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A Study Of PF-05082566 As A Single Agent And In Combination With Rituximab

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: NCT01307267
Recruitment Status : Completed
First Posted : March 2, 2011
Results First Posted : March 17, 2020
Last Update Posted : March 17, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Lymphoma, Non-Hodgkin
Lymphoma, Follicular
Lymphoma, Large B-Cell, Diffuse
Carcinoma, Non-Small-Cell Lung
Carcinoma, Renal Cell
Carcinoma, Squamous Cell of Head and Neck
Malignant Melanoma
Interventions Drug: PF-05082566
Drug: rituximab
Enrollment 190
Recruitment Details  
Pre-assignment Details There was 1 participant who was enrolled but withdrew the consent before starting any of the treatment arms; therefore, this participant was not included in the participant flow table.
Arm/Group Title Portion A: PF-05082566 0.006mg/kg Portion A: PF-05082566 0.03mg/kg Portion A: PF-05082566 0.06mg/kg Portion A: PF-05082566 0.12mg/kg Portion A: PF-05082566 0.18mg/kg Portion A: PF-05082566 0.24mg/kg Portion A: PF-05082566 0.3mg/kg Portion A: PF-05082566 0.6mg/kg Portion A: PF-05082566 1.2mg/kg Portion A: PF-05082566 2.4mg/kg Portion A: PF-05082566 5mg/kg Portion A: PF-05082566 10mg/kg Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
Hide Arm/Group Description Participants received PF-05082566 0.006 milligrams per kilogram (mg/kg) intravenously once every 4 weeks (q4wks) as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.03mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.06mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.12mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.18mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.24mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.3mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.6mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 2.4mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 5mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter [mg/m^2] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Period Title: Overall Study
Started 4 3 6 4 3 42 3 4 31 5 6 11 3 3 4 3 3 3 4 32 3 5 4
Completed 0 0 1 1 2 1 1 0 1 0 0 0 2 3 2 2 2 2 2 0 0 0 0
Not Completed 4 3 5 3 1 41 2 4 30 5 6 11 1 0 2 1 1 1 2 32 3 5 4
Reason Not Completed
Death             4             3             5             3             1             26             2             2             21             2             3             9             0             0             0             0             1             1             2             8             1             2             2
Lost to Follow-up             0             0             0             0             0             7             0             0             1             2             1             0             0             0             0             0             0             0             0             2             0             0             0
Withdrawal by Subject             0             0             0             0             0             1             0             1             5             1             1             1             0             0             0             0             0             0             0             3             0             0             0
Other             0             0             0             0             0             7             0             1             3             0             1             1             1             0             2             1             0             0             0             19             2             3             2
Arm/Group Title Portion A: PF-05082566 0.006mg/kg Portion A: PF-05082566 0.03mg/kg Portion A: PF-05082566 0.06mg/kg Portion A: PF-05082566 0.12mg/kg Portion A: PF-05082566 0.18mg/kg Portion A: PF-05082566 0.24mg/kg Portion A: PF-05082566 0.3mg/kg Portion A: PF-05082566 0.6mg/kg Portion A: PF-05082566 1.2mg/kg Portion A: PF-05082566 2.4mg/kg Portion A: PF-05082566 5mg/kg Portion A: PF-05082566 10mg/kg Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2 Total
Hide Arm/Group Description Participants received PF-05082566 0.006 milligrams per kilogram (mg/kg) intravenously once every 4 weeks (q4wks) as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.03mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.06mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.12mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.18mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.24mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.3mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.6mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 2.4mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 5mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter [mg/m^2] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Total of all reporting groups
Overall Number of Baseline Participants 4 3 6 4 3 42 3 4 31 5 6 11 3 3 4 3 3 3 4 32 3 5 4 189
Hide Baseline Analysis Population Description
All participants who received at least 1 dose of PF-05082566 or rituximab.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 6 participants 4 participants 3 participants 42 participants 3 participants 4 participants 31 participants 5 participants 6 participants 11 participants 3 participants 3 participants 4 participants 3 participants 3 participants 3 participants 4 participants 32 participants 3 participants 5 participants 4 participants 189 participants
<=18 years
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%
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%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
  75.0%
2
  66.7%
4
  66.7%
3
  75.0%
1
  33.3%
17
  40.5%
1
  33.3%
2
  50.0%
19
  61.3%
4
  80.0%
3
  50.0%
5
  45.5%
3
 100.0%
2
  66.7%
4
 100.0%
0
   0.0%
2
  66.7%
3
 100.0%
2
  50.0%
14
  43.8%
0
   0.0%
3
  60.0%
3
  75.0%
100
  52.9%
>=65 years
1
  25.0%
1
  33.3%
2
  33.3%
1
  25.0%
2
  66.7%
25
  59.5%
2
  66.7%
2
  50.0%
12
  38.7%
1
  20.0%
3
  50.0%
6
  54.5%
0
   0.0%
1
  33.3%
0
   0.0%
3
 100.0%
1
  33.3%
0
   0.0%
2
  50.0%
18
  56.3%
3
 100.0%
2
  40.0%
1
  25.0%
89
  47.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 6 participants 4 participants 3 participants 42 participants 3 participants 4 participants 31 participants 5 participants 6 participants 11 participants 3 participants 3 participants 4 participants 3 participants 3 participants 3 participants 4 participants 32 participants 3 participants 5 participants 4 participants 189 participants
Female
0
   0.0%
1
  33.3%
2
  33.3%
2
  50.0%
2
  66.7%
15
  35.7%
0
   0.0%
1
  25.0%
13
  41.9%
3
  60.0%
1
  16.7%
3
  27.3%
2
  66.7%
1
  33.3%
2
  50.0%
1
  33.3%
2
  66.7%
1
  33.3%
1
  25.0%
15
  46.9%
1
  33.3%
2
  40.0%
1
  25.0%
72
  38.1%
Male
4
 100.0%
2
  66.7%
4
  66.7%
2
  50.0%
1
  33.3%
27
  64.3%
3
 100.0%
3
  75.0%
18
  58.1%
2
  40.0%
5
  83.3%
8
  72.7%
1
  33.3%
2
  66.7%
2
  50.0%
2
  66.7%
1
  33.3%
2
  66.7%
3
  75.0%
17
  53.1%
2
  66.7%
3
  60.0%
3
  75.0%
117
  61.9%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 6 participants 4 participants 3 participants 42 participants 3 participants 4 participants 31 participants 5 participants 6 participants 11 participants 3 participants 3 participants 4 participants 3 participants 3 participants 3 participants 4 participants 32 participants 3 participants 5 participants 4 participants 189 participants
White
3
  75.0%
3
 100.0%
3
  50.0%
4
 100.0%
2
  66.7%
36
  85.7%
1
  33.3%
4
 100.0%
24
  77.4%
4
  80.0%
2
  33.3%
4
  36.4%
2
  66.7%
3
 100.0%
3
  75.0%
2
  66.7%
2
  66.7%
2
  66.7%
4
 100.0%
22
  68.8%
2
  66.7%
5
 100.0%
4
 100.0%
141
  74.6%
Black
0
   0.0%
0
   0.0%
1
  16.7%
0
   0.0%
0
   0.0%
1
   2.4%
1
  33.3%
0
   0.0%
1
   3.2%
1
  20.0%
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
  33.3%
0
   0.0%
0
   0.0%
7
   3.7%
Asian
1
  25.0%
0
   0.0%
2
  33.3%
0
   0.0%
0
   0.0%
1
   2.4%
0
   0.0%
0
   0.0%
2
   6.5%
0
   0.0%
3
  50.0%
7
  63.6%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
6
  18.8%
0
   0.0%
0
   0.0%
0
   0.0%
22
  11.6%
Other
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  33.3%
4
   9.5%
0
   0.0%
0
   0.0%
4
  12.9%
0
   0.0%
1
  16.7%
0
   0.0%
1
  33.3%
0
   0.0%
1
  25.0%
1
  33.3%
1
  33.3%
0
   0.0%
0
   0.0%
4
  12.5%
0
   0.0%
0
   0.0%
0
   0.0%
18
   9.5%
Unspecified
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%
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%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.5%
1.Primary Outcome
Title Number of Participants With Dose-Limiting Toxicities (DLTs) in First 2 Cycles of Portion A
Hide Description DLT: Any of the following adverse events (AEs) occurred in the first 2 cycles of treatment (up to 28 days post second dose) which was attributed to PF-05082566 alone for Portion A and not related to progressive disease. Hematologic: Grade 4 neutropenia lasting more than (>)7 days; febrile neutropenia; neutropenic infection; Grade ≥3 thrombocytopenia with bleeding; Grade 4 thrombocytopenia; Grade ≥3 hemolysis. Non-Hematologic: Grade ≥3 toxicities, except those Grade 3 events that responded to treatment (eg, Grade 3 nausea, vomiting, diarrhea responding to standard medical supportive care within 48 hours would not be considered a DLT). Severity of AEs were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (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). Each cycle=28 days.
