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

• 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: Pfizer
• 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

Participant Flow

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
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

Baseline Characteristics

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
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
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%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Dose-Limiting Toxicities (DLTs) in First 2 Cycles of Portion A
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)

Outcome Measure Data

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
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
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)

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
Description	Ctrough of PF-05082566 was observed directly from data.
Time Frame	Day 1 pre-dose of Cycle 2

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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)

Outcome Measure Data

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
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
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)

Outcome Measure Data

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
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
Description	Time to response: the time from Cycle 1 Day 1 to the first documentation of objective response (confirmed BOR of CR or 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-PD, indeterminate or missing, and without new lesions. For target lesions, CR: complete disappearance of all target lesions except nodal disease (target nodes