A Trial In Patients With Advanced Cancer And Leukemia | NCT00878189

ID	Type	Description	Link
2010-022036-36	EudraCT Number

A Trial In Patients With Advanced Cancer And Leukemia | NCT00878189 | Trialant

Arms/Interventions Module

Label	Type	Description	Intervention Names
1	Experimental		Drug: PF-03084014

Name	Type	Description	Arm Group Labels	Other Names
PF-03084014	Drug	10 mg, 50 mg or 100 mg tablets. Patients dosed from 20 mg - 500 mg, twice daily	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Solid Tumor Participants With First-Cycle Dose-Limiting Toxicity (DLT)	Any DLT event attributable to PF-03084014 during Cycle 1: non-hematologic toxicities >= Grade 3 despite optimal care; treatment delay >=7 days or unable to deliver at least 80% of planned dose due to treatment-related toxicities; Grade 4 neutropenia >7 days; febrile neutropenia; neutropenic infection; Grade >=3 thrombocytopenia with bleeding	Baseline to the end of Cycle 1 (Week 4)
Number of T-ALL/LBL Participants With First-Cycle DLT	Any DLT attributable to PF-03084014 at 1st Cycle: non-hematologic toxicities >= Grade 3 despite optimal care; treatment delay >=7 days; unable to deliver at least 80% of planned dose; absolute neutrophil count (ANC) <1000/microliter (uL), or platelet count <30,000/uL, or hemoglobin <8 gram/deciliter (g/dL) in a bone marrow with <5% blasts and no evidence of leukemia or abnormal dysplasia for >42 days	Baseline to the end of Cycle 1 (Week 4)

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All Causality)	An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of casual relationship. Treatment-emergent are events 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. A serious adverse event (SAE) was any untoward medical occurrence at any dose that: resulted in death, was life-threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), and resulted in congenital anomaly/birth defect.

Contacts/Locations Module

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

Facility	Status	City	State	ZIP	Country	Contacts
Anschutz Cancer Pavilion		Aurora	Colorado	80045	United States
University of Colorado Denver CTRC

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26407235	Derived	Papayannidis C, DeAngelo DJ, Stock W, Huang B, Shaik MN, Cesari R, Zheng X, Reynolds JM, English PA, Ozeck M, Aster JC, Kuo F, Huang D, Lira PD, McLachlan KR, Kern KA, Garcia-Manero G, Martinelli G. A Phase 1 study of the novel gamma-secretase inhibitor PF-03084014 in patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma. Blood Cancer J. 2015 Sep 25;5(9):e350. doi: 10.1038/bcj.2015.80. No abstract available.
23511909

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

Arm/Group Information

ID	Title	Description
FG000	PF-03084014 20 mg BID in Solid Tumor Participants	PF-03084014 20 mg was administered orally twice daily (BID), beginning on Day 1 of each cycle, for 21 days. In Cycle 1 only, participants with advanced solid tumor malignancies received PF-03084014 BID for 21 days (on Cycle 1 Day 21 only the morning dose was administered) followed by 7 days' off-treatment for the purpose of pharmacokinetic (PK) assessments. In Cycle 2 and beyond, PF-03084014 was administered BID continuously.
FG001	PF-03084014 40 mg BID in Solid Tumor Participants	PF-03084014 40 mg was administered orally BID, beginning on Day 1 of each cycle, for 21 days. In Cycle 1 only, participants with advanced solid tumor malignancies received PF-03084014 BID for 21 days (on Cycle 1 Day 21 only the morning dose was administered) followed by 7 days' off-treatment for the purpose of PK assessments. In Cycle 2 and beyond, PF-03084014 was administered BID continuously.
FG002	PF-03084014 80 mg BID in Solid Tumor Participants	PF-03084014 80 mg was administered orally BID, beginning on Day 1 of each cycle, for 21 days. In Cycle 1 only, participants with advanced solid tumor malignancies received PF-03084014 BID for 21 days (on Cycle 1 Day 21 only the morning dose was administered) followed by 7 days' off-treatment for the purpose of PK assessments. In Cycle 2 and beyond, PF-03084014 was administered BID continuously.
FG003	PF-03084014 100 mg BID in Solid Tumor Participants	PF-03084014 100 mg was administered orally BID, beginning on Day 1 of each cycle, for 21 days. In Cycle 1 only, participants with advanced solid tumor malignancies received PF-03084014 BID for 21 days (on Cycle 1 Day 21 only the morning dose was administered) followed by 7 days' off-treatment for the purpose of PK assessments. In Cycle 2 and beyond, PF-03084014 was administered BID continuously.
FG004	PF-03084014 130 mg BID in Solid Tumor Participants	PF-03084014 130 mg was administered orally BID, beginning on Day 1 of each cycle, for 21 days. In Cycle 1 only, participants with advanced solid tumor malignancies received PF-03084014 BID for 21 days (on Cycle 1 Day 21 only the morning dose was administered) followed by 7 days' off-treatment for the purpose of PK assessments. In Cycle 2 and beyond, PF-03084014 was administered BID continuously.
FG005	PF-03084014 150 mg BID in Solid Tumor Participants	PF-03084014 150 mg was administered orally BID, beginning on Day 1 of each cycle, for 21 days. In Cycle 1 only, participants with advanced solid tumor malignancies received PF-03084014 BID for 21 days (on Cycle 1 Day 21 only the morning dose was administered) followed by 7 days' off-treatment for the purpose of PK assessments. In Cycle 2 and beyond, PF-03084014 was administered BID continuously.
FG006	PF-03084014 220 mg BID in Solid Tumor Participants	PF-03084014 220 mg was administered orally BID, beginning on Day 1 of each cycle, for 21 days. In Cycle 1 only, participants with advanced solid tumor malignancies received PF-03084014 BID for 21 days (on Cycle 1 Day 21 only the morning dose was administered) followed by 7 days' off-treatment for the purpose of PK assessments. In Cycle 2 and beyond, PF-03084014 was administered BID continuously.
FG007	PF-03084014 330 mg BID in Solid Tumor Participants	PF-03084014 330 mg was administered orally BID, beginning on Day 1 of each cycle, for 21 days. In Cycle 1 only, participants with advanced solid tumor malignancies received PF-03084014 BID for 21 days (on Cycle 1 Day 21 only the morning dose was administered) followed by 7 days' off-treatment for the purpose of PK assessments. In Cycle 2 and beyond, PF-03084014 was administered BID continuously.
FG008	PF-03084014 150 mg BID in T-ALL/LBL Participants	PF-03084014 150 mg was administered orally BID to participants with T-cell acute lymphoblastic leukemia/lymphoblastic lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG0003 subjects FG0013 subjects FG0024 subjects FG0038 subjects FG0044 subjects FG00523 subjects FG00616 subjects FG0073 subjects FG0088 subjects
COMPLETED		FG0000 subjects FG0010 subjects FG0020 subjects FG0030 subjects FG004
NOT COMPLETED		FG0003 subjects FG0013 subjects FG0024 subjects FG0038 subjects FG004

Type	Comment	Reasons
Death		FG0000 subjects FG0011 subjects FG0020 subjects FG003

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	PF-03084014 in Solid Tumor Participants	PF-03084014 was administered orally BID, beginning on Day 1 of each cycle, for 21 days. In Cycle 1 only, participants with advanced solid tumor malignancies received PF-03084014 BID for 21 days (on Cycle 1 Day 21 only the morning dose was administered) followed by 7 days' off-treatment for the purpose of PK assessments. In Cycle 2 and beyond, PF-03084014 was administered BID continuously.

Units	Counts
Participants	BG000

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

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Solid Tumor Participants With First-Cycle Dose-Limiting Toxicity (DLT)

Any DLT event attributable to PF-03084014 during Cycle 1: non-hematologic toxicities >= Grade 3 despite optimal care; treatment delay >=7 days or unable to deliver at least 80% of planned dose due to treatment-related toxicities; Grade 4 neutropenia >7 days; febrile neutropenia; neutropenic infection; Grade >=3 thrombocytopenia with bleeding

Solid tumor participants enrolled for dose-escalation who started treatment and who did not have first cycle major treatment deviations (including less than 80% of the planned dose of PF-03084014 in Cycle 1 for reasons other than treatment-related toxicities) were evaluable for DLTs.

Posted

Number

participants

Baseline to the end of Cycle 1 (Week 4)

ID	Title	Description
OG000	PF-03084014 20 mg BID in Solid Tumor Participants	PF-03084014 20 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.

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-03084014 20 mg BID in Solid Tumor Participants	PF-03084014 20 mg was administered orally BID, beginning on Day 1 of each cycle, for 21 days. In Cycle 1 only, participants with advanced solid tumor malignancies received PF-03084014 BID for 21 days (on Cycle 1 Day 21 only the morning dose was administered) followed by 7 days' off-treatment for the purpose of PK assessments. In Cycle 2 and beyond, PF-03084014 was administered BID continuously.

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
GRAM POSITIVE COCCI	Investigations	MedDRA 19.1	Non-systematic Assessment

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
PRURITIS	Skin and subcutaneous tissue disorders	MedDRA 19.1	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

Condition Browse Module

ID	Term
D009370	Neoplasms by Histologic Type
D007938	Leukemia

ID	Term
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

ID	Term
C550722	nirogacestat

Primary

Number of T-ALL/LBL Participants With First-Cycle DLT

Any DLT attributable to PF-03084014 at 1st Cycle: non-hematologic toxicities >= Grade 3 despite optimal care; treatment delay >=7 days; unable to deliver at least 80% of planned dose; absolute neutrophil count (ANC) <1000/microliter (uL), or platelet count <30,000/uL, or hemoglobin <8 gram/deciliter (g/dL) in a bone marrow with <5% blasts and no evidence of leukemia or abnormal dysplasia for >42 days

T-ALL/LBL participants enrolled for dose-escalation who started treatment and who did not have first cycle major treatment deviations (including less than 80% of the planned dose of PF-03084014 in Cycle 1 for reasons other than treatment-related toxicities) were evaluable for DLTs.

