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PF-06671008 Dose Escalation Study in 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: NCT02659631
Recruitment Status : Terminated
First Posted : January 20, 2016
Results First Posted : May 6, 2020
Last Update Posted : May 6, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Neoplasms
Intervention Drug: PF-06671008
Enrollment 28
Recruitment Details  
Pre-assignment Details Twenty-eight (28) participants were enrolled and 27 participants received study drug. One participant discontinued before receiving treatment.
Arm/Group Title PF-06671008 1.5 ng/kg IV PF-06671008 7.5 ng/kg IV PF-06671008 20 ng/kg IV PF-06671008 50 ng/kg IV PF-06671008 100 ng/kg IV PF-06671008 200 ng/kg IV PF-06671008 300 ng/kg IV PF-06671008 400 ng/kg IV PF-06671008 200 ng/kg SC PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV
Hide Arm/Group Description PF-06671008 was administered as a weekly intravenous (IV) infusion in 21-day cycles at 1.5 nanogram/kilogram (ng/kg). PF-06671008 was administered for up to 4 cycles in this cohort. PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 7.5 ng/kg. PF-06671008 was administered for up to 3 cycles in this cohort. PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 20 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort. PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 50 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort. PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 100 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort. PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 16 cycles in this cohort. PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 300 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort. PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 400 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort. PF-06671008 was administered as a weekly subcutaneous (SC) injection in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 5 cycles in this cohort. PF-06671008 was administered as a weekly IV infusion in 21-day cycles at a priming dose of 200 ng/kg on Cycle 1 Day 1 (C1D1) and 300 ng/kg for all subsequent dosing. PF-06671008 was administered for up to 4 cycles in this cohort.
Period Title: Overall Study
Started [1] 1 2 3 2 5 5 4 3 2 1
Completed 0 0 0 0 0 2 3 0 0 1
Not Completed 1 2 3 2 5 3 1 3 2 0
Reason Not Completed
Lost to Follow-up             0             0             2             0             0             1             0             0             0             0
Withdrawal prior to treatment             0             0             0             0             1             0             0             0             0             0
Participant refused further follow-up             0             0             0             1             0             0             0             0             1             0
Death (follow-up phase)             1             2             1             1             3             2             0             3             1             0
Death (treatment phase)             0             0             0             0             1             0             1             0             0             0
[1]
This study was terminated early and Part 2 was not initiated. The form only includes arms in Part 1.
Arm/Group Title PF-06671008 1.5 ng/kg IV PF-06671008 7.5 ng/kg IV PF-06671008 20 ng/kg IV PF-06671008 50 ng/kg IV PF-06671008 100 ng/kg IV PF-06671008 200 ng/kg IV PF-06671008 300 ng/kg IV PF-06671008 400 ng/kg IV PF-06671008 200 ng/kg SC PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV Total
Hide Arm/Group Description PF-06671008 was administered as a weekly intravenous (IV) infusion in 21-day cycles at 1.5 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort. PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 7.5 ng/kg. PF-06671008 was administered for up to 3 cycles in this cohort. PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 20 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort. PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 50 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort. PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 100 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort. PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 16 cycles in this cohort. PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 300 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort. PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 400 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort. PF-06671008 was administered as a weekly subcutaneous (SC) injection in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 5 cycles in this cohort. PF-06671008 was administered as a weekly IV infusion in 21-day cycles at a priming dose of 200 ng/kg on Cycle 1 Day 1 (C1D1) and 300 ng/kg for all subsequent dosing. PF-06671008 was administered for up to 4 cycles in this cohort. Total of all reporting groups
Overall Number of Baseline Participants 1 2 3 2 4 5 4 3 2 1 27
Hide Baseline Analysis Population Description
Baseline analysis population included all participants treated (27)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1 participants 2 participants 3 participants 2 participants 4 participants 5 participants 4 participants 3 participants 2 participants 1 participants 27 participants
< 18 years 0 0 0 0 0 0 0 0 0 0 0
18 - 44 years 0 0 1 1 0 1 1 0 2 0 6
45 - 64 years 1 2 2 0 0 3 1 2 0 1 12
≥ 65 years 0 0 0 1 4 1 2 1 0 0 9
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 2 participants 3 participants 2 participants 4 participants 5 participants 4 participants 3 participants 2 participants 1 participants 27 participants
Female
0
   0.0%
1
  50.0%
2
  66.7%
2
 100.0%
1
  25.0%
4
  80.0%
0
   0.0%
1
  33.3%
1
  50.0%
0
   0.0%
12
  44.4%
Male
1
 100.0%
1
  50.0%
1
  33.3%
0
   0.0%
3
  75.0%
1
  20.0%
4
 100.0%
2
  66.7%
1
  50.0%
1
 100.0%
15
  55.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 2 participants 3 participants 2 participants 4 participants 5 participants 4 participants 3 participants 2 participants 1 participants 27 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
1
  20.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   7.4%
Not Hispanic or Latino
1
 100.0%
2
 100.0%
2
  66.7%
2
 100.0%
4
 100.0%
4
  80.0%
4
 100.0%
3
 100.0%
2
 100.0%
1
 100.0%
25
  92.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 2 participants 3 participants 2 participants 4 participants 5 participants 4 participants 3 participants 2 participants 1 participants 27 participants
White
1
 100.0%
1
  50.0%
3
 100.0%
2
 100.0%
3
  75.0%
3
  60.0%
3
  75.0%
2
  66.7%
2
 100.0%
1
 100.0%
21
  77.8%
Black
0
   0.0%
1
  50.0%
0
   0.0%
0
   0.0%
1
  25.0%
2
  40.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
4
  14.8%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
1
   3.7%
Other
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  25.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   3.7%
1.Primary Outcome
Title Number of Participants With Dose-Limiting Toxicities (DLTs) - Part 1
Hide Description DLT was defined as any of the following adverse events occurring in the first cycle of treatment (21 days after the first dose): a) Hematologic: Febrile neutropenia defined as an absolute neutrophil count (ANC) <1.0 x 10^9/L with a single temperature of >38.3°C, or 101°F, or a sustained temperature of >=38°C, or 100.4°F, for more than one hour; b) Non-hematologic: Delay by more than 2 weeks in receiving the next scheduled dose due to persisting treatment related toxicities; c) Any grade 3 or 4 clinically-relevant hematologic or non-hematologic toxicity.
Time Frame Baseline through Day 21 (Cycle 1)
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study intervention.
Arm/Group Title PF-06671008 1.5 ng/kg IV PF-06671008 7.5 ng/kg IV PF-06671008 20 ng/kg IV PF-06671008 50 ng/kg IV PF-06671008 100 ng/kg IV PF-06671008 200 ng/kg IV PF-06671008 300 ng/kg IV PF-06671008 400 ng/kg IV PF-06671008 200 ng/kg SC PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV
Hide Arm/Group Description:
PF-06671008 was administered as a weekly intravenous (IV) infusion in 21-day cycles at 1.5 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 7.5 ng/kg. PF-06671008 was administered for up to 3 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 20 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 50 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 100 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 16 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 300 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 400 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
PF-06671008 was administered as a weekly subcutaneous (SC) injection in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 5 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at a priming dose of 200 ng/kg on Cycle 1 Day 1 (C1D1) and 300 ng/kg for all subsequent dosing. PF-06671008 was administered for up to 4 cycles in this cohort.
Overall Number of Participants Analyzed 1 2 3 2 4 5 4 3 2 1
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
2.Primary Outcome
Title Number of Participants With Objective Response (OR) - Part 2
Hide Description

