A Study Evaluating The PF-03084014 In Combination With Do... | NCT01876251

ID	Type	Description	Link
2013-000659-41	EudraCT Number

Label	Type	Description	Intervention Names
PF-03084014 plus docetaxel	Experimental	PF 03084014 will be administered orally, continuously, twice daily at doses from 80 to 150 mg in combination with docetaxel given every 3 weeks at doses from 75 to 100 mg/m^2	Drug: PF-03084014 Drug: Docetaxel

Name	Type	Description	Arm Group Labels	Other Names
PF-03084014	Drug	Tablet, 10 mg, twice a day	PF-03084014 plus docetaxel

Measure	Description	Time Frame
Number of Participants With Dose-limiting Toxicities (DLTs) in Cycle 1	Any DLT event in Cycle 1: Grade 4 neutropenia lasting more than (>)7 days; febrile neutropenia (Grade more than or equal to [>=] 3 and body temperature >=38.5 degrees Celsius); Grade >=3 neutropenic infection; Grade >=3 thrombocytopenia with bleeding; Grade 4 thrombocytopenia without bleeding; Grade >=3 toxicities (except those that had not been maximally treated); Grade 3 prolongation of time from electrocardiogram (ECG) Q wave to the end of the T wave corresponding to electrical systole (QT) corrected for heart rate (QTc) which persisted after correction of reversible causes; delay of 2 weeks in receiving next scheduled cycle due to persisting treatment-related toxicities; and failure to deliver at least 80% of planned dose during first cycle due to treatment-related toxicities.	Cycle 1 Days 1-21
Progression-free Survival (PFS) at 6 Months - Expansion Cohort	The period from study entry until disease progression, death or date of last contact. Assessment of response was made using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.	Baseline till 6 months post-dose

Measure	Description	Time Frame
Number of Participants With All Causality and Treatment-related Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs	An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent AEs (TEAEs) are defined as newly occurring AEs or those worsening after first dose. AEs comprised both SAEs and non-SAEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Causality assessment was made by the investigator. Grading was per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) version 3.0: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life-threatening, Grade 5=death related to AE.

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

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35233	United States
University of Alabama at Birmingham, IDS Pharmacy

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

ID	Title	Description
FG000	PF-03084014 100 mg BID + Docetaxel 75 mg/m^2	PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m^2) intravenously.
FG001	PF-03084014 100 mg BID + Docetaxel 100 mg/m^2

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Dose-limiting Toxicities (DLTs) in Cycle 1

Any DLT event in Cycle 1: Grade 4 neutropenia lasting more than (>)7 days; febrile neutropenia (Grade more than or equal to [>=] 3 and body temperature >=38.5 degrees Celsius); Grade >=3 neutropenic infection; Grade >=3 thrombocytopenia with bleeding; Grade 4 thrombocytopenia without bleeding; Grade >=3 toxicities (except those that had not been maximally treated); Grade 3 prolongation of time from electrocardiogram (ECG) Q wave to the end of the T wave corresponding to electrical systole (QT) corrected for heart rate (QTc) which persisted after correction of reversible causes; delay of 2 weeks in receiving next scheduled cycle due to persisting treatment-related toxicities; and failure to deliver at least 80% of planned dose during first cycle due to treatment-related toxicities.

All enrolled participants who were eligible, received study treatment, and who either experienced DLT during the first cycle, or completed the 1-cycle observation period.

Posted

Number

participants

Cycle 1 Days 1-21

ID	Title	Description
OG000	PF-03084014 100 mg BID + Docetaxel 75 mg/m^2	PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m^2) intravenously.
OG001	PF-03084014 100 mg BID + Docetaxel 100 mg/m^2	PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 100 mg/square meters (m^2) intravenously.
OG002	PF-03084014 150 mg BID + Docetaxel 75 mg/m^2	PF-03084014 150 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m^2) intravenously.

Units	Counts
Participants	OG0008 OG0013 OG00211

Title

Denominators

Categories

Title	Measurements
	OG0001 OG0011 OG0024

Primary

Progression-free Survival (PFS) at 6 Months - Expansion Cohort

The period from study entry until disease progression, death or date of last contact. Assessment of response was made using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

The 6-month PFS was evaluated only for the participants in the expansion cohort (PF-03084014 100 mg BID + docetaxel 75 mg/m^2). Due to early study termination, only 7 participants were treated in the expansion cohort.

Posted

Median

95% Confidence Interval

months

Baseline till 6 months post-dose

ID	Title	Description
OG000	PF-03084014 100 mg BID + Docetaxel 75 mg/m^2	PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m^2) intravenously.

Units	Counts
Participants	OG000

Secondary

Number of Participants With All Causality and Treatment-related Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs

An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent AEs (TEAEs) are defined as newly occurring AEs or those worsening after first dose. AEs comprised both SAEs and non-SAEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Causality assessment was made by the investigator. Grading was per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) version 3.0: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life-threatening, Grade 5=death related to AE.

All 29 participants who received study treatment were included in the AE summarization/analysis.