Time Frame Cycle 1 Day 1 to Cycle 2 Day 29 in Portion A (up to 57 days, each cycle = 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of PF-05082566 in the first 2 cycles of Portion A.
Arm/Group Title Portion A: PF-05082566 0.006mg/kg Portion A: PF-05082566 0.03mg/kg Portion A: PF-05082566 0.06mg/kg Portion A: PF-05082566 0.12mg/kg Portion A: PF-05082566 0.18mg/kg Portion A: PF-05082566 0.24mg/kg Portion A: PF-05082566 0.3mg/kg Portion A: PF-05082566 0.6mg/kg Portion A: PF-05082566 1.2mg/kg Portion A: PF-05082566 2.4mg/kg Portion A: PF-05082566 5mg/kg Portion A: PF-05082566 10mg/kg
Hide Arm/Group Description:
Participants received PF-05082566 0.006 milligrams per kilogram (mg/kg) intravenously once every 4 weeks (q4wks) as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.03mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.06mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.12mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.18mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.24mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.3mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.6mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 2.4mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 5mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Overall Number of Participants Analyzed 4 3 6 4 3 42 3 4 31 5 6 11
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.4%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2.Primary Outcome
Title Number of Participants With DLTs in First 2 Cycles of Portion B
Hide Description DLT: Any of the following AEs occurred in the first 2 cycles of treatment (up to 28 days post second dose) which was attributed to PF-05082566 in combination with rituximab for Portion B and not related to progressive disease. Hematologic: Grade 4 neutropenia lasting more than (>)7 days; febrile neutropenia; neutropenic infection; Grade ≥3 thrombocytopenia with bleeding; Grade 4 thrombocytopenia; Grade ≥3 hemolysis. Non-Hematologic: Grade ≥3 toxicities, except those Grade 3 events that responded to treatment (eg, Grade 3 nausea, vomiting, diarrhea responding to standard medical supportive care within 48 hours would not be considered a DLT). Severity of AEs were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (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). Each cycle=28 days.
Time Frame Cycle 1 Day 1 to Cycle 2 Day 29 in Portion B (up to 57 days, each cycle = 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of PF-05082566 and 1 dose of rituximab in the first 2 cycles of Portion B.
Arm/Group Title Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
Hide Arm/Group Description:
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter [mg/m^2] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Overall Number of Participants Analyzed 3 3 4 3 3 3 3 31 3 5 4
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%
0
   0.0%
3.Secondary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) in Portion A
Hide Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. AEs included both non-serious AEs and SAEs. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study treatment. Causality of AEs was determined by the investigator.
Time Frame Up to approximately 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of PF-05082566 in Portion A.
Arm/Group Title Portion A: PF-05082566 0.006mg/kg Portion A: PF-05082566 0.03mg/kg Portion A: PF-05082566 0.06mg/kg Portion A: PF-05082566 0.12mg/kg Portion A: PF-05082566 0.18mg/kg Portion A: PF-05082566 0.24mg/kg Portion A: PF-05082566 0.3mg/kg Portion A: PF-05082566 0.6mg/kg Portion A: PF-05082566 1.2mg/kg Portion A: PF-05082566 2.4mg/kg Portion A: PF-05082566 5mg/kg Portion A: PF-05082566 10mg/kg
Hide Arm/Group Description:
Participants received PF-05082566 0.006 milligrams per kilogram (mg/kg) intravenously once every 4 weeks (q4wks) as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.03mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.06mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.12mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.18mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.24mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.3mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.6mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 2.4mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 5mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Overall Number of Participants Analyzed 4 3 6 4 3 42 3 4 31 5 6 11
Measure Type: Count of Participants
Unit of Measure: Participants
AEs
3
  75.0%
3
 100.0%
5
  83.3%
4
 100.0%
3
 100.0%
39
  92.9%
3
 100.0%
4
 100.0%
26
  83.9%
5
 100.0%
5
  83.3%
9
  81.8%
SAEs
0
   0.0%
0
   0.0%
2
  33.3%
1
  25.0%
0
   0.0%
13
  31.0%
0
   0.0%
0
   0.0%
8
  25.8%
1
  20.0%
2
  33.3%
3
  27.3%
AEs related to PF-05082566
2
  50.0%
1
  33.3%
2
  33.3%
1
  25.0%
2
  66.7%
25
  59.5%
1
  33.3%
1
  25.0%
10
  32.3%
1
  20.0%
2
  33.3%
4
  36.4%
SAEs related to PF-05082566
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
4
   9.5%
0
   0.0%
0
   0.0%
1
   3.2%
0
   0.0%
0
   0.0%
0
   0.0%
4.Secondary Outcome
Title Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A
Hide Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study treatment. Severity of AEs were graded 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).
Time Frame Up to approximately 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of PF-05082566 in Portion A.
Arm/Group Title Portion A: PF-05082566 0.006mg/kg Portion A: PF-05082566 0.03mg/kg Portion A: PF-05082566 0.06mg/kg Portion A: PF-05082566 0.12mg/kg Portion A: PF-05082566 0.18mg/kg Portion A: PF-05082566 0.24mg/kg Portion A: PF-05082566 0.3mg/kg Portion A: PF-05082566 0.6mg/kg Portion A: PF-05082566 1.2mg/kg Portion A: PF-05082566 2.4mg/kg Portion A: PF-05082566 5mg/kg Portion A: PF-05082566 10mg/kg
Hide Arm/Group Description:
Participants received PF-05082566 0.006 milligrams per kilogram (mg/kg) intravenously once every 4 weeks (q4wks) as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.03mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.06mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.12mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.18mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.24mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.3mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.6mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 2.4mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 5mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Overall Number of Participants Analyzed 4 3 6 4 3 42 3 4 31 5 6 11
Measure Type: Count of Participants
Unit of Measure: Participants
Grade 1
0
   0.0%
0
   0.0%
1
  16.7%
1
  25.0%
1
  33.3%
9
  21.4%
2
  66.7%
1
  25.0%
7
  22.6%
1
  20.0%
1
  16.7%
2
  18.2%
Grade 2
1
  25.0%
2
  66.7%
2
  33.3%
1
  25.0%
0
   0.0%
14
  33.3%
1
  33.3%
2
  50.0%
8
  25.8%
3
  60.0%
2
  33.3%
4
  36.4%
Grade 3
2
  50.0%
1
  33.3%
2
  33.3%
2
  50.0%
2
  66.7%
12
  28.6%
0
   0.0%
1
  25.0%
9
  29.0%
1
  20.0%
2
  33.3%
2
  18.2%
Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   4.8%
0
   0.0%
0
   0.0%
1
   3.2%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 5
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   4.8%
0
   0.0%
0
   0.0%
1
   3.2%
0
   0.0%
0
   0.0%
1
   9.1%
5.Secondary Outcome
Title Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A
Hide Description Following hematology laboratory abnormalities were graded per NCI CTCAE version 4.03: anemia, hemoglobin increased, lymphocyte count increased, lymphopenia, neutrophils (absolute), platelets, white blood cells. The abnormalities with at least 1 participant are presented here.
Time Frame Up to approximately 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of PF-05082566 in Portion A and had hematology laboratory test data.