Number of participants with OR based on assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumor (RECIST) v1.1.

CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions.

PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.

Time Frame Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated early and Part 2 was not initiated. Data for this outcome measure was not collected.
Arm/Group Title PF-06671008 1.5 ng/kg IV PF-06671008 7.5 ng/kg IV PF-06671008 20 ng/kg IV PF-06671008 50 ng/kg IV PF-06671008 100 ng/kg IV PF-06671008 200 ng/kg IV PF-06671008 300 ng/kg IV PF-06671008 400 ng/kg IV PF-06671008 200 ng/kg SC PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV
Hide Arm/Group Description:
PF-06671008 was administered as a weekly intravenous (IV) infusion in 21-day cycles at 1.5 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 7.5 ng/kg. PF-06671008 was administered for up to 3 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 20 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 50 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 100 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 16 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 300 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 400 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
PF-06671008 was administered as a weekly subcutaneous (SC) injection in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 5 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at a priming dose of 200 ng/kg on Cycle 1 Day 1 (C1D1) and 300 ng/kg for all subsequent dosing. PF-06671008 was administered for up to 4 cycles in this cohort.
Overall Number of Participants Analyzed 0 0 0 0 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Maximum Serum Concentration (Cmax) of PF-06671008
Hide Description

Maximum serum concentration (Cmax) of PF-06671008 was observed directly from data.

Geometric mean was not calculated if fewer than 3 participants had reportable parameter values.

Time Frame C1D1 0, 1, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose, C2D1 0, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest and who had no major protocol deviations influencing the PK assessment.
Arm/Group Title PF-06671008 1.5 ng/kg IV PF-06671008 7.5 ng/kg IV PF-06671008 20 ng/kg IV PF-06671008 50 ng/kg IV PF-06671008 100 ng/kg IV PF-06671008 200 ng/kg IV PF-06671008 300 ng/kg IV PF-06671008 400 ng/kg IV PF-06671008 200 ng/kg SC PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV
Hide Arm/Group Description:
PF-06671008 was administered as a weekly intravenous (IV) infusion in 21-day cycles at 1.5 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 7.5 ng/kg. PF-06671008 was administered for up to 3 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 20 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 50 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 100 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 16 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 300 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 400 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
PF-06671008 was administered as a weekly subcutaneous (SC) injection in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 5 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at a priming dose of 200 ng/kg on Cycle 1 Day 1 (C1D1) and 300 ng/kg for all subsequent dosing. PF-06671008 was administered for up to 4 cycles in this cohort.
Overall Number of Participants Analyzed 1 2 3 2 4 5 4 3 2 1
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram/milliliter (ng/mL)
Cycle 1 Day 1 Number Analyzed 1 participants 2 participants 3 participants 2 participants 4 participants 5 participants 4 participants 3 participants 2 participants 1 participants
NA [1] 
(NA%)
NA [1] 
(NA%)
0.1926
(20%)
NA [1] 
(NA%)
1.108
(32%)
2.008
(33%)
2.387
(36%)
4.049
(14%)
NA [1] 
(NA%)
NA [1] 
(NA%)
Cycle 2 Day 1 Number Analyzed 1 participants 2 participants 3 participants 1 participants 3 participants 4 participants 2 participants 0 participants 2 participants 1 participants
NA [1] 
(NA%)
NA [1] 
(NA%)
0.2470
(36%)
NA [1] 
(NA%)
0.8471
(51%)
2.014
(7%)
NA [1] 
(NA%)
NA [1] 
(NA%)
NA [1] 
(NA%)
[1]
Summary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
4.Secondary Outcome
Title Time to Reach Maximum Observed Serum Concentration (Tmax) of PF-06671008
Hide Description Time for Maximum serum concentration (Tmax) of PF-06671008 was observed directly from data as time of first occurrence.
Time Frame C1D1 0, 1, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose, C2D1 0, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest and who had no major protocol deviations influencing the PK assessment.
Arm/Group Title PF-06671008 1.5 ng/kg IV PF-06671008 7.5 ng/kg IV PF-06671008 20 ng/kg IV PF-06671008 50 ng/kg IV PF-06671008 100 ng/kg IV PF-06671008 200 ng/kg IV PF-06671008 300 ng/kg IV PF-06671008 400 ng/kg IV PF-06671008 200 ng/kg SC PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV
Hide Arm/Group Description:
PF-06671008 was administered as a weekly intravenous (IV) infusion in 21-day cycles at 1.5 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 7.5 ng/kg. PF-06671008 was administered for up to 3 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 20 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 50 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 100 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 16 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 300 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 400 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
PF-06671008 was administered as a weekly subcutaneous (SC) injection in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 5 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at a priming dose of 200 ng/kg on Cycle 1 Day 1 (C1D1) and 300 ng/kg for all subsequent dosing. PF-06671008 was administered for up to 4 cycles in this cohort.
Overall Number of Participants Analyzed 1 2 3 2 4 5 4 3 2 1
Median (Full Range)
Unit of Measure: hours
Cycle 1 Day 1 Number Analyzed 0 participants 1 participants 3 participants 2 participants 4 participants 5 participants 4 participants 3 participants 2 participants 1 participants
2.02
(2.02 to 2.02)
4.05
(2.00 to 4.08)
2.29
(1.92 to 2.65)
2.07
(2.00 to 4.10)
2.33
(2.00 to 3.98)
2.17
(2.05 to 3.63)
2.05
(2.05 to 3.00)
50.5
(8.12 to 92.9)
1.92
(1.92 to 1.92)
Cycle 2 Day 1 Number Analyzed 0 participants 1 participants 3 participants 1 participants 3 participants 4 participants 2 participants 0 participants 2 participants 1 participants
2.12
(2.12 to 2.12)
3.98
(2.00 to 4.22)
3.90
(3.90 to 3.90)
4.00
(2.17 to 4.28)
2.09
(1.92 to 2.17)
2.14
(2.10 to 2.17)
24.6
(23.4 to 25.7)
1.98
(1.98 to 1.98)
5.Secondary Outcome
Title Terminal Elimination Half-life (t1/2) of PF-06671008
Hide Description

