A Safety Study Of A Monoclonal Antibody Against A5B1 Inte... | NCT00915278

A Safety Study Of A Monoclonal Antibody Against A5B1 Inte... | NCT00915278 | Trialant

Arms/Interventions Module

Label	Type	Description	Intervention Names
PF-04605412	Experimental		Drug: PF-04605412

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PF-04605412	Drug	PF-04605412 will be administered as 2 hr IV infusion every 4 or 2 weeks. Start dose is 7.5 mg. Multiple doses are foreseen. Treatment will continue until intolerable toxicity, progression of disease or patient's refusal

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Dose-limiting Toxicities (DLT)	DLT was defined as any of the following events occurring during the first 28 days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 clinically-relevant non-hematologic toxicity,any >= Grade 3 adverse event (AE) graded by National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], version 3.0 without a clear alternative explanation to study treatment relationship occurring during the first 6 weeks of treatment with PF-04605412. DLT was used to determine maximum tolerated dose (MTD) in this study.	Baseline up to 6 weeks PF-04605412

Secondary Outcomes

Measure	Description	Time Frame
Maximum Observed Serum Concentration (Cmax)		Predose, 1, 2, 2.5, 3, 6, 10, 24 hours after the start of infusion on Day 1; Days 3, 5, 8, 11, 15, 22 of Cycle 1
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)	Area under the serum concentration time-curve from zero to the last measured concentration (AUClast).

Contacts/Locations Module

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Philadelphia	Pennsylvania	19111	United States
Pfizer Investigational Site

Label	URL
To obtain contact information for a study center near you, click here.	View source

Arm/Group Information

ID	Title	Description
FG000	PF-04605412 7.5 mg	PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
FG001	PF-04605412 11.25 mg	PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
FG002	PF-04605412 16.9 mg	PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
FG003	PF-04605412 34 mg	PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
FG004	PF-04605412 68 mg	PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
FG005	PF-04605412 136 mg	PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG0008 subjects FG0015 subjects FG0023 subjects FG0035 subjects FG0043 subjects FG0059 subjects
COMPLETED		FG0003 subjects FG0012 subjects FG0022 subjects FG0032 subjects FG004
NOT COMPLETED		FG0005 subjects FG0013 subjects FG0021 subjects FG0033 subjects FG004

Type	Comment	Reasons
Death		FG0001 subjects FG0010 subjects FG0020 subjects FG003

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	PF-04605412 7.5 mg	PF-04605412 7.5 mg was administered intravenously as 2 hour infusion. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
BG001	PF-04605412 11.25 mg

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Dose-limiting Toxicities (DLT)

DLT was defined as any of the following events occurring during the first 28 days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 clinically-relevant non-hematologic toxicity,any >= Grade 3 adverse event (AE) graded by National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], version 3.0 without a clear alternative explanation to study treatment relationship occurring during the first 6 weeks of treatment with PF-04605412. DLT was used to determine maximum tolerated dose (MTD) in this study.

All subjects enrolled in the dose escalation part of the study who received at least one dose of study medication that remained on study and/or provided safety follow-up for at least 6 weeks, unless discontinuing due to a DLT. Subjects discontinuing the study due to DLT are included

Posted

Number

participants

Baseline up to 6 weeks PF-04605412

ID	Title	Description
OG000

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	PF-04605412 7.5 mg	PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Bundle branch block left	Cardiac disorders	MedDRA v16.0	Non-systematic Assessment

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Lymphopenia	Blood and lymphatic system disorders	MedDRA v16.0	Non-systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Pfizer ClinicalTrials.gov Call Center	Pfizer, Inc.	1-800-718-1021		ClinicalTrials.gov_Inquiries@pfizer.com

ID	Term
D009369	Neoplasms

ID	Term
C000594806	PF-04605412

Secondary

Maximum Observed Serum Concentration (Cmax)

The analyzed population is all enrolled subjects treated who had received at least 1 dose of PF-04605412 and completed sampling for PK profiles for PF-04605412; N = number of subjects who had reportable Cmax.

