Trial Outcomes & Findings for A Trial To Assess Safety And Tolerability Of PF-04691502 In Cancer Patients (NCT NCT00927823)

Last Updated: 2014-08-12

Results Overview

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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. 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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

37 participants

Primary outcome timeframe

Baseline up to 28 days after the last dose

Results posted on

2014-08-12

Participant Flow

Participant milestones

Participant milestones
Measure	PF-04691502 2 mg Single oral dose of PF-04691502 2 milligram (mg) tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.	PF-04691502 4 mg Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.	PF-04691502 8 mg Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.	PF-04691502 11 mg Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
Lead-In Period STARTED	3	3	26	5
Lead-In Period COMPLETED	3	3	26	5
Lead-In Period NOT COMPLETED	0	0	0	0
Continuous Dosing Period STARTED	3	3	26	5
Continuous Dosing Period Treated	3	3	23	5
Continuous Dosing Period COMPLETED	0	0	0	0
Continuous Dosing Period NOT COMPLETED	3	3	26	5

Reasons for withdrawal

Reasons for withdrawal
Measure	PF-04691502 2 mg Single oral dose of PF-04691502 2 milligram (mg) tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.	PF-04691502 4 mg Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.	PF-04691502 8 mg Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.	PF-04691502 11 mg Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
Continuous Dosing Period Death	0	0	6	0
Continuous Dosing Period Lost to Follow-up	1	1	9	0
Continuous Dosing Period Withdrawal by Subject	1	0	2	2
Continuous Dosing Period Other	1	2	9	3

Baseline Characteristics

A Trial To Assess Safety And Tolerability Of PF-04691502 In Cancer Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Entire Study Population n=37 Participants All participants received either PF-04691502 2 mg, 4 mg, 8 mg or 11 mg tablet as a single oral dose in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by same PF-04691502 dose orally once daily continuously in 21 day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
Age, Continuous	59.6 years STANDARD_DEVIATION 10.5 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline up to 28 days after the last dose

Population: Safety analysis set included all enrolled participants who started the treatment.

Outcome measures

Outcome measures
Measure	PF-04691502 2 mg n=3 Participants Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.	PF-04691502 4 mg n=3 Participants Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.	PF-04691502 8 mg n=26 Participants Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.	PF-04691502 11 mg n=5 Participants Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) AEs	3 participants	3 participants	25 participants	5 participants
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) SAEs	2 participants	1 participants	15 participants	3 participants

PRIMARY outcome

Timeframe: Baseline up to Cycle 1 Day 21

Population: Safety analysis set included all enrolled participants who started the treatment.

DLT was classified as per common terminology criteria for adverse events (CTCAE) version 4.0 and defined as any of the following events occurring after first dose of study medication and considered at least possibly-related to study medication. Hematological: grade 4 neutropenia (absolute neutrophil count \[ANC\] \<500 cells per cubic millimeter \[cells/mm\^3\]) for 1 week or greater, febrile neutropenia (fever \>=38.5 degree celsius with ANC \<1000/mm\^3), grade 3 (50,000 cells/mm\^3) and grade 4 (\<25,000 cells/mm\^3) thrombocytopenia; Non-Hematologic: grade 3 or 4 nausea, vomiting, or diarrhea and any clinically significant grade 3 or greater non-hematologic toxicity, despite the use of adequate/maximal medical intervention and/or prophylaxis, and any persistent, intolerable PF-04691502 related toxicity which delayed retreatment for \>14 days.

Outcome measures

Outcome measures
Measure	PF-04691502 2 mg n=3 Participants Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.	PF-04691502 4 mg n=3 Participants Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.	PF-04691502 8 mg n=26 Participants Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.	PF-04691502 11 mg n=5 Participants Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
Number of Participants With Dose Limiting Toxicities (DLTs)	0 participants	0 participants	1 participants	2 participants

PRIMARY outcome

Timeframe: Baseline up to Cycle 1 Day 21

Population: Safety analysis set included all enrolled participants who started the treatment.

RP2D was determined based on the safety profile and pharmacodynamic findings, as per investigator's discretion.

Outcome measures

Outcome measures
Measure	PF-04691502 2 mg n=37 Participants Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.	PF-04691502 4 mg Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.	PF-04691502 8 mg Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.	PF-04691502 11 mg Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
Recommended Phase-2 Dose (RP2D)	8 milligram	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24, 48, 72, 96 hours post-dose in Lead-in period; pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24 hours post-dose on Cycle 1 Day 21 (C1D21)

Population: PK population included all randomized participants who received treatment and had at least 1 of the PK parameters of interest estimated. n=participants evaluable at specified time point for each arm, respectively.

The pharmacokinetics (PK) of PF-04691502 was assessed following a single oral dose administration in lead-in-dose period (single dose PK) and repeated oral dose administration for 21 days in Cycle 1 (multiple dose PK).

Outcome measures

Outcome measures
Measure	PF-04691502 2 mg n=3 Participants Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.	PF-04691502 4 mg n=3 Participants Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.	PF-04691502 8 mg n=26 Participants Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.	PF-04691502 11 mg n=5 Participants Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
Maximum Observed Plasma Concentration (Cmax) Single Dose: Cmax (n=3, 3, 26, 5)	18.07 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 13	58.29 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 35	66.40 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 41	82.51 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 15
Maximum Observed Plasma Concentration (Cmax) Multiple Dose: Cmax (n=3, 3, 20, 1)	26.30 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 19	78.91 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 25	102.3 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 41	89.8 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation NA Geometric coefficient of variation was not estimable since only 1 participant was evaluable.

SECONDARY outcome

Timeframe: Pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24, 48, 72, 96 hours post-dose in Lead-in period; pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24 hours post-dose on C1D21

The PK of PF-04691502 was assessed following a single oral dose administration in lead-in-dose period (single dose PK) and repeated oral dose administration for 21 days in Cycle 1 (multiple dose PK).