Terminal elimination half-life (t1/2) of PF-06671008 was calculated as ln(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.

Arithmetic mean was not calculated if fewer than 3 participants had reportable parameter values.

Time Frame C1D1 0, 1, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose, C2D1 0, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest and who had no major protocol deviations influencing the PK assessment.
Arm/Group Title PF-06671008 1.5 ng/kg IV PF-06671008 7.5 ng/kg IV PF-06671008 20 ng/kg IV PF-06671008 50 ng/kg IV PF-06671008 100 ng/kg IV PF-06671008 200 ng/kg IV PF-06671008 300 ng/kg IV PF-06671008 400 ng/kg IV PF-06671008 200 ng/kg SC PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV
Hide Arm/Group Description:
PF-06671008 was administered as a weekly intravenous (IV) infusion in 21-day cycles at 1.5 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 7.5 ng/kg. PF-06671008 was administered for up to 3 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 20 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 50 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 100 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 16 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 300 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 400 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
PF-06671008 was administered as a weekly subcutaneous (SC) injection in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 5 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at a priming dose of 200 ng/kg on Cycle 1 Day 1 (C1D1) and 300 ng/kg for all subsequent dosing. PF-06671008 was administered for up to 4 cycles in this cohort.
Overall Number of Participants Analyzed 1 2 3 2 4 5 4 3 2 1
Mean (Standard Deviation)
Unit of Measure: hours
Cycle 1 Day 1 Number Analyzed 0 participants 0 participants 0 participants 2 participants 3 participants 3 participants 2 participants 2 participants 0 participants 1 participants
NA [1]   (NA) 31.77  (7.6055) 35.30  (5.4065) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA)
Cycle 2 Day 1 Number Analyzed 0 participants 0 participants 0 participants 0 participants 1 participants 2 participants 1 participants 0 participants 0 participants 0 participants
NA [1]   (NA) NA [1]   (NA) NA [1]   (NA)
[1]
Summary statistics are not presented as arithmetic means were not calculated if fewer than 3 participants had reportable values.
6.Secondary Outcome
Title Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06671008
Hide Description

Tau refers to the dosing interval, which was 1 week. Area under the concentration-time profile from time 0 to time tau (AUCtau) was determined using linear/log trapezoidal method.

Geometric mean was not calculated if fewer than 3 participants had reportable parameter values.