Posted

Geometric Mean

Geometric Coefficient of Variation

nanogram/milliliter (ng/mL)

Predose, 1, 2, 2.5, 3, 6, 10, 24 hours after the start of infusion on Day 1; Days 3, 5, 8, 11, 15, 22 of Cycle 1

ID	Title	Description
OG000	PF-04605412 7.5 mg	PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG001	PF-04605412 11.25 mg	PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG002	PF-04605412 16.9 mg	PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG003	PF-04605412 34 mg	PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG004	PF-04605412 68 mg	PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG005	PF-04605412 136 mg	PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.

Units	Counts
Participants	OG0007 OG0014 OG0023 OG003

Title

Denominators

Categories

Title	Measurements
	OG000578.3± 37(37 to ) OG0011229± 27(27 to ) OG0021826± 90(90 to )

Secondary

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

Area under the serum concentration time-curve from zero to the last measured concentration (AUClast).

Posted

Geometric Mean

Geometric Coefficient of Variation

nanogram*hour/milliliter (ng*hr/mL)

Predose, 1, 2, 2.5, 3, 6, 10, 24 hours after the start of infusion on Day 1; Days 3, 5, 8, 11, 15, 22 of Cycle 1

ID	Title	Description
OG000	PF-04605412 7.5 mg	PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG001	PF-04605412 11.25 mg	PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG002	PF-04605412 16.9 mg	PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG003	PF-04605412 34 mg	PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG004	PF-04605412 68 mg	PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG005	PF-04605412 136 mg	PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.

Units	Counts
Participants	OG0007 OG0014 OG0023 OG003

Title

Denominators

Categories

Title	Measurements
	OG0004784± 171(171 to ) OG00114440± 170(170 to ) OG00212930± 103(103 to )

Secondary

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - Inf)]

AUC (0 - inf)= Area under the serum concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf).

Posted

Geometric Mean

Geometric Coefficient of Variation

ng*hr/mL

Predose, 1, 2, 2.5, 3, 6, 10, 24 hours after the start of infusion on Day 1; Days 3, 5, 8, 11, 15, 22 of Cycle 1

ID	Title	Description
OG000	PF-04605412 7.5 mg	PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG001	PF-04605412 11.25 mg	PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG002	PF-04605412 16.9 mg	PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG003	PF-04605412 34 mg	PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG004	PF-04605412 68 mg	PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG005	PF-04605412 136 mg	PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.

Units	Counts
Participants	OG0002 OG0010 OG0022 OG003

Title

Denominators

Categories

Title	Measurements
	OG0002000± NA(NA to )Geometric mean was not reported for n=\<2, instead median was reported OG00227650± NA(NA to )Geometric mean was not reported for n=\<2, instead median was reported OG003

Secondary

Serum Decay Half-Life (t1/2)

Serum decay half-life is the time measured for the plasma concentration to decrease by one half.

Posted

Mean

Standard Deviation

hours

Predose, 1, 2, 2.5, 3, 6, 10, 24 hours after the start of infusion on Day 1; Days 3, 5, 8, 11, 15, 22 of Cycle 1

ID	Title	Description
OG000	PF-04605412 7.5 mg	PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG001	PF-04605412 11.25 mg	PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG002	PF-04605412 16.9 mg	PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG003	PF-04605412 34 mg	PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG004	PF-04605412 68 mg	PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG005	PF-04605412 136 mg	PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.

Units	Counts
Participants	OG0002 OG0010 OG0022 OG003

Title

Denominators

Categories

Title	Measurements
	OG0002.70± NAMean was not reported for n=\<2, instead median was reported OG0027.27± NAMean was not reported for n=\<2, instead median was reported OG00313.5

Secondary

Time to Reach Maximum Observed Serum Concentration (Tmax)

Posted

Median

Full Range

hours

Predose, 1, 2, 2.5, 3, 6, 10, 24 hours after the start of infusion on Day 1; Days 3, 5, 8, 11, 15, 22 of Cycle 1

ID	Title	Description
OG000	PF-04605412 7.5 mg	PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG001	PF-04605412 11.25 mg	PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG002	PF-04605412 16.9 mg	PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG003	PF-04605412 34 mg	PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG004	PF-04605412 68 mg	PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG005	PF-04605412 136 mg	PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.