Posted

Number

participants

Baseline up to 28-35 days after treatment discontinuation (up to Day 280)

ID	Title	Description
OG000	PF-03084014 100 mg BID + Docetaxel 75 mg/m^2	PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m^2) intravenously.
OG001	PF-03084014 100 mg BID + Docetaxel 100 mg/m^2

Secondary

Number of Participants With Laboratory Abnormalities

Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters included hematology, coagulation, liver function, renal function, electrolytes, clinical chemistry, and urinalysis (dipstick).

All 29 participants who received study treatment were included in the safety analyses.

Posted

Number

participants

Baseline up to 28-35 days after treatment discontinuation (up to Day 280)

ID	Title	Description
OG000	PF-03084014 100 mg BID + Docetaxel 75 mg/m^2	PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m^2) intravenously.
OG001	PF-03084014 100 mg BID + Docetaxel 100 mg/m^2	PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 100 mg/square meters (m^2) intravenously.
OG002	PF-03084014 150 mg BID + Docetaxel 75 mg/m^2	PF-03084014 150 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m^2) intravenously.

Secondary

Percentage of Participants With Objective Response (OR)

OR was based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 millimeters [mm]). No new lesions. PR was defined as more than or equal to (>=) 30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.

All 29 participants who received study treatment were included in this analysis.

Posted

Number

95% Confidence Interval

percentage of participants

Baseline, every 6 weeks from Cycle 2 onwards up to 26 months

ID	Title	Description
OG000	PF-03084014 100 mg BID + Docetaxel 75 mg/m^2	PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m^2) intravenously.
OG001	PF-03084014 100 mg BID + Docetaxel 100 mg/m^2	PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 100 mg/square meters (m^2) intravenously.

Secondary

Area Under the Concentration-time Curve (AUC) From Time 0 to Time of Last Measured Concentration (AUClast) of PF-03084014 in Dose-finding Cohort

Serum PF-03084014 pharmacokinetic (PK) parameters were calculated following twice daily (BID) doses of PF-03084014 given alone (Cycle 1 Day 21) and in combination with docetaxel (Cycle 1 Day 2 and Cycle 2 Day 1).

All 22 participants treated in the dose escalation stage were included in the analysis. n=number of evaluable participants at the specified time point.

Posted

Geometric Mean

Geometric Coefficient of Variation

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

Cycle (C) 1 Days (D) 1, 2, 8, and 21; Day 1 of subsequent cycles and at EOT (max reached: Cycle 12)

ID	Title	Description
OG000	PF-03084014 100 mg BID + Docetaxel 75 mg/m^2	PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m^2) intravenously.
OG001	PF-03084014 100 mg BID + Docetaxel 100 mg/m^2	PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 100 mg/square meters (m^2) intravenously.
OG002	PF-03084014 150 mg BID + Docetaxel 75 mg/m^2

Secondary

AUClast and AUC From Time 0 Extrapolated to Infinite Time (AUCinf) of Docetaxel in Dose-finding Cohort

Plasma docetaxel PK parameters were calculated following a 1-hr infusion of docetaxel given alone (Cycle 1 Day 1) and in combination with BID dosing of PF-03084014 (Cycle 2 Day 1)

All 22 participants treated in the dose escalation stage were included in the analysis. n=number of evaluable participants at the specified time point.

Posted

Geometric Mean

Geometric Coefficient of Variation

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

C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12)

ID	Title	Description
OG000	PF-03084014 100 mg BID + Docetaxel 75 mg/m^2	PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m^2) intravenously.
OG001	PF-03084014 100 mg BID + Docetaxel 100 mg/m^2	PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 100 mg/square meters (m^2) intravenously.
OG002	PF-03084014 150 mg BID + Docetaxel 75 mg/m^2

Secondary

Maximum Serum or Plasma Concentration (Cmax) and Predose Concentration (Ctrough) of PF-03084014 in Dose-finding Cohort

Serum PF-03084014 PK parameters were calculated following BID doses of PF-03084014 given alone (Cycle 1 Day 21) and in combination with docetaxel (Cycle 1 Day 2 and Cycle 2 Day 1)

All 22 participants treated in the dose escalation stage were included in the analysis. n=number of evaluable participants at the specified time point.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12)

ID	Title	Description
OG000	PF-03084014 100 mg BID + Docetaxel 75 mg/m^2	PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m^2) intravenously.
OG001	PF-03084014 100 mg BID + Docetaxel 100 mg/m^2	PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 100 mg/square meters (m^2) intravenously.
OG002	PF-03084014 150 mg BID + Docetaxel 75 mg/m^2	PF-03084014 150 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m^2) intravenously.

Secondary

Cmax of Docetaxel in Dose-finding Cohort

Plasma docetaxel PK parameters were calculated following a 1-hr infusion of docetaxel given alone (Cycle 1 Day 1) and in combination with BID dosing of PF-03084014 (Cycle 2 Day 1)

All 22 participants treated in the dose escalation stage were included in the analysis. n=number of evaluable participants at the specified time point.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12)

ID	Title	Description
OG000	PF-03084014 100 mg BID + Docetaxel 75 mg/m^2	PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m^2) intravenously.
OG001	PF-03084014 100 mg BID + Docetaxel 100 mg/m^2	PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 100 mg/square meters (m^2) intravenously.
OG002	PF-03084014 150 mg BID + Docetaxel 75 mg/m^2	PF-03084014 150 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m^2) intravenously.