Outcome measures

Outcome measures
Measure	PF-04691502 2 mg n=3 Participants Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.	PF-04691502 4 mg n=3 Participants Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.	PF-04691502 8 mg n=26 Participants Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.	PF-04691502 11 mg n=5 Participants Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
Time to Reach Maximum Observed Plasma Concentration (Tmax) Single Dose: Tmax (n=3, 3, 26, 5)	4.00 hours Interval 3.98 to 4.03	0.683 hours Interval 0.5 to 2.02	2.03 hours Interval 0.5 to 48.0	4.07 hours Interval 2.02 to 8.05
Time to Reach Maximum Observed Plasma Concentration (Tmax) Multiple Dose: Tmax (n=3, 3, 20, 1)	2.00 hours Interval 1.0 to 4.0	2.00 hours Interval 2.0 to 2.08	2.01 hours Interval 0.5 to 6.67	2.15 hours Interval 2.15 to 2.15

SECONDARY outcome

Timeframe: Pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24, 48, 72, 96 hours post-dose in Lead-in period

Population: PK population included all randomized participants who received treatment and had at least 1 of the PK parameters of interest estimated.

Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). It was evaluated following a single oral dose in lead-in-dose period (single dose PK) only.

Outcome measures

Outcome measures
Measure	PF-04691502 2 mg n=3 Participants Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.	PF-04691502 4 mg n=3 Participants Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.	PF-04691502 8 mg n=26 Participants Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.	PF-04691502 11 mg n=5 Participants Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)	330.3 ng*hr/mL Geometric Coefficient of Variation 20	734.4 ng*hr/mL Geometric Coefficient of Variation 18	1130 ng*hr/mL Geometric Coefficient of Variation 41	1320 ng*hr/mL Geometric Coefficient of Variation 32

SECONDARY outcome

Timeframe: Pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24, 48, 72, 96 hours (hrs) post-dose in Lead-in period; pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24 hrs post-dose on C1D21

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Plasma decay half-life of PF-04691502 was assessed following a single oral dose administration in lead-in-dose period (single dose PK) and repeat oral dose administration for 21 days in Cycle 1 (multiple dose PK).

Outcome measures

Outcome measures
Measure	PF-04691502 2 mg n=3 Participants Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.	PF-04691502 4 mg n=3 Participants Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.	PF-04691502 8 mg n=26 Participants Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.	PF-04691502 11 mg n=5 Participants Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
Plasma Decay Half-Life (t1/2) Single Dose: t1/2 (n=3, 3, 26, 5)	13.23 hours Standard Deviation 2.8746	10.87 hours Standard Deviation 0.90738	13.77 hours Standard Deviation 5.2150	11.66 hours Standard Deviation 1.7315
Plasma Decay Half-Life (t1/2) Multiple Dose: t1/2 (n=1, 0, 5, 1)	9.19 hours Standard Deviation NA Standard deviation was not estimable since only 1 participant was evaluable.	NA hours Standard Deviation NA Results not reported because none of the participants were evaluable.	8.984 hours Standard Deviation 0.70840	7.83 hours Standard Deviation NA Standard deviation was not estimable since only 1 participant was evaluable.

SECONDARY outcome

Timeframe: Pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24, 48, 72, 96 hours post-dose in Lead-in period

Population: PK population included all randomized participants who received treatment and had at least 1 of the PK parameters of interest estimated.

AUC (0-∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞). It was evaluated following a single oral dose in lead-in-dose period (single dose PK) only.

Outcome measures

Outcome measures
Measure	PF-04691502 2 mg n=3 Participants Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.	PF-04691502 4 mg n=3 Participants Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.	PF-04691502 8 mg n=26 Participants Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.	PF-04691502 11 mg n=5 Participants Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]	340.4 ng*hr/mL Geometric Coefficient of Variation 18	741.6 ng*hr/mL Geometric Coefficient of Variation 17	1150 ng*hr/mL Geometric Coefficient of Variation 42	1328 ng*hr/mL Geometric Coefficient of Variation 32

SECONDARY outcome

Timeframe: Pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24 hrs post-dose on C1D21

Population: PK population included all randomized participants who received treatment and had at least 1 of the PK parameters of interest estimated. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

AUCtau is the area under the plasma concentration time-curve from time zero to end of dosing interval (tau), where tau is the dosing interval of 24 hours. It was evaluated following repeated oral dose administration for 21 days in Cycle 1 (multiple dose PK) only.

Outcome measures

Outcome measures
Measure	PF-04691502 2 mg n=3 Participants Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.	PF-04691502 4 mg n=3 Participants Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.	PF-04691502 8 mg n=20 Participants Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.	PF-04691502 11 mg n=1 Participants Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)	371.7 ng*hr/mL Geometric Coefficient of Variation 5	966.4 ng*hr/mL Geometric Coefficient of Variation 25	1287 ng*hr/mL Geometric Coefficient of Variation 46	1020 ng*hr/mL

SECONDARY outcome

Timeframe: Pre-dose, 30 minutes, 1, 2, 4, 8, 24, 48, hrs post-dose in Lead-in period; 1 hour post-dose on C1D8, C1D15; 1, 2, 4, 8 hours post-dose on C1D21; 1 hour post-dose C2D1, C2D15, D1 of subsequent cycles up to C8; EOT

Population: QTc analysis set included all enrolled participants who had at least 1 ECG assessment after receiving PF-04691502.

Triplicate 12-lead electrocardiogram (ECG) measurements (each recording separated by approximately 2-4 minutes) were performed and average calculated. QT interval is the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF is the QT interval corrected for heart rate. Corrected QT interval using Fridericia's heart rate correction formula: QTcF = QT/RR\^1/3, where RR=RR interval in seconds. End of treatment (EOT) data included values from participants who came off-treatment before cycle 8.