Arm/Group Title Portion A: PF-05082566 0.006mg/kg Portion A: PF-05082566 0.03mg/kg Portion A: PF-05082566 0.06mg/kg Portion A: PF-05082566 0.12mg/kg Portion A: PF-05082566 0.18mg/kg Portion A: PF-05082566 0.24mg/kg Portion A: PF-05082566 0.3mg/kg Portion A: PF-05082566 0.6mg/kg Portion A: PF-05082566 1.2mg/kg Portion A: PF-05082566 2.4mg/kg Portion A: PF-05082566 5mg/kg Portion A: PF-05082566 10mg/kg
Hide Arm/Group Description:
Participants received PF-05082566 0.006 milligrams per kilogram (mg/kg) intravenously once every 4 weeks (q4wks) as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.03mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.06mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.12mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.18mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.24mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.3mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.6mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 2.4mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 5mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Overall Number of Participants Analyzed 4 3 6 4 3 42 3 4 28 4 6 11
Measure Type: Count of Participants
Unit of Measure: Participants
Anemia, Grade 1
1
  25.0%
3
 100.0%
3
  50.0%
3
  75.0%
1
  33.3%
20
  47.6%
2
  66.7%
1
  25.0%
12
  42.9%
1
  25.0%
3
  50.0%
6
  54.5%
Anemia, Grade 2
2
  50.0%
0
   0.0%
3
  50.0%
1
  25.0%
1
  33.3%
6
  14.3%
0
   0.0%
2
  50.0%
8
  28.6%
0
   0.0%
2
  33.3%
5
  45.5%
Anemia, Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  33.3%
1
   2.4%
0
   0.0%
0
   0.0%
0
   0.0%
1
  25.0%
0
   0.0%
0
   0.0%
Lymphocyte count increased, Grade 2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   9.1%
Lymphopenia, Grade 1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
7
  16.7%
0
   0.0%
1
  25.0%
4
  14.3%
1
  25.0%
0
   0.0%
6
  54.5%
Lymphopenia, Grade 2
3
  75.0%
0
   0.0%
2
  33.3%
0
   0.0%
2
  66.7%
10
  23.8%
1
  33.3%
1
  25.0%
6
  21.4%
1
  25.0%
3
  50.0%
2
  18.2%
Lymphopenia, Grade 3
1
  25.0%
1
  33.3%
1
  16.7%
3
  75.0%
1
  33.3%
7
  16.7%
1
  33.3%
1
  25.0%
2
   7.1%
1
  25.0%
1
  16.7%
0
   0.0%
Lymphopenia, Grade 4
0
   0.0%
1
  33.3%
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%
Neutrophils (absolute), Grade 1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.4%
0
   0.0%
0
   0.0%
1
   3.6%
0
   0.0%
1
  16.7%
1
   9.1%
Neutrophils (absolute), Grade 2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   7.1%
0
   0.0%
0
   0.0%
0
   0.0%
Neutrophils (absolute), Grade 3
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%
0
   0.0%
0
   0.0%
0
   0.0%
Platelets, Grade 1
2
  50.0%
2
  66.7%
2
  33.3%
1
  25.0%
2
  66.7%
7
  16.7%
1
  33.3%
2
  50.0%
2
   7.1%
1
  25.0%
1
  16.7%
1
   9.1%
White blood cells, Grade 1
1
  25.0%
1
  33.3%
1
  16.7%
2
  50.0%
0
   0.0%
4
   9.5%
1
  33.3%
2
  50.0%
6
  21.4%
0
   0.0%
2
  33.3%
3
  27.3%
White blood cells, Grade 2
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White blood cells, Grade 3
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
   3.6%
0
   0.0%
0
   0.0%
0
   0.0%
6.Secondary Outcome
Title Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A
Hide Description Following chemistries laboratory abnormalities were graded per NCI CTCAE version 4.03: alanine aminotransferase (ALT), Alkaline phosphatase, Aspartate aminotransferase (AST), bilirubin (total), creatinine, gamma glutamyl transferase (GGT), hypercalcemia, hyperglycemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia, hypophosphatemia. The abnormalities with at least 1 participant are presented here.
Time Frame Up to approximately 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
"Number of Participants Analyzed" represents all participants who received at least 1 dose of PF-05082566 in Portion A and had chemistries laboratory test data. "Number Analyzed" represents all participants who received at least 1 dose of PF-05082566 in Portion A and had data for the specified category.
Arm/Group Title Portion A: PF-05082566 0.006mg/kg Portion A: PF-05082566 0.03mg/kg Portion A: PF-05082566 0.06mg/kg Portion A: PF-05082566 0.12mg/kg Portion A: PF-05082566 0.18mg/kg Portion A: PF-05082566 0.24mg/kg Portion A: PF-05082566 0.3mg/kg Portion A: PF-05082566 0.6mg/kg Portion A: PF-05082566 1.2mg/kg Portion A: PF-05082566 2.4mg/kg Portion A: PF-05082566 5mg/kg Portion A: PF-05082566 10mg/kg
Hide Arm/Group Description:
Participants received PF-05082566 0.006 milligrams per kilogram (mg/kg) intravenously once every 4 weeks (q4wks) as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.03mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.06mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.12mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.18mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.24mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.3mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.6mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 2.4mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 5mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Overall Number of Participants Analyzed 4 3 6 4 3 42 3 4 28 4 6 11
Measure Type: Count of Participants
Unit of Measure: Participants
ALT, Grade 1 Number Analyzed 4 participants 3 participants 6 participants 4 participants 3 participants 42 participants 3 participants 4 participants 28 participants 4 participants 6 participants 11 participants
1
  25.0%
1
  33.3%
1
  16.7%
1
  25.0%
0
   0.0%
1
   2.4%
0
   0.0%
1
  25.0%
6
  21.4%
0
   0.0%
0
   0.0%
1
   9.1%
ALT, Grade 2 Number Analyzed 4 participants 3 participants 6 participants 4 participants 3 participants 42 participants 3 participants 4 participants 28 participants 4 participants 6 participants 11 participants
0
   0.0%
0
   0.0%
1
  16.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   3.6%
0
   0.0%
0
   0.0%
0
   0.0%
Alkaline phosphatase, Grade 1 Number Analyzed 4 participants 3 participants 6 participants 4 participants 3 participants 42 participants 3 participants 4 participants 28 participants 4 participants 6 participants 11 participants
2
  50.0%
0
   0.0%
1
  16.7%
0
   0.0%
2
  66.7%
13
  31.0%
0
   0.0%
0
   0.0%
6
  21.4%
1
  25.0%
3
  50.0%
4
  36.4%
Alkaline phosphatase, Grade 2 Number Analyzed 4 participants 3 participants 6 participants 4 participants 3 participants 42 participants 3 participants 4 participants 28 participants 4 participants 6 participants 11 participants
0
   0.0%
0
   0.0%
1
  16.7%
0
   0.0%
0
   0.0%
3
   7.1%
1
  33.3%
0
   0.0%
2
   7.1%
0
   0.0%
0
   0.0%
0
   0.0%
Alkaline phosphatase, Grade 3 Number Analyzed 4 participants 3 participants 6 participants 4 participants 3 participants 42 participants 3 participants 4 participants 28 participants 4 participants 6 participants 11 participants
0
   0.0%
1
  33.3%
1
  16.7%
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%
AST, Grade 1 Number Analyzed 4 participants 3 participants 6 participants 4 participants 3 participants 42 participants 3 participants 4 participants 28 participants 4 participants 6 participants 11 participants
3
  75.0%
2
  66.7%
1
  16.7%
1
  25.0%
2
  66.7%
12
  28.6%
2
  66.7%
2
  50.0%
7
  25.0%
1
  25.0%
2
  33.3%
1
   9.1%
AST, Grade 2 Number Analyzed 4 participants 3 participants 6 participants 4 participants 3 participants 42 participants 3 participants 4 participants 28 participants 4 participants 6 participants 11 participants
0
   0.0%
0
   0.0%
1
  16.7%
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%
Bilirubin (total), Grade 1 Number Analyzed 4 participants 3 participants 6 participants 4 participants 3 participants 42 participants 3 participants 4 participants 28 participants 4 participants 6 participants 11 participants
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
0
   0.0%
3
   7.1%
0
   0.0%
0
   0.0%
1
   3.6%
0
   0.0%
0
   0.0%
0
   0.0%
Bilirubin (total), Grade 2 Number Analyzed 4 participants 3 participants 6 participants 4 participants 3 participants 42 participants 3 participants 4 participants 28 participants 4 participants 6 participants 11 participants
1
  25.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  33.3%
3
   7.1%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Creatinine, Grade 1 Number Analyzed 4 participants 3 participants 6 participants 4 participants 3 participants 42 participants 3 participants 4 participants 28 participants 4 participants 6 participants 11 participants
3
  75.0%
3
 100.0%
5
  83.3%
4
 100.0%
3
 100.0%
22
  52.4%
2
  66.7%
2
  50.0%
19
  67.9%
4
 100.0%
5
  83.3%
6
  54.5%
Creatinine, Grade 2 Number Analyzed 4 participants 3 participants 6 participants 4 participants 3 participants 42 participants 3 participants 4 participants 28 participants 4 participants 6 participants 11 participants
1
  25.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   4.8%
0
   0.0%
1
  25.0%
1
   3.6%