Posted

Number

participants

Baseline to the end of Cycle 1 (Week 4)

ID	Title	Description
OG000	PF-03084014 150 mg BID in T-ALL/LBL Participants	PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.

Units	Counts
Participants	OG0005

Title

Denominators

Categories

Title	Measurements
	OG0001

Secondary

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All Causality)

An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of casual relationship. Treatment-emergent are events 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. A serious adverse event (SAE) was any untoward medical occurrence at any dose that: resulted in death, was life-threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), and resulted in congenital anomaly/birth defect.

All participants who received at least 1 dose of study medication.

Posted

Number

participants

Baseline up to end of study (maximum of 84 months)

ID	Title	Description
OG000	PF-03084014 20 mg BID in Solid Tumor Participants	PF-03084014 20 mg was administered orally twice daily (BID) to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG001	PF-03084014 40 mg BID in Solid Tumor Participants	PF-03084014 40 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG002	PF-03084014 80 mg BID in Solid Tumor Participants	PF-03084014 80 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG003	PF-03084014 100 mg BID in Solid Tumor Participants	PF-03084014 100 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG004	PF-03084014 130 mg BID in Solid Tumor Participants	PF-03084014 130 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG005	PF-03084014 150 mg BID in Solid Tumor Participants	PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG006	PF-03084014 220 mg BID in Solid Tumor Participants	PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG007	PF-03084014 330 mg BID in Solid Tumor Participants	PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG008	PF-03084014 150 mg BID in T-ALL/LBL Participants	PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.

Units	Counts
Participants	OG0003 OG0013 OG0024 OG003

Title

Denominators

Categories

No. of Participants With AEs

Title	Measurements
	OG0003 OG0013 OG0024 OG003

Secondary

Number of Participants With TEAEs (Treatment-Related)

An AE was any untoward medical occurrence in a participant who received study drug. Treatment-related events were those assessed by the investigator as related to study medication. An SAE was any untoward medical occurrence at any dose that: resulted in death, was life-threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), and resulted in congenital anomaly/birth defect.

All participants who received at least 1 dose of study medication.

Posted

Number

participants

Baseline up to end of study (maximum of 84 months)

ID	Title	Description
OG000	PF-03084014 20 mg BID in Solid Tumor Participants	PF-03084014 20 mg was administered orally twice daily (BID) to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG001	PF-03084014 40 mg BID in Solid Tumor Participants	PF-03084014 40 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG002	PF-03084014 80 mg BID in Solid Tumor Participants	PF-03084014 80 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG003	PF-03084014 100 mg BID in Solid Tumor Participants	PF-03084014 100 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG004	PF-03084014 130 mg BID in Solid Tumor Participants	PF-03084014 130 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG005	PF-03084014 150 mg BID in Solid Tumor Participants	PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG006	PF-03084014 220 mg BID in Solid Tumor Participants	PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG007	PF-03084014 330 mg BID in Solid Tumor Participants	PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG008	PF-03084014 150 mg BID in T-ALL/LBL Participants	PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.

Units	Counts
Participants	OG0003 OG0013 OG0024 OG003

Title

Denominators

Categories

No. of Participants With AEs

Title	Measurements
	OG0002 OG0011 OG0022 OG003

Secondary

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All Causality) by Severity (by Maximum Common Terminology Criteria for Adverse Events [CTCAE] Grade)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events 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. CTCAE version 3.0 was used for AE grading: Grade 1 mild AE; Grade 2 moderate AE; Grade 3 severe AE; Grade 4 life-threatening or disabling AE; Grade 5 death related to AE.

All participants who received at least 1 dose of study medication.

Posted

Number

participants

Baseline up to end of study (maximum of 84 months)

ID	Title	Description
OG000	PF-03084014 20 mg BID in Solid Tumor Participants	PF-03084014 20 mg was administered orally twice daily (BID) to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG001	PF-03084014 40 mg BID in Solid Tumor Participants	PF-03084014 40 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG002	PF-03084014 80 mg BID in Solid Tumor Participants	PF-03084014 80 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG003	PF-03084014 100 mg BID in Solid Tumor Participants	PF-03084014 100 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG004	PF-03084014 130 mg BID in Solid Tumor Participants	PF-03084014 130 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG005	PF-03084014 150 mg BID in Solid Tumor Participants	PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG006	PF-03084014 220 mg BID in Solid Tumor Participants	PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG007	PF-03084014 330 mg BID in Solid Tumor Participants	PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG008	PF-03084014 150 mg BID in T-ALL/LBL Participants	PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.

Units	Counts
Participants	OG0003 OG0013 OG0024 OG003

Title

Denominators

Categories

Any AEs, Grade 1

Title	Measurements
	OG0000 OG0010 OG0021 OG003

Secondary

Number of Participants With TEAEs (Treatment-Related) by Severity (by Maximum CTCAE Grade)

An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-related events were those assessed by the investigator as related to study medication. CTCAE version 3.0 was used for AE grading: Grade 1 mild AE; Grade 2 moderate AE; Grade 3 severe AE; Grade 4 life-threatening or disabling AE; Grade 5 death related to AE.

All participants who received at least 1 dose of study medication.

Posted

Number

participants

Baseline up to end of study (maximum of 84 months)

ID	Title	Description
OG000	PF-03084014 20 mg BID in Solid Tumor Participants	PF-03084014 20 mg was administered orally twice daily (BID) to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG001	PF-03084014 40 mg BID in Solid Tumor Participants	PF-03084014 40 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG002	PF-03084014 80 mg BID in Solid Tumor Participants	PF-03084014 80 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG003	PF-03084014 100 mg BID in Solid Tumor Participants	PF-03084014 100 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG004	PF-03084014 130 mg BID in Solid Tumor Participants	PF-03084014 130 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG005	PF-03084014 150 mg BID in Solid Tumor Participants	PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG006	PF-03084014 220 mg BID in Solid Tumor Participants	PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG007	PF-03084014 330 mg BID in Solid Tumor Participants	PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG008	PF-03084014 150 mg BID in T-ALL/LBL Participants	PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.

Units	Counts
Participants	OG0003 OG0013 OG0024 OG003

Title

Denominators

Categories

Any AEs, Grade 1

Title	Measurements
	OG0001 OG0010 OG0021 OG003

Secondary

Number of Participants With Potentially Clinical Significant Categorical Changes From Baseline in Electrocardiogram (ECG) Findings in QTc Interval

Criteria for potentially important changes in ECG were defined as: maximum (max.) post-dose (post-baseline) time from electrocardiogram Q wave to the corresponding to electrical systole (QT interval) corrected for Fridericia's factor (QTcF), or QT interval corrected for Bazett's factor (QTcB): <450, 450 -<480, 480-<500, and >=500 msec. Maximum increase (inc.) from baseline in QTcF or QTcB: change (chg) <30, 30>=chg<60, and chg >=60 msec.

All participants who received at least 1 dose of study medication.

Posted

Number

participants

Baseline up to end of study (maximum of 84 months)

ID	Title	Description
OG000	PF-03084014 20 mg BID in Solid Tumor Participants	PF-03084014 20 mg was administered orally twice daily (BID) to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG001	PF-03084014 40 mg BID in Solid Tumor Participants	PF-03084014 40 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG002	PF-03084014 80 mg BID in Solid Tumor Participants	PF-03084014 80 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG003	PF-03084014 100 mg BID in Solid Tumor Participants	PF-03084014 100 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG004	PF-03084014 130 mg BID in Solid Tumor Participants	PF-03084014 130 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG005	PF-03084014 150 mg BID in Solid Tumor Participants	PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG006	PF-03084014 220 mg BID in Solid Tumor Participants	PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG007	PF-03084014 330 mg BID in Solid Tumor Participants	PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG008	PF-03084014 150 mg BID in T-ALL/LBL Participants	PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.

Units	Counts
Participants	OG0003 OG0013 OG0024 OG003

Title

Denominators

Categories

Max. QTcB interval <450 msec

Title	Measurements
	OG0000 OG0013 OG0022 OG003

Secondary

Number of Participants With Laboratory Tests Abnormalities Meeting the Criteria of Potential Clinical Concern (Hematology and Chemistries, All Cycles)

Parameters analyzed included: white blood cell (WBC) count plus differential, absolute (abs) neutrophil count, platelets, hemoglobin, sodium, potassium, bicarbonate, chloride, blood urea nitrogen, creatinine, glucose, uric acid, calcium, phosphate, magnesium, total protein, albumin, total bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), partial prothrombin time/international normalized ratio (PTT/INR). Urinalysis: pH, specific gravity, protein, glucose, ketones, blood, leukocyte esterase, and nitrites. Pregnancy test: Serum or urine pregnancy test for women of childbearing potential. There were no changes in urine protein among the solid tumor and T-ALL/LBL participants that were clinically significant. Clinical significance was judged by the investigator.

All participants who received at least 1 dose of study medication.

Posted

Number

participants

Baseline up to end of study (maximum of 84 months)

ID	Title	Description
OG000	PF-03084014 in Solid Tumor Participants	PF-03084014 20, 40, 80, 100, 150, 220, 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG001	PF-03084014 150 mg BID in T-ALL/LBL Participants	PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.

Units	Counts
Participants	OG00064 OG0018

Title

Denominators

Categories

Hemoglobin

Title	Measurements
	OG00045 OG0018

Lymphocytes (abs)

Title	Measurements
	OG000

Secondary

Maximum Observed Serum Concentration (Cmax) After a Single Dose on Cycle 1 Day 1

Cmax was the maximum observed serum concentration.