Secondary

Time to Cmax (Tmax) of PF-03084014 in Dose-finding Cohort

Serum PF-03084014 PK parameters were calculated following BID doses of PF-03084014 given alone (Cycle 1 Day 21) and in combination with docetaxel (Cycle 1 Day 2 and Cycle 2 Day 1)

All 22 participants treated in the dose escalation stage were included in the analysis. n=number of evaluable participants at the specified time point.

Posted

Median

Full Range

C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12)

ID	Title	Description
OG000	PF-03084014 100 mg BID + Docetaxel 75 mg/m^2	PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m^2) intravenously.
OG001	PF-03084014 100 mg BID + Docetaxel 100 mg/m^2	PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 100 mg/square meters (m^2) intravenously.
OG002	PF-03084014 150 mg BID + Docetaxel 75 mg/m^2	PF-03084014 150 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m^2) intravenously.

Secondary

Tmax of Docetaxel in Dose-finding Cohort

Plasma docetaxel PK parameters were calculated following a 1-hr infusion of docetaxel given alone (Cycle 1 Day 1) and in combination with BID dosing of PF-03084014 (Cycle 2 Day 1)

All 22 participants treated in the dose escalation stage were included in the analysis. n=number of evaluable participants at the specified time point.

Posted

Median

Full Range

C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12)

ID	Title	Description
OG000	PF-03084014 100 mg BID + Docetaxel 75 mg/m^2	PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m^2) intravenously.
OG001	PF-03084014 100 mg BID + Docetaxel 100 mg/m^2	PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 100 mg/square meters (m^2) intravenously.
OG002	PF-03084014 150 mg BID + Docetaxel 75 mg/m^2	PF-03084014 150 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m^2) intravenously.

Secondary

Systemic Clearance (CL) of Docetaxel in Dose-finding Cohort

Plasma docetaxel PK parameters were calculated following a 1-hr infusion of docetaxel given alone (Cycle 1 Day 1) and in combination with BID dosing of PF-03084014 (Cycle 2 Day 1)

All 22 participants treated in the dose escalation stage were included in the analysis. n=number of evaluable participants at the specified time point.

Posted

Geometric Mean

Geometric Coefficient of Variation

liter (L)/hr

C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12)

ID	Title	Description
OG000	PF-03084014 100 mg BID + Docetaxel 75 mg/m^2	PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m^2) intravenously.
OG001	PF-03084014 100 mg BID + Docetaxel 100 mg/m^2	PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 100 mg/square meters (m^2) intravenously.
OG002	PF-03084014 150 mg BID + Docetaxel 75 mg/m^2	PF-03084014 150 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m^2) intravenously.

Secondary

Terminal Half-life (t1/2) of Docetaxel in Dose-finding Cohort

Plasma docetaxel PK parameters were calculated following a 1-hr infusion of docetaxel given alone (Cycle 1 Day 1) and in combination with BID dosing of PF-03084014 (Cycle 2 Day 1)

All 22 participants treated in the dose escalation stage were included in the analysis. n=number of evaluable participants at the specified time point.

Posted

Mean

Standard Deviation

C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12)

ID	Title	Description
OG000	PF-03084014 100 mg BID + Docetaxel 75 mg/m^2	PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m^2) intravenously.
OG001	PF-03084014 100 mg BID + Docetaxel 100 mg/m^2	PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 100 mg/square meters (m^2) intravenously.
OG002	PF-03084014 150 mg BID + Docetaxel 75 mg/m^2	PF-03084014 150 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m^2) intravenously.

Secondary

Volume of Distribution (Vss) of Docetaxel in Dose-finding Cohort

Plasma docetaxel PK parameters were calculated following a 1-hr infusion of docetaxel given alone (Cycle 1 Day 1) and in combination with BID dosing of PF-03084014 (Cycle 2 Day 1)

All 22 participants treated in the dose escalation stage were included in the analysis. n=number of evaluable participants at the specified time point.

Posted

Geometric Mean

Geometric Coefficient of Variation

C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12)

ID	Title	Description
OG000	PF-03084014 100 mg BID + Docetaxel 75 mg/m^2	PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m^2) intravenously.
OG001	PF-03084014 100 mg BID + Docetaxel 100 mg/m^2	PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 100 mg/square meters (m^2) intravenously.
OG002	PF-03084014 150 mg BID + Docetaxel 75 mg/m^2	PF-03084014 150 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m^2) intravenously.

Secondary

AUClast of PF-03084014 in the Expansion Cohort

All 7 participants who received treatment in the expansion cohort were included in the analysis. n=number of evaluable participants at the specified time point.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng*hr/mL

C1D1, C1D21, and Day 1 of subsequent cycles and at EOT (max reached: C12)

ID	Title	Description
OG000	PF-03084014 100 mg BID + Docetaxel 75 mg/m^2	PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m^2) intravenously.