0
   0.0%
0
   0.0%
1
   9.1%
GGT, Grade 2 Number Analyzed 4 participants 3 participants 3 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
1
  25.0%
0
   0.0%
1
  33.3%
GGT, Grade 3 Number Analyzed 4 participants 3 participants 3 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
1
  25.0%
2
  66.7%
1
  33.3%
Hypercalcemia, Grade 1 Number Analyzed 4 participants 3 participants 6 participants 4 participants 3 participants 42 participants 3 participants 4 participants 28 participants 4 participants 6 participants 11 participants
1
  25.0%
1
  33.3%
0
   0.0%
0
   0.0%
1
  33.3%
3
   7.1%
0
   0.0%
0
   0.0%
1
   3.6%
1
  25.0%
0
   0.0%
0
   0.0%
Hyperglycemia, Grade 1 Number Analyzed 4 participants 3 participants 6 participants 4 participants 3 participants 42 participants 3 participants 4 participants 28 participants 4 participants 6 participants 11 participants
2
  50.0%
0
   0.0%
3
  50.0%
3
  75.0%
3
 100.0%
20
  47.6%
3
 100.0%
3
  75.0%
13
  46.4%
2
  50.0%
4
  66.7%
6
  54.5%
Hyperglycemia, Grade 2 Number Analyzed 4 participants 3 participants 6 participants 4 participants 3 participants 42 participants 3 participants 4 participants 28 participants 4 participants 6 participants 11 participants
2
  50.0%
2
  66.7%
2
  33.3%
0
   0.0%
0
   0.0%
7
  16.7%
0
   0.0%
1
  25.0%
3
  10.7%
1
  25.0%
1
  16.7%
3
  27.3%
Hyperglycemia, Grade 3 Number Analyzed 4 participants 3 participants 6 participants 4 participants 3 participants 42 participants 3 participants 4 participants 28 participants 4 participants 6 participants 11 participants
0
   0.0%
0
   0.0%
0
   0.0%
1
  25.0%
0
   0.0%
1
   2.4%
0
   0.0%
0
   0.0%
2
   7.1%
0
   0.0%
0
   0.0%
0
   0.0%
Hyperkalemia, Grade 1 Number Analyzed 4 participants 3 participants 6 participants 4 participants 3 participants 42 participants 3 participants 4 participants 28 participants 4 participants 6 participants 11 participants
0
   0.0%
0
   0.0%
1
  16.7%
0
   0.0%
0
   0.0%
2
   4.8%
0
   0.0%
0
   0.0%
3
  10.7%
1
  25.0%
0
   0.0%
0
   0.0%
Hyperkalemia, Grade 2 Number Analyzed 4 participants 3 participants 6 participants 4 participants 3 participants 42 participants 3 participants 4 participants 28 participants 4 participants 6 participants 11 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.4%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hypermagnesemia, Grade 1 Number Analyzed 4 participants 3 participants 6 participants 4 participants 3 participants 42 participants 3 participants 4 participants 27 participants 4 participants 6 participants 11 participants
0
   0.0%
0
   0.0%
1
  16.7%
0
   0.0%
1
  33.3%
3
   7.1%
1
  33.3%
1
  25.0%
3
  11.1%
0
   0.0%
1
  16.7%
0
   0.0%
Hypermagnesemia, Grade 3 Number Analyzed 4 participants 3 participants 6 participants 4 participants 3 participants 42 participants 3 participants 4 participants 27 participants 4 participants 6 participants 11 participants
0
   0.0%
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%
0
   0.0%
Hypernatremia, Grade 1 Number Analyzed 4 participants 3 participants 6 participants 4 participants 3 participants 42 participants 3 participants 4 participants 28 participants 4 participants 6 participants 11 participants
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.4%
0
   0.0%
0
   0.0%
1
   3.6%
0
   0.0%
0
   0.0%
0
   0.0%
Hypoalbuminemia, Grade 1 Number Analyzed 4 participants 3 participants 6 participants 4 participants 3 participants 42 participants 3 participants 4 participants 28 participants 4 participants 6 participants 11 participants
1
  25.0%
1
  33.3%
4
  66.7%
4
 100.0%
1
  33.3%
18
  42.9%
1
  33.3%
3
  75.0%
9
  32.1%
2
  50.0%
2
  33.3%
4
  36.4%
Hypoalbuminemia, Grade 2 Number Analyzed 4 participants 3 participants 6 participants 4 participants 3 participants 42 participants 3 participants 4 participants 28 participants 4 participants 6 participants 11 participants
2
  50.0%
1
  33.3%
2
  33.3%
0
   0.0%
1
  33.3%
1
   2.4%
0
   0.0%
0
   0.0%
3
  10.7%
0
   0.0%
1
  16.7%
4
  36.4%
Hypoalbuminemia, Grade 3 Number Analyzed 4 participants 3 participants 6 participants 4 participants 3 participants 42 participants 3 participants 4 participants 28 participants 4 participants 6 participants 11 participants
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%
0
   0.0%
0
   0.0%
0
   0.0%
Hypocalcemia, Grade 1 Number Analyzed 4 participants 3 participants 6 participants 4 participants 3 participants 42 participants 3 participants 4 participants 28 participants 4 participants 6 participants 11 participants
1
  25.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
7
  16.7%
0
   0.0%
1
  25.0%
5
  17.9%
0
   0.0%
3
  50.0%
0
   0.0%
Hypocalcemia, Grade 2 Number Analyzed 4 participants 3 participants 6 participants 4 participants 3 participants 42 participants 3 participants 4 participants 28 participants 4 participants 6 participants 11 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  33.3%
1
   2.4%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hypocalcemia, Grade 3 Number Analyzed 4 participants 3 participants 6 participants 4 participants 3 participants 42 participants 3 participants 4 participants 28 participants 4 participants 6 participants 11 participants
0
   0.0%
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%
0
   0.0%
Hypoglycemia, Grade 1 Number Analyzed 4 participants 3 participants 6 participants 4 participants 3 participants 42 participants 3 participants 4 participants 28 participants 4 participants 6 participants 11 participants
1
  25.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.4%
0
   0.0%
1
  25.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hypoglycemia, Grade 2 Number Analyzed 4 participants 3 participants 6 participants 4 participants 3 participants 42 participants 3 participants 4 participants 28 participants 4 participants 6 participants 11 participants
0
   0.0%
0
   0.0%
1
  16.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  25.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hypokalemia, Grade 1 Number Analyzed 4 participants 3 participants 6 participants 4 participants 3 participants 42 participants 3 participants 4 participants 28 participants 4 participants 6 participants 11 participants
1
  25.0%
0
   0.0%
2
  33.3%
1
  25.0%
1
  33.3%
4
   9.5%
2
  66.7%
1
  25.0%
3
  10.7%
1
  25.0%
0
   0.0%
2
  18.2%
Hypokalemia, Grade 3 Number Analyzed 4 participants 3 participants 6 participants 4 participants 3 participants 42 participants 3 participants 4 participants 28 participants 4 participants 6 participants 11 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%
1
  25.0%
1
  16.7%
0
   0.0%
Hypokalemia, Grade 4 Number Analyzed 4 participants 3 participants 6 participants 4 participants 3 participants 42 participants 3 participants 4 participants 28 participants 4 participants 6 participants 11 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.4%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hypomagnesemia, Grade 1 Number Analyzed 4 participants 3 participants 6 participants 4 participants 3 participants 42 participants 3 participants 4 participants 27 participants 4 participants 6 participants 11 participants
2
  50.0%
1
  33.3%
1
  16.7%
2
  50.0%
0
   0.0%
8
  19.0%
0
   0.0%
1
  25.0%
3
  11.1%
1
  25.0%
1
  16.7%
0
   0.0%
Hyponatremia, Grade 1 Number Analyzed 4 participants 3 participants 6 participants 4 participants 3 participants 42 participants 3 participants 4 participants 28 participants 4 participants 6 participants 11 participants
2
  50.0%
2
  66.7%
2
  33.3%
1
  25.0%
0
   0.0%
17
  40.5%
2
  66.7%
0
   0.0%
8
  28.6%
4
 100.0%
1
  16.7%
2
  18.2%
Hyponatremia, Grade 3 Number Analyzed 4 participants 3 participants 6 participants 4 participants 3 participants 42 participants 3 participants 4 participants 28 participants 4 participants 6 participants 11 participants
1
  25.0%
0
   0.0%
0
   0.0%
1
  25.0%
0
   0.0%
1
   2.4%
0
   0.0%
1
  25.0%
1
   3.6%
0
   0.0%
2
  33.3%
0
   0.0%
Hypophosphatemia, Grade 2 Number Analyzed 4 participants 3 participants 5 participants 3 participants 3 participants 40 participants 3 participants 4 participants 27 participants 4 participants 6 participants 11 participants
0
   0.0%
2
  66.7%
0
   0.0%
2
  66.7%
0
   0.0%
8
  20.0%
2
  66.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
3
  27.3%
Hypophosphatemia, Grade 3 Number Analyzed 4 participants 3 participants 5 participants 3 participants 3 participants 40 participants 3 participants 4 participants 27 participants 4 participants 6 participants 11 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  33.3%
1
   2.5%
0
   0.0%
0
   0.0%
1
   3.7%
0
   0.0%
1
  16.7%
0
   0.0%
7.Secondary Outcome
Title Number of Participants With Clinically Significant Vital Sign Abnormalities in Portion A
Hide Description For vital signs in Portion A, blood pressure and pulse rate were measured. Clinical significance was determined by the investigator.