Outcome measures

Outcome measures
Measure	PF-04691502 2 mg n=3 Participants Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.	PF-04691502 4 mg n=3 Participants Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.	PF-04691502 8 mg n=26 Participants Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.	PF-04691502 11 mg n=5 Participants Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
Number of Participants With Increase From Baseline in QT Interval Corrected Using Fridericia's Formula (QTcF) Maximum QTcF Interval Increase (Change <30 msec)	2 participants	3 participants	19 participants	5 participants
Number of Participants With Increase From Baseline in QT Interval Corrected Using Fridericia's Formula (QTcF) Maximum QTcF Interval Increase (Change >=60 sec)	0 participants	0 participants	0 participants	0 participants
Number of Participants With Increase From Baseline in QT Interval Corrected Using Fridericia's Formula (QTcF) MaximumQTcF Interval Increase(Change>=30to<60msec)	1 participants	0 participants	7 participants	0 participants

SECONDARY outcome

Population: QTc analysis set included all enrolled participants had at least 1 ECG assessment after receiving PF-04691502.

Outcome measures

Outcome measures
Measure	PF-04691502 2 mg n=3 Participants Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.	PF-04691502 4 mg n=3 Participants Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.	PF-04691502 8 mg n=26 Participants Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.	PF-04691502 11 mg n=5 Participants Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
Number of Participants With Maximum Post-dose QT Interval Corrected Using Fridericia's Formula (QTcF) Maximum QTcF Interval (450 to <480 msec)	1 participants	0 participants	5 participants	3 participants
Number of Participants With Maximum Post-dose QT Interval Corrected Using Fridericia's Formula (QTcF) Maximum QTcF Interval (<450 msec)	2 participants	3 participants	18 participants	2 participants
Number of Participants With Maximum Post-dose QT Interval Corrected Using Fridericia's Formula (QTcF) Maximum QTcF Interval (480 to <500 msec)	0 participants	0 participants	3 participants	0 participants
Number of Participants With Maximum Post-dose QT Interval Corrected Using Fridericia's Formula (QTcF) Maximum QTcF Interval (>=500 msec)	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Baseline, C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and EOT

Population: Serum biomarker analysis set included all enrolled participants who started treatment and had baseline and on-treatment serum biomarker samples (insulin, glucose, and c-peptide) successfully analyzed for at least 1 of the biomarkers. n=participants evaluable at specified time point for each arm, respectively.

Serum glucose level was measured following 4 hours fasting. EOT data included values from participants who came off-treatment before cycle 8.

Outcome measures

Outcome measures
Measure	PF-04691502 2 mg n=3 Participants Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.	PF-04691502 4 mg n=3 Participants Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.	PF-04691502 8 mg n=25 Participants Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.	PF-04691502 11 mg n=5 Participants Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
Change From Baseline in Serum Glucose at Cycle 1 Day 8 (C1D8), C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and End of Treatment (EOT) Change at C1D8 (n=3, 3, 23, 5)	14.0 milligram per deciliter (mg/dL) Standard Deviation 7.55	16.7 milligram per deciliter (mg/dL) Standard Deviation 27.59	20.0 milligram per deciliter (mg/dL) Standard Deviation 25.77	18.8 milligram per deciliter (mg/dL) Standard Deviation 5.26
Change From Baseline in Serum Glucose at Cycle 1 Day 8 (C1D8), C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and End of Treatment (EOT) Change at C3D1 (n=2, 2, 7, 0)	39.0 milligram per deciliter (mg/dL) Standard Deviation 26.87	15.0 milligram per deciliter (mg/dL) Standard Deviation 28.28	36.0 milligram per deciliter (mg/dL) Standard Deviation 26.34	NA milligram per deciliter (mg/dL) Standard Deviation NA Results not reported because none of the participants were evaluable.
Change From Baseline in Serum Glucose at Cycle 1 Day 8 (C1D8), C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and End of Treatment (EOT) Change at C6D1 (n=2, 0, 4, 0)	19.0 milligram per deciliter (mg/dL) Standard Deviation 4.24	NA milligram per deciliter (mg/dL) Standard Deviation NA Results not reported because none of the participants were evaluable.	7.0 milligram per deciliter (mg/dL) Standard Deviation 41.75	NA milligram per deciliter (mg/dL) Standard Deviation NA Results not reported because none of the participants were evaluable.