Units	Counts
Participants	OG000

Secondary

Cmax of PF-03084014 in the Expansion Cohort

All 7 participants who received treatment in the expansion cohort were included in the analysis. n=number of evaluable participants at the specified time point.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

C1D1, C1D21, and Day 1 of subsequent cycles and at EOT (max reached: C12)

ID	Title	Description
OG000	PF-03084014 100 mg BID + Docetaxel 75 mg/m^2	PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m^2) intravenously.

Units	Counts
Participants	OG000

Secondary

Tmax of PF-03084014 in the Expansion Cohort

All 7 participants who received treatment in the expansion cohort were included in the analysis. n=number of evaluable participants at the specified time point.

Posted

Median

Full Range

C1D1, C1D21, and Day 1 of subsequent cycles and at EOT (max reached: C12)

ID	Title	Description
OG000	PF-03084014 100 mg BID + Docetaxel 75 mg/m^2	PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m^2) intravenously.

Units	Counts
Participants	OG000

Secondary

Ctrough of PF-03084014 in the Expansion Cohort

All 7 participants who received treatment in the expansion cohort were included in the analysis. At Cycle 1 Day 21, only 5 participants had available data for Ctrough.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

C1D1, C1D21, and Day 1 of subsequent cycles and at EOT (max reached: C12)

ID	Title	Description
OG000	PF-03084014 100 mg BID + Docetaxel 75 mg/m^2	PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m^2) intravenously.

Units	Counts
Participants	OG000

Secondary

Duration of Response (DR)

Duration of response (DR) defined as time from start of first documented objective tumor response [Complete Response (CR) or Partial Response (PR)] to first documented objective tumor progression or death due to any cause, whichever occurs first. DR = (the end date for DR minus first subsequent confirmed CR or PR plus 1) divided by 7.02. CR: disappearance of all target lesions. PR: at least 30% decrease in the sum of diameters of target lesions.

Only 4 participants had CR or PR, 2 each in the PF-03084014 100 mg BID + docetaxel 75 mg/m^2 and PF-03084014 150 mg BID + docetaxel 75 mg/m^2 groups.

Posted

Number

months

Baseline up to 28-35 days after treatment discontinuation (up to Day 280)

ID	Title	Description
OG000	PF-03084014 100 mg BID + Docetaxel 75 mg/m^2	PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m^2) intravenously.
OG001	PF-03084014 150 mg BID + Docetaxel 75 mg/m^2	PF-03084014 150 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m^2) intravenously.

Secondary

Number of Participants With QTc Values Meeting Categorical Summarization Criteria

Criteria for categorical summarization of the time corresponding to the beginning of depolarization to repolarization of the ventricles (QT) corrected for heart rate (QTc) using Bazett's correction (QTcB) or Fridericia's correction (QTcF) included: maximum QTcB or QTcF less than or equal to (<=) 450 milliseconds (msec), 450 to <=480 msec, 480 to <=500 msec, more than (>) 500 msec; maximum QTcB or QTcF changes (increases/decreases) from baseline (BL) less than (<) 30 msec, 30 to <60 msec, more than or equal to (>=) 60 msec.

All 29 participants who received study treatment were analyzed for safety.

Posted

Number

participants

Screening, C1D1, C1D21, Day 1 of subsequent cycles, and EOT (maximum reached: C12)

ID	Title	Description
OG000	PF-03084014 100 mg BID + Docetaxel 75 mg/m^2	PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m^2) intravenously.
OG001	PF-03084014 100 mg BID + Docetaxel 100 mg/m^2	PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 100 mg/square meters (m^2) intravenously.
OG002

Secondary

Percentage Change From Baseline in Notch 1 to 4 Ribonucleic Acid (RNA) in Blood

As PF-03084014 acts on the Notch pathway as an inhibitor, it is of interest to investigate its effects, if any, on the Notch family of receptors, mainly Notch 1-4.

All treated participants who had at least 1 screening and post treatment biomarker assessment. n=number of evaluable participants for the specified biomarker at the specified time point.

Posted

Mean

Standard Deviation

percentage change

C1D1, C1D2, C1D8, C1D21 and EOT (maximum reached: C12)

ID	Title	Description
OG000	PF-03084014 100 mg BID + Docetaxel 75 mg/m^2	PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m^2) intravenously.
OG001	PF-03084014 100 mg BID + Docetaxel 100 mg/m^2	PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 100 mg/square meters (m^2) intravenously.
OG002	PF-03084014 150 mg BID + Docetaxel 75 mg/m^2	PF-03084014 150 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m^2) intravenously.