Time Frame Up to approximately 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of PF-05082566 in Portion A.
Arm/Group Title Portion A: PF-05082566 0.006mg/kg Portion A: PF-05082566 0.03mg/kg Portion A: PF-05082566 0.06mg/kg Portion A: PF-05082566 0.12mg/kg Portion A: PF-05082566 0.18mg/kg Portion A: PF-05082566 0.24mg/kg Portion A: PF-05082566 0.3mg/kg Portion A: PF-05082566 0.6mg/kg Portion A: PF-05082566 1.2mg/kg Portion A: PF-05082566 2.4mg/kg Portion A: PF-05082566 5mg/kg Portion A: PF-05082566 10mg/kg
Hide Arm/Group Description:
Participants received PF-05082566 0.006 milligrams per kilogram (mg/kg) intravenously once every 4 weeks (q4wks) as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.03mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.06mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.12mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.18mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.24mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.3mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.6mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 2.4mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 5mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Overall Number of Participants Analyzed 4 3 6 4 3 42 3 4 31 5 6 11
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%
0
   0.0%
0
   0.0%
8.Secondary Outcome
Title PF-05082566 Maximum Observed Serum Concentration (Cmax) in Portion A
Hide Description Cmax of PF-05082566 was observed directly from data.
Time Frame Day 1 of Cycle 1 and Cycle 2 at pre-dose, and 1, 1.5, 2, 6, 24, 48, 168, 336 and 504 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of PF-05082566 in Portion A and had at least 1 of the PK parameters of interest. "Number Analyzed" represents those participants who had data for each specified category.
Arm/Group Title Portion A: PF-05082566 0.006mg/kg Portion A: PF-05082566 0.03mg/kg Portion A: PF-05082566 0.06mg/kg Portion A: PF-05082566 0.12mg/kg Portion A: PF-05082566 0.18mg/kg Portion A: PF-05082566 0.24mg/kg Portion A: PF-05082566 0.3mg/kg Portion A: PF-05082566 0.6mg/kg Portion A: PF-05082566 1.2mg/kg Portion A: PF-05082566 2.4mg/kg Portion A: PF-05082566 5mg/kg Portion A: PF-05082566 10mg/kg
Hide Arm/Group Description:
Participants received PF-05082566 0.006 milligrams per kilogram (mg/kg) intravenously once every 4 weeks (q4wks) as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.03mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.06mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.12mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.18mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.24mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.3mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.6mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 2.4mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 5mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Overall Number of Participants Analyzed 4 3 6 4 3 40 3 4 29 5 6 11
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: micrograms per milliliter (μg/mL)
Cycle 1 Number Analyzed 4 participants 3 participants 6 participants 4 participants 3 participants 40 participants 3 participants 4 participants 29 participants 5 participants 6 participants 11 participants
0.1515
(12%)
0.4952
(34%)
1.014
(24%)
2.614
(23%)
4.219
(16%)
3.246
(30%)
7.038
(23%)
11.72
(28%)
18.02
(24%)
49.63
(24%)
97.75
(13%)
150.3
(24%)
Cycle 2 Number Analyzed 2 participants 3 participants 6 participants 3 participants 3 participants 37 participants 2 participants 4 participants 24 participants 3 participants 5 participants 10 participants
0.1250 [1] 
(NA%)
0.5049
(7%)
1.093
(47%)
3.408
(25%)
4.013
(25%)
2.955
(46%)
8.349 [2] 
(NA%)
14.80
(24%)
17.61
(36%)
58.38
(33%)
101.6
(17%)
167.0
(21%)
[1]
Geometric coefficient of variation (CV) was not calculated when there were less than 3 participants with data.
[2]
Geometric CV was not calculated when there were less than 3 participants with data.
9.Secondary Outcome
Title PF-05082566 Pre-dose Trough Concentration During Multiple Dosing (Ctrough) in Portion A
Hide Description Ctrough of PF-05082566 was observed directly from data.
Time Frame Day 1 pre-dose of Cycle 2
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of PF-05082566 in Portion A and had data for Ctrough.
Arm/Group Title Portion A: PF-05082566 0.006mg/kg Portion A: PF-05082566 0.03mg/kg Portion A: PF-05082566 0.06mg/kg Portion A: PF-05082566 0.12mg/kg Portion A: PF-05082566 0.18mg/kg Portion A: PF-05082566 0.24mg/kg Portion A: PF-05082566 0.3mg/kg Portion A: PF-05082566 0.6mg/kg Portion A: PF-05082566 1.2mg/kg Portion A: PF-05082566 2.4mg/kg Portion A: PF-05082566 5mg/kg Portion A: PF-05082566 10mg/kg
Hide Arm/Group Description:
Participants received PF-05082566 0.006 milligrams per kilogram (mg/kg) intravenously once every 4 weeks (q4wks) as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.03mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.06mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.12mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.18mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.24mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.3mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.6mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 2.4mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 5mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Overall Number of Participants Analyzed 2 3 6 3 3 37 2 4 24 3 5 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: μg/mL
NA [1] 
(NA%)
0.1063
(24%)
0.1092
(24%)
0.3268
(12%)
0.4285
(49%)
0.3868
(46%)
0.8597 [2] 
(NA%)
1.520
(22%)
1.313
(61%)
7.054
(52%)
9.934
(35%)
9.963
(250%)
[1]
Geometric mean cannot be calculated when there were participants with a zero value (ie, Ctrough below the limit of quantification). Geometric CV was not calculated when there were less than 3 participants with data.
[2]
Geometric CV was not calculated when there were less than 3 participants with data.
10.Secondary Outcome
Title PF-05082566 Time for Maximum Observed Serum Concentration (Tmax) in Portion A
Hide Description Tmax of PF-05082566 was observed directly from data as time of Cmax.
Time Frame Day 1 of Cycle 1 and Cycle 2 at pre-dose, and 1, 1.5, 2, 6, 24, 48, 168, 336 and 504 hours post-dose.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of PF-05082566 in Portion A and had at least 1 of the PK parameters of interest. "Number Analyzed" represents those participants who had data for each specified category.