Change From Baseline in Serum Glucose at Cycle 1 Day 8 (C1D8), C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and End of Treatment (EOT) Change at C8D1 (n=1, 0, 1, 0)	30.0 milligram per deciliter (mg/dL) Standard Deviation NA Standard deviation was not estimable since only 1 participant was evaluable.	NA milligram per deciliter (mg/dL) Standard Deviation NA Results not reported because none of the participants were evaluable.	8.0 milligram per deciliter (mg/dL) Standard Deviation NA Standard deviation was not estimable since only 1 participant was evaluable.	NA milligram per deciliter (mg/dL) Standard Deviation NA Results not reported because none of the participants were evaluable.
Change From Baseline in Serum Glucose at Cycle 1 Day 8 (C1D8), C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and End of Treatment (EOT) Change at End of Treatment (n=1, 0, 17, 3)	33.0 milligram per deciliter (mg/dL) Standard Deviation NA Standard deviation was not estimable since only 1 participant was evaluable.	NA milligram per deciliter (mg/dL) Standard Deviation NA Results not reported because none of the participants were evaluable.	43.1 milligram per deciliter (mg/dL) Standard Deviation 94.07	13.7 milligram per deciliter (mg/dL) Standard Deviation 12.22
Change From Baseline in Serum Glucose at Cycle 1 Day 8 (C1D8), C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and End of Treatment (EOT) Change at C1D15 (n=3, 3, 21, 3)	16.7 milligram per deciliter (mg/dL) Standard Deviation 3.79	11.7 milligram per deciliter (mg/dL) Standard Deviation 19.66	17.0 milligram per deciliter (mg/dL) Standard Deviation 27.23	99.3 milligram per deciliter (mg/dL) Standard Deviation 116.43
Change From Baseline in Serum Glucose at Cycle 1 Day 8 (C1D8), C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and End of Treatment (EOT) Change at C2D1 (n=3, 3, 18, 1)	8.0 milligram per deciliter (mg/dL) Standard Deviation 13.53	4.7 milligram per deciliter (mg/dL) Standard Deviation 14.57	36.8 milligram per deciliter (mg/dL) Standard Deviation 37.60	0.0 milligram per deciliter (mg/dL) Standard Deviation NA Standard deviation was not estimable since only 1 participant was evaluable.
Change From Baseline in Serum Glucose at Cycle 1 Day 8 (C1D8), C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and End of Treatment (EOT) Change at C2D15 (n=3, 3, 14, 1)	12.0 milligram per deciliter (mg/dL) Standard Deviation 10.15	11.7 milligram per deciliter (mg/dL) Standard Deviation 16.77	22.6 milligram per deciliter (mg/dL) Standard Deviation 28.68	32.0 milligram per deciliter (mg/dL) Standard Deviation NA Standard deviation was not estimable since only 1 participant was evaluable.
Change From Baseline in Serum Glucose at Cycle 1 Day 8 (C1D8), C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and End of Treatment (EOT) Change at C4D1 (n=2, 0, 4, 0)	10.5 milligram per deciliter (mg/dL) Standard Deviation 2.12	NA milligram per deciliter (mg/dL) Standard Deviation NA Results not reported because none of the participants were evaluable.	35.0 milligram per deciliter (mg/dL) Standard Deviation 32.38	NA milligram per deciliter (mg/dL) Standard Deviation NA Results not reported because none of the participants were evaluable.
Change From Baseline in Serum Glucose at Cycle 1 Day 8 (C1D8), C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and End of Treatment (EOT) Change at C5D1 (n=2, 0, 4, 0)	21.5 milligram per deciliter (mg/dL) Standard Deviation 6.36	NA milligram per deciliter (mg/dL) Standard Deviation NA Results not reported because none of the participants were evaluable.	71.3 milligram per deciliter (mg/dL) Standard Deviation 57.66	NA milligram per deciliter (mg/dL) Standard Deviation NA Results not reported because none of the participants were evaluable.
Change From Baseline in Serum Glucose at Cycle 1 Day 8 (C1D8), C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and End of Treatment (EOT) Change at C7D1 (n=1, 0, 2, 0)	19.0 milligram per deciliter (mg/dL) Standard Deviation NA Standard deviation was not estimable since only 1 participant was evaluable.	NA milligram per deciliter (mg/dL) Standard Deviation NA Results not reported because none of the participants were evaluable.	50.5 milligram per deciliter (mg/dL) Standard Deviation 105.36	NA milligram per deciliter (mg/dL) Standard Deviation NA Results not reported because none of the participants were evaluable.
Change From Baseline in Serum Glucose at Cycle 1 Day 8 (C1D8), C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and End of Treatment (EOT) Baseline (n=3, 3, 25, 5)	87.7 milligram per deciliter (mg/dL) Standard Deviation 3.51	84.3 milligram per deciliter (mg/dL) Standard Deviation 0.58	87.3 milligram per deciliter (mg/dL) Standard Deviation 16.70	91.8 milligram per deciliter (mg/dL) Standard Deviation 12.44