Time Frame C1D1 0, 1, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose, C2D1 0, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest and who had no major protocol deviations influencing the PK assessment.
Arm/Group Title PF-06671008 1.5 ng/kg IV PF-06671008 7.5 ng/kg IV PF-06671008 20 ng/kg IV PF-06671008 50 ng/kg IV PF-06671008 100 ng/kg IV PF-06671008 200 ng/kg IV PF-06671008 300 ng/kg IV PF-06671008 400 ng/kg IV PF-06671008 200 ng/kg SC PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV
Hide Arm/Group Description:
PF-06671008 was administered as a weekly intravenous (IV) infusion in 21-day cycles at 1.5 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 7.5 ng/kg. PF-06671008 was administered for up to 3 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 20 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 50 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 100 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 16 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 300 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 400 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
PF-06671008 was administered as a weekly subcutaneous (SC) injection in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 5 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at a priming dose of 200 ng/kg on Cycle 1 Day 1 (C1D1) and 300 ng/kg for all subsequent dosing. PF-06671008 was administered for up to 4 cycles in this cohort.
Overall Number of Participants Analyzed 1 2 3 2 4 5 4 3 2 1
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram.hour/milliliter (ng.hr/mL)
Cycle 1 Day 1 Number Analyzed 1 participants 2 participants 3 participants 2 participants 4 participants 5 participants 2 participants 2 participants 2 participants 1 participants
NA [1] 
(NA%)
NA [1] 
(NA%)
5.252
(25%)
NA [1] 
(NA%)
42.75
(35%)
87.31
(29%)
NA [1] 
(NA%)
NA [1] 
(NA%)
NA [1] 
(NA%)
NA [1] 
(NA%)
Cycle 2 Day 1 Number Analyzed 1 participants 2 participants 3 participants 1 participants 1 participants 3 participants 1 participants 0 participants 2 participants 1 participants
NA [1] 
(NA%)
NA [1] 
(NA%)
10.31
(43%)
NA [1] 
(NA%)
NA [1] 
(NA%)
79.17
(36%)
NA [1] 
(NA%)
NA [1] 
(NA%)
NA [1] 
(NA%)
[1]
Summary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
7.Secondary Outcome
Title Area Under the Curve From Time 0 Extrapolated to Infinity Time (AUCinf) of PF-06671008
Hide Description

AUCinf was calculated as AUClast +(Clast*/kel), where AUClast is area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast* is the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis, kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.

Geometric mean was not calculated if fewer than 3 participants had reportable parameter values.

Time Frame C1D1 0, 1, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose, C2D1 0, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest and who had no major protocol deviations influencing the PK assessment.
Arm/Group Title PF-06671008 1.5 ng/kg IV PF-06671008 7.5 ng/kg IV PF-06671008 20 ng/kg IV PF-06671008 50 ng/kg IV PF-06671008 100 ng/kg IV PF-06671008 200 ng/kg IV PF-06671008 300 ng/kg IV PF-06671008 400 ng/kg IV PF-06671008 200 ng/kg SC PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV
Hide Arm/Group Description:
PF-06671008 was administered as a weekly intravenous (IV) infusion in 21-day cycles at 1.5 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 7.5 ng/kg. PF-06671008 was administered for up to 3 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 20 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 50 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 100 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 16 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 300 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 400 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
PF-06671008 was administered as a weekly subcutaneous (SC) injection in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 5 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at a priming dose of 200 ng/kg on Cycle 1 Day 1 (C1D1) and 300 ng/kg for all subsequent dosing. PF-06671008 was administered for up to 4 cycles in this cohort.
Overall Number of Participants Analyzed 1 2 3 2 4 5 4 3 2 1
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng.hr/mL
Cycle 1 Day 1 Number Analyzed 0 participants 0 participants 0 participants 2 participants 3 participants 3 participants 2 participants 2 participants 0 participants 1 participants
NA [1] 
(NA%)
47.09
(41%)
90.35
(19%)
NA [1] 
(NA%)
NA [1] 
(NA%)
NA [1] 
(NA%)
Cycle 2 Day 1 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
[1]
Summary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
8.Secondary Outcome
Title Systemic Clearance (CL) of PF-06671008
Hide Description

Systemic Clearance (CL) was calculated as dose/AUCinf, where AUCinf was area under the serum concentration-time profile from time 0 extrapolated to infinite time. This outcome measure only applies to IV arms.

Geometric mean was not calculated if fewer than 3 participants had reportable parameter values.

Time Frame C1D1 0, 1, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose, C2D1 0, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest and who had no major protocol deviations influencing the PK assessment.
Arm/Group Title PF-06671008 1.5 ng/kg IV PF-06671008 7.5 ng/kg IV PF-06671008 20 ng/kg IV PF-06671008 50 ng/kg IV PF-06671008 100 ng/kg IV PF-06671008 200 ng/kg IV PF-06671008 300 ng/kg IV PF-06671008 400 ng/kg IV PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV
Hide Arm/Group Description:
PF-06671008 was administered as a weekly intravenous (IV) infusion in 21-day cycles at 1.5 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 7.5 ng/kg. PF-06671008 was administered for up to 3 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 20 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 50 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 100 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 16 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 300 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 400 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at a priming dose of 200 ng/kg on Cycle 1 Day 1 (C1D1) and 300 ng/kg for all subsequent dosing. PF-06671008 was administered for up to 4 cycles in this cohort.
Overall Number of Participants Analyzed 1 2 3 2 4 5 4 3 1
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: milliliter/hour/kilogram (mL/hr/kg)
Cycle 1 Day 1 Number Analyzed 0 participants 0 participants 0 participants 2 participants 3 participants 3 participants 2 participants 2 participants 1 participants
NA [1] 
(NA%)
2.191
(47%)
2.236
(20%)
NA [1] 
(NA%)
NA [1] 
(NA%)
NA [1] 
(NA%)
Cycle 2 Day 1 Number Analyzed 0 participants 1 participants 3 participants 1 participants 1 participants 3 participants 1 participants 0 participants 1 participants
NA [1] 
(NA%)
1.954
(40%)
NA [1] 
(NA%)
NA [1] 
(NA%)
1.827
(77%)
NA [1] 
(NA%)
NA [1] 
(NA%)
[1]
Summary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
9.Secondary Outcome
Title Apparent Clearance (CL/F) of PF-06671008
Hide Description

Apparent Clearance (CL/F) was calculated as dose/AUCinf, where AUCinf was area under the serum concentration-time profile from time 0 extrapolated to infinite time. This outcome measure only applies to SC arm.

Geometric mean was not calculated if fewer than 3 participants had reportable parameter values.