All treated participants who had at least 1 of the PK parameters of interest. N=number of participants evaluable for this outcome measure (OM).

Posted

Geometric Mean

Geometric Coefficient of Variation

nanogram/milliliter (ng/mL)

Cycle 1 Day 1 (pre-dose and 0.5, 1, 2, 4, and 10 hr post-dose)

ID	Title	Description
OG000	PF-03084014 20 mg BID in Solid Tumor Participants	PF-03084014 20 mg was administered orally twice daily (BID) to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG001	PF-03084014 40 mg BID in Solid Tumor Participants	PF-03084014 40 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG002	PF-03084014 80 mg BID in Solid Tumor Participants	PF-03084014 80 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG003	PF-03084014 100 mg BID in Solid Tumor Participants	PF-03084014 100 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG004	PF-03084014 130 mg BID in Solid Tumor Participants	PF-03084014 130 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG005	PF-03084014 150 mg BID in Solid Tumor Participants	PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG006	PF-03084014 220 mg BID in Solid Tumor Participants	PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG007	PF-03084014 330 mg BID in Solid Tumor Participants	PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG008	PF-03084014 150 mg BID in T-ALL/LBL Participants	PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.

Units	Counts
Participants	OG0003 OG0013 OG0024 OG003

Title

Denominators

Categories

Title	Measurements
	OG000163± 62 OG001368± 48 OG002230± 193 OG003

Secondary

Dose-normalized Cmax [Cmax (dn)] After a Single Dose on Cycle 1 Day 1

Cmax(dn) was calculated by maximum observed serum concentration (Cmax) divided by administered dose.

All treated participants who had at least 1 of the PK parameters of interest. N=number of participants evaluable for this OM.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL/mg

Cycle 1 Day 1 (pre-dose and 0.5, 1, 2, 4, and 10 hr post-dose)

ID	Title	Description
OG000	PF-03084014 20 mg BID in Solid Tumor Participants	PF-03084014 20 mg was administered orally twice daily (BID) to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG001	PF-03084014 40 mg BID in Solid Tumor Participants	PF-03084014 40 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG002	PF-03084014 80 mg BID in Solid Tumor Participants	PF-03084014 80 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG003	PF-03084014 100 mg BID in Solid Tumor Participants	PF-03084014 100 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG004	PF-03084014 130 mg BID in Solid Tumor Participants	PF-03084014 130 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG005	PF-03084014 150 mg BID in Solid Tumor Participants	PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG006	PF-03084014 220 mg BID in Solid Tumor Participants	PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG007	PF-03084014 330 mg BID in Solid Tumor Participants	PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG008	PF-03084014 150 mg BID in T-ALL/LBL Participants	PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.

Units	Counts
Participants	OG0003 OG0013 OG0024 OG003

Title

Denominators

Categories

Title	Measurements
	OG0008.1± 63 OG0019.2± 48 OG0022.9± 193 OG003

Secondary

Area Under the Time-Concentration Curve From Time 0 to the Dosing Interval (AUCtau) After a Single Dose on Cycle 1 Day 1

AUCtau was area under the serum concentration-time profile from time 0 to tau (dosing interval). CV is the coefficient of variation.

All treated participants who had at least 1 of the PK parameters of interest. Overall Number of Participants Analyzed (N) =number of participants evaluable for this outcome measure (OM).

Posted

Geometric Mean

Geometric Coefficient of Variation

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

Cycle 1 Day 1 (pre-dose and 0.5, 1, 2, 4, and 10 hr post-dose)

ID	Title	Description
OG000	PF-03084014 20 mg BID in Solid Tumor Participants	PF-03084014 20 mg was administered orally twice daily (BID) to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG001	PF-03084014 40 mg BID in Solid Tumor Participants	PF-03084014 40 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG002	PF-03084014 80 mg BID in Solid Tumor Participants	PF-03084014 80 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG003	PF-03084014 100 mg BID in Solid Tumor Participants	PF-03084014 100 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG004	PF-03084014 130 mg BID in Solid Tumor Participants	PF-03084014 130 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG005	PF-03084014 150 mg BID in Solid Tumor Participants	PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG006	PF-03084014 220 mg BID in Solid Tumor Participants	PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG007	PF-03084014 330 mg BID in Solid Tumor Participants	PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG008	PF-03084014 150 mg BID in T-ALL/LBL Participants	PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.

Units	Counts
Participants	OG0003 OG0013 OG0023 OG003

Title

Denominators

Categories

Title	Measurements
	OG000409± 83 OG0011329± 87 OG0021649± 98 OG003

Secondary

Dose-normalized AUCtau [AUCtau (dn) ] After a Single Dose on Cycle 1 Day 1

AUCtau (dn) was calculated by area under the serum concentration-time profile from time 0 to tau (dosing interval) (AUCtau) divided by administered dose. NE is not estimable.

All treated participants who had at least 1 of the PK parameters of interest. N=number of participants evaluable for this OM.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng*hr/mL/mg

Cycle 1 Day 1 (pre-dose and 0.5, 1, 2, 4, and 10 hr post-dose)

ID	Title	Description
OG000	PF-03084014 20 mg BID in Solid Tumor Participants	PF-03084014 20 mg was administered orally twice daily (BID) to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG001	PF-03084014 40 mg BID in Solid Tumor Participants	PF-03084014 40 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG002	PF-03084014 80 mg BID in Solid Tumor Participants	PF-03084014 80 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG003	PF-03084014 100 mg BID in Solid Tumor Participants	PF-03084014 100 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG004	PF-03084014 130 mg BID in Solid Tumor Participants	PF-03084014 130 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG005	PF-03084014 150 mg BID in Solid Tumor Participants	PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG006	PF-03084014 220 mg BID in Solid Tumor Participants	PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG007	PF-03084014 330 mg BID in Solid Tumor Participants	PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG008	PF-03084014 150 mg BID in T-ALL/LBL Participants	PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.

Units	Counts
Participants	OG0003 OG0013 OG0023 OG003

Title

Denominators

Categories

Title	Measurements
	OG00020.4± 83 OG00133.2± 87 OG00220.6± 98 OG003

Secondary

Time to Reach Cmax (Tmax) After a Single Dose on Cycle 1 Day 1

Tmax was the time to reach maximum serum concentration (Cmax).

All treated participants who had at least 1 of the PK parameters of interest. N=number of participants evaluable for this OM.

Posted

Median

Full Range

hours

Cycle 1 Day 1 (pre-dose and 0.5, 1, 2, 4, and 10 hr post-dose)

ID	Title	Description
OG000	PF-03084014 20 mg BID in Solid Tumor Participants	PF-03084014 20 mg was administered orally twice daily (BID) to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG001	PF-03084014 40 mg BID in Solid Tumor Participants	PF-03084014 40 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG002	PF-03084014 80 mg BID in Solid Tumor Participants	PF-03084014 80 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG003	PF-03084014 100 mg BID in Solid Tumor Participants	PF-03084014 100 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG004	PF-03084014 130 mg BID in Solid Tumor Participants	PF-03084014 130 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG005	PF-03084014 150 mg BID in Solid Tumor Participants	PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG006	PF-03084014 220 mg BID in Solid Tumor Participants	PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG007	PF-03084014 330 mg BID in Solid Tumor Participants	PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG008	PF-03084014 150 mg BID in T-ALL/LBL Participants	PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.

Units	Counts
Participants	OG0003 OG0013 OG0024 OG003

Title

Denominators

Categories

Title	Measurements
	OG0001.0(0.9 to 1.0) OG0011.0(1.0 to 1.3) OG0022.0(1.0 to 8.0) OG003

Secondary

Cmax After Multiple Dose on Cycle 1 Day 21

Cmax was the maximum observed serum concentration. Cycle 1 Day 21 PK parameter summaries are presented only for participants who were considered to be dose compliant. CV is the coefficient of variation.

All participants who had at least 6 days of uninterrupted dosing prior to the Cycle 1 Day 21 PK assessment. The 6-day duration was chosen based on the observed terminal half-life of PF-03084014. N=number of participants evaluable for this OM.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

Cycle 1 Day 21 (pre-dose and 0.5, 1, 2, 4, 10, 24, 48, 96 and 120 hr post-dose)

ID	Title	Description
OG000	PF-03084014 20 mg BID in Solid Tumor Participants	PF-03084014 20 mg was administered orally twice daily (BID) to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG001	PF-03084014 40 mg BID in Solid Tumor Participants	PF-03084014 40 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG002	PF-03084014 80 mg BID in Solid Tumor Participants	PF-03084014 80 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG003	PF-03084014 100 mg BID in Solid Tumor Participants	PF-03084014 100 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG004	PF-03084014 130 mg BID in Solid Tumor Participants	PF-03084014 130 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG005	PF-03084014 150 mg BID in Solid Tumor Participants	PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG006	PF-03084014 220 mg BID in Solid Tumor Participants	PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG007	PF-03084014 150 mg BID in T-ALL/LBL Participants	PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.

Units	Counts
Participants	OG0002 OG0012 OG0023 OG003

Title

Denominators

Categories

Title	Measurements
	OG00064.5± NAGeometric %CV was not estimable when number of participants analyzed is less than 3, hence data for Geometric %CV was not calculated. OG001381± NAGeometric %CV was not estimable when number of participants analyzed is less than 3, hence data for Geometric %CV was not calculated. OG002

Secondary

Time to Reach Cmax (Tmax) After Multiple Dose on Cycle 1 Day 21

Tmax was the time to reach maximum serum concentration (Cmax). Cycle 1 Day 21 PK parameter summaries are presented only for participants who were considered to be dose compliant.