SECONDARY outcome

Timeframe: Baseline, C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and EOT

Serum insulin level was measured following 4 hours fasting. EOT data included values from participants who came off-treatment before cycle 8.

Outcome measures

Outcome measures
Measure	PF-04691502 2 mg n=3 Participants Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.	PF-04691502 4 mg n=3 Participants Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.	PF-04691502 8 mg n=18 Participants Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.	PF-04691502 11 mg n=4 Participants Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
Change From Baseline in Serum Insulin at Cycle 1 Day 8 (C1D8), C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and End of Treatment (EOT) Baseline (n=3, 3, 18, 4)	6.2 micro International Unit/mL (mc IU/mL) Standard Deviation 2.67	5.8 micro International Unit/mL (mc IU/mL) Standard Deviation 3.72	8.0 micro International Unit/mL (mc IU/mL) Standard Deviation 5.62	21.4 micro International Unit/mL (mc IU/mL) Standard Deviation 25.70
Change From Baseline in Serum Insulin at Cycle 1 Day 8 (C1D8), C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and End of Treatment (EOT) Change at C1D8 (n=3, 3, 17, 2)	7.2 micro International Unit/mL (mc IU/mL) Standard Deviation 4.17	38.2 micro International Unit/mL (mc IU/mL) Standard Deviation 56.39	28.2 micro International Unit/mL (mc IU/mL) Standard Deviation 27.34	15.4 micro International Unit/mL (mc IU/mL) Standard Deviation 15.13
Change From Baseline in Serum Insulin at Cycle 1 Day 8 (C1D8), C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and End of Treatment (EOT) Change at C1D15 (n=3, 3, 16, 3)	5.6 micro International Unit/mL (mc IU/mL) Standard Deviation 2.32	8.6 micro International Unit/mL (mc IU/mL) Standard Deviation 6.17	25.2 micro International Unit/mL (mc IU/mL) Standard Deviation 33.35	60.5 micro International Unit/mL (mc IU/mL) Standard Deviation 30.75
Change From Baseline in Serum Insulin at Cycle 1 Day 8 (C1D8), C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and End of Treatment (EOT) Change at C2D1 (n=2, 3, 13, 0)	1.4 micro International Unit/mL (mc IU/mL) Standard Deviation 1.08	11.4 micro International Unit/mL (mc IU/mL) Standard Deviation 8.17	26.1 micro International Unit/mL (mc IU/mL) Standard Deviation 17.25	NA micro International Unit/mL (mc IU/mL) Standard Deviation NA Results not reported because none of the participants were evaluable.
Change From Baseline in Serum Insulin at Cycle 1 Day 8 (C1D8), C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and End of Treatment (EOT) Change at C2D15 (n=3, 3, 10, 1)	-0.1 micro International Unit/mL (mc IU/mL) Standard Deviation 8.15	12.0 micro International Unit/mL (mc IU/mL) Standard Deviation 6.64	12.3 micro International Unit/mL (mc IU/mL) Standard Deviation 10.95	29.2 micro International Unit/mL (mc IU/mL) Standard Deviation NA Standard deviation was not estimable since only 1 participant was evaluable.
Change From Baseline in Serum Insulin at Cycle 1 Day 8 (C1D8), C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and End of Treatment (EOT) Change at C3D1 (n=2, 2, 4, 0)	36.0 micro International Unit/mL (mc IU/mL) Standard Deviation 45.21	14.8 micro International Unit/mL (mc IU/mL) Standard Deviation 16.33	-1.0 micro International Unit/mL (mc IU/mL) Standard Deviation 5.92	NA micro International Unit/mL (mc IU/mL) Standard Deviation NA Results not reported because none of the participants were evaluable.
Change From Baseline in Serum Insulin at Cycle 1 Day 8 (C1D8), C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and End of Treatment (EOT) Change at C4D1 (n=1, 0, 4, 0)	9.1 micro International Unit/mL (mc IU/mL) Standard Deviation NA Standard deviation was not estimable since only 1 participant was evaluable.	NA micro International Unit/mL (mc IU/mL) Standard Deviation NA Results not reported because none of the participants were evaluable.	20.3 micro International Unit/mL (mc IU/mL) Standard Deviation 15.72	NA micro International Unit/mL (mc IU/mL) Standard Deviation NA Results not reported because none of the participants were evaluable.
Change From Baseline in Serum Insulin at Cycle 1 Day 8 (C1D8), C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and End of Treatment (EOT) Change at C5D1 (n=2, 0, 4, 0)	5.7 micro International Unit/mL (mc IU/mL) Standard Deviation 1.91	NA micro International Unit/mL (mc IU/mL) Standard Deviation NA Results not reported because none of the participants were evaluable.	21.2 micro International Unit/mL (mc IU/mL) Standard Deviation 14.38	NA micro International Unit/mL (mc IU/mL) Standard Deviation NA Results not reported because none of the participants were evaluable.
Change From Baseline in Serum Insulin at Cycle 1 Day 8 (C1D8), C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and End of Treatment (EOT) Change at C6D1 (n=1, 0, 4, 0)	1.0 micro International Unit/mL (mc IU/mL) Standard Deviation NA Standard deviation was not estimable since only 1 participant was evaluable.	NA micro International Unit/mL (mc IU/mL) Standard Deviation NA Results not reported because none of the participants were evaluable.	13.7 micro International Unit/mL (mc IU/mL) Standard Deviation 10.53	NA micro International Unit/mL (mc IU/mL) Standard Deviation NA Results not reported because none of the participants were evaluable.
Change From Baseline in Serum Insulin at Cycle 1 Day 8 (C1D8), C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and End of Treatment (EOT) Change at C7D1 (n=0, 0, 2, 0)	NA micro International Unit/mL (mc IU/mL) Standard Deviation NA Results not reported because none of the participants were evaluable.	NA micro International Unit/mL (mc IU/mL) Standard Deviation NA Results not reported because none of the participants were evaluable.	10.4 micro International Unit/mL (mc IU/mL) Standard Deviation 14.71	NA micro International Unit/mL (mc IU/mL) Standard Deviation NA Results not reported because none of the participants were evaluable.
Change From Baseline in Serum Insulin at Cycle 1 Day 8 (C1D8), C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and End of Treatment (EOT) Change at C8D1 (n=0, 0, 1, 0)	NA micro International Unit/mL (mc IU/mL) Standard Deviation NA Results not reported because none of the participants were evaluable.	NA micro International Unit/mL (mc IU/mL) Standard Deviation NA Results not reported because none of the participants were evaluable.	8.4 micro International Unit/mL (mc IU/mL) Standard Deviation NA Standard deviation was not estimable since only 1 participant was evaluable.	NA micro International Unit/mL (mc IU/mL) Standard Deviation NA Results not reported because none of the participants were evaluable.
Change From Baseline in Serum Insulin at Cycle 1 Day 8 (C1D8), C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and End of Treatment (EOT) Change at End of Treatment (n=1, 0, 10, 2)	9.0 micro International Unit/mL (mc IU/mL) Standard Deviation NA Standard deviation was not estimable since only 1 participant was evaluable.	NA micro International Unit/mL (mc IU/mL) Standard Deviation NA Results not reported because none of the participants were evaluable.	7.8 micro International Unit/mL (mc IU/mL) Standard Deviation 14.05	13.1 micro International Unit/mL (mc IU/mL) Standard Deviation 3.89

SECONDARY outcome

Timeframe: Baseline, C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and EOT

Population: Serum biomarker analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable at specified time point for each arm, respectively. Results of PF-04691502 2 mg and 4 mg arm not reported because none of the participants were evaluable.

Serum C-peptide level was measured following 4 hours fasting. EOT data included values from participants who came off-treatment before cycle 8.