Units	Counts
Participants	OG0007 OG0014 OG0023 OG003

Title

Denominators

Categories

Title	Measurements
	OG0002.00(1.00 to 44.7) OG0013.04(3.00 to 5.50) OG0022.43(2.05 to 3.02) OG003

Secondary

Systemic Clearance (CL)

CL is a quantitative measure of the rate at which a drug substance is removed from the body.

Posted

Geometric Mean

Geometric Coefficient of Variation

Liter/hour (L/hr)

Predose, 1, 2, 2.5, 3, 6, 10, 24 hours after the start of infusion on Day 1; Days 3, 5, 8, 11, 15, 22 of Cycle 1

ID	Title	Description
OG000	PF-04605412 7.5 mg	PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG001	PF-04605412 11.25 mg	PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG002	PF-04605412 16.9 mg	PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG003	PF-04605412 34 mg	PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG004	PF-04605412 68 mg	PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG005	PF-04605412 136 mg	PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.

Units	Counts
Participants	OG0002 OG0010 OG0022 OG003

Title

Denominators

Categories

Title	Measurements
	OG0003.79± NA(NA to )Geometric mean was not reported for n=\<2, instead median was reported OG0020.95± NA(NA to )Geometric mean was not reported for n=\<2, instead median was reported OG003

Secondary

Volume of Distribution at Steady State (Vss)

Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.

Posted

Geometric Mean

Geometric Coefficient of Variation

Liter

Predose, 1, 2, 2.5, 3, 6, 10, 24 hours after the start of infusion on Day 1; Days 3, 5, 8, 11, 15, 22 of Cycle 1

ID	Title	Description
OG000	PF-04605412 7.5 mg	PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG001	PF-04605412 11.25 mg	PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG002	PF-04605412 16.9 mg	PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG003	PF-04605412 34 mg	PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG004	PF-04605412 68 mg	PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG005	PF-04605412 136 mg	PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.

Units	Counts
Participants	OG0002 OG0010 OG0022 OG003

Title

Denominators

Categories

Title	Measurements
	OG00013.65± NA(NA to )Geometric mean was not reported for n=\<2, instead median was reported OG00210.87± NA(NA to )Geometric mean was not reported for n=\<2, instead median was reported OG003

Secondary

Number of Participants Positive for Anti-PF04605412 Antibodies

Serum samples were analyzed for anti-drug antibodies (ADA) or human anti-human antibodies (HAHA). This was used to evaluate immunogenicity.

All subjects enrolled in this study who were treated with at least one dose of PF-04605412.

Posted

Number

participants

Baseline up to end of treatment

ID	Title	Description
OG000	PF-04605412 7.5 mg	PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG001	PF-04605412 11.25 mg	PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG002	PF-04605412 16.9 mg	PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG003	PF-04605412 34 mg	PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG004	PF-04605412 68 mg	PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG005	PF-04605412 136 mg	PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.

Units	Counts
Participants	OG0008 OG0015 OG0023 OG003

Title

Denominators

Categories

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Secondary

Objective Response - Number of Participants With Objective Response

Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.

Per RECIST v1.0: CR defined as disappearance of all target lesions and non-target lesions. PR defined as ≥30% decrease in sum of the longest diameters dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non target lesions.

All subjects enrolled in this study who were treated with at least one dose of PF-04605412.

Posted

Number

participants

Baseline up to 6 weeks after the first infusion of PF-04605412 (end of Cycle 2) and approximately every 6 weeks thereafter only in the absence of progressive disease

ID	Title	Description
OG000	PF-04605412 7.5 mg	PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG001	PF-04605412 11.25 mg	PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG002	PF-04605412 16.9 mg	PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG003	PF-04605412 34 mg	PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG004	PF-04605412 68 mg	PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG005	PF-04605412 136 mg	PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.

Units	Counts
Participants	OG0008 OG0015 OG0023 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Secondary

Percent Change in Transfer Constant (Ktrans) From Baseline to Cycle 1 Day 15

Percent change in Ktrans for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) from baseline to Cycle 1 day 15 aimed at defining the effect of PF-04605412 on tumor vasculature.

The data was not statistically analyzed as planned due to early study termination.

