A Study Of PF-04449913 Administered Alone In Select Solid... | NCT01286467

A Study Of PF-04449913 Administered Alone In Select Solid... | NCT01286467 | Trialant

Arms/Interventions Module

Label	Type	Description	Intervention Names
1	Experimental		Drug: PF-04449913

Name	Type	Description	Arm Group Labels	Other Names
PF-04449913	Drug	Escalating dose of PF-04449913 administered as tablets PO QD in 28-day cycles	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With First Cycle Dose Limiting Toxicities (DLTs)	Any DLT event in Cycle 1: (1) Grade 4 neutropenia lasting more than 7 days; (2) Febrile neutropenia; (3) Grade >=3 neutropenic infection; (4) Grade >=3 thrombocytopenia with bleeding; (5) Grade 4 thrombocytopenia lasting more than 7 days; (6) Grade >=3 non-hematologic toxicity; (7) Failure to deliver at least 80% of the planned doses due to toxicities attributable to PF-04449913	Baseline up to end of Cycle 1 (Study Day 28)

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Treatment-emergent Adverse Events (AEs), by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (Version 4.0) Grade	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs are events occurred between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. If the same participant in a given treatment had more than one occurrence in the same preferred term event category, only the worst CTCAE grade was reported. Grades as per NCI CTCAE, v4.0 were classified as: Grade 1- mild, Grade 2- moderate, Grade 3- severe, Grade 4- life threatening, and Grade 5- death.

Contacts/Locations Module

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Keck Hospital of University of Southern California		Los Angeles	California	90033	United States
Los Angeles County-University of Southern California Medical Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33993815	Derived	Fostvedt LK, Shaik N, Martinelli G, Wagner AJ, Ruiz-Garcia A. Exposure-response modeling of the effect of glasdegib on cardiac repolarization in patients with cancer. Expert Rev Clin Pharmacol. 2021 Jul;14(7):927-935. doi: 10.1080/17512433.2021.1925538. Epub 2021 May 18.
25388167	Derived	Wagner AJ, Messersmith WA, Shaik MN, Li S, Zheng X, McLachlan KR, Cesari R, Courtney R, Levin WJ, El-Khoueiry AB. A phase I study of PF-04449913, an oral hedgehog inhibitor, in patients with advanced solid tumors. Clin Cancer Res. 2015 Mar 1;21(5):1044-51. doi: 10.1158/1078-0432.CCR-14-1116. Epub 2014 Nov 11.

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

Arm/Group Information

ID	Title	Description
FG000	PF-04449913 80 mg	Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
FG001	PF-04449913 160 mg	Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
FG002	PF-04449913 320 mg	Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
FG003	PF-04449913 640 mg	Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG0004 subjects FG0014 subjects FG0027 subjects FG0038 subjects
COMPLETED		FG0000 subjects FG0010 subjects FG0020 subjects FG0030 subjects
NOT COMPLETED		FG0004 subjects FG0014 subjects FG0027 subjects FG0038 subjects

Type	Comment	Reasons
Death		FG0001 subjects FG0011 subjects FG0021 subjects FG003

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	PF-04449913 80 mg	Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Customized			Count of Participants

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 First Cycle Dose Limiting Toxicities (DLTs)

Any DLT event in Cycle 1: (1) Grade 4 neutropenia lasting more than 7 days; (2) Febrile neutropenia; (3) Grade >=3 neutropenic infection; (4) Grade >=3 thrombocytopenia with bleeding; (5) Grade 4 thrombocytopenia lasting more than 7 days; (6) Grade >=3 non-hematologic toxicity; (7) Failure to deliver at least 80% of the planned doses due to toxicities attributable to PF-04449913

Per-Protocol Analysis Set: all enrolled participants who received at least 1 dose of study medication and did not have major treatment deviations during Cycle 1.