Arm/Group Title Portion A: PF-05082566 0.006mg/kg Portion A: PF-05082566 0.03mg/kg Portion A: PF-05082566 0.06mg/kg Portion A: PF-05082566 0.12mg/kg Portion A: PF-05082566 0.18mg/kg Portion A: PF-05082566 0.24mg/kg Portion A: PF-05082566 0.3mg/kg Portion A: PF-05082566 0.6mg/kg Portion A: PF-05082566 1.2mg/kg Portion A: PF-05082566 2.4mg/kg Portion A: PF-05082566 5mg/kg Portion A: PF-05082566 10mg/kg
Hide Arm/Group Description:
Participants received PF-05082566 0.006 milligrams per kilogram (mg/kg) intravenously once every 4 weeks (q4wks) as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.03mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.06mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.12mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.18mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.24mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.3mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.6mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 2.4mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 5mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Overall Number of Participants Analyzed 4 3 6 4 3 40 3 4 29 5 6 11
Median (Full Range)
Unit of Measure: hours (hr)
Cycle 1 Number Analyzed 4 participants 3 participants 6 participants 4 participants 3 participants 40 participants 3 participants 4 participants 29 participants 5 participants 6 participants 11 participants
1.75
(1.50 to 2.00)
1.63
(1.50 to 1.67)
2.00
(1.00 to 5.42)
1.26
(1.00 to 2.00)
1.25
(0.967 to 6.00)
1.03
(0.833 to 24.2)
1.00
(1.00 to 1.50)
1.80
(1.62 to 2.00)
1.17
(1.00 to 5.53)
1.50
(1.00 to 1.58)
1.06
(1.00 to 1.48)
1.50
(1.07 to 2.02)
Cycle 2 Number Analyzed 2 participants 3 participants 6 participants 3 participants 3 participants 37 participants 2 participants 4 participants 24 participants 3 participants 5 participants 10 participants
13.0
(2.00 to 24.0)
1.50
(1.50 to 2.00)
1.54
(1.00 to 2.00)
1.00
(1.00 to 2.00)
2.00
(1.50 to 2.00)
1.03
(0.833 to 2.00)
1.00
(1.00 to 1.00)
1.46
(1.00 to 1.70)
1.02
(0.883 to 1.22)
1.08
(1.00 to 1.08)
1.92
(1.08 to 2.00)
1.31
(1.03 to 5.55)
11.Secondary Outcome
Title PF-05082566 Area Under the Serum Concentration-Time Profile (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUClast) in Portion A
Hide Description AUClast of PF-05082566 was determined by linear/log trapezoidal method.
Time Frame Day 1 of Cycle 1 and Cycle 2 at pre-dose, and 1, 1.5, 2, 6, 24, 48, 168, 336 and 504 hours post-dose.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of PF-05082566 in Portion A and had at least 1 of the PK parameters of interest. "Number Analyzed" represents those participants who had data for each specified category.
Arm/Group Title Portion A: PF-05082566 0.006mg/kg Portion A: PF-05082566 0.03mg/kg Portion A: PF-05082566 0.06mg/kg Portion A: PF-05082566 0.12mg/kg Portion A: PF-05082566 0.18mg/kg Portion A: PF-05082566 0.24mg/kg Portion A: PF-05082566 0.3mg/kg Portion A: PF-05082566 0.6mg/kg Portion A: PF-05082566 1.2mg/kg Portion A: PF-05082566 2.4mg/kg Portion A: PF-05082566 5mg/kg Portion A: PF-05082566 10mg/kg
Hide Arm/Group Description:
Participants received PF-05082566 0.006 milligrams per kilogram (mg/kg) intravenously once every 4 weeks (q4wks) as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.03mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.06mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.12mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.18mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.24mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.3mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.6mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 2.4mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 5mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Overall Number of Participants Analyzed 4 3 6 4 3 40 3 4 29 5 6 11
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: microgram*hour per milliliter (μg*hr/mL)
Cycle 1 Number Analyzed 4 participants 3 participants 6 participants 4 participants 3 participants 34 participants 3 participants 4 participants 27 participants 5 participants 6 participants 11 participants
8.212
(251%)
101.0
(9%)
148.1
(33%)
389.4
(58%)
703.3
(32%)
481.1
(48%)
996.1
(29%)
2165
(21%)
2383
(61%)
5731
(101%)
15540
(22%)
25520
(24%)
Cycle 2 Number Analyzed 2 participants 3 participants 6 participants 3 participants 3 participants 5 participants 2 participants 4 participants 4 participants 3 participants 5 participants 10 participants
14.21 [1] 
(NA%)
105.2
(49%)
93.59
(152%)
614.9
(7%)
808.0
(53%)
818.7
(38%)
1662 [1] 
(NA%)
1918
(40%)
4035
(25%)
6741
(6%)
18140
(24%)
19900
(51%)
[1]
Geometric CV was not calculated when there were less than 3 participants with data.
12.Secondary Outcome
Title PF-05082566 AUC From Time 0 to Infinity (AUCinf) in Portion A
Hide Description AUCinf = AUClast + (Clast*/kel), where Clast* is the estimated concentration at the time of the last measurable concentration and kel is the terminal phase rate constant calculated as the absolute value of the slope of a linear regression during the terminal phase of the natural log-transformed concentration time profile.
Time Frame Day 1 of Cycle 1 and Cycle 2 at pre-dose, and 1, 1.5, 2, 6, 24, 48, 168, 336 and 504 hours post-dose.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of PF-05082566 in Portion A and had at least 1 of the PK parameters of interest. "Number Analyzed" represents those participants who had data for each specified category.
Arm/Group Title Portion A: PF-05082566 0.006mg/kg Portion A: PF-05082566 0.03mg/kg Portion A: PF-05082566 0.06mg/kg Portion A: PF-05082566 0.12mg/kg Portion A: PF-05082566 0.18mg/kg Portion A: PF-05082566 0.24mg/kg Portion A: PF-05082566 0.3mg/kg Portion A: PF-05082566 0.6mg/kg Portion A: PF-05082566 1.2mg/kg Portion A: PF-05082566 2.4mg/kg Portion A: PF-05082566 5mg/kg Portion A: PF-05082566 10mg/kg
Hide Arm/Group Description:
Participants received PF-05082566 0.006 milligrams per kilogram (mg/kg) intravenously once every 4 weeks (q4wks) as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.03mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.06mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.12mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.18mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.24mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.3mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.6mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 2.4mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 5mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Overall Number of Participants Analyzed 4 3 6 4 3 40 3 4 29 5 6 11
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: μg*hr/mL
Cycle 1 Number Analyzed 0 participants 1 participants 6 participants 3 participants 2 participants 15 participants 1 participants 2 participants 21 participants 2 participants 4 participants 8 participants
120 [1] 
(NA%)
187.5
(31%)
667.0
(13%)
989.5 [1] 
(NA%)
687.9
(43%)
770.0 [1] 
(NA%)
2916 [1] 
(NA%)
3111
(36%)
7628 [1] 
(NA%)
18430
(24%)
28280
(28%)
Cycle 2 Number Analyzed 0 participants 2 participants 3 participants 1 participants 3 participants 5 participants 1 participants 2 participants 3 participants 1 participants 3 participants 3 participants
169.8 [1] 
(NA%)
251.4
(17%)
931.0 [1] 
(NA%)
1072
(57%)
960.8
(47%)
2000 [1] 
(NA%)
1782 [1] 
(NA%)
4649
(25%)
8480 [1] 
(NA%)
20950
(23%)
22400
(26%)
[1]
Geometric CV was not calculated when there were less than 3 participants with data.
13.Secondary Outcome
Title PF-05082566 AUC From Time 0 to Time of Dosing Interval (AUCtau) in Portion A
Hide Description AUCtau of PF-05082566 was determined using linear/log trapezoidal method.
Time Frame Day 1 of Cycle 1 and Cycle 2 at pre-dose, and 1, 1.5, 2, 6, 24, 48, 168, 336 and 504 hours post-dose.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of PF-05082566 in Portion A and had at least 1 of the PK parameters of interest. "Number Analyzed" represents those participants who had data for each specified category.