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA version 18.1	Non-systematic Assessment	EG00010 affected15 at risk EG0011 affected3 at risk EG0025 affected11 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA version 18.1	Non-systematic Assessment	EG0003 affected15 at risk EG0011 affected3 at risk EG0020 affected11 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA version 18.1	Non-systematic Assessment	EG0000 affected15 at risk EG0010 affected3 at risk EG0021 affected11 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA version 18.1	Non-systematic Assessment	EG00010 affected15 at risk EG0012 affected3 at risk EG0025 affected11 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA version 18.1	Non-systematic Assessment	EG00012 affected15 at risk EG0013 affected3 at risk EG0028 affected11 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA version 18.1	Non-systematic Assessment	EG0004 affected15 at risk EG0012 affected3 at risk EG0022 affected11 at risk
Sinus bradycardia	Cardiac disorders	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected3 at risk EG0020 affected11 at risk
Tachycardia	Cardiac disorders	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected3 at risk EG0020 affected11 at risk
Deafness	Ear and labyrinth disorders	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected3 at risk EG0020 affected11 at risk
Ear disorder	Ear and labyrinth disorders	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected3 at risk EG0020 affected11 at risk
Vertigo	Ear and labyrinth disorders	MedDRA version 18.1	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected3 at risk EG0021 affected11 at risk
Diplopia	Eye disorders	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected3 at risk EG0020 affected11 at risk
Eye irritation	Eye disorders	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected3 at risk EG0020 affected11 at risk
Periorbital oedema	Eye disorders	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected3 at risk EG0020 affected11 at risk
Visual impairment	Eye disorders	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected3 at risk EG0020 affected11 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected3 at risk EG0020 affected11 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected3 at risk EG0021 affected11 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0011 affected3 at risk EG0022 affected11 at risk
Constipation	Gastrointestinal disorders	MedDRA version 18.1	Non-systematic Assessment	EG0006 affected15 at risk EG0010 affected3 at risk EG0025 affected11 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA version 18.1	Non-systematic Assessment	EG00010 affected15 at risk EG0012 affected3 at risk EG0028 affected11 at risk
Dry mouth	Gastrointestinal disorders	MedDRA version 18.1	Non-systematic Assessment	EG0000 affected15 at risk EG0010 affected3 at risk EG0022 affected11 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA version 18.1	Non-systematic Assessment	EG0002 affected15 at risk EG0010 affected3 at risk EG0021 affected11 at risk
Dysphagia	Gastrointestinal disorders	MedDRA version 18.1	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected3 at risk EG0020 affected11 at risk
Flatulence	Gastrointestinal disorders	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected3 at risk EG0021 affected11 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected3 at risk EG0021 affected11 at risk
Hemorrhoids	Gastrointestinal disorders	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected3 at risk EG0021 affected11 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected3 at risk EG0020 affected11 at risk
Nausea	Gastrointestinal disorders	MedDRA version 18.1	Non-systematic Assessment	EG00011 affected15 at risk EG0013 affected3 at risk EG0028 affected11 at risk
Oedema mouth	Gastrointestinal disorders	MedDRA version 18.1	Non-systematic Assessment	EG0000 affected15 at risk EG0010 affected3 at risk EG0021 affected11 at risk
Oral pain	Gastrointestinal disorders	MedDRA version 18.1	Non-systematic Assessment	EG0000 affected15 at risk EG0010 affected3 at risk EG0022 affected11 at risk
Proctalgia	Gastrointestinal disorders	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected3 at risk EG0020 affected11 at risk
Stomatitis	Gastrointestinal disorders	MedDRA version 18.1	Non-systematic Assessment	EG0002 affected15 at risk EG0011 affected3 at risk EG0024 affected11 at risk
Vomiting	Gastrointestinal disorders	MedDRA version 18.1	Non-systematic Assessment	EG0005 affected15 at risk EG0011 affected3 at risk EG0029 affected11 at risk
Asthenia	General disorders	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected3 at risk EG0021 affected11 at risk
Chest pain	General disorders	MedDRA version 18.1	Non-systematic Assessment	EG0002 affected15 at risk EG0010 affected3 at risk EG0020 affected11 at risk
Face oedema	General disorders	MedDRA version 18.1	Non-systematic Assessment	EG0000 affected15 at risk EG0010 affected3 at risk EG0021 affected11 at risk
Fatigue	General disorders	MedDRA version 18.1	Non-systematic Assessment	EG00012 affected15 at risk EG0012 affected3 at risk EG00211 affected11 at risk
Influenza like illness	General disorders	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected3 at risk EG0022 affected11 at risk
Local swelling	General disorders	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected3 at risk EG0020 affected11 at risk
Mucosal inflammation	General disorders	MedDRA version 18.1	Non-systematic Assessment	EG0009 affected15 at risk EG0012 affected3 at risk EG0023 affected11 at risk
Oedema peripheral	General disorders	MedDRA version 18.1	Non-systematic Assessment	EG0003 affected15 at risk EG0011 affected3 at risk EG0021 affected11 at risk
Pain	General disorders	MedDRA version 18.1	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected3 at risk EG0020 affected11 at risk
Performance status decreased	General disorders	MedDRA version 18.1	Non-systematic Assessment	EG0000 affected15 at risk EG0010 affected3 at risk EG0021 affected11 at risk
Pyrexia	General disorders	MedDRA version 18.1	Non-systematic Assessment	EG0004 affected15 at risk EG0013 affected3 at risk EG0024 affected11 at risk