Time Frame C1D1 0, 1, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose, C2D1 0, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest and who had no major protocol deviations influencing the PK assessment.
Arm/Group Title PF-06671008 200 ng/kg SC
Hide Arm/Group Description:
PF-06671008 was administered as a weekly subcutaneous (SC) injection in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 5 cycles in this cohort.
Overall Number of Participants Analyzed 2
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mL/hr/kg
Cycle 1 Day 1 Number Analyzed 0 participants
Cycle 2 Day 1 Number Analyzed 2 participants
NA [1] 
(NA%)
[1]
Summary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
10.Secondary Outcome
Title Number of Participants With OR - Part 1
Hide Description

Number of participants with OR based on assessment of CR or PR according to RECIST v1.1.

CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions.

PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.

Time Frame Baseline and every 6 weeks for the first 6 months, then every 12 weeks until disease progression, unacceptable toxicity, or up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study intervention, had measurable disease baseline assessment and at least 1 post baseline assessment or disease progression or death before the first tumor assessment. No participants met the criteria of OR.
Arm/Group Title PF-06671008 1.5 ng/kg IV PF-06671008 7.5 ng/kg IV PF-06671008 20 ng/kg IV PF-06671008 50 ng/kg IV PF-06671008 100 ng/kg IV PF-06671008 200 ng/kg IV PF-06671008 300 ng/kg IV PF-06671008 400 ng/kg IV PF-06671008 200 ng/kg SC PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV
Hide Arm/Group Description:
PF-06671008 was administered as a weekly intravenous (IV) infusion in 21-day cycles at 1.5 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 7.5 ng/kg. PF-06671008 was administered for up to 3 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 20 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 50 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 100 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 16 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 300 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 400 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
PF-06671008 was administered as a weekly subcutaneous (SC) injection in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 5 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at a priming dose of 200 ng/kg on Cycle 1 Day 1 (C1D1) and 300 ng/kg for all subsequent dosing. PF-06671008 was administered for up to 4 cycles in this cohort.
Overall Number of Participants Analyzed 1 2 3 2 4 5 4 3 2 1
Measure Type: Count of Participants
Unit of Measure: 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%
0
   0.0%
11.Secondary Outcome
Title Number of Participants With Progression Free Survival (PFS) - Part 2
Hide Description The period from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death").
Time Frame Baseline and every 6 weeks for the first 6 months, then every 12 weeks until disease progression or unacceptable toxicity, or up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated early and Part 2 was not initiated. Data for this outcome measure were not collected.
Arm/Group Title PF-06671008 1.5 ng/kg IV PF-06671008 7.5 ng/kg IV PF-06671008 20 ng/kg IV PF-06671008 50 ng/kg IV PF-06671008 100 ng/kg IV PF-06671008 200 ng/kg IV PF-06671008 300 ng/kg IV PF-06671008 400 ng/kg IV PF-06671008 200 ng/kg SC PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV
Hide Arm/Group Description:
PF-06671008 was administered as a weekly intravenous (IV) infusion in 21-day cycles at 1.5 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 7.5 ng/kg. PF-06671008 was administered for up to 3 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 20 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 50 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 100 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 16 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 300 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 400 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
PF-06671008 was administered as a weekly subcutaneous (SC) injection in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 5 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at a priming dose of 200 ng/kg on Cycle 1 Day 1 (C1D1) and 300 ng/kg for all subsequent dosing. PF-06671008 was administered for up to 4 cycles in this cohort.
Overall Number of Participants Analyzed 0 0 0 0 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Number of Participants With Overall Survival (OS) - Part 2
Hide Description The period from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 7. Death was determined from AE data (where outcome was death) or from follow-up contact data (where the participant current status was death).
Time Frame Baseline and every 6 weeks for the first 6 months, then every 12 weeks until disease progression or unacceptable toxicity, or up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated early and Part 2 was not initiated. Data for this outcome measure were not collected.
Arm/Group Title PF-06671008 1.5 ng/kg IV PF-06671008 7.5 ng/kg IV PF-06671008 20 ng/kg IV PF-06671008 50 ng/kg IV PF-06671008 100 ng/kg IV PF-06671008 200 ng/kg IV PF-06671008 300 ng/kg IV PF-06671008 400 ng/kg IV PF-06671008 200 ng/kg SC PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV
Hide Arm/Group Description:
PF-06671008 was administered as a weekly intravenous (IV) infusion in 21-day cycles at 1.5 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 7.5 ng/kg. PF-06671008 was administered for up to 3 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 20 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 50 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 100 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 16 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 300 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 400 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
PF-06671008 was administered as a weekly subcutaneous (SC) injection in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 5 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at a priming dose of 200 ng/kg on Cycle 1 Day 1 (C1D1) and 300 ng/kg for all subsequent dosing. PF-06671008 was administered for up to 4 cycles in this cohort.
Overall Number of Participants Analyzed 0 0 0 0 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title Number of Participants With Anti Drug Antibodies (ADA) and Neutralizing Antibodies (NAb) Against PF-06671008
Hide Description ADA against PF-06671008 in human serum samples was determined following a tiered approach using screening, confirmation, and titer/quantification by semi-quantitative enzyme linked immunosorbent assay (ELISA). Endpoint titer >=1.18 was considered positive.
Time Frame C1D1 0 hrs, D15 0 hrs, and C2D1 0 hrs, and D1 0 hrs post additional dosings, up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study intervention and had at least one post dose ADA sample analyzed.
Arm/Group Title PF-06671008 1.5 ng/kg IV PF-06671008 7.5 ng/kg IV PF-06671008 20 ng/kg IV PF-06671008 50 ng/kg IV PF-06671008 100 ng/kg IV PF-06671008 200 ng/kg IV PF-06671008 300 ng/kg IV PF-06671008 400 ng/kg IV PF-06671008 200 ng/kg SC PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV
Hide Arm/Group Description:
PF-06671008 was administered as a weekly intravenous (IV) infusion in 21-day cycles at 1.5 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 7.5 ng/kg. PF-06671008 was administered for up to 3 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 20 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 50 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 100 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 16 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 300 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 400 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
PF-06671008 was administered as a weekly subcutaneous (SC) injection in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 5 cycles in this cohort.
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at a priming dose of 200 ng/kg on Cycle 1 Day 1 (C1D1) and 300 ng/kg for all subsequent dosing. PF-06671008 was administered for up to 4 cycles in this cohort.
Overall Number of Participants Analyzed 1 2 3 2 4 5 4 3 2 1
Measure Type: Count of Participants
Unit of Measure: Participants
ADA
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  50.0%
0
   0.0%
NAb NA [1]  NA [1]  NA [1]  NA [1]  NA [1]  NA [1]  NA [1]  NA [1]  NA [1]  NA [1] 
[1]
NAb samples were not analyzed for this study.
Time Frame For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
Adverse Event Reporting Description The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
 