Posted

Count of Participants

Participants

Baseline up to end of Cycle 1 (Study Day 28)

ID	Title	Description
OG000	PF-04449913 80 mg	Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).

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-04449913 80 mg	Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA version 15.1	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
C000592580	glasdegib

Secondary

Percentage of Participants With Treatment-emergent Adverse Events (AEs), by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (Version 4.0) Grade

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs are events occurred between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. If the same participant in a given treatment had more than one occurrence in the same preferred term event category, only the worst CTCAE grade was reported. Grades as per NCI CTCAE, v4.0 were classified as: Grade 1- mild, Grade 2- moderate, Grade 3- severe, Grade 4- life threatening, and Grade 5- death.

Safety Analysis Set: all enrolled participants who received at least 1 dose of study medication.

Posted

Number

percentage of participants

Baseline up to 28 days post last dose of study medication (maximum duration: 14 cycles [each cycle of 28 days])

ID	Title	Description
OG000	PF-04449913 80 mg	Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
OG001	PF-04449913 160 mg	Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
OG002	PF-04449913 320 mg	Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
OG003	PF-04449913 640 mg	Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).

Units	Counts
Participants	OG0004 OG0014 OG0027 OG003

Title

Denominators

Categories

Any AEs, Grade 1

Title	Measurements
	OG0000.0 OG0010.0 OG00214.3 OG003

Secondary

Percentage of Participants With Treatment-related AEs, by NCI CTCAE (Version 4.0) Grade

An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-related AEs are events that were assessed by the investigator as related to study medication. If the same participant in a given treatment had more than one occurrence in the same preferred term event category, only the worst CTCAE grade was reported. Grades as per NCI CTCAE, v4.0 were classified as: Grade 1- mild, Grade 2- moderate, Grade 3- severe, Grade 4- life threatening, and Grade 5- death.

Safety Analysis Set: all enrolled participants who received at least 1 dose of study medication.

Posted

Number

percentage of participants

Baseline up to 28 days post last dose of study medication (maximum duration: 14 cycles [each cycle of 28 days])

ID	Title	Description
OG000	PF-04449913 80 mg	Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
OG001	PF-04449913 160 mg	Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
OG002	PF-04449913 320 mg	Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
OG003	PF-04449913 640 mg	Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).

Units	Counts
Participants	OG0004 OG0014 OG0027 OG003

Title

Denominators

Categories

Any AEs, Grade 1

Title	Measurements
	OG00050.0 OG00125.0 OG00242.9 OG003

Secondary

Hedgehog Biomarker Modulation: Relative GLI1 Gene Expression (Ratio) to Baseline for Normal Skin on Cycle 1/Day 15

Ribonucleic acid (RNA) was extracted from skin samples and complementary deoxyribonucleic acid (cDNA) was prepared. Gene expression was measured using custom Taqman low density array (TLDA) cards run on the Applied Biosystems ViiATM 7 system. The ratio for each participant at each dosing level was calculated at C1D15 to baseline assay readout (C1D1), and the mean of it is reported in this outcome measure.

Pharmacodynamic (PD) Analysis Set: all enrolled participants who received at least 1 dose of study medication, and had baseline and at least 1 on-treatment PD result.

Posted

Mean

Standard Deviation

ratio

Baseline and Cycle 1/Day 15

ID	Title	Description
OG000	PF-04449913 80 mg	Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
OG001	PF-04449913 160 mg	Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
OG002	PF-04449913 320 mg	Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
OG003	PF-04449913 640 mg	Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).

Units	Counts
Participants	OG0003 OG0013 OG0024 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000.1± 0.01 OG0010.1± 0.09 OG0020.1± 0.04 OG003

Secondary

Maximum Observed Plasma Concentration (Cmax) on Cycle 1/Day 1

Cmax of PF-04449913 on Cycle 1/Day 1 has been reported.

