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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00927823
Recruitment Status : Completed
First Posted : June 25, 2009
Results First Posted : August 12, 2014
Last Update Posted : August 12, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cancer
Intervention Drug: PF-04691502
Enrollment 37
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PF-04691502 2 mg PF-04691502 4 mg PF-04691502 8 mg PF-04691502 11 mg
Hide Arm/Group Description 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. 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. 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. 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.
Period Title: Lead-In Period
Started 3 3 26 5
Completed 3 3 26 5
Not Completed 0 0 0 0
Period Title: Continuous Dosing Period
Started 3 3 26 5
Treated 3 3 23 5
Completed 0 0 0 0
Not Completed 3 3 26 5
Reason Not Completed
Death             0             0             6             0
Lost to Follow-up             1             1             9             0
Withdrawal by Subject             1             0             2             2
Other             1             2             9             3
Arm/Group Title Entire Study Population
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 37
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 37 participants
59.6  (10.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants
Female
20
  54.1%
Male
17
  45.9%
1.Primary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Hide Description 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.
Time Frame Baseline up to 28 days after the last dose
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all enrolled participants who started the treatment.
Arm/Group Title PF-04691502 2 mg PF-04691502 4 mg PF-04691502 8 mg PF-04691502 11 mg
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 3 3 26 5
Measure Type: Number
Unit of Measure: participants
AEs 3 3 25 5
SAEs 2 1 15 3
2.Primary Outcome
Title Number of Participants With Dose Limiting Toxicities (DLTs)
Hide Description 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.
Time Frame Baseline up to Cycle 1 Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all enrolled participants who started the treatment.
Arm/Group Title PF-04691502 2 mg PF-04691502 4 mg PF-04691502 8 mg PF-04691502 11 mg
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 3 3 26 5
Measure Type: Number
Unit of Measure: participants
0 0 1 2
3.Primary Outcome
Title Recommended Phase-2 Dose (RP2D)
Hide Description RP2D was determined based on the safety profile and pharmacodynamic findings, as per investigator's discretion.
Time Frame Baseline up to Cycle 1 Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all enrolled participants who started the treatment.
Arm/Group Title PF-04691502
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 37
Measure Type: Number
Unit of Measure: milligram
8
4.Secondary Outcome
Title Maximum Observed Plasma Concentration (Cmax)
Hide Description 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).
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title PF-04691502 2 mg PF-04691502 4 mg PF-04691502 8 mg PF-04691502 11 mg
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 3 3 26 5
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram per milliliter (ng/mL)
Single Dose: Cmax (n=3, 3, 26, 5)
18.07
(13%)
58.29
(35%)
66.40
(41%)
82.51
(15%)
Multiple Dose: Cmax (n=3, 3, 20, 1)
26.30
(19%)
78.91
(25%)
102.3
(41%)
89.8 [1] 
(NA%)
[1]
Geometric coefficient of variation was not estimable since only 1 participant was evaluable.
5.Secondary Outcome
Title Time to Reach Maximum Observed Plasma Concentration (Tmax)
Hide Description 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).
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title PF-04691502 2 mg PF-04691502 4 mg PF-04691502 8 mg PF-04691502 11 mg
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 3 3 26 5
Median (Full Range)
Unit of Measure: hours
Single Dose: Tmax (n=3, 3, 26, 5)
4.00
(3.98 to 4.03)
0.683
(0.500 to 2.02)
2.03
(0.500 to 48.0)
4.07
(2.02 to 8.05)
Multiple Dose: Tmax (n=3, 3, 20, 1)
2.00
(1.00 to 4.00)
2.00
(2.00 to 2.08)
2.01
(0.500 to 6.67)
2.15
(2.15 to 2.15)
6.Secondary Outcome
Title Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Hide Description 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.
Time Frame Pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24, 48, 72, 96 hours post-dose in Lead-in period
Hide Outcome Measure Data
Hide Analysis Population Description
PK population included all randomized participants who received treatment and had at least 1 of the PK parameters of interest estimated.
Arm/Group Title PF-04691502 2 mg PF-04691502 4 mg PF-04691502 8 mg PF-04691502 11 mg
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 3 3 26 5
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*hr/mL
330.3
(20%)
734.4
(18%)
1130
(41%)
1320
(32%)
7.Secondary Outcome
Title Plasma Decay Half-Life (t1/2)
Hide Description 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).
