PF-00477736 Is Being Studied In Advanced Solid Tumors In... | NCT00437203

PF-00477736 Is Being Studied In Advanced Solid Tumors In... | NCT00437203 | Trialant

Arms/Interventions Module

Label	Type	Description	Intervention Names
1	Experimental		Drug: PF-00477736 Drug: gemcitabine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PF-00477736	Drug	Escalating doses of PF-00477736 will be administered intravenously on Days 2 and 9 and gemcitabine will be administered intravenously on Days 1 and 8 of a 21-day cycle (doses to be evaluated range from 750 to 1250 mg/m2 in three separated cohorts). If a patient is administered Cycle 0 - only PF-0047736 will be administered intravenously on Days 1 and 8 of a 21-day cycle for patients who have a 3-hour infusion and Days 1 and 8 of a 14-day cycle for patients who have a 24-hour infusion.

Outcomes Module

Measure	Description	Time Frame
Maximum Tolerated Dose (MTD) of PF-00477736 When Administered in Combination With Gemcitabine		Up to Day 21 Cycle 1

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With Objective Response (OR)	OR based assessment of confirmed complete response(CR)/confirmed partial response(PR)/stable disease(SD)/progressive disease(PD) as per Response Evaluation Criteria in Solid Tumors(RECIST).CR:disappearance of target lesions;PR:at least(>=) 30% decrease in sum of longest dimensions of target lesions(reference:baseline sum of longest dimensions);PD:>=20% increase in sum of longest dimensions of target lesions(reference:smallest sum of longest dimensions recorded since treatment started)/appearance of any new lesions;SD:no adequate shrinkage to qualify for PR/adequate increase to qualify for PD.

Contacts/Locations Module

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

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Los Angeles	California	90095-6984	United States
Pfizer Investigational Site

Arm/Group Information

ID	Title	Description
FG000	PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)	PF-00477736 50 milligram (mg) 3 hours (hrs) infusion intravenously (IV) on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg per square meter (mg/m^2) 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
FG001	PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)	PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
FG002	PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)	PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
FG003	PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)	PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
FG004	PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)	PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
FG005	PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)	PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
FG006	PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)	PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
FG007	PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)	PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
FG008	PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)	PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
FG009	PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)	PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG0006 subjects FG0018 subjects FG0023 subjects FG0033 subjects FG0043 subjects FG0053 subjects FG0067 subjects FG0073 subjects FG0083 subjects FG0094 subjects
COMPLETED		FG0000 subjects FG0010 subjects FG0020 subjects FG0030 subjects FG004
NOT COMPLETED		FG0006 subjects FG0018 subjects FG0023 subjects FG0033 subjects FG004

Type	Comment	Reasons
Death		FG0000 subjects FG0010 subjects FG0021 subjects FG003

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)	PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.

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

Maximum Tolerated Dose (MTD) of PF-00477736 When Administered in Combination With Gemcitabine

Full analysis set (FAS) included all enrolled participants who received at least 1 dose of study medication.

Posted

Number

Up to Day 21 Cycle 1

ID	Title	Description
OG000	PF-00477736 + Gemcitabine 750 mg/m^2	PF-00477736 infusion 50 mg, 65 mg or 80 mg IV administered over 3 hrs on Days 1 and 8 of Cycle 0 (21 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle), or PF-00477736 infusion 80 mg, 120 mg, 180 mg, 270 mg or 340 mg IV administered over 24 hrs on Days 1 and 8 of Cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 750 mg/m^2 IV administered over 30 minutes on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
OG001

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-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)	PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Coronary artery disease	Cardiac disorders	MedDRA 13.0	Non-systematic Assessment

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 13.0	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

Intervention Browse Module

ID	Term
C532366	PF 00477736
D000093542	Gemcitabine

ID	Term
D006571	Heterocyclic Compounds
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides

Title

Denominators

Categories

Title	Measurements
	OG0001 OG0010 OG0021 OG003

Secondary

Maximum Observed Plasma Concentration (Cmax)

Data was not analyzed, as study was terminated due to business reasons.

Posted

Geometric Mean

Standard Deviation

ng/mL

0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start:Day 1, 8 Cycle 0 Cohort 1-3; 0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10

ID	Title	Description
OG000	PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)	PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
OG001	PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)	PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
OG002	PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)	PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
OG003	PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)	PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
OG004	PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)	PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
OG005	PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)	PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
OG006	PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)	PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
OG007	PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)	PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
OG008	PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)	PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
OG009	PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)	PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).