Posted

Median

Full Range

hour

Cycle 1 Day 21 (pre-dose and 0.5, 1, 2, 4, 10, 24, 48, 96 and 120 hr post-dose)

ID	Title	Description
OG000	PF-03084014 20 mg BID in Solid Tumor Participants	PF-03084014 20 mg was administered orally twice daily (BID) to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG001	PF-03084014 40 mg BID in Solid Tumor Participants	PF-03084014 40 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG002	PF-03084014 80 mg BID in Solid Tumor Participants	PF-03084014 80 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG003	PF-03084014 100 mg BID in Solid Tumor Participants	PF-03084014 100 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG004	PF-03084014 130 mg BID in Solid Tumor Participants	PF-03084014 130 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG005	PF-03084014 150 mg BID in Solid Tumor Participants	PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG006	PF-03084014 220 mg BID in Solid Tumor Participants	PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG007	PF-03084014 150 mg BID in T-ALL/LBL Participants	PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.

Units	Counts
Participants	OG0002 OG0012 OG0023 OG003

Title

Denominators

Categories

Title	Measurements
	OG0001.1(1.0 to 1.1) OG0011.0(1.0 to 1.0) OG0021.1(1.0 to 4.0) OG003

Secondary

AUCtau After Multiple Dose on Cycle 1 Day 21

AUCtau was area under the serum concentration-time profile from time 0 to tau (dosing interval). Cycle 1 Day 21 PK parameter summaries are presented only for participants who were considered to be dose compliant.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng*hr/mL

Cycle 1 Day 21 (pre-dose and 0.5, 1, 2, 4, 10, 24, 48, 96 and 120 hr post-dose)

ID	Title	Description
OG000	PF-03084014 20 mg BID in Solid Tumor Participants	PF-03084014 20 mg was administered orally twice daily (BID) to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG001	PF-03084014 40 mg BID in Solid Tumor Participants	PF-03084014 40 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG002	PF-03084014 80 mg BID in Solid Tumor Participants	PF-03084014 80 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG003	PF-03084014 100 mg BID in Solid Tumor Participants	PF-03084014 100 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG004	PF-03084014 130 mg BID in Solid Tumor Participants	PF-03084014 130 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG005	PF-03084014 150 mg BID in Solid Tumor Participants	PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG006	PF-03084014 220 mg BID in Solid Tumor Participants	PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG007	PF-03084014 150 mg BID in T-ALL/LBL Participants	PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.

Units	Counts
Participants	OG0002 OG0012 OG0023 OG003

Title

Denominators

Categories

Title	Measurements
	OG000309.0± NAGeometric %CV was not estimable when number of participants analyzed is less than 3, hence data for Geometric %CV was not calculated. OG0012521± NAGeometric %CV was not estimable when number of participants analyzed is less than 3, hence data for Geometric %CV was not calculated. OG002

Secondary

Apparent Volume of Distribution (Vz/F) on Cycle 1 Day 21

Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired concentration of a drug. Cycle 1 Day 21 PK parameter summaries are presented only for participants who were considered to be dose compliant.

Posted

Geometric Mean

Geometric Coefficient of Variation

liter (L)

Cycle 1 Day 21 (pre-dose and 0.5, 1, 2, 4, 10, 24, 48, 96 and 120 hr post-dose)

ID	Title	Description
OG000	PF-03084014 20 mg BID in Solid Tumor Participants	PF-03084014 20 mg was administered orally twice daily (BID) to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG001	PF-03084014 40 mg BID in Solid Tumor Participants	PF-03084014 40 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG002	PF-03084014 80 mg BID in Solid Tumor Participants	PF-03084014 80 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG003	PF-03084014 100 mg BID in Solid Tumor Participants	PF-03084014 100 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG004	PF-03084014 130 mg BID in Solid Tumor Participants	PF-03084014 130 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG005	PF-03084014 150 mg BID in Solid Tumor Participants	PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG006	PF-03084014 220 mg BID in Solid Tumor Participants	PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG007	PF-03084014 150 mg BID in T-ALL/LBL Participants	PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.

Units	Counts
Participants	OG0002 OG0012 OG0022 OG003

Title

Denominators

Categories

Title	Measurements
	OG0002810± NAGeometric %CV was not estimable when number of participants analyzed is less than 3, hence data for Geometric %CV was not calculated. OG001516± NAGeometric %CV was not estimable when number of participants analyzed is less than 3, hence data for Geometric %CV was not calculated. OG002

Secondary

Serum Decay Half-Life (t1/2) After Multiple Dose on Cycle 1 Day 21

Serum decay half-life (t1/2) is the time measured for the serum concentration to decrease by one half. Cycle 1 Day 21 PK parameter summaries are presented only for participants who were considered to be dose compliant.

Posted

Mean

Standard Deviation

hours

Cycle 1 Day 21 (pre-dose and 0.5, 1, 2, 4, 10, 24, 48, 96 and 120 hr post-dose)

ID	Title	Description
OG000	PF-03084014 20 mg BID in Solid Tumor Participants	PF-03084014 20 mg was administered orally twice daily (BID) to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG001	PF-03084014 40 mg BID in Solid Tumor Participants	PF-03084014 40 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG002	PF-03084014 80 mg BID in Solid Tumor Participants	PF-03084014 80 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG003	PF-03084014 100 mg BID in Solid Tumor Participants	PF-03084014 100 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG004	PF-03084014 130 mg BID in Solid Tumor Participants	PF-03084014 130 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG005	PF-03084014 150 mg BID in Solid Tumor Participants	PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG006	PF-03084014 220 mg BID in Solid Tumor Participants	PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG007	PF-03084014 150 mg BID in T-ALL/LBL Participants	PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.

Units	Counts
Participants	OG0002 OG0012 OG0022 OG003

Title

Denominators

Categories

Title	Measurements
	OG00030.3± NAGeometric %CV was not estimable when number of participants analyzed is less than 3, hence data for Geometric %CV was not calculated. OG00122.6± NAGeometric %CV was not estimable when number of participants analyzed is less than 3, hence data for Geometric %CV was not calculated.. OG002

Secondary

Apparent Oral Clearance (CL/F) on Cycle 1 Day 21

Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Cycle 1 Day 21 PK parameter summaries are presented only for participants who were considered to be dose compliant.

Posted

Geometric Mean

Geometric Coefficient of Variation

liter/hour (L/hr)

Cycle 1 Day 21 (pre-dose and 0.5, 1, 2, 4, 10, 24, 48, 96 and 120 hr post-dose)

ID	Title	Description
OG000	PF-03084014 20 mg BID in Solid Tumor Participants	PF-03084014 20 mg was administered orally twice daily (BID) to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG001	PF-03084014 40 mg BID in Solid Tumor Participants	PF-03084014 40 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG002	PF-03084014 80 mg BID in Solid Tumor Participants	PF-03084014 80 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG003	PF-03084014 100 mg BID in Solid Tumor Participants	PF-03084014 100 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG004	PF-03084014 130 mg BID in Solid Tumor Participants	PF-03084014 130 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG005	PF-03084014 150 mg BID in Solid Tumor Participants	PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG006	PF-03084014 220 mg BID in Solid Tumor Participants	PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG007	PF-03084014 150 mg BID in T-ALL/LBL Participants	PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.

Units	Counts
Participants	OG0002 OG0012 OG0023 OG003

Title

Denominators

Categories

Title	Measurements
	OG00064.8± NAGeometric %CV was not estimable when number of participants analyzed is less than 3, hence data for Geometric %CV was not calculated. OG00115.9± NAGeometric %CV was not estimable when number of participants analyzed is less than 3, hence data for Geometric %CV was not calculated. OG002

Secondary

Minimum Observed Serum Concentration (Cmin) After Multiple Dose on Cycle 1 Day 21

Cmin was the minimum serum concentration. Cycle 1 Day 21 PK parameter summaries are presented only for participants who were considered to be dose compliant.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

Cycle 1 Day 21 (pre-dose and 0.5, 1, 2, 4, 10, 24, 48, 96 and 120 hr post-dose)

ID	Title	Description
OG000	PF-03084014 20 mg BID in Solid Tumor Participants	PF-03084014 20 mg was administered orally twice daily (BID) to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG001	PF-03084014 40 mg BID in Solid Tumor Participants	PF-03084014 40 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG002	PF-03084014 80 mg BID in Solid Tumor Participants	PF-03084014 80 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG003	PF-03084014 100 mg BID in Solid Tumor Participants	PF-03084014 100 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG004	PF-03084014 130 mg BID in Solid Tumor Participants	PF-03084014 130 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG005	PF-03084014 150 mg BID in Solid Tumor Participants	PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG006	PF-03084014 220 mg BID in Solid Tumor Participants	PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG007	PF-03084014 150 mg BID in T-ALL/LBL Participants	PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.

Units	Counts
Participants	OG0002 OG0012 OG0023 OG003

Title

Denominators

Categories

Title	Measurements
	OG00010.7± NAGeometric %CV was not estimable when number of participants analyzed is less than 3, hence data for Geometric %CV was not calculated. OG001126± NAGeometric %CV was not estimable when number of participants analyzed is less than 3, hence data for Geometric %CV was not calculated. OG002

Secondary

Average Serum Concentration (Cavg) at Steady State on Cycle 1 Day 21

Cavg was the average serum concentration at steady state. Cycle 1 Day 21 PK parameter summaries are presented only for participants who were considered to be dose compliant.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

Cycle 1 Day 21 (pre-dose and 0.5, 1, 2, 4, 10, 24, 48, 96 and 120 hr post-dose)

ID	Title	Description
OG000	PF-03084014 20 mg BID in Solid Tumor Participants	PF-03084014 20 mg was administered orally twice daily (BID) to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG001	PF-03084014 40 mg BID in Solid Tumor Participants	PF-03084014 40 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG002	PF-03084014 80 mg BID in Solid Tumor Participants	PF-03084014 80 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG003	PF-03084014 100 mg BID in Solid Tumor Participants	PF-03084014 100 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG004	PF-03084014 130 mg BID in Solid Tumor Participants	PF-03084014 130 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG005	PF-03084014 150 mg BID in Solid Tumor Participants	PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG006	PF-03084014 220 mg BID in Solid Tumor Participants	PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG007	PF-03084014 150 mg BID in T-ALL/LBL Participants	PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.