Arm/Group Title PF-06671008 1.5 ng/kg IV PF-06671008 7.5 ng/kg IV PF-06671008 20 ng/kg IV PF-06671008 50 ng/kg IV PF-06671008 100 ng/kg IV PF-06671008 200 ng/kg IV PF-06671008 300 ng/kg IV PF-06671008 400 ng/kg IV PF-06671008 200 ng/kg SC PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV
Hide Arm/Group Description PF-06671008 was administered as a weekly intravenous (IV) infusion in 21-day cycles at 1.5 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort. PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 7.5 ng/kg. PF-06671008 was administered for up to 3 cycles in this cohort. PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 20 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort. PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 50 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort. PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 100 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort. PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 16 cycles in this cohort. PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 300 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort. PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 400 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort. PF-06671008 was administered as a weekly subcutaneous (SC) injection in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 5 cycles in this cohort. PF-06671008 was administered as a weekly IV infusion in 21-day cycles at a priming dose of 200 ng/kg on Cycle 1 Day 1 (C1D1) and 300 ng/kg for all subsequent dosing. PF-06671008 was administered for up to 4 cycles in this cohort.
All-Cause Mortality
PF-06671008 1.5 ng/kg IV PF-06671008 7.5 ng/kg IV PF-06671008 20 ng/kg IV PF-06671008 50 ng/kg IV PF-06671008 100 ng/kg IV PF-06671008 200 ng/kg IV PF-06671008 300 ng/kg IV PF-06671008 400 ng/kg IV PF-06671008 200 ng/kg SC PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/1 (100.00%)   2/2 (100.00%)   1/3 (33.33%)   1/2 (50.00%)   4/4 (100.00%)   2/5 (40.00%)   1/4 (25.00%)   3/3 (100.00%)   1/2 (50.00%)   0/1 (0.00%) 
Hide Serious Adverse Events
PF-06671008 1.5 ng/kg IV PF-06671008 7.5 ng/kg IV PF-06671008 20 ng/kg IV PF-06671008 50 ng/kg IV PF-06671008 100 ng/kg IV PF-06671008 200 ng/kg IV PF-06671008 300 ng/kg IV PF-06671008 400 ng/kg IV PF-06671008 200 ng/kg SC PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   1/2 (50.00%)   1/3 (33.33%)   2/2 (100.00%)   4/4 (100.00%)   4/5 (80.00%)   3/4 (75.00%)   2/3 (66.67%)   0/2 (0.00%)   0/1 (0.00%) 
Blood and lymphatic system disorders                     
Anaemia * 1  0/1 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Gastrointestinal disorders                     
Diarrhoea * 1  0/1 (0.00%)  0/2 (0.00%)  1/3 (33.33%)  0/2 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Immune system disorders                     
Cytokine release syndrome * 1  0/1 (0.00%)  0/2 (0.00%)  1/3 (33.33%)  2/2 (100.00%)  4/4 (100.00%)  4/5 (80.00%)  3/4 (75.00%)  2/3 (66.67%)  0/2 (0.00%)  0/1 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                     
Neoplasm progression * 1  0/1 (0.00%)  1/2 (50.00%)  0/3 (0.00%)  0/2 (0.00%)  1/4 (25.00%)  0/5 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Rectal adenocarcinoma * 1  0/1 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Respiratory, thoracic and mediastinal disorders                     
Pneumonitis * 1  0/1 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
1
Term from vocabulary, MedDRA 21.1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PF-06671008 1.5 ng/kg IV PF-06671008 7.5 ng/kg IV PF-06671008 20 ng/kg IV PF-06671008 50 ng/kg IV PF-06671008 100 ng/kg IV PF-06671008 200 ng/kg IV PF-06671008 300 ng/kg IV PF-06671008 400 ng/kg IV PF-06671008 200 ng/kg SC PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/1 (100.00%)   2/2 (100.00%)   3/3 (100.00%)   2/2 (100.00%)   4/4 (100.00%)   5/5 (100.00%)   4/4 (100.00%)   3/3 (100.00%)   2/2 (100.00%)   1/1 (100.00%) 
Blood and lymphatic system disorders                     
Anaemia * 1  0/1 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  1/4 (25.00%)  1/5 (20.00%)  0/4 (0.00%)  0/3 (0.00%)  1/2 (50.00%)  0/1 (0.00%) 
Neutropenia * 1  0/1 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Cardiac disorders                     
Palpitations * 1  0/1 (0.00%)  0/2 (0.00%)  1/3 (33.33%)  0/2 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Sinus arrhythmia * 1  0/1 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Tachycardia * 1  0/1 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  0/2 (0.00%)  1/1 (100.00%) 
Ventricular arrhythmia * 1  0/1 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  1/2 (50.00%)  0/4 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Ear and labyrinth disorders                     
Tinnitus * 1  0/1 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Vertigo * 1  0/1 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Eye disorders                     
Periorbital oedema * 1  0/1 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  1/4 (25.00%)  0/5 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Vision blurred * 1  0/1 (0.00%)  0/2 (0.00%)  1/3 (33.33%)  0/2 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Gastrointestinal disorders                     
Abdominal pain * 1  0/1 (0.00%)  1/2 (50.00%)  1/3 (33.33%)  0/2 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Abdominal pain upper * 1  0/1 (0.00%)  1/2 (50.00%)  0/3 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Aphthous ulcer * 1  0/1 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Constipation * 1  0/1 (0.00%)  1/2 (50.00%)  0/3 (0.00%)  1/2 (50.00%)  0/4 (0.00%)  1/5 (20.00%)  1/4 (25.00%)  0/3 (0.00%)  1/2 (50.00%)  1/1 (100.00%) 