Arm/Group Title Portion A: PF-05082566 0.006mg/kg Portion A: PF-05082566 0.03mg/kg Portion A: PF-05082566 0.06mg/kg Portion A: PF-05082566 0.12mg/kg Portion A: PF-05082566 0.18mg/kg Portion A: PF-05082566 0.24mg/kg Portion A: PF-05082566 0.3mg/kg Portion A: PF-05082566 0.6mg/kg Portion A: PF-05082566 1.2mg/kg Portion A: PF-05082566 2.4mg/kg Portion A: PF-05082566 5mg/kg Portion A: PF-05082566 10mg/kg
Hide Arm/Group Description:
Participants received PF-05082566 0.006 milligrams per kilogram (mg/kg) intravenously once every 4 weeks (q4wks) as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.03mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.06mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.12mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.18mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.24mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.3mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.6mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 2.4mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 5mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Overall Number of Participants Analyzed 4 3 6 4 3 40 3 4 29 5 6 11
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: μg*hr/mL
Cycle 1 Number Analyzed 4 participants 3 participants 6 participants 3 participants 3 participants 32 participants 3 participants 4 participants 25 participants 4 participants 6 participants 11 participants
13.70
(181%)
104.8
(9%)
154.2
(27%)
503.9
(14%)
690.9
(33%)
538.6
(33%)
1012
(27%)
2195
(21%)
2761
(34%)
8204
(36%)
15760
(20%)
25250
(23%)
Cycle 2 Number Analyzed 0 participants 2 participants 3 participants 2 participants 3 participants 5 participants 2 participants 3 participants 4 participants 1 participants 5 participants 4 participants
130.8 [1] 
(NA%)
224.4
(19%)
618.6 [1] 
(NA%)
864.1
(47%)
824.3
(37%)
1681 [1] 
(NA%)
2107
(43%)
4068
(27%)
7460 [1] 
(NA%)
19040
(18%)
20490
(17%)
[1]
Geometric CV was not calculated when there were less than 3 participants with data.
14.Secondary Outcome
Title PF-05082566 Clearance (CL) in Portion A
Hide Description CL = Dose/AUCinf for Cycle 1 and Dose/AUCtau for Cycle 2. It was reported in units of milliliter per hour per kilogram (mL/hr/kg).
Time Frame Day 1 of Cycle 1 and Cycle 2 at pre-dose, and 1, 1.5, 2, 6, 24, 48, 168, 336 and 504 hours post-dose.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of PF-05082566 in Portion A and had at least 1 of the PK parameters of interest. "Number Analyzed" represents those participants who had data for each specified category.
Arm/Group Title Portion A: PF-05082566 0.006mg/kg Portion A: PF-05082566 0.03mg/kg Portion A: PF-05082566 0.06mg/kg Portion A: PF-05082566 0.12mg/kg Portion A: PF-05082566 0.18mg/kg Portion A: PF-05082566 0.24mg/kg Portion A: PF-05082566 0.3mg/kg Portion A: PF-05082566 0.6mg/kg Portion A: PF-05082566 1.2mg/kg Portion A: PF-05082566 2.4mg/kg Portion A: PF-05082566 5mg/kg Portion A: PF-05082566 10mg/kg
Hide Arm/Group Description:
Participants received PF-05082566 0.006 milligrams per kilogram (mg/kg) intravenously once every 4 weeks (q4wks) as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.03mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.06mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.12mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.18mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.24mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.3mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.6mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 2.4mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 5mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Overall Number of Participants Analyzed 4 3 6 4 3 40 3 4 29 5 6 11
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: milliliter/hour/kilogram (mL/hr/kg)
Cycle 1 Number Analyzed 0 participants 1 participants 6 participants 3 participants 2 participants 15 participants 1 participants 2 participants 21 participants 2 participants 4 participants 8 participants
0.2510 [1] 
(NA%)
0.3203
(31%)
0.1800
(13%)
0.1823 [1] 
(NA%)
0.3490
(42%)
0.3890 [1] 
(NA%)
0.2054 [1] 
(NA%)
0.3861
(36%)
0.3145 [1] 
(NA%)
0.2711
(24%)
0.3536
(28%)
Cycle 2 Number Analyzed 0 participants 2 participants 3 participants 2 participants 3 participants 5 participants 2 participants 3 participants 4 participants 1 participants 5 participants 4 participants
0.2296 [1] 
(NA%)
0.2676
(19%)
0.1939 [1] 
(NA%)
0.2082
(47%)
0.2906
(37%)
0.1786 [1] 
(NA%)
0.2847
(43%)
0.2950
(27%)
0.3220 [1] 
(NA%)
0.2626
(18%)
0.4883
(17%)
[1]
Geometric CV was not calculated when there were less than 3 participants with data.
15.Secondary Outcome
Title PF-05082566 Volume of Distribution at Steady State (Vss) in Portion A
Hide Description Vss = CL × MRT, where CL is clearance and MRT is the mean residence time after intravenous administration.
Time Frame Day 1 of Cycle 1 and Cycle 2 at pre-dose, and 1, 1.5, 2, 6, 24, 48, 168, 336 and 504 hours post-dose.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of PF-05082566 in Portion A and had at least 1 of the PK parameters of interest. "Number Analyzed" represents those participants who had data for each specified category.
Arm/Group Title Portion A: PF-05082566 0.006mg/kg Portion A: PF-05082566 0.03mg/kg Portion A: PF-05082566 0.06mg/kg Portion A: PF-05082566 0.12mg/kg Portion A: PF-05082566 0.18mg/kg Portion A: PF-05082566 0.24mg/kg Portion A: PF-05082566 0.3mg/kg Portion A: PF-05082566 0.6mg/kg Portion A: PF-05082566 1.2mg/kg Portion A: PF-05082566 2.4mg/kg Portion A: PF-05082566 5mg/kg Portion A: PF-05082566 10mg/kg
Hide Arm/Group Description:
Participants received PF-05082566 0.006 milligrams per kilogram (mg/kg) intravenously once every 4 weeks (q4wks) as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.03mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.06mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.12mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.18mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.24mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.3mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.6mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 2.4mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 5mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Overall Number of Participants Analyzed 4 3 6 4 3 40 3 4 29 5 6 11
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: milliliter per kilogram (mL/kg)
Cycle 1 Number Analyzed 0 participants 1 participants 6 participants 3 participants 2 participants 15 participants 1 participants 2 participants 21 participants 2 participants 4 participants 8 participants
65.50 [1] 
(NA%)
101.1
(20%)
83.63
(15%)
74.38 [1] 
(NA%)
110.7
(28%)
75.20 [1] 
(NA%)
82.38 [1] 
(NA%)
112.2
(29%)
110.4 [1] 
(NA%)
97.07
(26%)
125.5
(21%)
Cycle 2 Number Analyzed 0 participants 2 participants 3 participants 1 participants 3 participants 5 participants 1 participants 2 participants 3 participants 1 participants 3 participants 3 participants
102.1 [1] 
(NA%)
74.11
(21%)
90.80 [1] 
(NA%)
81.69
(27%)
86.50
(29%)
51.00 [1] 
(NA%)
61.54 [1] 
(NA%)
116.5
(62%)
99.80 [1] 
(NA%)
87.37
(43%)
139.5
(29%)
[1]
Geometric CV was not calculated when there were less than 3 participants with data.
16.Secondary Outcome
Title Number of Participants With Positive Anti-Drug Antibody (ADA) for PF-05082566 in Portion A
Hide Description ADA for PF-05082566 was detected using electrochemiluminescence assay. Positive ADA for PF-05082566: titer>=6.23.
Time Frame Up to approximately 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of PF-05082566 in Portion A and was tested for ADA.