Units	Counts
Participants	OG0002 OG0012 OG0023 OG003

Title

Denominators

Categories

Title	Measurements
	OG00025.7± NAGeometric %CV was not estimable when number of participants analyzed is less than 3, hence data for Geometric %CV was not calculated. OG001210± NAGeometric %CV was not estimable when number of participants analyzed is less than 3, hence data for Geometric %CV was not calculated. OG002

Secondary

Accumulation Ratio (Rac) on Cycle 1 Day 21

Accumulation was calculated as AUCtau at steady state (Cycle 1 Day 21) divided by AUCtau after a single dose on Cycle 1 Day 1. Cycle 1 Day 21 PK parameter summaries are presented only for participants who were considered to be dose compliant.

Posted

Median

Full Range

ratio

Cycle 1 Day 1 (pre-dose and 0.5, 1, 2, 4, and 10 hr post-dose), Cycle 1 Day 21 (pre-dose and 0.5, 1, 2, 4, 10, 24, 48, 96 and 120 hr post-dose)

ID	Title	Description
OG000	PF-03084014 20 mg BID in Solid Tumor Participants	PF-03084014 20 mg was administered orally twice daily (BID) to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG001	PF-03084014 40 mg BID in Solid Tumor Participants	PF-03084014 40 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG002	PF-03084014 80 mg BID in Solid Tumor Participants	PF-03084014 80 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG003	PF-03084014 100 mg BID in Solid Tumor Participants	PF-03084014 100 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG004	PF-03084014 130 mg BID in Solid Tumor Participants	PF-03084014 130 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG005	PF-03084014 150 mg BID in Solid Tumor Participants	PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG006	PF-03084014 220 mg BID in Solid Tumor Participants	PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG007	PF-03084014 150 mg BID in T-ALL/LBL Participants	PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.

Units	Counts
Participants	OG0002 OG0012 OG0022 OG003

Title

Denominators

Categories

Title	Measurements
	OG0001.18(0.72 to 1.63) OG0011.60(1.45 to 1.74) OG0021.36(0.93 to 1.79) OG003

Secondary

Dose-normalized AUCtau [AUCtau (dn)] After Multiple Dose on Cycle 1 Day 21

AUCtau (dn) was calculated by area under the serum concentration-time profile from time 0 to tau (dosing interval) (AUCtau) divided by administered dose. Cycle 1 Day 21 PK parameter summaries are presented only for participants who were considered to be dose compliant.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng*hr/mL/mg

Cycle 1 Day 21 (pre-dose and 0.5, 1, 2, 4, 10, 24, 48, 96 and 120 hr post-dose)

ID	Title	Description
OG000	PF-03084014 20 mg BID in Solid Tumor Participants	PF-03084014 20 mg was administered orally twice daily (BID) to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG001	PF-03084014 40 mg BID in Solid Tumor Participants	PF-03084014 40 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG002	PF-03084014 80 mg BID in Solid Tumor Participants	PF-03084014 80 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG003	PF-03084014 100 mg BID in Solid Tumor Participants	PF-03084014 100 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG004	PF-03084014 130 mg BID in Solid Tumor Participants	PF-03084014 130 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG005	PF-03084014 150 mg BID in Solid Tumor Participants	PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG006	PF-03084014 220 mg BID in Solid Tumor Participants	PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG007	PF-03084014 150 mg BID in T-ALL/LBL Participants	PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.

Units	Counts
Participants	OG0002 OG0012 OG0023 OG003

Title

Denominators

Categories

Title	Measurements
	OG00015.4± NAGeometric %CV was not estimable when number of participants analyzed is less than 3, hence data for Geometric %CV was not calculated. OG00163.0± NAGeometric %CV was not estimable when number of participants analyzed is less than 3, hence data for Geometric %CV was not calculated. OG002

Secondary

Dose-normalized Cmax [Cmax (dn)] After Multiple Dose on Cycle 1 Day 21

Cmax(dn) was calculated by maximum observed serum concentration (Cmax) divided by administered dose. Cycle 1 Day 21 PK parameter summaries are presented only for participants who were considered to be dose compliant.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL/mg

Cycle 1 Day 21 (pre-dose and 0.5, 1, 2, 4, 10, 24, 48, 96 and 120 hr post-dose)

ID	Title	Description
OG000	PF-03084014 20 mg BID in Solid Tumor Participants	PF-03084014 20 mg was administered orally twice daily (BID) to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG001	PF-03084014 40 mg BID in Solid Tumor Participants	PF-03084014 40 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG002	PF-03084014 80 mg BID in Solid Tumor Participants	PF-03084014 80 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG003	PF-03084014 100 mg BID in Solid Tumor Participants	PF-03084014 100 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG004	PF-03084014 130 mg BID in Solid Tumor Participants	PF-03084014 130 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG005	PF-03084014 150 mg BID in Solid Tumor Participants	PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG006	PF-03084014 220 mg BID in Solid Tumor Participants	PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG007	PF-03084014 150 mg BID in T-ALL/LBL Participants	PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.

Units	Counts
Participants	OG0002 OG0012 OG0023 OG003

Title

Denominators

Categories

Title	Measurements
	OG0003.2± NAGeometric %CV was not estimable when number of participants analyzed is less than 3, hence data for Geometric %CV was not calculated. OG0019.6± NAGeometric %CV was not estimable when number of participants analyzed is less than 3, hence data for Geometric %CV was not calculated. OG002

Secondary

AUCtau in the Fasted State for Solid Tumor Participants

AUCtau was area under the serum concentration-time profile from time 0 to tau (dosing interval).

Solid tumor participants who were enrolled in the food-effect sub-study, were treated and had evaluable PK data under both fed and fasted states.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng*hr/mL

Cycle 1 Day 1 (pre-dose and 0.5, 1, 2, 4, 10 and 24 hr post-dose) or Cycle 2 Day 1 (pre-dose and 0.5, 1, 2, 4, 10 and 24 hr post-dose)

ID	Title	Description
OG000	PF-03084014 150 mg BID in Solid Tumor Participants	PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1=28 days [with a 7-day washout]). On Cycle 1 Day 1 and Cycle 2 Day 1, only the morning dose was administered. Each participant was to serve as their own control in which PF-03084014 was administered in the morning under either "fed" or "fasted" conditions on Day 1 of Cycle 1 and Cycle 2. The testing order for fed versus fasted conditions was as follows: The first 6 participants in this sub-study were tested under fed followed by fasted conditions, the next 6 participants were tested under fasted followed by fed conditions.
OG001	PF-03084014 220 mg BID in Solid Tumor Participants	PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1=28 days [with a 7-day washout]). On Cycle 1 Day 1 and Cycle 2 Day 1, only the morning dose was administered. Each participant was to serve as their own control in which PF-03084014 was administered in the morning under either "fed" or "fasted" conditions on Day 1 of Cycle 1 and Cycle 2. The testing order for fed versus fasted conditions was as follows: The first 6 participants in this sub-study were tested under fed followed by fasted conditions, the next 6 participants were tested under fasted followed by fed conditions.

Units	Counts
Participants	OG0007 OG0014

Title

Denominators

Categories

Title	Measurements
	OG0002547± 101 OG0019353± 100

Secondary

AUCtau in the Fed State for Solid Tumor Participants

AUCtau was area under the serum concentration-time profile from time 0 to tau (dosing interval).

Solid tumor participants who were enrolled in the food-effect sub-study, were treated and had evaluable PK data under both fed and fasted states.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng*hr/mL

Cycle 1 Day 1 (pre-dose and 0.5, 1, 2, 4, 10 and 24 hr post-dose) or Cycle 2 Day 1 (pre-dose and 0.5, 1, 2, 4, 10 and 24 hr post-dose)

ID	Title	Description
OG000	PF-03084014 150 mg BID in Solid Tumor Participants	PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1=28 days [with a 7-day washout]). On Cycle 1 Day 1 and Cycle 2 Day 1, only the morning dose was administered. Each participant was to serve as their own control in which PF-03084014 was administered in the morning under either "fed" or "fasted" conditions on Day 1 of Cycle 1 and Cycle 2. The testing order for fed versus fasted conditions was as follows: The first 6 participants in this sub-study were tested under fed followed by fasted conditions, the next 6 participants were tested under fasted followed by fed conditions.
OG001	PF-03084014 220 mg BID in Solid Tumor Participants	PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1=28 days [with a 7-day washout]). On Cycle 1 Day 1 and Cycle 2 Day 1, only the morning dose was administered. Each participant was to serve as their own control in which PF-03084014 was administered in the morning under either "fed" or "fasted" conditions on Day 1 of Cycle 1 and Cycle 2. The testing order for fed versus fasted conditions was as follows: The first 6 participants in this sub-study were tested under fed followed by fasted conditions, the next 6 participants were tested under fasted followed by fed conditions.

Units	Counts
Participants	OG0007 OG0014

Title

Denominators

Categories

Title	Measurements
	OG0003163± 83 OG0015573± 39

Secondary

Cmax in the Fasted State for Solid Tumor Participants

Cmax was the maximum observed serum concentration.

