poisoning and procedural complications         
Contusion * 1  0/11 (0.00%)  0/6 (0.00%)  1/4 (25.00%)  0/3 (0.00%) 
Infusion related reaction * 1  1/11 (9.09%)  1/6 (16.67%)  1/4 (25.00%)  0/3 (0.00%) 
Investigations         
Activated partial thromboplastin time prolonged * 1  1/11 (9.09%)  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%) 
Blood alkaline phosphatase increased * 1  0/11 (0.00%)  0/6 (0.00%)  1/4 (25.00%)  0/3 (0.00%) 
Blood creatinine increased * 1  0/11 (0.00%)  0/6 (0.00%)  1/4 (25.00%)  0/3 (0.00%) 
Lymphocyte count decreased * 1  1/11 (9.09%)  1/6 (16.67%)  1/4 (25.00%)  0/3 (0.00%) 
Weight decreased * 1  0/11 (0.00%)  1/6 (16.67%)  0/4 (0.00%)  1/3 (33.33%) 
Metabolism and nutrition disorders         
Decreased appetite * 1  1/11 (9.09%)  2/6 (33.33%)  0/4 (0.00%)  1/3 (33.33%) 
Dehydration * 1  0/11 (0.00%)  0/6 (0.00%)  1/4 (25.00%)  0/3 (0.00%) 
Hyperuricaemia * 1  0/11 (0.00%)  0/6 (0.00%)  1/4 (25.00%)  0/3 (0.00%) 
Hypocalcaemia * 1  0/11 (0.00%)  1/6 (16.67%)  0/4 (0.00%)  0/3 (0.00%) 
Hypomagnesaemia * 1  1/11 (9.09%)  1/6 (16.67%)  0/4 (0.00%)  0/3 (0.00%) 
Hyponatraemia * 1  0/11 (0.00%)  0/6 (0.00%)  1/4 (25.00%)  0/3 (0.00%) 
Hypophosphataemia * 1  1/11 (9.09%)  1/6 (16.67%)  0/4 (0.00%)  0/3 (0.00%) 
Malnutrition * 1  1/11 (9.09%)  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%) 
Vitamin B12 deficiency * 1  0/11 (0.00%)  1/6 (16.67%)  0/4 (0.00%)  0/3 (0.00%) 
Musculoskeletal and connective tissue disorders         
Arthralgia * 1  0/11 (0.00%)  1/6 (16.67%)  1/4 (25.00%)  0/3 (0.00%) 
Back pain * 1  0/11 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  1/3 (33.33%) 
Joint range of motion decreased * 1  0/11 (0.00%)  1/6 (16.67%)  0/4 (0.00%)  0/3 (0.00%) 
Musculoskeletal chest pain * 1  1/11 (9.09%)  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%) 
Musculoskeletal stiffness * 1  0/11 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  1/3 (33.33%) 
Myalgia * 1  0/11 (0.00%)  1/6 (16.67%)  0/4 (0.00%)  0/3 (0.00%) 
Neck pain * 1  1/11 (9.09%)  0/6 (0.00%)  0/4 (0.00%)  1/3 (33.33%) 
Pain in extremity * 1  0/11 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  1/3 (33.33%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Tumour pain * 1  0/11 (0.00%)  1/6 (16.67%)  0/4 (0.00%)  0/3 (0.00%) 
Nervous system disorders         
Dysgeusia * 1  0/11 (0.00%)  1/6 (16.67%)  0/4 (0.00%)  0/3 (0.00%) 
Headache * 1  1/11 (9.09%)  1/6 (16.67%)  1/4 (25.00%)  1/3 (33.33%) 
Peripheral sensory neuropathy * 1  1/11 (9.09%)  1/6 (16.67%)  0/4 (0.00%)  0/3 (0.00%) 
Syncope * 1  1/11 (9.09%)  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%) 
Psychiatric disorders         
Abnormal dreams * 1  3/11 (27.27%)  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%) 
Insomnia * 1  1/11 (9.09%)  1/6 (16.67%)  1/4 (25.00%)  0/3 (0.00%) 
Renal and urinary disorders         
Proteinuria * 1  0/11 (0.00%)  1/6 (16.67%)  0/4 (0.00%)  0/3 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Cough * 1  1/11 (9.09%)  1/6 (16.67%)  0/4 (0.00%)  0/3 (0.00%) 
Dyspnoea * 1  1/11 (9.09%)  2/6 (33.33%)  0/4 (0.00%)  0/3 (0.00%) 
Haemoptysis * 1  0/11 (0.00%)  1/6 (16.67%)  0/4 (0.00%)  0/3 (0.00%) 
Nasal oedema * 1  0/11 (0.00%)  0/6 (0.00%)  1/4 (25.00%)  0/3 (0.00%) 
Oropharyngeal pain * 1  0/11 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  1/3 (33.33%) 
Pneumonitis * 1  0/11 (0.00%)  1/6 (16.67%)  0/4 (0.00%)  0/3 (0.00%) 
Productive cough * 1  0/11 (0.00%)  1/6 (16.67%)  0/4 (0.00%)  0/3 (0.00%) 
Pulmonary haemorrhage * 1  0/11 (0.00%)  1/6 (16.67%)  0/4 (0.00%)  0/3 (0.00%) 
Respiratory tract congestion * 1  1/11 (9.09%)  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%) 
Rhinorrhoea * 1  2/11 (18.18%)  1/6 (16.67%)  0/4 (0.00%)  0/3 (0.00%) 
Wheezing * 1  0/11 (0.00%)  1/6 (16.67%)  0/4 (0.00%)  0/3 (0.00%) 
Skin and subcutaneous tissue disorders         
Dry skin * 1  1/11 (9.09%)  1/6 (16.67%)  0/4 (0.00%)  0/3 (0.00%) 
Erythema * 1  0/11 (0.00%)  0/6 (0.00%)  1/4 (25.00%)  0/3 (0.00%) 
Night sweats * 1  0/11 (0.00%)  0/6 (0.00%)  1/4 (25.00%)  0/3 (0.00%) 
Papule * 1  0/11 (0.00%)  0/6 (0.00%)  1/4 (25.00%)  0/3 (0.00%) 
Pruritus * 1  1/11 (9.09%)  2/6 (33.33%)  1/4 (25.00%)  0/3 (0.00%) 
Rash * 1  5/11 (45.45%)  0/6 (0.00%)  0/4 (0.00%)  2/3 (66.67%) 
Rash erythematous * 1  1/11 (9.09%)  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%) 
Rash maculo-papular * 1  0/11 (0.00%)  1/6 (16.67%)  0/4 (0.00%)  1/3 (33.33%) 
Skin exfoliation * 1  0/11 (0.00%)  0/6 (0.00%)  1/4 (25.00%)  0/3 (0.00%) 
Vascular disorders         
Hypertension * 1  0/11 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  1/3 (33.33%) 
Hypotension * 1  0/11 (0.00%)  0/6 (0.00%)  1/4 (25.00%)  0/3 (0.00%) 
Orthostatic hypotension * 1  1/11 (9.09%)  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%) 
1
Term from vocabulary, MedDRA 20.1
*
Indicates events were collected by non-systematic assessment
The study was terminated due to marginal efficacy and change in sponsor prioritization. No participants were enrolled in the dose-expansion portion.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02444793    
Other Study ID Numbers: B1641004
First Submitted: May 12, 2015
First Posted: May 14, 2015
Results First Submitted: September 26, 2018
Results First Posted: February 15, 2019
Last Update Posted: February 27, 2019