Outcome measures

Outcome measures
Measure	PF-04691502 2 mg n=13 Participants Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.	PF-04691502 4 mg n=1 Participants Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.	PF-04691502 8 mg Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.	PF-04691502 11 mg Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
Change From Baseline in Serum C-peptide at Cycle 1 Day 8 (C1D8), C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and End of Treatment (EOT) Baseline (n=13, 1)	3.1 nanogram per milliliter (ng/mL) Standard Deviation 1.79	3.7 nanogram per milliliter (ng/mL)	—	—
Change From Baseline in Serum C-peptide at Cycle 1 Day 8 (C1D8), C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and End of Treatment (EOT) Change at C1D8 (n=13, 1)	5.2 nanogram per milliliter (ng/mL) Standard Deviation 3.36	2.0 nanogram per milliliter (ng/mL)	—	—
Change From Baseline in Serum C-peptide at Cycle 1 Day 8 (C1D8), C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and End of Treatment (EOT) Change at C1D15 (n=12, 0)	4.4 nanogram per milliliter (ng/mL) Standard Deviation 3.58	NA nanogram per milliliter (ng/mL) Results not reported because none of the participants were evaluable.	—	—
Change From Baseline in Serum C-peptide at Cycle 1 Day 8 (C1D8), C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and End of Treatment (EOT) Change at C2D1 (n=10, 0)	6.2 nanogram per milliliter (ng/mL) Standard Deviation 3.33	NA nanogram per milliliter (ng/mL) Results not reported because none of the participants were evaluable.	—	—
Change From Baseline in Serum C-peptide at Cycle 1 Day 8 (C1D8), C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and End of Treatment (EOT) Change at C2D15 (n=8, 0)	4.5 nanogram per milliliter (ng/mL) Standard Deviation 3.62	NA nanogram per milliliter (ng/mL) Results not reported because none of the participants were evaluable.	—	—
Change From Baseline in Serum C-peptide at Cycle 1 Day 8 (C1D8), C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and End of Treatment (EOT) Change at C3D1 (n=3, 0)	2.0 nanogram per milliliter (ng/mL) Standard Deviation 1.35	NA nanogram per milliliter (ng/mL) Results not reported because none of the participants were evaluable.	—	—
Change From Baseline in Serum C-peptide at Cycle 1 Day 8 (C1D8), C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and End of Treatment (EOT) Change at C4D1 (n=1, 0)	4.9 nanogram per milliliter (ng/mL) Standard Deviation NA Standard deviation was not estimable since only 1 participant was evaluable.	NA nanogram per milliliter (ng/mL) Results not reported because none of the participants were evaluable.	—	—
Change From Baseline in Serum C-peptide at Cycle 1 Day 8 (C1D8), C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and End of Treatment (EOT) Change at C5D1 (n=1, 0)	4.8 nanogram per milliliter (ng/mL) Standard Deviation NA Standard deviation was not estimable since only 1 participant was evaluable.	NA nanogram per milliliter (ng/mL) Results not reported because none of the participants were evaluable.	—	—
Change From Baseline in Serum C-peptide at Cycle 1 Day 8 (C1D8), C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and End of Treatment (EOT) Change at C6D1 (n=1, 0)	0.7 nanogram per milliliter (ng/mL) Standard Deviation NA Standard deviation was not estimable since only 1 participant was evaluable.	NA nanogram per milliliter (ng/mL) Results not reported because none of the participants were evaluable.	—	—
Change From Baseline in Serum C-peptide at Cycle 1 Day 8 (C1D8), C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and End of Treatment (EOT) Change at C7D1 (n=1, 0)	5.8 nanogram per milliliter (ng/mL) Standard Deviation NA Standard deviation was not estimable since only 1 participant was evaluable.	NA nanogram per milliliter (ng/mL) Results not reported because none of the participants were evaluable.	—	—
Change From Baseline in Serum C-peptide at Cycle 1 Day 8 (C1D8), C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and End of Treatment (EOT) Change at C8D1 (n=1, 0)	1.5 nanogram per milliliter (ng/mL) Standard Deviation NA Standard deviation was not estimable since only 1 participant was evaluable.	NA nanogram per milliliter (ng/mL) Results not reported because none of the participants were evaluable.	—	—
Change From Baseline in Serum C-peptide at Cycle 1 Day 8 (C1D8), C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and End of Treatment (EOT) Change at End of Treatment (n=6, 1)	3.4 nanogram per milliliter (ng/mL) Standard Deviation 2.21	0.9 nanogram per milliliter (ng/mL)	—	—

SECONDARY outcome

Timeframe: Baseline; 4 hours post-dose on C1D21

Population: Fresh tumor biopsy analysis set included all enrolled participants in the tumor biopsy cohort who started treatment and had baseline and on-treatment fresh tumor tissue successfully analyzed for at least 1 of the biomarkers. n=participants evaluable at specified time point. Only PF-04691502 8 mg treatment arm was evaluable for this outcome.

Fresh tumor biopsy samples analysis included assessment of status of proteins indicative of phosphoinositide 3-kinase/mammalian target of rapamycin (PI3K/mTOR) related pathways signaling status and cell cycle status. The biomarkers included phosphorylated activated kinase (AKT) S473, AKT T308, signal transducer and activator of transcription 3 (STAT3) and forkhead transcription factor Foxo1 (FKHR) T24/forkhead in rhabdomysacoma-like 1 (FKHRL1) T32. The method of analysis was reverse phase microarray (RPMA). The signal (normalized fluorescence unit \[NFU\]) for each pathway biomarker was normalized against the signal (NFU) for cytokeratin. The final concentration for each pathway biomarker was reported as a cytokeratin normalized fluorescence unit (NFC) value.

Outcome measures

Outcome measures
Measure	PF-04691502 2 mg n=5 Participants Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.	PF-04691502 4 mg Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.	PF-04691502 8 mg Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.	PF-04691502 11 mg Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
Change From Baseline in Fresh Tumor Biopsy Biomarkers at Cycle 1 Day 21 Baseline: AKT S473 (n=5)	98.5 NFC Standard Deviation 100.19	—	—	—
Change From Baseline in Fresh Tumor Biopsy Biomarkers at Cycle 1 Day 21 Baseline: AKT T308 (n=4)	102.9 NFC Standard Deviation 61.87	—	—	—
Change From Baseline in Fresh Tumor Biopsy Biomarkers at Cycle 1 Day 21 Baseline: FKHR T24 FKHRL1 T32 (n=5)	193.4 NFC Standard Deviation 120.50	—	—	—
Change From Baseline in Fresh Tumor Biopsy Biomarkers at Cycle 1 Day 21 Baseline: STAT3 (n=5)	260.9 NFC Standard Deviation 192.49	—	—	—
Change From Baseline in Fresh Tumor Biopsy Biomarkers at Cycle 1 Day 21 Change at C1D21: AKT S473 (n=5)	-72.6 NFC Standard Deviation 82.26	—	—	—
Change From Baseline in Fresh Tumor Biopsy Biomarkers at Cycle 1 Day 21 Change at C1D21: AKT T308 (n=4)	-48.6 NFC Standard Deviation 40.37	—	—	—
Change From Baseline in Fresh Tumor Biopsy Biomarkers at Cycle 1 Day 21 Change at C1D21: FKHR T24 FKHRL1 T32 (n=5)	-81.5 NFC Standard Deviation 47.70	—	—	—
Change From Baseline in Fresh Tumor Biopsy Biomarkers at Cycle 1 Day 21 Change at C1D21: STAT3 (n=5)	-112.2 NFC Standard Deviation 78.14	—	—	—

SECONDARY outcome

Timeframe: Baseline; pre-dose, 2, 4, 24 hours post-dose on C1D21

Population: Hair follicle analysis set included participants with hair follicles collected and analyzed for biomarkers at screening and on treatment. n=participants evaluable at specified time point. Only PF-04691502 8 mg treatment arm was evaluable for this outcome.