Solid tumor participants who were enrolled in the food-effect sub-study, were treated and had evaluable PK data under both fed and fasted states.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

Cycle 1 Day 1 (pre-dose and 0.5, 1, 2, 4, 10 and 24 hr post-dose) or Cycle 2 Day 1 (pre-dose and 0.5, 1, 2, 4, 10 and 24 hr post-dose)

ID	Title	Description
OG000	PF-03084014 150 mg BID in Solid Tumor Participants	PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1=28 days [with a 7-day washout]). On Cycle 1 Day 1 and Cycle 2 Day 1, only the morning dose was administered. Each participant was to serve as their own control in which PF-03084014 was administered in the morning under either "fed" or "fasted" conditions on Day 1 of Cycle 1 and Cycle 2. The testing order for fed versus fasted conditions was as follows: The first 6 participants in this sub-study were tested under fed followed by fasted conditions, the next 6 participants were tested under fasted followed by fed conditions.
OG001	PF-03084014 220 mg BID in Solid Tumor Participants	PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1=28 days [with a 7-day washout]). On Cycle 1 Day 1 and Cycle 2 Day 1, only the morning dose was administered. Each participant was to serve as their own control in which PF-03084014 was administered in the morning under either "fed" or "fasted" conditions on Day 1 of Cycle 1 and Cycle 2. The testing order for fed versus fasted conditions was as follows: The first 6 participants in this sub-study were tested under fed followed by fasted conditions, the next 6 participants were tested under fasted followed by fed conditions.

Units	Counts
Participants	OG0009 OG0014

Title

Denominators

Categories

Title	Measurements
	OG000795.1± 104 OG0012334± 93

Secondary

Cmax in the Fed State for Solid Tumor Participants

Cmax was the maximum observed serum concentration.

Solid tumor participants who were enrolled in the food-effect sub-study, were treated and had evaluable PK data under both fed and fasted states.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

Cycle 1 Day 1 (pre-dose and 0.5, 1, 2, 4, 10 and 24 hr post-dose) or Cycle 2 Day 1 (pre-dose and 0.5, 1, 2, 4, 10 and 24 hr post-dose)

ID	Title	Description
OG000	PF-03084014 150 mg BID in Solid Tumor Participants	PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1=28 days [with a 7-day washout]). On Cycle 1 Day 1 and Cycle 2 Day 1, only the morning dose was administered. Each participant was to serve as their own control in which PF-03084014 was administered in the morning under either "fed" or "fasted" conditions on Day 1 of Cycle 1 and Cycle 2. The testing order for fed versus fasted conditions was as follows: The first 6 participants in this sub-study were tested under fed followed by fasted conditions, the next 6 participants were tested under fasted followed by fed conditions.
OG001	PF-03084014 220 mg BID in Solid Tumor Participants	PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1=28 days [with a 7-day washout]). On Cycle 1 Day 1 and Cycle 2 Day 1, only the morning dose was administered. Each participant was to serve as their own control in which PF-03084014 was administered in the morning under either "fed" or "fasted" conditions on Day 1 of Cycle 1 and Cycle 2. The testing order for fed versus fasted conditions was as follows: The first 6 participants in this sub-study were tested under fed followed by fasted conditions, the next 6 participants were tested under fasted followed by fed conditions.

Units	Counts
Participants	OG0009 OG0014

Title

Denominators

Categories

Title	Measurements
	OG000862.3± 74 OG001924.4± 40

Secondary

Dose-normalized AUCtau [AUCtau(dn)] in the Fasted State for Solid Tumor Participants

AUCtau(dn) was calculated by area under the serum concentration-time profile from time 0 to tau (dosing interval) (AUCtau) divided by administered dose.

Solid tumor participants who were enrolled in the food-effect sub-study, were treated and had evaluable PK data under both fed and fasted states. Due to the limited number of evaluable participants (7 at 150 mg BID and 4 at 220 mg BID for Cmax) and a generally dose-proportional exposure (AUCtau and Cmax), data were combined for the 2 dose levels.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng*hr/mL/mg

Cycle 1 Day 1 (pre-dose and 0.5, 1, 2, 4, 10 and 24 hr post-dose) or Cycle 2 Day 1 (pre-dose and 0.5, 1, 2, 4, 10 and 24 hr post-dose)

ID	Title	Description
OG000	PF-03084014 in Solid Tumor Participants	PF-03084014 150 mg or 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1=28 days [with a 7-day washout]). On Cycle 1 Day 1 and Cycle 2 Day 1, only the morning dose was administered. Each participant was to serve as their own control in which PF-03084014 was administered in the morning under either "fed" or "fasted" conditions on Day 1 of Cycle 1 and Cycle 2. The testing order for fed versus fasted conditions was as follows: The first 6 participants in this sub-study were tested under fed followed by fasted conditions, the next 6 participants were tested under fasted followed by fed conditions.

Units	Counts
Participants	OG00011

Title

Denominators

Categories

Title	Measurements
	OG00023.71± 115

Secondary

Dose-normalized AUCtau [AUCtau(dn)] in the Fed State for Solid Tumor Participants

AUCtau(dn) was calculated by area under the serum concentration-time profile from time 0 to tau (dosing interval) (AUCtau) divided by administered dose.

Solid tumor participants who were enrolled in the food-effect sub-study, started treatment and had evaluable PK data under both fed and fasted states. Due to the limited number of evaluable participants (7 at 150 mg BID and 4 at 220 mg BID for Cmax) and a generally dose-proportional exposure (AUCtau and Cmax), data were combined for 2 dose levels.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng*hr/mL/mg

Cycle 1 Day 1 (pre-dose and 0.5, 1, 2, 4, 10 and 24 hr post-dose) or Cycle 2 Day 1 (pre-dose and 0.5, 1, 2, 4, 10 and 24 hr post-dose)

ID	Title	Description
OG000	PF-03084014 in Solid Tumor Participants	PF-03084014 150 mg or 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1=28 days [with a 7-day washout]). On Cycle 1 Day 1 and Cycle 2 Day 1, only the morning dose was administered. Each participant was to serve as their own control in which PF-03084014 was administered in the morning under either "fed" or "fasted" conditions on Day 1 of Cycle 1 and Cycle 2. The testing order for fed versus fasted conditions was as follows: The first 6 participants in this sub-study were tested under fed followed by fasted conditions, the next 6 participants were tested under fasted followed by fed conditions.

Units	Counts
Participants	OG00011

Title

Denominators

Categories

Title	Measurements
	OG00022.54± 67

Secondary

Dose-normalized Cmax [Cmax(dn)] in the Fasted State for Solid Tumor Participants

Cmax(dn) was calculated by maximum observed serum concentration (Cmax) divided by administered dose.

Participants who were enrolled in the food-effect sub-study, started treatment and had evaluable PK data under both fed and fasted states. Due to the limited number of evaluable participants (9 at 150 mg BID and 4 at 220 mg BID for Cmax) and a generally dose-proportional exposure (AUCtau and Cmax), data were combined for the 2 dose levels.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL/mg

Cycle 1 Day 1 (pre-dose and 0.5, 1, 2, 4, 10 and 24 hr post-dose) or Cycle 2 Day 1 (pre-dose and 0.5, 1, 2, 4, 10 and 24 hr post-dose)

ID	Title	Description
OG000	PF-03084014 in Solid Tumor Participants	PF-03084014 150 mg or 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1=28 days [with a 7-day washout]). On Cycle 1 Day 1 and Cycle 2 Day 1, only the morning dose was administered. Each participant was to serve as their own control in which PF-03084014 was administered in the morning under either "fed" or "fasted" conditions on Day 1 of Cycle 1 and Cycle 2. The testing order for fed versus fasted conditions was as follows: The first 6 participants in this sub-study were tested under fed followed by fasted conditions, the next 6 participants were tested under fasted followed by fed conditions.

Units	Counts
Participants	OG00013

Title

Denominators

Categories

Title	Measurements
	OG0006.56± 106

Secondary

Dose-Normalized Cmax [Cmax(dn)] in the Fed State for Solid Tumor Participants

Cmax(dn) was calculated by maximum observed serum concentration (Cmax) divided by administered dose.

Solid tumor participants who were enrolled in the food-effect sub-study, were treated and had evaluable PK data under both fed and fasted states. Due to the limited number of evaluable participants (9 at 150 mg BID and 4 at 220 mg BID for Cmax) and a generally dose-proportional exposure (AUCtau and Cmax), data were combined for the 2 dose levels.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL/mg

Cycle 1 Day 1 (pre-dose and 0.5, 1, 2, 4, 10 and 24 hr post-dose) or Cycle 2 Day 1 (pre-dose and 0.5, 1, 2, 4, 10 and 24 hr post-dose).

ID	Title	Description
OG000	PF-03084014 in Solid Tumor Participants	PF-03084014 150 mg or 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1=28 days [with a 7-day washout]). On Cycle 1 Day 1 and Cycle 2 Day 1, only the morning dose was administered. Each participant was to serve as their own control in which PF-03084014 was administered in the morning under either "fed" or "fasted" conditions on Day 1 of Cycle 1 and Cycle 2. The testing order for fed versus fasted conditions was as follows: The first 6 participants in this sub-study were tested under fed followed by fasted conditions, the next 6 participants were tested under fasted followed by fed conditions.

Units	Counts
Participants	OG00013

Title

Denominators

Categories

Title	Measurements
	OG0005.22± 64

Secondary

AUCtau on Cycle 2 Day 1

AUCtau was area under the serum concentration-time profile from time 0 to tau (dosing interval). Data for this outcome measure was planned to be analyzed for two arms only.

All treated participants who had at least 1 of the PK parameters of interest. N=number of participants evaluable for this OM.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng*hr/mL

Cycle 2 Day 1 (pre-dose and 0.5, 1, 2, 4, 10 and 24 hr post-dose)

ID	Title	Description
OG000	PF-03084014 150 mg BID in Solid Tumor Participants	PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG001	PF-03084014 220 mg BID in Solid Tumor Participants	PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.

Units	Counts
Participants	OG0008 OG0014

Title

Denominators

Categories

Title	Measurements
	OG0002784± 80 OG00111870± 57

Secondary

Dose-normalized AUCtau [AUCtau (dn)] on Cycle 2 Day 1

AUCtau(dn) was calculated by area under the serum concentration-time profile from time 0 to tau (dosing interval) (AUCtau) divided by administered dose. Data for this outcome measure was planned to be analyzed for two arms only.