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title PF-04691502 2 mg PF-04691502 4 mg PF-04691502 8 mg PF-04691502 11 mg
Hide Arm/Group Description:
Single oral dose of PF-04691502 2 milligram (mg) tablet in lead-in period (4 to 10 days prior to Day 1) followed by PF-04691502 2 mg tablet orally, once daily, continuously in 21-day cycles up to 1 year.
Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Day 1) followed by PF-04691502 4 mg tablet orally, once daily, continuously in 21-day cycles up to 1 year.
Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Day 1) followed by PF-04691502 8 mg tablet orally, once daily, continuously in 21-day cycles up to 1 year.
Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Day 1) followed by PF-04691502 11 mg tablet orally, once daily, continuously in 21-day cycles up to 1 year.
Overall Number of Participants Analyzed 3 3 26 5
Mean (Standard Deviation)
Unit of Measure: hours
Single Dose: t1/2 (n=3, 3, 26, 5) 13.23  (2.8746) 10.87  (0.90738) 13.77  (5.2150) 11.66  (1.7315)
Multiple Dose: t1/2 (n=1, 0, 5, 1) 9.19 [1]   (NA) NA [2]   (NA) 8.984  (0.70840) 7.83 [1]   (NA)
[1]
Standard deviation was not estimable since only 1 participant was evaluable.
[2]
Results not reported because none of the participants were evaluable.
8.Secondary Outcome
Title Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
Hide Description 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.
Time Frame Pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24, 48, 72, 96 hours post-dose in Lead-in period
Hide Outcome Measure Data
Hide Analysis Population Description
PK population included all randomized participants who received treatment and had at least 1 of the PK parameters of interest estimated.
Arm/Group Title PF-04691502 2 mg PF-04691502 4 mg PF-04691502 8 mg PF-04691502 11 mg
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 3 3 26 5
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*hr/mL
340.4
(18%)
741.6
(17%)
1150
(42%)
1328
(32%)
9.Secondary Outcome
Title Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)
Hide Description 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.
Time Frame Pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24 hrs post-dose on C1D21
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title PF-04691502 2 mg PF-04691502 4 mg PF-04691502 8 mg PF-04691502 11 mg
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 3 3 20 1
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*hr/mL
371.7
(5%)
966.4
(25%)
1287
(46%)
1020
10.Secondary Outcome
Title Number of Participants With Increase From Baseline in QT Interval Corrected Using Fridericia's Formula (QTcF)
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
QTc analysis set included all enrolled participants who had at least 1 ECG assessment after receiving PF-04691502.
Arm/Group Title PF-04691502 2 mg PF-04691502 4 mg PF-04691502 8 mg PF-04691502 11 mg
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 3 3 26 5
Measure Type: Number
Unit of Measure: participants
Maximum QTcF Interval Increase (Change <30 msec) 2 3 19 5
MaximumQTcF Interval Increase(Change>=30to<60msec) 1 0 7 0
Maximum QTcF Interval Increase (Change >=60 sec) 0 0 0 0
11.Secondary Outcome
Title Number of Participants With Maximum Post-dose QT Interval Corrected Using Fridericia's Formula (QTcF)
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
QTc analysis set included all enrolled participants had at least 1 ECG assessment after receiving PF-04691502.
Arm/Group Title PF-04691502 2 mg PF-04691502 4 mg PF-04691502 8 mg PF-04691502 11 mg
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 3 3 26 5
Measure Type: Number
Unit of Measure: participants
Maximum QTcF Interval (<450 msec) 2 3 18 2
Maximum QTcF Interval (450 to <480 msec) 1 0 5 3
Maximum QTcF Interval (480 to <500 msec) 0 0 3 0
Maximum QTcF Interval (>=500 msec) 0 0 0 0
12.Secondary Outcome
Title 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)
Hide Description Serum glucose level was measured following 4 hours fasting. EOT data included values from participants who came off-treatment before cycle 8.