Diarrhoea * 1  1/1 (100.00%)  0/2 (0.00%)  1/3 (33.33%)  0/2 (0.00%)  1/4 (25.00%)  1/5 (20.00%)  1/4 (25.00%)  0/3 (0.00%)  0/2 (0.00%)  1/1 (100.00%) 
Dry mouth * 1  0/1 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Dyspepsia * 1  0/1 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Dysphagia * 1  0/1 (0.00%)  0/2 (0.00%)  1/3 (33.33%)  0/2 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Gastrooesophageal reflux disease * 1  0/1 (0.00%)  0/2 (0.00%)  1/3 (33.33%)  0/2 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  1/3 (33.33%)  0/2 (0.00%)  0/1 (0.00%) 
Nausea * 1  0/1 (0.00%)  1/2 (50.00%)  2/3 (66.67%)  0/2 (0.00%)  2/4 (50.00%)  1/5 (20.00%)  2/4 (50.00%)  1/3 (33.33%)  1/2 (50.00%)  1/1 (100.00%) 
Pancreatitis * 1  0/1 (0.00%)  1/2 (50.00%)  0/3 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Stomatitis * 1  0/1 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  1/2 (50.00%)  0/1 (0.00%) 
Vomiting * 1  0/1 (0.00%)  1/2 (50.00%)  0/3 (0.00%)  0/2 (0.00%)  1/4 (25.00%)  0/5 (0.00%)  2/4 (50.00%)  1/3 (33.33%)  1/2 (50.00%)  0/1 (0.00%) 
General disorders                     
Chest pain * 1  0/1 (0.00%)  0/2 (0.00%)  1/3 (33.33%)  0/2 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  1/2 (50.00%)  0/1 (0.00%) 
Chills * 1  0/1 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  1/4 (25.00%)  0/3 (0.00%)  1/2 (50.00%)  1/1 (100.00%) 
Fatigue * 1  0/1 (0.00%)  1/2 (50.00%)  1/3 (33.33%)  0/2 (0.00%)  3/4 (75.00%)  2/5 (40.00%)  0/4 (0.00%)  0/3 (0.00%)  1/2 (50.00%)  0/1 (0.00%) 
Infusion site extravasation * 1  0/1 (0.00%)  0/2 (0.00%)  1/3 (33.33%)  0/2 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Injection site erythema * 1  0/1 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  1/2 (50.00%)  0/1 (0.00%) 
Nodule * 1  0/1 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  1/2 (50.00%)  0/4 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Oedema peripheral * 1  0/1 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  2/5 (40.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Pain * 1  0/1 (0.00%)  1/2 (50.00%)  0/3 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Pyrexia * 1  0/1 (0.00%)  1/2 (50.00%)  0/3 (0.00%)  0/2 (0.00%)  1/4 (25.00%)  3/5 (60.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  1/1 (100.00%) 
Immune system disorders                     
Cytokine release syndrome * 1  0/1 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  1/2 (50.00%)  2/4 (50.00%)  3/5 (60.00%)  2/4 (50.00%)  1/3 (33.33%)  1/2 (50.00%)  1/1 (100.00%) 
Infections and infestations                     
Cystitis * 1  0/1 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Ear infection * 1  0/1 (0.00%)  0/2 (0.00%)  1/3 (33.33%)  0/2 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Lung infection * 1  0/1 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  1/4 (25.00%)  0/5 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Mucosal infection * 1  0/1 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  1/4 (25.00%)  0/5 (0.00%)  0/4 (0.00%)  1/3 (33.33%)  0/2 (0.00%)  0/1 (0.00%) 
Oral candidiasis * 1  0/1 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  1/4 (25.00%)  0/5 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Oral herpes * 1  0/1 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Pneumonia * 1  0/1 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  1/3 (33.33%)  0/2 (0.00%)  0/1 (0.00%) 
Rash pustular * 1  0/1 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  1/2 (50.00%)  0/1 (0.00%) 
Soft tissue infection * 1  0/1 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  1/4 (25.00%)  0/5 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Urinary tract infection * 1  0/1 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  1/4 (25.00%)  0/5 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Injury, poisoning and procedural complications                     
Fall * 1  0/1 (0.00%)  0/2 (0.00%)  1/3 (33.33%)  1/2 (50.00%)  0/4 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Infusion related reaction * 1  0/1 (0.00%)  0/2 (0.00%)  1/3 (33.33%)  0/2 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Investigations                     
Alanine aminotransferase increased * 1  0/1 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Amylase increased * 1  0/1 (0.00%)  1/2 (50.00%)  0/3 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Aspartate aminotransferase increased * 1  0/1 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Blood bilirubin increased * 1  0/1 (0.00%)  0/2 (0.00%)  1/3 (33.33%)  0/2 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Blood creatinine increased * 1  0/1 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Electrocardiogram QT prolonged * 1  0/1 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  1/1 (100.00%) 
Lipase increased * 1  0/1 (0.00%)  1/2 (50.00%)  0/3 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Lymphocyte count decreased * 1  0/1 (0.00%)  0/2 (0.00%)  1/3 (33.33%)  0/2 (0.00%)  3/4 (75.00%)  2/5 (40.00%)  2/4 (50.00%)  1/3 (33.33%)  0/2 (0.00%)  0/1 (0.00%) 
Platelet count decreased * 1  0/1 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  2/4 (50.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Weight decreased * 1  0/1 (0.00%)  1/2 (50.00%)  0/3 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
White blood cell count decreased * 1  0/1 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  1/4 (25.00%)  0/5 (0.00%)  2/4 (50.00%)  1/3 (33.33%)  0/2 (0.00%)  0/1 (0.00%) 