PK Analysis Set: all treated participants who had at least 1 of the PK parameters of interest. N=number of participants evaluable for the outcome measure

Posted

Mean

Standard Deviation

nanogram/milliliter (ng/mL)

Pre dose, 1, 2, 4, 6, 10 and 24 hours post dose on Cycle 1/Day 1

ID	Title	Description
OG000	PF-04449913 80 mg	Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
OG001	PF-04449913 160 mg	Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
OG002	PF-04449913 320 mg	Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
OG003	PF-04449913 640 mg	Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).

Units	Counts
Participants	OG0004 OG0014 OG0027 OG003

Title

Denominators

Categories

Title	Measurements
	OG0001161± 389 OG0011126± 949 OG0022624± 611 OG003

Secondary

Maximum Observed Plasma Concentration (Cmax) on Cycle 1/Day 25

Cmax of PF-04449913 on Cycle 1/Day 25 has been reported.

PK Analysis Set: all treated participants who had at least 1 of the PK parameters of interest. N=number of participants evaluable for the outcome measure

Posted

Mean

Standard Deviation

ng/mL

Pre dose, 1, 2, 4, 10, 24, 48, 72 and 96 hours post dose on Cycle 1/Day 25

ID	Title	Description
OG000	PF-04449913 80 mg	Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
OG001	PF-04449913 160 mg	Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
OG002	PF-04449913 320 mg	Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
OG003	PF-04449913 640 mg	Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).

Units	Counts
Participants	OG0004 OG0013 OG0026 OG003

Title

Denominators

Categories

Title	Measurements
	OG0001373± 542 OG0011567± 475 OG0023363± 1716 OG003

Secondary

Time to Reach Maximum Observed Plasma Concentration (Tmax) on Cycle 1/Day 1

Tmax of PF-04449913 on Cycle 1/Day 1 has been reported.

PK Analysis Set: all treated participants who had at least 1 of the PK parameters of interest. N=number of participants evaluable for the outcome measure

Posted

Median

Full Range

hours

Pre dose, 1, 2, 4, 6, 10 and 24 hours post dose on Cycle 1/Day 1

ID	Title	Description
OG000	PF-04449913 80 mg	Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
OG001	PF-04449913 160 mg	Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
OG002	PF-04449913 320 mg	Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
OG003	PF-04449913 640 mg	Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).

Units	Counts
Participants	OG0004 OG0014 OG0027 OG003

Title

Denominators

Categories

Title	Measurements
	OG0001.5(1 to 2.2) OG0012(1 to 8) OG0022.1(1 to 4) OG003

Secondary

Time to Reach Maximum Observed Plasma Concentration (Tmax) on Cycle 1/Day 25

Tmax of PF-04449913 on Cycle 1/Day 25 has been reported.

PK Analysis Set: all treated participants who had at least 1 of the PK parameters of interest. N=number of participants evaluable for the outcome measure

Posted

Median

Full Range

hours

Pre dose, 1, 2, 4, 10, 24, 48, 72 and 96 hours post dose on Cycle 1/Day 25

ID	Title	Description
OG000	PF-04449913 80 mg	Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
OG001	PF-04449913 160 mg	Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
OG002	PF-04449913 320 mg	Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
OG003	PF-04449913 640 mg	Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).

Units	Counts
Participants	OG0004 OG0013 OG0026 OG003

Title

Denominators

Categories

Title	Measurements
	OG0001(0.9 to 2) OG0012(2 to 10) OG0022(1 to 10) OG003

Secondary

Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) on Cycle 1/Day 1

AUCtau of PF-04449913 on Cycle 1/Day 1 has been reported. AUCtau is defined as area under the curve from time 0 to tau, where tau is the dosing interval of 24 hours.

PK Analysis Set: all treated participants who had at least 1 of the PK parameters of interest. N=number of participants evaluable for the outcome measure

Posted

Mean

Standard Deviation

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

Pre dose, 1, 2, 4, 6, 10 and 24 hours post dose on Cycle 1/Day 1

ID	Title	Description
OG000	PF-04449913 80 mg	Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
OG001	PF-04449913 160 mg	Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
OG002	PF-04449913 320 mg	Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
OG003	PF-04449913 640 mg	Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).