Arm/Group Title Portion A: PF-05082566 0.006mg/kg Portion A: PF-05082566 0.03mg/kg Portion A: PF-05082566 0.06mg/kg Portion A: PF-05082566 0.12mg/kg Portion A: PF-05082566 0.18mg/kg Portion A: PF-05082566 0.24mg/kg Portion A: PF-05082566 0.3mg/kg Portion A: PF-05082566 0.6mg/kg Portion A: PF-05082566 1.2mg/kg Portion A: PF-05082566 2.4mg/kg Portion A: PF-05082566 5mg/kg Portion A: PF-05082566 10mg/kg
Hide Arm/Group Description:
Participants received PF-05082566 0.006 milligrams per kilogram (mg/kg) intravenously once every 4 weeks (q4wks) as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.03mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.06mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.12mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.18mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.24mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.3mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.6mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 2.4mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 5mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Overall Number of Participants Analyzed 4 3 6 4 3 42 3 4 31 5 6 11
Measure Type: Count of Participants
Unit of Measure: Participants
4
 100.0%
2
  66.7%
5
  83.3%
0
   0.0%
0
   0.0%
20
  47.6%
1
  33.3%
3
  75.0%
14
  45.2%
1
  20.0%
3
  50.0%
2
  18.2%
17.Secondary Outcome
Title Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A
Hide Description Categorical summarization criteria for QTc interval (time from ECG Q wave to the end of the T wave corresponding to electrical systole corrected for heart rate): 1) absolute value of >450 to <=480 milliseconds (msec), >480 to <=500 msec, >500 msec; 2) a maximum change from baseline of >30 to <=60 msec or >60 msec.
Time Frame Up to approximately 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of PF-05082566 in Portion A and had post-baseline QTc data. "Number Analyzed" represents those participants who had data for each specified category.
Arm/Group Title Portion A: PF-05082566 0.006mg/kg Portion A: PF-05082566 0.03mg/kg Portion A: PF-05082566 0.06mg/kg Portion A: PF-05082566 0.12mg/kg Portion A: PF-05082566 0.18mg/kg Portion A: PF-05082566 0.24mg/kg Portion A: PF-05082566 0.3mg/kg Portion A: PF-05082566 0.6mg/kg Portion A: PF-05082566 1.2mg/kg Portion A: PF-05082566 2.4mg/kg Portion A: PF-05082566 5mg/kg Portion A: PF-05082566 10mg/kg
Hide Arm/Group Description:
Participants received PF-05082566 0.006 milligrams per kilogram (mg/kg) intravenously once every 4 weeks (q4wks) as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.03mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.06mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.12mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.18mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.24mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.3mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.6mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 2.4mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 5mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Overall Number of Participants Analyzed 4 3 6 4 3 40 3 4 29 5 6 11
Measure Type: Count of Participants
Unit of Measure: Participants
QTc >450 to <=480 msec Number Analyzed 4 participants 3 participants 6 participants 4 participants 3 participants 40 participants 3 participants 4 participants 29 participants 5 participants 6 participants 11 participants
1
  25.0%
0
   0.0%
0
   0.0%
2
  50.0%
0
   0.0%
10
  25.0%
0
   0.0%
1
  25.0%
8
  27.6%
2
  40.0%
3
  50.0%
4
  36.4%
QTc >480 to <=500 msec Number Analyzed 4 participants 3 participants 6 participants 4 participants 3 participants 40 participants 3 participants 4 participants 29 participants 5 participants 6 participants 11 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   5.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   9.1%
QTc >500 msec Number Analyzed 4 participants 3 participants 6 participants 4 participants 3 participants 40 participants 3 participants 4 participants 29 participants 5 participants 6 participants 11 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%
1
   3.4%
0
   0.0%
0
   0.0%
0
   0.0%
QTc change >30 to <=60 msec Number Analyzed 4 participants 3 participants 6 participants 4 participants 3 participants 39 participants 3 participants 4 participants 29 participants 5 participants 6 participants 11 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  33.3%
6
  15.4%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
  33.3%
3
  27.3%
QTc change >60 msec Number Analyzed 4 participants 3 participants 6 participants 4 participants 3 participants 39 participants 3 participants 4 participants 29 participants 5 participants 6 participants 11 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.6%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
18.Secondary Outcome
Title Percentage of Participants Achieving Objective Response Per Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 in Portion A
Hide Description Objective response: confirmed best overall response (BOR) of complete response (CR) or partial response (PR) per RECIST version 1.1. BOR of CR: target lesions and non-target diseases achieved CR, without new lesions. BOR of PR: target lesions achieved CR or PR while non-target diseases were non-CR/non-progression of disease (non-PD), indeterminate or missing, and without new lesions. For target lesions, CR: complete disappearance of all target lesions except nodal disease (target nodes must decrease to normal size); PR: >=30% decrease under baseline of the sum of diameters of all target measurable lesions. For non-target diseases, CR: disappearance of all non-target lesions and normalization of tumor marker levels; non-CR/non-PD: persistence of any non-target lesions and/or tumor marker level above the normal limits; Indeterminate: progression had not been determined and >=1 non-target sites were not assessed or assessment methods were inconsistent with those used at baseline.
Time Frame Every 8 weeks from Cycle 1 Day 1 for the first 10 months on study treatment, then every 16 weeks till follow-up visit (assessed up to approximately 2 years)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of PF-05082566 in Portion A and had tumor assessments.
Arm/Group Title Portion A: PF-05082566 0.006mg/kg Portion A: PF-05082566 0.03mg/kg Portion A: PF-05082566 0.06mg/kg Portion A: PF-05082566 0.12mg/kg Portion A: PF-05082566 0.18mg/kg Portion A: PF-05082566 0.24mg/kg Portion A: PF-05082566 0.3mg/kg Portion A: PF-05082566 0.6mg/kg Portion A: PF-05082566 1.2mg/kg Portion A: PF-05082566 2.4mg/kg Portion A: PF-05082566 5mg/kg Portion A: PF-05082566 10mg/kg
Hide Arm/Group Description:
Participants received PF-05082566 0.006 milligrams per kilogram (mg/kg) intravenously once every 4 weeks (q4wks) as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.03mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.06mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.12mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.18mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.24mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.3mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.6mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 2.4mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 5mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Overall Number of Participants Analyzed 4 3 6 4 1 42 3 4 31 5 6 11
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0 to 60.2)
0
(0 to 70.8)
0
(0 to 45.9)
0
(0 to 60.2)
0
(0 to 97.5)
4.8
(0.6 to 16.2)
0
(0 to 70.8)
25.0
(0.6 to 80.6)
0
(0 to 11.2)
0
(0 to 52.2)
0
(0 to 45.9)
0
(0 to 28.5)
19.Secondary Outcome
Title Duration of Response in Portion A
Hide Description Duration of response: the time from first documentation of objective response (confirmed BOR of CR or PR per RECIST version 1.1) to the date of first documentation of objective progression of disease (PD) or death due to any cause. Objective PD per RECIST version 1.1: >=20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum was observed during therapy), with a minimum absolute increase of 5 millimeters (mm); or unequivocal progression of pre-existing lesions for non-target disease; or appearance of new lesions. This outcome measure reports the individual values for evaluable participants (instead of medians etc) due to the limited number of events.
Time Frame Every 8 weeks from Cycle 1 Day 1 for the first 10 months on study treatment, then every 16 weeks till follow-up visit (assessed up to approximately 2 years)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of PF-05082566 in Portion A and achieved an objective response. "Number analyzed" represents the number of such participants for each specified category.
Arm/Group Title Portion A: PF-05082566 0.006mg/kg Portion A: PF-05082566 0.03mg/kg Portion A: PF-05082566 0.06mg/kg Portion A: PF-05082566 0.12mg/kg Portion A: PF-05082566 0.18mg/kg Portion A: PF-05082566 0.24mg/kg Portion A: PF-05082566 0.3mg/kg Portion A: PF-05082566 0.6mg/kg Portion A: PF-05082566 1.2mg/kg Portion A: PF-05082566 2.4mg/kg Portion A: PF-05082566 5mg/kg Portion A: PF-05082566 10mg/kg
Hide Arm/Group Description:
Participants received PF-05082566 0.006 milligrams per kilogram (mg/kg) intravenously once every 4 weeks (q4wks) as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.03mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.06mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.12mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.18mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.24mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.3mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 0.6mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 2.4mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 5mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
Overall Number of Participants Analyzed 0 0 0 0 0 2 0 1 0 0 0 0
Measure Type: Number
Unit of Measure: months
For Participant X in 0.24 mg/kg Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
5.8
For Participant Y in 0.24 mg/kg Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
24.2
For Participant Z in 0.6 mg/kg Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants 0 participants 0 participants 0 participants 0 participants
22.8
20.Secondary Outcome
Title Time to Response in Portion A
Hide