All treated participants who had at least 1 of the PK parameters of interest. N=number of participants evaluable for this OM.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng*hr/mL/mg

Cycle 2 Day 1 (pre-dose and 0.5, 1, 2, 4, 10 and 24 hr post-dose)

ID	Title	Description
OG000	PF-03084014 150 mg BID in Solid Tumor Participants	PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG001	PF-03084014 220 mg BID in Solid Tumor Participants	PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.

Units	Counts
Participants	OG0008 OG0014

Title

Denominators

Categories

Title	Measurements
	OG00018.6± 80 OG00154.0± 57

Secondary

Cmax on Cycle 2 Day 1

Cmax was the maximum observed serum concentration. Data for this outcome measure was planned to be analyzed for two arms only.

All treated participants who had at least 1 of the PK parameters of interest. N=number of participants evaluable for this OM.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

Cycle 2 Day 1 (pre-dose and 0.5, 1, 2, 4, 10 and 24 hr post-dose)

ID	Title	Description
OG000	PF-03084014 150 mg BID in Solid Tumor Participants	PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG001	PF-03084014 220 mg BID in Solid Tumor Participants	PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.

Units	Counts
Participants	OG0009 OG0014

Title

Denominators

Categories

Title	Measurements
	OG000834.6± 76 OG0012640± 63

Secondary

Dose-normalized Cmax [Cmax (dn)] on Cycle 2 Day 1

Cmax(dn) was calculated by maximum observed serum concentration (Cmax) divided by administered dose. Data for this outcome measure was planned to be analyzed for two arms only.

All treated participants who had at least 1 of the PK parameters of interest. N=number of participants evaluable for this OM.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL/mg

Cycle 2 Day 1 (pre-dose and 0.5, 1, 2, 4, 10 and 24 hr post-dose)

ID	Title	Description
OG000	PF-03084014 150 mg BID in Solid Tumor Participants	PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG001	PF-03084014 220 mg BID in Solid Tumor Participants	PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.

Units	Counts
Participants	OG0009 OG0014

Title

Denominators

Categories

Title	Measurements
	OG0005.6± 76 OG00112.0± 63

Secondary

Tmax on Cycle 2 Day 1

Tmax was the time to reach maximum serum concentration (Cmax). Data for this outcome measure was planned to be analyzed for two arms only.

All treated participants who had at least 1 of the PK parameters of interest. N=number of participants evaluable for this OM.

Posted

Median

Full Range

Cycle 2 Day 1 (pre-dose and 0.5, 1, 2, 4, 10 and 24 hr post-dose)

ID	Title	Description
OG000	PF-03084014 150 mg BID in Solid Tumor Participants	PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG001	PF-03084014 220 mg BID in Solid Tumor Participants	PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.

Units	Counts
Participants	OG0009 OG0014

Title

Denominators

Categories

Title	Measurements
	OG0002.00(1.00 to 4.03) OG0011.53(0.98 to 4.00)

Secondary

Percentage of Solid Tumor Participants With Objective Response (OR)

Objective response (OR) was defined as confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as >=30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study >=4 weeks after initial documentation of response.

All solid tumor participants who received study treatment, had baseline assessments and at least 1 on study tumor assessment prior to any new anti-cancer therapies were considered evaluable for response.

Posted

Number

95% Confidence Interval

percentage of participants

Baseline, Cycle 2 Day 1, Cycle 3 Day 1 and then Day 1 (plus [+] or minus [-] 5 days) of every odd cycle or as clinically indicated, up to Cycle 9; afterwards assessed on Day 1 (+ or -5 days) every 4 cycles

ID	Title	Description
OG000	PF-03084014 20 mg BID in Solid Tumor Participants	PF-03084014 20 mg was administered orally twice daily (BID) to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG001	PF-03084014 40 mg BID in Solid Tumor Participants	PF-03084014 40 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG002	PF-03084014 80 mg BID in Solid Tumor Participants	PF-03084014 80 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG003	PF-03084014 100 mg BID in Solid Tumor Participants	PF-03084014 100 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG004	PF-03084014 130 mg BID in Solid Tumor Participants	PF-03084014 130 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG005	PF-03084014 150 mg BID in Solid Tumor Participants	PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG006	PF-03084014 220 mg BID in Solid Tumor Participants	PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG007	PF-03084014 330 mg BID in Solid Tumor Participants	PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.

Units	Counts
Participants	OG0003 OG0013 OG0023 OG003

Title

Denominators

Categories

Title	Measurements
	OG00033.3(0.8 to 90.6) OG0010(0.0 to 70.8) OG00266.7(9.4 to 99.2) OG003

Secondary

Time to Tumor Progression (TTP) for Solid Tumor Participants

Time from Cycle 1 Day 1 to first documentation of disease progression. Progression was defined as per RECIST version 1.0, as a 20% increase in the sum of the longest diameter of target lesions, or target lesions over nadir, uneuivocal progression of non-target disease, or the appearance of new lesions. TTP (months) was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.

All solid tumor participants who received at least 1 dose of study medication.

Posted

Median

95% Confidence Interval

months

Baseline until first documented objective progression (up to maximum of 84 months)

ID	Title	Description
OG000	PF-03084014 20 mg BID in Solid Tumor Participants	PF-03084014 20 mg was administered orally twice daily (BID) to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG001	PF-03084014 40 mg BID in Solid Tumor Participants	PF-03084014 40 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG002	PF-03084014 80 mg BID in Solid Tumor Participants	PF-03084014 80 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG003	PF-03084014 100 mg BID in Solid Tumor Participants	PF-03084014 100 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG004	PF-03084014 130 mg BID in Solid Tumor Participants	PF-03084014 130 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG005	PF-03084014 150 mg BID in Solid Tumor Participants	PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG006	PF-03084014 220 mg BID in Solid Tumor Participants	PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG007	PF-03084014 330 mg BID in Solid Tumor Participants	PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.

Units	Counts
Participants	OG0003 OG0013 OG0024 OG003

Title

Denominators

Categories

Title	Measurements
	OG000NA(0.8 to NA)Data was not estimable due to insufficient number of participants with events. OG0011.2(1.0 to 2.8) OG002NA(1.7 to NA)

Secondary

Duration of Response (DR) for Solid Tumor Participants

Time from the first documentation of OR to objective disease progression or death due to any cause. DR was only calculated for participants with an OR. DR (months) was calculated as (date of first documentation of objective progression or death minus date of first documentation of PR or CR plus 1) divided by 30.

Only solid tumor participants with an OR were analyzed; however, all these participants were censored as of the time of data cut-off on 09 January 2013. Of these 6 participants, 4 participants were still on study with 1 participant discontinued for non-compliance and the other 1 participant missing tumor assessment.

Posted

Median

95% Confidence Interval

months

Baseline, Cycle 2 Day 1, Cycle 3 Day 1 and then Day 1 (+ or -5 days) of every odd cycle or as clinically indicated, up to Cycle 9. Afterwards, assessed on Day 1 (+ or -5 days) every 4 cycles (up to maximum of 84 months)

ID	Title	Description
OG000	PF-03084014 20 mg BID in Solid Tumor Participants	PF-03084014 20 mg was administered orally twice daily (BID) to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG001	PF-03084014 80 mg BID in Solid Tumor Participants	PF-03084014 80 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG002	PF-03084014 150 mg BID in Solid Tumor Participants	PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG003	PF-03084014 220 mg BID in Solid Tumor Participants	PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG004	PF-03084014 330 mg BID in Solid Tumor Participants	PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.

Units	Counts
Participants	OG0001 OG0012 OG0021 OG003

Title

Denominators

Categories

Title	Measurements
	OG000NA(NA to NA)Data was not estimable due to insufficient number of participants with events. OG001NA(NA to NA)Data was not estimable due to insufficient number of participants with events. OG002

Secondary

Progression-Free Survival (PFS) for Solid Tumor Participants

PFS was defined as the time from Cycle 1 Day 1 to date of first documentation of progression or death due to any cause. Progression was defined as per RECIST version 1.0, as a 20% increase in the sum of the longest diameter of target lesions, or target lesions over nadir, unequivocal progression of non-target disease, or the appearance of new lesions. PFS (months) was calculated as (the first event date minus the date of first dose of study medication plus 1) divided by 30.

All solid tumor participants who received at least 1 dose of study medication.

Posted

Median

95% Confidence Interval

months

Baseline, Cycle 2 Day 1, Cycle 3 Day 1 and then Day 1 (+ or - 5 days) of every odd cycle or as clinically indicated, up to Cycle 9; afterwards assessed on Day 1 (+ or -5 days) every 4 cycles (up to maximum of 84 months)

ID	Title	Description
OG000	PF-03084014 20 mg BID in Solid Tumor Participants	PF-03084014 20 mg was administered orally twice daily (BID) to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG001	PF-03084014 40 mg BID in Solid Tumor Participants	PF-03084014 40 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG002	PF-03084014 80 mg BID in Solid Tumor Participants	PF-03084014 80 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG003	PF-03084014 100 mg BID in Solid Tumor Participants	PF-03084014 100 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG004	PF-03084014 130 mg BID in Solid Tumor Participants	PF-03084014 130 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG005	PF-03084014 150 mg BID in Solid Tumor Participants	PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG006	PF-03084014 220 mg BID in Solid Tumor Participants	PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG007	PF-03084014 330 mg BID in Solid Tumor Participants	PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.