Posted

Screening, and Cycle 1 Day 15

ID	Title	Description
OG000	PF-04605412 7.5 mg	PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG001	PF-04605412 11.25 mg	PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG002	PF-04605412 16.9 mg	PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG003	PF-04605412 34 mg	PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG004	PF-04605412 68 mg	PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG005	PF-04605412 136 mg	PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.

Units	Counts
Participants	OG0000 OG0010 OG0020 OG003

Secondary

Percent Change in Initial Area Under the Curve (IAUC)

Percent change in the IAUC for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) from baseline to Cycle 1 Day 15. IAUC reflects the contrast distribution volume (extravascular extracellular space) in addition to contrast delivery and transport across the vascular endothelium. An IAUC value of zero indicates the absence of disease (ie, no leakage of the contrast agent into the synovial volume); therefore, an increase in this parameter indicates worsening disease (ie, greater permeability of the synovial membrane).

The data was not statistically analyzed as planned due to early study termination.

Posted

Screening, and Cycle 1 Day 15

ID	Title	Description
OG000	PF-04605412 7.5 mg	PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG001	PF-04605412 11.25 mg	PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG002	PF-04605412 16.9 mg	PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG003	PF-04605412 34 mg	PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG004	PF-04605412 68 mg	PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG005	PF-04605412 136 mg	PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.

Units	Counts
Participants	OG0000 OG0010 OG0020 OG003

Secondary

Number of Participants With Tissue Macrophage Infiltration

Immunohistochemical staining of tissue biopsies was performed with monoclonal antibodies directed against tissue macrophages.

The data was not statistically analyzed as planned due to early study termination.

Posted

Predose and postdose

ID	Title	Description
OG000	PF-04605412 7.5 mg	PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG001	PF-04605412 11.25 mg	PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG002	PF-04605412 16.9 mg	PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG003	PF-04605412 34 mg	PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG004	PF-04605412 68 mg	PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG005	PF-04605412 136 mg	PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.

Units	Counts
Participants	OG0000 OG0010 OG0020 OG003

Secondary

Number of Participants With Integrin Alpha 5 Beta 1 Expression

Immunohistochemical staining of tissue biopsies was performed with monoclonal antibodies directed against integrin alpha 5 beta 1.

The data was not statistically analyzed as planned due to early study termination.

Posted

Predose and postdose

ID	Title	Description
OG000	PF-04605412 7.5 mg	PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG001	PF-04605412 11.25 mg	PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG002	PF-04605412 16.9 mg	PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG003	PF-04605412 34 mg	PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG004	PF-04605412 68 mg	PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG005	PF-04605412 136 mg	PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.

Units	Counts
Participants	OG0000 OG0010 OG0020 OG003

Secondary

Number of Participants With CD68 Expression

Immunohistochemical staining of tissue biopsies was performed with monoclonal antibodies CD68.

The data was not statistically analyzed as planned due to early study termination.

Posted

Predose and postdose

ID	Title	Description
OG000	PF-04605412 7.5 mg	PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG001	PF-04605412 11.25 mg	PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG002	PF-04605412 16.9 mg	PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG003	PF-04605412 34 mg	PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG004	PF-04605412 68 mg	PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG005	PF-04605412 136 mg	PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.

Units	Counts
Participants	OG0000 OG0010 OG0020 OG003

Secondary

Number of Participants With Granzyme B Expression

Immunohistochemical staining of tissue biopsies was performed with monoclonal antibodies directed against Granzyme B.

The data was not statistically analyzed as planned due to early study termination.

Posted

Predose and postdose

ID	Title	Description
OG000	PF-04605412 7.5 mg	PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG001	PF-04605412 11.25 mg	PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG002	PF-04605412 16.9 mg	PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG003	PF-04605412 34 mg	PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG004	PF-04605412 68 mg	PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG005	PF-04605412 136 mg	PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.

Units	Counts
Participants	OG0000 OG0010 OG0020 OG003

Secondary

Number of Participants With CD56 Expression

Immunohistochemical staining of tissue biopsies was performed with monoclonal antibodies directed against CD56.