Units	Counts
Participants	OG0004 OG0014 OG0027 OG003

Title

Denominators

Categories

Title	Measurements
	OG00010510± 3948 OG00112540± 8583 OG00231160± 11140 OG003

Secondary

Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) on Cycle 1/Day 25

AUCtau of PF-04449913 on Cycle 1/Day 25 has been reported. AUCtau is defined as area under the curve from time 0 to tau, where tau is the dosing interval of 24 hours.

PK Analysis Set: all treated participants who had at least 1 of the PK parameters of interest. N=number of participants evaluable for the outcome measure

Posted

Mean

Standard Deviation

ng*hr/mL

Pre dose, 1, 2, 4, 10, 24, 48, 72 and 96 hours post dose on Cycle 1/Day 25

ID	Title	Description
OG000	PF-04449913 80 mg	Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
OG001	PF-04449913 160 mg	Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
OG002	PF-04449913 320 mg	Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
OG003	PF-04449913 640 mg	Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).

Units	Counts
Participants	OG0004 OG0013 OG0026 OG003

Title

Denominators

Categories

Title	Measurements
	OG00013930± 6967 OG00118670± 5050 OG00246670± 20336 OG003

Secondary

Plasma Decay Half-life (t1/2) on Cycle 1/Day 25

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

PK Analysis Set: all treated participants who had at least 1 of the PK parameters of interest. N=number of participants evaluable for the outcome measure

Posted

Mean

Standard Deviation

hours

Pre dose, 1, 2, 4, 10, 24, 48, 72 and 96 hours post dose on Cycle 1/Day 25

ID	Title	Description
OG000	PF-04449913 80 mg	Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
OG001	PF-04449913 160 mg	Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
OG002	PF-04449913 320 mg	Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
OG003	PF-04449913 640 mg	Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).

Units	Counts
Participants	OG0004 OG0013 OG0026 OG003

Title

Denominators

Categories

Title	Measurements
	OG00019± 5 OG00121± 6.7 OG00221± 4.9 OG003

Secondary

Apparent Oral Clearance (CL/F) on Cycle 1/Day 25

Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.

PK Analysis Set: all treated participants who had at least 1 of the PK parameters of interest. N=number of participants evaluable for the outcome measure

Posted

Mean

Standard Deviation

liter/hour (L/hr)

Pre dose, 1, 2, 4, 10, 24, 48, 72 and 96 hours post dose on Cycle 1/Day 25

ID	Title	Description
OG000	PF-04449913 80 mg	Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
OG001	PF-04449913 160 mg	Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
OG002	PF-04449913 320 mg	Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
OG003	PF-04449913 640 mg	Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).

Units	Counts
Participants	OG0004 OG0013 OG0026 OG003

Title

Denominators

Categories

Title	Measurements
	OG0007.2± 4.2 OG0019.1± 2.9 OG0028.0± 3.5 OG003

Secondary

Apparent Volume of Distribution (Vz/F) on Cycle 1/Day 25

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 plasma concentration of a drug.

PK Analysis Set: all treated participants who had at least 1 of the PK parameters of interest. N=number of participants evaluable for the outcome measure

Posted

Mean

Standard Deviation

liter (L)

Pre dose, 1, 2, 4, 10, 24, 48, 72 and 96 hours post dose on Cycle 1/Day 25

ID	Title	Description
OG000	PF-04449913 80 mg	Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
OG001	PF-04449913 160 mg	Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
OG002	PF-04449913 320 mg	Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
OG003	PF-04449913 640 mg	Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).