Metabolism and nutrition disorders                     
Decreased appetite * 1  0/1 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  2/4 (50.00%)  0/5 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Dehydration * 1  0/1 (0.00%)  1/2 (50.00%)  0/3 (0.00%)  1/2 (50.00%)  0/4 (0.00%)  1/5 (20.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Hyperglycaemia * 1  0/1 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  1/4 (25.00%)  0/5 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Hyperuricaemia * 1  0/1 (0.00%)  1/2 (50.00%)  0/3 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Hypoalbuminaemia * 1  0/1 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  1/4 (25.00%)  0/5 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Hypocalcaemia * 1  0/1 (0.00%)  0/2 (0.00%)  1/3 (33.33%)  0/2 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Hypokalaemia * 1  0/1 (0.00%)  1/2 (50.00%)  0/3 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  1/3 (33.33%)  0/2 (0.00%)  0/1 (0.00%) 
Hypomagnesaemia * 1  0/1 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  1/4 (25.00%)  0/5 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Hypophosphataemia * 1  0/1 (0.00%)  0/2 (0.00%)  2/3 (66.67%)  0/2 (0.00%)  2/4 (50.00%)  2/5 (40.00%)  0/4 (0.00%)  2/3 (66.67%)  0/2 (0.00%)  0/1 (0.00%) 
Musculoskeletal and connective tissue disorders                     
Arthralgia * 1  0/1 (0.00%)  0/2 (0.00%)  1/3 (33.33%)  0/2 (0.00%)  1/4 (25.00%)  0/5 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  0/2 (0.00%)  1/1 (100.00%) 
Back pain * 1  0/1 (0.00%)  1/2 (50.00%)  0/3 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Flank pain * 1  0/1 (0.00%)  1/2 (50.00%)  0/3 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Muscle spasms * 1  0/1 (0.00%)  0/2 (0.00%)  1/3 (33.33%)  0/2 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Muscular weakness * 1  0/1 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  1/2 (50.00%)  1/4 (25.00%)  0/5 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Myalgia * 1  0/1 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  2/4 (50.00%)  0/5 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Neck pain * 1  0/1 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Pain in extremity * 1  0/1 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/4 (0.00%)  0/3 (0.00%)  1/2 (50.00%)  0/1 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                     
Metastases to central nervous system * 1  0/1 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Nervous system disorders                     
Dizziness * 1  0/1 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  1/2 (50.00%)  1/4 (25.00%)  0/5 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Headache * 1  0/1 (0.00%)  0/2 (0.00%)  1/3 (33.33%)  0/2 (0.00%)  0/4 (0.00%)  2/5 (40.00%)  1/4 (25.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Paraesthesia * 1  0/1 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Psychiatric disorders                     
Anxiety * 1  0/1 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Restlessness * 1  0/1 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Renal and urinary disorders                     
Acute kidney injury * 1  0/1 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  1/2 (50.00%)  0/4 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Urinary tract pain * 1  0/1 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  1/4 (25.00%)  0/5 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Reproductive system and breast disorders                     
Vaginal discharge * 1  0/1 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Respiratory, thoracic and mediastinal disorders                     
Cough * 1  0/1 (0.00%)  1/2 (50.00%)  0/3 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Dyspnoea * 1  0/1 (0.00%)  1/2 (50.00%)  1/3 (33.33%)  0/2 (0.00%)  1/4 (25.00%)  2/5 (40.00%)  0/4 (0.00%)  0/3 (0.00%)  1/2 (50.00%)  0/1 (0.00%) 
Hypoxia * 1  0/1 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  0/2 (0.00%)  1/1 (100.00%) 
Nasal congestion * 1  0/1 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Pleural effusion * 1  0/1 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  1/4 (25.00%)  1/5 (20.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Pulmonary oedema * 1  0/1 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Skin and subcutaneous tissue disorders                     
Erythema * 1  0/1 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Pruritus * 1  0/1 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  2/5 (40.00%)  0/4 (0.00%)  0/3 (0.00%)  1/2 (50.00%)  0/1 (0.00%) 
Rash macular * 1  0/1 (0.00%)  0/2 (0.00%)  1/3 (33.33%)  0/2 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Rash maculo-papular * 1  0/1 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  1/2 (50.00%)  0/1 (0.00%) 
Vascular disorders                     
Embolism * 1  0/1 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  1/4 (25.00%)  0/5 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Hot flush * 1  0/1 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Hypertension * 1  0/1 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  0/2 (0.00%)  1/1 (100.00%) 
1
Term from vocabulary, MedDRA 21.1
*
Indicates events were collected by non-systematic assessment
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: NCT02659631    
Other Study ID Numbers: B7831001
First Submitted: January 15, 2016
First Posted: January 20, 2016
Results First Submitted: March 20, 2020
Results First Posted: May 6, 2020
Last Update Posted: May 6, 2020