Posted

Number

Participants

Predose and postdose

ID	Title	Description
OG000	PF-04605412 7.5 mg	PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG001	PF-04605412 11.25 mg	PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG002	PF-04605412 16.9 mg	PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG003	PF-04605412 34 mg	PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG004	PF-04605412 68 mg	PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG005	PF-04605412 136 mg	PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.

Units	Counts
Participants	OG0007 OG0014 OG0023 OG003

Title

Denominators

Categories

Title	Measurements
	OG0006 OG0012 OG0022 OG003

Secondary

Number of Participants With CD16 Expression

Immunohistochemical staining of tissue biopsies was performed with monoclonal antibodies directed against CD16.

Posted

Number

Participants

Predose and postdose

ID	Title	Description
OG000	PF-04605412 7.5 mg	PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG001	PF-04605412 11.25 mg	PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG002	PF-04605412 16.9 mg	PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG003	PF-04605412 34 mg	PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG004	PF-04605412 68 mg	PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG005	PF-04605412 136 mg	PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.

Units	Counts
Participants	OG0007 OG0014 OG0023 OG003

Title

Denominators

Categories

Title	Measurements
	OG0006 OG0012 OG0022 OG003

Secondary

Number of Participants With pFAK Expression

Immunohistochemical staining of tissue biopsies was performed with monoclonal antibodies directed against pFAK.

The data was not statistically analyzed as planned due to early study termination.

Posted

Predose and postdose

ID	Title	Description
OG000	PF-04605412 7.5 mg	PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG001	PF-04605412 11.25 mg	PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG002	PF-04605412 16.9 mg	PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG003	PF-04605412 34 mg	PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG004	PF-04605412 68 mg	PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG005	PF-04605412 136 mg	PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.

Units	Counts
Participants	OG0000 OG0010 OG0020 OG003

Secondary

Number of Participants With CD31 Expression

Immunohistochemical staining of tissue biopsies was performed with monoclonal antibodies directed against CD31.

The data was not statistically analyzed as planned due to early study termination.

Posted

Predose and postdose

ID	Title	Description
OG000	PF-04605412 7.5 mg	PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG001	PF-04605412 11.25 mg	PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG002	PF-04605412 16.9 mg	PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG003	PF-04605412 34 mg	PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG004	PF-04605412 68 mg	PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG005	PF-04605412 136 mg	PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.

Units	Counts
Participants	OG0000 OG0010 OG0020 OG003

Secondary

Number of Participants With Caspase 3 Expression

Immunohistochemical staining of tissue biopsies was performed with monoclonal antibodies directed against Caspase 3.

The data was not statistically analyzed as planned due to early study termination.

Posted

Predose and postdose

ID	Title	Description
OG000	PF-04605412 7.5 mg	PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG001	PF-04605412 11.25 mg	PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG002	PF-04605412 16.9 mg	PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG003	PF-04605412 34 mg	PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG004	PF-04605412 68 mg	PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG005	PF-04605412 136 mg	PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.

Units	Counts
Participants	OG0000 OG0010 OG0020 OG003

Secondary

Number of Participants With Ki67 Expression

Immunohistochemical staining of tissue biopsies was performed with monoclonal antibodies directed against Ki67.

The data was not statistically analyzed as planned due to early study termination.

Posted

Predose and postdose

ID	Title	Description
OG000	PF-04605412 7.5 mg	PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG001	PF-04605412 11.25 mg	PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG002	PF-04605412 16.9 mg	PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG003	PF-04605412 34 mg	PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG004	PF-04605412 68 mg	PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG005	PF-04605412 136 mg	PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.

Units	Counts
Participants	OG0000 OG0010 OG0020 OG003

Secondary

Number of Participants With Perforin Expression

Immunohistochemical staining of tissue biopsies was performed with monoclonal antibodies directed against Perforin.

The data was not statistically analyzed as planned due to early study termination.

Posted

Predose and postdose

ID	Title	Description
OG000	PF-04605412 7.5 mg	PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG001	PF-04605412 11.25 mg	PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG002	PF-04605412 16.9 mg	PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG003	PF-04605412 34 mg	PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG004	PF-04605412 68 mg	PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
OG005	PF-04605412 136 mg	PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.

Units	Counts
Participants	OG0000 OG0010 OG0020 OG003