Units	Counts
Participants	OG0004 OG0013 OG0026 OG003

Title

Denominators

Categories

Title	Measurements
	OG000182± 69 OG001286± 146 OG002234± 93 OG003

Secondary

Accumulation Ratio (Rac) on Cycle 1/Day 25

Accumulation ratio was calculated as AUCtau at steady state (Cycle 1/Day 25)/AUCtau on Study Day 1

PK Analysis Set: all treated participants who had at least 1 of the PK parameters of interest. N=number of participants evaluable for the outcome measure

Posted

Median

Full Range

ratio

Pre dose, 1, 2, 4, 6, 10 and 24 hours post dose on Cycle 1/Day 1, and pre dose, 1, 2, 4, 10, 24, 48, 72 and 96 hours post dose on Cycle 1/Day 25

ID	Title	Description
OG000	PF-04449913 80 mg	Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
OG001	PF-04449913 160 mg	Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
OG002	PF-04449913 320 mg	Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
OG003	PF-04449913 640 mg	Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).

Units	Counts
Participants	OG0004 OG0013 OG0026 OG003

Title

Denominators

Categories

Title	Measurements
	OG0001.4(0.9 to 1.6) OG0012.2(1.3 to 4.4) OG0021.7(0.6 to 2.9) OG003

Secondary

Average Concentration at Steady State (Cavg) on Cycle 1/Day 25

PK Analysis Set: all treated participants who had at least 1 of the PK parameters of interest. N=number of participants evaluable for the outcome measure

Posted

Mean

Standard Deviation

ng/mL

Pre dose, 1, 2, 4, 10, 24, 48, 72 and 96 hours post dose on Cycle 1/Day 25

ID	Title	Description
OG000	PF-04449913 80 mg	Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
OG001	PF-04449913 160 mg	Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
OG002	PF-04449913 320 mg	Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
OG003	PF-04449913 640 mg	Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).

Units	Counts
Participants	OG0004 OG0013 OG0026 OG003

Title

Denominators

Categories

Title	Measurements
	OG000580± 290 OG001777± 211 OG0021942± 848 OG003

Secondary

Number of Participants With Increase From Baseline in Corrected QT Using Fridericia's Formula (QTcF) Interval

Triplicate 12-lead electrocardiogram (ECG) measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time from electrocardiogram Q wave to the end of the T wave corresponding to electrical systole (QT) was corrected for heart rate (QTc). QTc using Fridericia's formula (QTcF) was calculated. Participants with maximum increase from baseline of less than (<) 30 millisecond (msec), 30 to <60 msec and >=60 msec were summarized.

QTc Analysis Set: all enrolled participants who had at least 1 ECG assessment after receiving at least 1 dose of study medication.

Posted

Number

participants

Baseline up to Cycle 14 (each cycle 28 days)

ID	Title	Description
OG000	PF-04449913 80 mg	Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
OG001	PF-04449913 160 mg	Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
OG002	PF-04449913 320 mg	Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
OG003	PF-04449913 640 mg	Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).

Units	Counts
Participants	OG0004 OG0014 OG0027 OG003

Title

Denominators

Categories

QTcF, maximum increase from baseline: <30 msec

Title	Measurements
	OG0003 OG0014 OG0024 OG003

Secondary

Number of Participants With Decrease From Baseline in QTcF Interval

Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. QTcF was calculated. Participants with maximum decrease from baseline of <30 msec, 30 to <60 msec and >=60 msec were summarized.

QTc Analysis Set: all enrolled participants who had at least 1 ECG assessment after receiving at least 1 dose of study medication.

Posted

Number

participants

Baseline up to Cycle 14 (each cycle 28 days)

ID	Title	Description
OG000	PF-04449913 80 mg	Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
OG001	PF-04449913 160 mg	Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
OG002	PF-04449913 320 mg	Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
OG003	PF-04449913 640 mg	Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).