Vessel puncture site bruise	General disorders	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected3 at risk EG0020 affected11 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA version 18.1	Non-systematic Assessment	EG0000 affected15 at risk EG0010 affected3 at risk EG0021 affected11 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA version 18.1	Non-systematic Assessment	EG0000 affected15 at risk EG0010 affected3 at risk EG0021 affected11 at risk
Hypersensitivity	Immune system disorders	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected3 at risk EG0020 affected11 at risk
Candida infection	Infections and infestations	MedDRA version 18.1	Non-systematic Assessment	EG0002 affected15 at risk EG0010 affected3 at risk EG0021 affected11 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA version 18.1	Non-systematic Assessment	EG0000 affected15 at risk EG0010 affected3 at risk EG0021 affected11 at risk
Conjunctivitis	Infections and infestations	MedDRA version 18.1	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected3 at risk EG0020 affected11 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected3 at risk EG0020 affected11 at risk
Folliculitis	Infections and infestations	MedDRA version 18.1	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected3 at risk EG0021 affected11 at risk
Herpes simplex	Infections and infestations	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected3 at risk EG0020 affected11 at risk
Influenza	Infections and infestations	MedDRA version 18.1	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected3 at risk EG0020 affected11 at risk
Lung infection	Infections and infestations	MedDRA version 18.1	Non-systematic Assessment	EG0002 affected15 at risk EG0010 affected3 at risk EG0020 affected11 at risk
Oral candidiasis	Infections and infestations	MedDRA version 18.1	Non-systematic Assessment	EG0000 affected15 at risk EG0010 affected3 at risk EG0022 affected11 at risk
Oral herpes	Infections and infestations	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected3 at risk EG0020 affected11 at risk
Pharyngitis	Infections and infestations	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected3 at risk EG0023 affected11 at risk
Pneumonia	Infections and infestations	MedDRA version 18.1	Non-systematic Assessment	EG0000 affected15 at risk EG0010 affected3 at risk EG0022 affected11 at risk
Pulpitis dental	Infections and infestations	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected3 at risk EG0020 affected11 at risk
Sepsis	Infections and infestations	MedDRA version 18.1	Non-systematic Assessment	EG0000 affected15 at risk EG0010 affected3 at risk EG0021 affected11 at risk
Skin infection	Infections and infestations	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected3 at risk EG0020 affected11 at risk
Urinary tract infection	Infections and infestations	MedDRA version 18.1	Non-systematic Assessment	EG0002 affected15 at risk EG0011 affected3 at risk EG0020 affected11 at risk
Urinary tract infection enterococcal	Infections and infestations	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected3 at risk EG0020 affected11 at risk
Vaginal infection	Infections and infestations	MedDRA version 18.1	Non-systematic Assessment	EG0002 affected15 at risk EG0010 affected3 at risk EG0021 affected11 at risk
Vulvovaginal candidiasis	Infections and infestations	MedDRA version 18.1	Non-systematic Assessment	EG0000 affected15 at risk EG0010 affected3 at risk EG0021 affected11 at risk
Fall	Injury, poisoning and procedural complications	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected3 at risk EG0020 affected11 at risk
Incision site erythema	Injury, poisoning and procedural complications	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected3 at risk EG0020 affected11 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected3 at risk EG0020 affected11 at risk
Activated partial thromboplastin time prolonged	Investigations	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected3 at risk EG0020 affected11 at risk
Alanine aminotransferase increased	Investigations	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0011 affected3 at risk EG0021 affected11 at risk
Aspartate aminotransferase increased	Investigations	MedDRA version 18.1	Non-systematic Assessment	EG0002 affected15 at risk EG0011 affected3 at risk EG0021 affected11 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected3 at risk EG0021 affected11 at risk
Blood creatinine increased	Investigations	MedDRA version 18.1	Non-systematic Assessment	EG0000 affected15 at risk EG0010 affected3 at risk EG0021 affected11 at risk
Blood glucose increased	Investigations	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected3 at risk EG0020 affected11 at risk
Blood magnesium decreased	Investigations	MedDRA version 18.1	Non-systematic Assessment	EG0000 affected15 at risk EG0010 affected3 at risk EG0021 affected11 at risk
Blood potassium decreased	Investigations	MedDRA version 18.1	Non-systematic Assessment	EG0000 affected15 at risk EG0010 affected3 at risk EG0021 affected11 at risk
Body temperature increased	Investigations	MedDRA version 18.1	Non-systematic Assessment	EG0000 affected15 at risk EG0010 affected3 at risk EG0021 affected11 at risk
Eosinophil count decreased	Investigations	MedDRA version 18.1	Non-systematic Assessment	EG0000 affected15 at risk EG0010 affected3 at risk EG0021 affected11 at risk
International normalized ratio increased	Investigations	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected3 at risk EG0020 affected11 at risk
Lymphocyte count decreased	Investigations	MedDRA version 18.1	Non-systematic Assessment	EG0000 affected15 at risk EG0010 affected3 at risk EG0021 affected11 at risk
Monocyte count decreased	Investigations	MedDRA version 18.1	Non-systematic Assessment	EG0000 affected15 at risk EG0010 affected3 at risk EG0021 affected11 at risk
Neutrophil count decreased	Investigations	MedDRA version 18.1	Non-systematic Assessment	EG0002 affected15 at risk EG0010 affected3 at risk EG0021 affected11 at risk