Hair follicle biopsy samples analysis included assessment of status of proteins indicative of PI3K/mTOR related pathways signaling status and cell cycle status. The analytes measured were phosphorylated AKT S473, AKT T308, KI67, STAT3 (Y705) and proline-rich Akt substrate of 40 kilodaltons at Thr246 (PRAS40 T246). The method of analysis was reverse phase microarray (RPMA). The signal for each biomarker expressed as normalized fluorescence intensity (NFI) was normalized by their respective total protein concentration. This normalization was performed by dividing the biomarker NFI by total protein concentration (mg/mL) of the sample printed to give total protein normalized fluorescence unit (NFU). All clinical sample test results are reported in NFU.

Outcome measures

Outcome measures
Measure	PF-04691502 2 mg n=10 Participants Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.	PF-04691502 4 mg Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.	PF-04691502 8 mg Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.	PF-04691502 11 mg Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
Change From Baseline in Hair Follicle Biopsy Biomarkers at Cycle 1 Day 21 Baseline: AKT S473 (n=10)	21.7 NFU Standard Deviation 10.47	—	—	—
Change From Baseline in Hair Follicle Biopsy Biomarkers at Cycle 1 Day 21 Baseline: AKT T308 (n=7)	50.3 NFU Standard Deviation 14.33	—	—	—
Change From Baseline in Hair Follicle Biopsy Biomarkers at Cycle 1 Day 21 Baseline: KI67 (n=6)	117.9 NFU Standard Deviation 41.19	—	—	—
Change From Baseline in Hair Follicle Biopsy Biomarkers at Cycle 1 Day 21 Baseline: PRAS40 (T246) (n=7)	136.7 NFU Standard Deviation 37.37	—	—	—
Change From Baseline in Hair Follicle Biopsy Biomarkers at Cycle 1 Day 21 Baseline: STAT3 (Y705) (n=7)	189.8 NFU Standard Deviation 46.52	—	—	—
Change From Baseline in Hair Follicle Biopsy Biomarkers at Cycle 1 Day 21 Change at 0 hour: AKT S473 (n=6)	-3.0 NFU Standard Deviation 8.63	—	—	—
Change From Baseline in Hair Follicle Biopsy Biomarkers at Cycle 1 Day 21 Change at 0 hour: AKT T308 (n=5)	-5.9 NFU Standard Deviation 12.21	—	—	—
Change From Baseline in Hair Follicle Biopsy Biomarkers at Cycle 1 Day 21 Change at 0 hour: KI67 (n=4)	2.0 NFU Standard Deviation 36.24	—	—	—
Change From Baseline in Hair Follicle Biopsy Biomarkers at Cycle 1 Day 21 Change at 0 hour: PRAS40 (T246) (n=6)	-3.7 NFU Standard Deviation 39.12	—	—	—
Change From Baseline in Hair Follicle Biopsy Biomarkers at Cycle 1 Day 21 Change at 0 hour: STAT3 (Y705) (n=4)	2.5 NFU Standard Deviation 39.98	—	—	—
Change From Baseline in Hair Follicle Biopsy Biomarkers at Cycle 1 Day 21 Change at 2 hours: AKT S473 (n=9)	-2.5 NFU Standard Deviation 5.47	—	—	—
Change From Baseline in Hair Follicle Biopsy Biomarkers at Cycle 1 Day 21 Change at 2 hours: AKT T308 (n=6)	-10.9 NFU Standard Deviation 13.00	—	—	—
Change From Baseline in Hair Follicle Biopsy Biomarkers at Cycle 1 Day 21 Change at 2 hours: KI67 (n=5)	-8.6 NFU Standard Deviation 32.67	—	—	—
Change From Baseline in Hair Follicle Biopsy Biomarkers at Cycle 1 Day 21 Change at 2 hours: PRAS40 (T246) (n=5)	-21.2 NFU Standard Deviation 28.91	—	—	—
Change From Baseline in Hair Follicle Biopsy Biomarkers at Cycle 1 Day 21 Change at 2 hours: STAT3 (Y705) (n=5)	21.4 NFU Standard Deviation 62.76	—	—	—
Change From Baseline in Hair Follicle Biopsy Biomarkers at Cycle 1 Day 21 Change at 4 hours: AKT S473 (n=7)	-2.9 NFU Standard Deviation 6.15	—	—	—
Change From Baseline in Hair Follicle Biopsy Biomarkers at Cycle 1 Day 21 Change at 4 hours: AKT T308 (n=5)	13.6 NFU Standard Deviation 29.98	—	—	—
Change From Baseline in Hair Follicle Biopsy Biomarkers at Cycle 1 Day 21 Change at 4 hours: KI67 (n=3)	27.0 NFU Standard Deviation 18.39	—	—	—
Change From Baseline in Hair Follicle Biopsy Biomarkers at Cycle 1 Day 21 Change at 4 hours: PRAS40 (T246) (n=5)	-15.7 NFU Standard Deviation 23.74	—	—	—
Change From Baseline in Hair Follicle Biopsy Biomarkers at Cycle 1 Day 21 Change at 4 hours: STAT3 (Y705) (n=5)	-9.3 NFU Standard Deviation 48.67	—	—	—
Change From Baseline in Hair Follicle Biopsy Biomarkers at Cycle 1 Day 21 Change at 24 hours: AKT S473 (n=7)	3.2 NFU Standard Deviation 9.46	—	—	—
Change From Baseline in Hair Follicle Biopsy Biomarkers at Cycle 1 Day 21 Change at 24 hours: AKT T308 (n=3)	7.1 NFU Standard Deviation 14.89	—	—	—
Change From Baseline in Hair Follicle Biopsy Biomarkers at Cycle 1 Day 21 Change at 24 hours: KI67 (n=4)	-12.2 NFU Standard Deviation 31.68	—	—	—
Change From Baseline in Hair Follicle Biopsy Biomarkers at Cycle 1 Day 21 Change at 24 hours: PRAS40 (T246) (n=6)	10.4 NFU Standard Deviation 45.68	—	—	—
Change From Baseline in Hair Follicle Biopsy Biomarkers at Cycle 1 Day 21 Change at 24 hours: STAT3 (Y705) (n=5)	-10.8 NFU Standard Deviation 65.89	—	—	—