Units	Counts
Participants	OG0000 OG0010 OG0020 OG003

Secondary

Minimum Observed Plasma Trough Concentration (Cmin)

Data was not analyzed, as study was terminated due to business reasons.

Posted

Geometric Mean

Standard Deviation

ng/mL

ID	Title	Description
OG000	PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)	PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
OG001	PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)	PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
OG002	PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)	PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
OG003	PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)	PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
OG004	PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)	PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
OG005	PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)	PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
OG006	PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)	PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
OG007	PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)	PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
OG008	PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)	PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
OG009	PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)	PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).

Units	Counts
Participants	OG0000 OG0010 OG0020 OG003

Secondary

Time to Reach Maximum Observed Plasma Concentration (Tmax)

Data was not analyzed, as study was terminated due to business reasons.

Posted

Median

Full Range

ID	Title	Description
OG000	PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)	PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
OG001	PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)	PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
OG002	PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)	PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
OG003	PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)	PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
OG004	PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)	PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
OG005	PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)	PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
OG006	PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)	PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
OG007	PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)	PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
OG008	PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)	PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
OG009	PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)	PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).

Units	Counts
Participants	OG0000 OG0010 OG0020 OG003

Secondary

Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)]

AUC (0-24) = Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-24).

Data was not analyzed, as study was terminated due to business reasons.

Posted

Geometric Mean

Standard Deviation

ng*hr/mL

0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start: Day 1, 8 Cycle 0

ID	Title	Description
OG000	PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)	PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
OG001	PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)	PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
OG002	PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)	PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.

Units	Counts
Participants	OG0000 OG0010 OG0020

Secondary

Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-48)]

AUC (0-48)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-48).

Data was not analyzed, as study was terminated due to business reasons.

Posted

Geometric Mean

Standard Deviation

ng*hr/mL

0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10

ID	Title	Description
OG000	PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)	PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
OG001	PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)	PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
OG002	PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)	PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
OG003	PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)	PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
OG004	PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)	PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
OG005	PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)	PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
OG006	PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)	PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).

Units	Counts
Participants	OG0000 OG0010 OG0020 OG003

Secondary

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

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

Data was not analyzed, as study was terminated due to business reasons.

Posted

Geometric Mean

Standard Deviation

ng*hr/mL

ID	Title	Description
OG000	PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)	PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
OG001	PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)	PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
OG002	PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)	PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
OG003	PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)	PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
OG004	PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)	PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
OG005	PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)	PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
OG006	PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)	PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
OG007	PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)	PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
OG008	PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)	PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
OG009	PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)	PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).

Units	Counts
Participants	OG0000 OG0010 OG0020 OG003

Secondary

Concentration of PF-00477736 in Urine

Data was not analyzed, as study was terminated due to business reasons.

Posted

Geometric Mean

Standard Deviation

ng/mL

ID	Title	Description
OG000	PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)	PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
OG001	PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)	PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
OG002	PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)	PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
OG003	PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)	PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
OG004	PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)	PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
OG005	PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)	PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
OG006	PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)	PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
OG007	PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)	PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
OG008	PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)	PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
OG009	PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)	PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).

Units	Counts
Participants	OG0000 OG0010 OG0020 OG003

Secondary

Plasma Decay Half-Life (t1/2)

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

Data was not analyzed, as study was terminated due to business reasons.

Posted

Mean

Standard Deviation

ID	Title	Description
OG000	PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)	PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
OG001	PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)	PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
OG002	PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)	PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
OG003	PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)	PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
OG004	PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)	PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
OG005	PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)	PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
OG006	PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)	PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
OG007	PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)	PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
OG008	PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)	PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
OG009	PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)	PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).

Units	Counts
Participants	OG0000 OG0010 OG0020 OG003

Secondary

Metabolite Profile of PF-00477736 in Plasma and Urine

Data was not analyzed, as study was terminated due to business reasons.

Posted

Number

percentage of recovered metabolite

ID	Title	Description
OG000	PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)	PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
OG001	PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)	PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
OG002	PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)	PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
OG003	PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)	PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
OG004	PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)	PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
OG005	PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)	PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
OG006	PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)	PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
OG007	PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)	PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
OG008	PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)	PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
OG009	PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)	PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).

Units	Counts
Participants	OG0000 OG0010 OG0020 OG003