Platelet count decreased	Investigations	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected3 at risk EG0020 affected11 at risk
Prothrombin time prolonged	Investigations	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected3 at risk EG0020 affected11 at risk
Transaminases increased	Investigations	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected3 at risk EG0020 affected11 at risk
Weight decreased	Investigations	MedDRA version 18.1	Non-systematic Assessment	EG0000 affected15 at risk EG0010 affected3 at risk EG0021 affected11 at risk
Weight increased	Investigations	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0011 affected3 at risk EG0021 affected11 at risk
White blood cell count decreased	Investigations	MedDRA version 18.1	Non-systematic Assessment	EG0002 affected15 at risk EG0010 affected3 at risk EG0021 affected11 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA version 18.1	Non-systematic Assessment	EG0000 affected15 at risk EG0010 affected3 at risk EG0021 affected11 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA version 18.1	Non-systematic Assessment	EG0002 affected15 at risk EG0011 affected3 at risk EG0023 affected11 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA version 18.1	Non-systematic Assessment	EG0000 affected15 at risk EG0010 affected3 at risk EG0021 affected11 at risk
Fluid retention	Metabolism and nutrition disorders	MedDRA version 18.1	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected3 at risk EG0020 affected11 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected3 at risk EG0020 affected11 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA version 18.1	Non-systematic Assessment	EG0005 affected15 at risk EG0010 affected3 at risk EG0021 affected11 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected3 at risk EG0020 affected11 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA version 18.1	Non-systematic Assessment	EG0004 affected15 at risk EG0011 affected3 at risk EG0021 affected11 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA version 18.1	Non-systematic Assessment	EG0003 affected15 at risk EG0012 affected3 at risk EG0022 affected11 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA version 18.1	Non-systematic Assessment	EG0002 affected15 at risk EG0011 affected3 at risk EG0021 affected11 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA version 18.1	Non-systematic Assessment	EG0003 affected15 at risk EG0011 affected3 at risk EG0021 affected11 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA version 18.1	Non-systematic Assessment	EG0007 affected15 at risk EG0012 affected3 at risk EG0023 affected11 at risk
Vitamin K deficiency	Metabolism and nutrition disorders	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected3 at risk EG0020 affected11 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA version 18.1	Non-systematic Assessment	EG0002 affected15 at risk EG0011 affected3 at risk EG0023 affected11 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA version 18.1	Non-systematic Assessment	EG0000 affected15 at risk EG0010 affected3 at risk EG0021 affected11 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected3 at risk EG0020 affected11 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected3 at risk EG0020 affected11 at risk
Muscle twitching	Musculoskeletal and connective tissue disorders	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected3 at risk EG0020 affected11 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA version 18.1	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected3 at risk EG0020 affected11 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA version 18.1	Non-systematic Assessment	EG0000 affected15 at risk EG0010 affected3 at risk EG0021 affected11 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA version 18.1	Non-systematic Assessment	EG0002 affected15 at risk EG0011 affected3 at risk EG0021 affected11 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0011 affected3 at risk EG0022 affected11 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0011 affected3 at risk EG0020 affected11 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 18.1	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected3 at risk EG0021 affected11 at risk
Skin papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected3 at risk EG0020 affected11 at risk
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 18.1	Non-systematic Assessment	EG0002 affected15 at risk EG0010 affected3 at risk EG0021 affected11 at risk
Dizziness	Nervous system disorders	MedDRA version 18.1	Non-systematic Assessment	EG0002 affected15 at risk EG0010 affected3 at risk EG0021 affected11 at risk
Dysgeusia	Nervous system disorders	MedDRA version 18.1	Non-systematic Assessment	EG0002 affected15 at risk EG0010 affected3 at risk EG0021 affected11 at risk
Headache	Nervous system disorders	MedDRA version 18.1	Non-systematic Assessment	EG0004 affected15 at risk EG0012 affected3 at risk EG0026 affected11 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected3 at risk EG0020 affected11 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA version 18.1	Non-systematic Assessment	EG0003 affected15 at risk EG0010 affected3 at risk EG0021 affected11 at risk
Seizure	Nervous system disorders	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected3 at risk EG0020 affected11 at risk
Visual field defect	Nervous system disorders	MedDRA version 18.1	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected3 at risk EG0020 affected11 at risk
Anxiety	Psychiatric disorders	MedDRA version 18.1	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected3 at risk EG0021 affected11 at risk
Insomnia	Psychiatric disorders	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0011 affected3 at risk EG0022 affected11 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA version 18.1	Non-systematic Assessment	EG0000 affected15 at risk EG0010 affected3 at risk EG0021 affected11 at risk
Proteinuria	Renal and urinary disorders	MedDRA version 18.1	Non-systematic Assessment	EG0004 affected15 at risk EG0011 affected3 at risk EG0022 affected11 at risk