Units	Counts
Participants	OG0004 OG0014 OG0027 OG003

Title

Denominators

Categories

QTcF, maximum decrease from baseline: <30 msec

Title	Measurements
	OG0004 OG0014 OG0026 OG003

Secondary

Number of Participants With Post-baseline QTcF Interval Greater Than or Equal to 500 Msec

Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. Participants with post-baseline absolute QTcF values >=500 msec were summarized.

QTc Analysis Set: all enrolled participants who had at least 1 ECG assessment after receiving at least 1 dose of study medication.

Posted

Number

participants

Baseline up to Cycle 14 (each cycle 28 days)

ID	Title	Description
OG000	PF-04449913 80 mg	Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
OG001	PF-04449913 160 mg	Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
OG002	PF-04449913 320 mg	Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
OG003	PF-04449913 640 mg	Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).

Units	Counts
Participants	OG0004 OG0014 OG0027 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0010 OG0021 OG003

Secondary

Percentage of Participants With Objective Response

Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Confirmed responses were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. PR was defined as >=30% decrease under baseline of the sum of diameters of all target measurable lesions.

Efficacy Analysis Set: all enrolled participants who received at least 1 dose of study medication.

Posted

Number

95% Confidence Interval

percentage of participants

Baseline up to Cycle 14 (each cycle 28 days)

ID	Title	Description
OG000	PF-04449913 80 mg	Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
OG001	PF-04449913 160 mg	Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
OG002	PF-04449913 320 mg	Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
OG003	PF-04449913 640 mg	Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).

Units	Counts
Participants	OG0004 OG0014 OG0027 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000(0.0 to 60.2) OG0010(0.0 to 60.2) OG0020(0.0 to 41.0) OG003

Secondary

Progression-Free Survival (PFS)

Time from Cycle 1/Day 1 to first documentation of disease progression or to death due to any cause, whichever occurred first. Progression was defined using RECIST 1.1 as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5 mm. PFS (days) was calculated as (first event date minus the date of first dose of study medication plus 1).

This OM was planned for expansion cohort only. Since none of the participants were enrolled in expansion cohort, no data was collected for progression free survival and thus the outcome measure was not performed.

Posted

Baseline up to Cycle 14 (each cycle 28 days)

ID	Title	Description
OG000	PF-04449913 80 mg	Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
OG001	PF-04449913 160 mg	Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
OG002	PF-04449913 320 mg	Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
OG003	PF-04449913 640 mg	Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).

Units	Counts
Participants	OG0000 OG0010 OG0020 OG003

Secondary

Time to Progression (TTP)

Time from Cycle 1/Day 1 to first documentation of disease progression. Progression was defined using RECIST 1.1 as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5 mm. TTP (days) was calculated as (first event date minus the date of first dose of study medication plus 1).

This OM was planned for expansion cohort only. Since none of the participants were enrolled in expansion cohort, no data was collected for time to progression and thus the outcome measure was not performed.

Posted

Baseline up to Cycle 14 (each cycle 28 days)

ID	Title	Description
OG000	PF-04449913 80 mg	Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
OG001	PF-04449913 160 mg	Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
OG002	PF-04449913 320 mg	Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
OG003	PF-04449913 640 mg	Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).

Units	Counts
Participants	OG0000 OG0010 OG0020 OG003

Secondary

Duration of Response (DR)

Duration from date of first documentation of objective response to date of first documentation of disease progression or death. Progression was defined using RECIST 1.1 as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5 mm. DR was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first objective response that was subsequently confirmed plus 1).

This OM was planned for expansion cohort only. Since none of the participants were enrolled in expansion cohort, no data was collected for duration of response and thus the outcome measure was not performed.

Posted

Baseline up to Cycle 14 (each cycle 28 days)

ID	Title	Description
OG000	PF-04449913 80 mg	Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
OG001	PF-04449913 160 mg	Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
OG002	PF-04449913 320 mg	Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
OG003	PF-04449913 640 mg	Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).

Units	Counts
Participants	OG0000 OG0010 OG0020 OG003