Units	Counts
Participants	OG0003 OG0013 OG0024 OG003

Title

Denominators

Categories

Title	Measurements
	OG000NA(0.8 to NA)Unable to calculate as 2 participants were censored and only 1 participant was evaluable. OG0011.2(1.0 to 2.8) OG002NA(1.7 to NA)

Secondary

Percentage of T-ALL/LBL Participants With OR

OR was adapted from International Working Group Response Criteria for Acute Myeloid Leukemia (AML). The response categories of interest were CR, complete response with incomplete hematopoietic recovery (CRi), and PR. CR: ANC >1500/microliter (uL), no circulating blasts. Platelets >100,000/uL, <5% marrow blast cells, no extramedullary disease, bone marrow cellularity >20% with tri-lineage hematopoiesis and <5% marrow blast cells, none of which were neoplastic; CRi: same as CR but ANC may be >1500/uL or platelet count >100,000/uL, no requirement on bone marrow cellularity; PR: same as CR but bone marrow with >= 50% reduction of leukemia blast cells and an absolute blast count between 5% and 25%.

All T-ALL/LBL participants who received at least 1 dose of study medication.

Posted

Number

95% Confidence Interval

percentage of participants

Baseline, Cycle 2 Day 1, Cycle 3 Day 1 and then Day 1 (+ or - 5 days) of every odd cycle or as clinically indicated, up to Cycle 9 (up to maximum of 84 months)

ID	Title	Description
OG000	PF-03084014 150 mg BID in T-ALL/LBL Participants	PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.

Units	Counts
Participants	OG0008

Title

Denominators

Categories

Title	Measurements
	OG00012.5(0.3 to 52.7)

Secondary

Relapse Free Survival (RFS) for T-ALL/LBL Participants

The RFS of CR was defined as the time from the date of first attaining CR to the date of relapse or death from any cause, whichever occurred first. Similarly, the RFS of CR + CRi (or RFS of CR + CRi + PR) was defined as the time from the date of first attaining CR + CRi (or CR + CRi + PR) to the date of relapse or death from any cause, whichever occurred first.

Due to halting of T-AA/LBL participants enrollment and limited number of evaluable participants, data for RFS was not collected.

Posted

Baseline, Cycle 2 Day 1, Cycle 3 Day 1 and then Day 1 (+ or - 5 days) of every odd cycle or as clinically indicated, up to Cycle 9 (up to maximum of 84 months)

ID	Title	Description
OG000	PF-03084014 150 mg BID in T-ALL/LBL Participants	PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.

Units	Counts
Participants	OG0000

Secondary

Peripheral Blast Count Reduction (PBR) for T-ALL/LBL Participants

PBR was the maximum percentage of peripheral blast count reduction for each participant who received at least one dose of study medication. PBR was derived by the Sponsor from percentage of peripheral blood Blast Count reported by sites.

Due to halting of T-AA/LBL participants enrollment and limited number of evaluable participants, data for PBR was not collected.

Posted

Baseline, Cycle 2 Day 1, Cycle 3 Day 1 and then Day 1 (+ or - 5 days) of every odd cycle or as clinically indicated, up to Cycle 9 (up to maximum of 84 months)

ID	Title	Description
OG000	PF-03084014 150 mg BID in T-ALL/LBL Participants	PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.

Units	Counts
Participants	OG0000

Secondary

Changes in Expression Levels of Notch 1 Target Genes in Tumor Biopsies for Solid Tumor Participants: Hairy and Enhancer of Split-4 (Hes4) Gene Expression Levels on Cycle 1 Day 21 Relative to That at Baseline

Gene expression analysis in tumor biopsies was done using cDNA prepared from RNA extracted from tumor biopsies. Gene expression was measured by custom Taqman low density array (TLDA) cards run on Applied Biosystems 7900HT Fast Real-Time polymerase chain reaction (PCR) system. Changes from baseline were calculated as ratios to baseline. Only Hes4 gene showed consistent down modulation across dosing cohorts (150 mg and 220 mg BID) and therefore results were reported for Hes4 only. Data for this outcome measure was planned to be analyzed for two arms only.

Pharmacodynamic Biomarker analysis set was defined separately for T-ALL and advanced solid tumor malignancy participants. In both cases it will comprise all participants enrolled in study having at least one biomarker assessment at baseline and at least one assessment after being treated. Here, "N" signifies participants evaluable for this OM.

Posted

Mean

Standard Deviation

ratio

Baseline, Cycle 1 Day 21 (-5 days)

ID	Title	Description
OG000	PF-03084014 150 mg BID in Solid Tumor Participants	PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG001	PF-03084014 220 mg BID in Solid Tumor Participants	PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.

Units	Counts
Participants	OG0003 OG0012

Title

Denominators

Categories

Title	Measurements
	OG0000.9± 0.57 OG0010.5± 0.50

Secondary

Changes From Baseline in Expression Levels of Notch 1 Target Genes in Peripheral Blood for T-ALL/LBL Participants: Hes4 Gene Expression Levels on Cycle 1 Day 8, Cycle 1 Day 15, Cycle 1 Day 21 Relative to That at Baseline

Ribonucleic acid (RNA) was extracted from peripheral blood and used as a template to synthesize complementary deoxyribonucleic acid (cDNA). Gene expression in cDNA was measured by custom Taqman low density array (TLDA) cards run on Applied Biosystems 7900HT Fast Real-Time polymerase chain reaction (PCR) system. Changes from baseline were calculated as ratios to baseline. Results were reported Only for Hes4 as this was the only gene to show consistent down modulation across dosing cohorts (150 mg and 220 mg).

Pharmacodynamic biomarker analysis set. In both cases, it will comprise all participants enrolled in study having at least 1 biomarker assessment at baseline and at least 1 assessment after being treated. Here, "N"=participants evaluable for this OM. This OM was planned to be analyze for T-ALL/LBL arm only.

Posted

Mean

Standard Deviation

ratio

Baseline (morning), Cycle 1 Days 8, 15 and 21 (morning, matched with the first PK sample of the particular day), Cycle 1 Day 21 (24, 48, and 120 hr post-dose) and at end of treatment (EOT)

ID	Title	Description
OG000	PF-03084014 150 mg BID in T-ALL/LBL Participants	PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.

Units	Counts
Participants	OG0008

Title

Denominators

Categories

Cycle 1 Day 8

- ParticipantsOG0007

Title	Measurements
	OG0000.7± 0.65

Cycle 1 Day 15

- ParticipantsOG000

Secondary

Changes in Expression Levels of Notch 1 Target Genes in Peripheral Blood for Solid Tumor Participants: Hes4 Gene Expression Level on Cycle 1 Day 8 and Cycle 1 Day 21 Relative to That at Baseline

Posted

Mean

Standard Deviation

ratio

Baseline (morning), Cycle 1 Days 8 and 21 (pre-dose)

ID	Title	Description
OG000	PF-03084014 150 mg BID in Solid Tumor Participants	PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG001	PF-03084014 220 mg BID in Solid Tumor Participants	PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.

Units	Counts
Participants	OG00011 OG0017

Title

Denominators

Categories

Cycle 1 Day 8

- ParticipantsOG00011
- ParticipantsOG0017

Title	Measurements
	OG0000.3± 0.24

Secondary

Changes From Baseline in Notch Intracellular Domain (NICD) Levels in Peripheral Blood for T-ALL/LBL Participants

Notch intracellular domain (NICD) levels was measured in peripheral blood mononuclear cell (PBMC) pellets using a validated enzyme-linked immunosorbent assay (ELISA).

No data were reported for the results of NICD measurement in T-ALL/LBL participants because NICD levels fell below the limit of quantitation of the assay in most cases.

Posted

Baseline, Cycle 1 Days 8 and 15 (pre-dose AM), Cycle 1 Day 21 (pre-dose AM and 24, 48 and 120 hr post-dose) and end of treatment (EOT).

ID	Title	Description
OG000	PF-03084014 150 mg BID in T-ALL/LBL Participants	PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.

Units	Counts
Participants	OG0000

Secondary

Changes From Baseline in Notch Intracellular Domain (NICD) Levels in Bone Marrow for T-ALL/LBL Participants

Notch intracellular domain (NICD) was to be measured in bone marrow monoculear cell (BMMC) cell pellets using a validated ELISA.

NICD analyses in bone marrow samples were not done because the number of bone marrow samples received was insufficient and because the analyses were not mandatory per protocol.

Posted

Baseline, Cycle 1 Day 1 and Cycle 2 Day 1

ID	Title	Description
OG000	PF-03084014 150 mg BID in T-ALL/LBL Participants	PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.

Units	Counts
Participants	OG0000

Post-Hoc

Time to Response (TTR) for Solid Tumor Participants

Time to response (TTR) was only defined for participants with an objective response (OR). TTR (months) was calculated as (date of first documentation of PR or CR minus date of first dose of study medication plus 1) divided by 30.

Only solid tumor participants with an OR were analyzed.

Posted

Median

95% Confidence Interval

months

Baseline, Cycle 2 Day 1, Cycle 3 Day 1 and then Day 1 (+ or -5 days) of every odd cycle or as clinically indicated, up to Cycle 9. Afterwards, assessed on Day 1 (+ or -5 days) every 4 cycles.

ID	Title	Description
OG000	PF-03084014 20 mg BID in Solid Tumor Participants	PF-03084014 20 mg was administered orally twice daily (BID) to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG001	PF-03084014 80 mg BID in Solid Tumor Participants	PF-03084014 80 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG002	PF-03084014 150 mg BID in Solid Tumor Participants	PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG003	PF-03084014 220 mg BID in Solid Tumor Participants	PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
OG004	PF-03084014 330 mg BID in Solid Tumor Participants	PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.

Units	Counts
Participants	OG0001 OG0012 OG0021 OG003

Title

Denominators

Categories

Title	Measurements
	OG00011.2(NA to NA)Data for upper and lower limit of 95% CI were not estimable since only 1 participant was analyzed. OG00119.4(8.5 to 30.4) OG0022.9