Breast inflammation	Reproductive system and breast disorders	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected3 at risk EG0020 affected11 at risk
Breast pain	Reproductive system and breast disorders	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected3 at risk EG0020 affected11 at risk
Vaginal inflammation	Reproductive system and breast disorders	MedDRA version 18.1	Non-systematic Assessment	EG0000 affected15 at risk EG0010 affected3 at risk EG0021 affected11 at risk
Vulvovaginal rash	Reproductive system and breast disorders	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected3 at risk EG0021 affected11 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA version 18.1	Non-systematic Assessment	EG0003 affected15 at risk EG0010 affected3 at risk EG0024 affected11 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA version 18.1	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected3 at risk EG0020 affected11 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA version 18.1	Non-systematic Assessment	EG0004 affected15 at risk EG0011 affected3 at risk EG0020 affected11 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA version 18.1	Non-systematic Assessment	EG0002 affected15 at risk EG0011 affected3 at risk EG0022 affected11 at risk
Laryngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected3 at risk EG0020 affected11 at risk
Nasal dryness	Respiratory, thoracic and mediastinal disorders	MedDRA version 18.1	Non-systematic Assessment	EG0000 affected15 at risk EG0010 affected3 at risk EG0021 affected11 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected3 at risk EG0020 affected11 at risk
Paranasal sinus discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected3 at risk EG0020 affected11 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA version 18.1	Non-systematic Assessment	EG0000 affected15 at risk EG0010 affected3 at risk EG0021 affected11 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected3 at risk EG0020 affected11 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA version 18.1	Non-systematic Assessment	EG0000 affected15 at risk EG0010 affected3 at risk EG0022 affected11 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA version 18.1	Non-systematic Assessment	EG0008 affected15 at risk EG0012 affected3 at risk EG0026 affected11 at risk
Dermatitis acneiform	Skin and subcutaneous tissue disorders	MedDRA version 18.1	Non-systematic Assessment	EG0002 affected15 at risk EG0010 affected3 at risk EG0021 affected11 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0011 affected3 at risk EG0020 affected11 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected3 at risk EG0020 affected11 at risk
Hyperkeratosis	Skin and subcutaneous tissue disorders	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected3 at risk EG0020 affected11 at risk
Nail discolouration	Skin and subcutaneous tissue disorders	MedDRA version 18.1	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected3 at risk EG0020 affected11 at risk
Nail disorder	Skin and subcutaneous tissue disorders	MedDRA version 18.1	Non-systematic Assessment	EG0004 affected15 at risk EG0010 affected3 at risk EG0021 affected11 at risk
Onycholysis	Skin and subcutaneous tissue disorders	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected3 at risk EG0020 affected11 at risk
Onychomadesis	Skin and subcutaneous tissue disorders	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected3 at risk EG0020 affected11 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected3 at risk EG0021 affected11 at risk
Papule	Skin and subcutaneous tissue disorders	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected3 at risk EG0020 affected11 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA version 18.1	Non-systematic Assessment	EG0003 affected15 at risk EG0011 affected3 at risk EG0021 affected11 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA version 18.1	Non-systematic Assessment	EG0003 affected15 at risk EG0013 affected3 at risk EG0026 affected11 at risk
Rash erythematosus	Skin and subcutaneous tissue disorders	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected3 at risk EG0020 affected11 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected3 at risk EG0020 affected11 at risk
Skin discolouration	Skin and subcutaneous tissue disorders	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected3 at risk EG0020 affected11 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected3 at risk EG0020 affected11 at risk
Deep vein thrombosis	Vascular disorders	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected3 at risk EG0020 affected11 at risk
Hot flush	Vascular disorders	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected3 at risk EG0020 affected11 at risk
Hypotension	Vascular disorders	MedDRA version 18.1	Non-systematic Assessment	EG0000 affected15 at risk EG0010 affected3 at risk EG0021 affected11 at risk
Lymphoedema	Vascular disorders	MedDRA version 18.1	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected3 at risk EG0020 affected11 at risk

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D004224	Diterpenes
D013729	Terpenes

ID	Title	Description
BG000	PF-03084014 100 mg BID + Docetaxel 75 mg/m^2	PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m^2) intravenously.
BG001	PF-03084014 100 mg BID + Docetaxel 100 mg/m^2	PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 100 mg/square meters (m^2) intravenously.
BG002	PF-03084014 150 mg BID + Docetaxel 75 mg/m^2	PF-03084014 150 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m^2) intravenously.
BG003	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	PF-03084014 100 mg BID + Docetaxel 75 mg/m^2	PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m^2) intravenously.	4	15	15	15
EG001	PF-03084014 100 mg BID + Docetaxel 100 mg/m^2	PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 100 mg/square meters (m^2) intravenously.	3	3	3	3
EG002	PF-03084014 150 mg BID + Docetaxel 75 mg/m^2	PF-03084014 150 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m^2) intravenously.	6	11	11	11