SECONDARY outcome

Timeframe: Baseline; 4 hours post-dose on C1D21

Population: Baseline tumor tissue biomarker analysis set: all enrolled participants who started treatment, had baseline tumor tissues (archived paraffin block/unstained slides/fresh tumor tissue) analyzed for at least 1 of biomarkers. N (number of participants analyzed)=participants evaluable for this measure. n=participants evaluable at specified time point.

Biopsied tumor tissue was analyzed for alterations in the phosphoinositide-3-kinase/rat sarcoma (PI3K/RAS) signaling pathway by molecular approaches. The biomarkers studied were phosphoinositide-3-kinase, catalytic, alpha (PIK3CA) gene mutation, PIK3CA gene amplification, and phosphatase and tensin homolog (PTEN) protein deficiency status by immunohistochemistry.

Outcome measures

Outcome measures
Measure	PF-04691502 2 mg n=18 Participants Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.	PF-04691502 4 mg Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.	PF-04691502 8 mg Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.	PF-04691502 11 mg Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
Number of Participants With Mutation, Deletion, Amplification in Phosphatidylinositol 3-kinase (PI3K) Pathway Signaling Related Genes and/or Proteins in Biopsied Tumor Tissue PIK3CA mutation status: Detectable (n=17)	3 participants	—	—	—
Number of Participants With Mutation, Deletion, Amplification in Phosphatidylinositol 3-kinase (PI3K) Pathway Signaling Related Genes and/or Proteins in Biopsied Tumor Tissue PIK3CA mutation status: Undetectable (n=17)	14 participants	—	—	—
Number of Participants With Mutation, Deletion, Amplification in Phosphatidylinositol 3-kinase (PI3K) Pathway Signaling Related Genes and/or Proteins in Biopsied Tumor Tissue PTEN status: Present (n=18)	9 participants	—	—	—
Number of Participants With Mutation, Deletion, Amplification in Phosphatidylinositol 3-kinase (PI3K) Pathway Signaling Related Genes and/or Proteins in Biopsied Tumor Tissue PTEN status: Absent (n=18)	9 participants	—	—	—
Number of Participants With Mutation, Deletion, Amplification in Phosphatidylinositol 3-kinase (PI3K) Pathway Signaling Related Genes and/or Proteins in Biopsied Tumor Tissue PIK3CA amplification: Positive (n=17)	2 participants	—	—	—
Number of Participants With Mutation, Deletion, Amplification in Phosphatidylinositol 3-kinase (PI3K) Pathway Signaling Related Genes and/or Proteins in Biopsied Tumor Tissue PIK3CA amplification: Negative (n=17)	15 participants	—	—	—

SECONDARY outcome

Timeframe: Baseline, prior to Day 1 of Cycle every odd-numbered cycle or when progressive disease was suspected

Population: Response analysis set included all participants who started treatment and had an adequate baseline tumor assessment.

Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to response evaluation criteria in solid tumors version 1.1 (RECIST v1.1). Confirmed responses are those that persist on repeat imaging study \>=4 weeks after initial documentation of response. 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 \<10 mm). No new lesions. PR was defined as \>=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.

Outcome measures

Outcome measures
Measure	PF-04691502 2 mg n=3 Participants Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.	PF-04691502 4 mg n=3 Participants Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.	PF-04691502 8 mg n=26 Participants Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.	PF-04691502 11 mg n=4 Participants Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
Number of Participants With Objective Response	0 participants Interval 0.0 to 70.8	0 participants Interval 0.0 to 70.8	0 participants Interval 0.0 to 13.2	0 participants Interval 0.0 to 60.2

Adverse Events

PF-04691502 2 mg

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

PF-04691502 4 mg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

PF-04691502 8 mg

Serious events: 15 serious events

Other events: 24 other events

Deaths: 0 deaths

PF-04691502 11 mg

Serious events: 3 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER

Measure	PF-04691502 2 mg n=3 participants at risk Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.	PF-04691502 4 mg n=3 participants at risk Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.	PF-04691502 8 mg n=26 participants at risk Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.	PF-04691502 11 mg n=5 participants at risk Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
Gastrointestinal disorders Colitis	0.00% 0/3 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.8% 1/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/5 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Intestinal obstruction	33.3% 1/3 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/5 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Small intestinal obstruction	33.3% 1/3 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 2/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/5 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Vomiting	0.00% 0/3 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.8% 1/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/5 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Disease progression	0.00% 0/3 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	19.2% 5/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	20.0% 1/5 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Bacteraemia	0.00% 0/3 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.8% 1/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/5 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Pneumonia	0.00% 0/3 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	33.3% 1/3 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 2/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	20.0% 1/5 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/3 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.8% 1/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/5 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Transient ischaemic attack	0.00% 0/3 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.8% 1/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/5 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/3 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.8% 1/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/5 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 2/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/5 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/3 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.8% 1/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/5 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/3 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.8% 1/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/5 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Rash	0.00% 0/3 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.8% 1/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	20.0% 1/5 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Embolism	0.00% 0/3 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.8% 1/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/5 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.