Time Frame Baseline, C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and EOT
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title PF-04691502 2 mg PF-04691502 4 mg PF-04691502 8 mg PF-04691502 11 mg
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 3 3 25 5
Mean (Standard Deviation)
Unit of Measure: milligram per deciliter (mg/dL)
Baseline (n=3, 3, 25, 5) 87.7  (3.51) 84.3  (0.58) 87.3  (16.70) 91.8  (12.44)
Change at C1D8 (n=3, 3, 23, 5) 14.0  (7.55) 16.7  (27.59) 20.0  (25.77) 18.8  (5.26)
Change at C1D15 (n=3, 3, 21, 3) 16.7  (3.79) 11.7  (19.66) 17.0  (27.23) 99.3  (116.43)
Change at C2D1 (n=3, 3, 18, 1) 8.0  (13.53) 4.7  (14.57) 36.8  (37.60) 0.0 [1]   (NA)
Change at C2D15 (n=3, 3, 14, 1) 12.0  (10.15) 11.7  (16.77) 22.6  (28.68) 32.0 [1]   (NA)
Change at C3D1 (n=2, 2, 7, 0) 39.0  (26.87) 15.0  (28.28) 36.0  (26.34) NA [2]   (NA)
Change at C4D1 (n=2, 0, 4, 0) 10.5  (2.12) NA [2]   (NA) 35.0  (32.38) NA [2]   (NA)
Change at C5D1 (n=2, 0, 4, 0) 21.5  (6.36) NA [2]   (NA) 71.3  (57.66) NA [2]   (NA)
Change at C6D1 (n=2, 0, 4, 0) 19.0  (4.24) NA [2]   (NA) 7.0  (41.75) NA [2]   (NA)
Change at C7D1 (n=1, 0, 2, 0) 19.0 [1]   (NA) NA [2]   (NA) 50.5  (105.36) NA [2]   (NA)
Change at C8D1 (n=1, 0, 1, 0) 30.0 [1]   (NA) NA [2]   (NA) 8.0 [1]   (NA) NA [2]   (NA)
Change at End of Treatment (n=1, 0, 17, 3) 33.0 [1]   (NA) NA [2]   (NA) 43.1  (94.07) 13.7  (12.22)
[1]
Standard deviation was not estimable since only 1 participant was evaluable.
[2]
Results not reported because none of the participants were evaluable.
13.Secondary Outcome
Title 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)
Hide Description Serum insulin level was measured following 4 hours fasting. EOT data included values from participants who came off-treatment before cycle 8.
Time Frame Baseline, C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and EOT
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title PF-04691502 2 mg PF-04691502 4 mg PF-04691502 8 mg PF-04691502 11 mg
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 3 3 18 4
Mean (Standard Deviation)
Unit of Measure: micro International Unit/mL (mc IU/mL)
Baseline (n=3, 3, 18, 4) 6.2  (2.67) 5.8  (3.72) 8.0  (5.62) 21.4  (25.70)
Change at C1D8 (n=3, 3, 17, 2) 7.2  (4.17) 38.2  (56.39) 28.2  (27.34) 15.4  (15.13)
Change at C1D15 (n=3, 3, 16, 3) 5.6  (2.32) 8.6  (6.17) 25.2  (33.35) 60.5  (30.75)
Change at C2D1 (n=2, 3, 13, 0) 1.4  (1.08) 11.4  (8.17) 26.1  (17.25) NA [1]   (NA)
Change at C2D15 (n=3, 3, 10, 1) -0.1  (8.15) 12.0  (6.64) 12.3  (10.95) 29.2 [2]   (NA)
Change at C3D1 (n=2, 2, 4, 0) 36.0  (45.21) 14.8  (16.33) -1.0  (5.92) NA [1]   (NA)
Change at C4D1 (n=1, 0, 4, 0) 9.1 [2]   (NA) NA [1]   (NA) 20.3  (15.72) NA [1]   (NA)
Change at C5D1 (n=2, 0, 4, 0) 5.7  (1.91) NA [1]   (NA) 21.2  (14.38) NA [1]   (NA)
Change at C6D1 (n=1, 0, 4, 0) 1.0 [2]   (NA) NA [1]   (NA) 13.7  (10.53) NA [1]   (NA)
Change at C7D1 (n=0, 0, 2, 0) NA [1]   (NA) NA [1]   (NA) 10.4  (14.71) NA [1]   (NA)
Change at C8D1 (n=0, 0, 1, 0) NA [1]   (NA) NA [1]   (NA) 8.4 [2]   (NA) NA [1]   (NA)
Change at End of Treatment (n=1, 0, 10, 2) 9.0 [2]   (NA) NA [1]   (NA) 7.8  (14.05) 13.1  (3.89)
[1]
Results not reported because none of the participants were evaluable.
[2]
Standard deviation was not estimable since only 1 participant was evaluable.
14.Secondary Outcome
Title 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)
Hide Description Serum C-peptide level was measured following 4 hours fasting. EOT data included values from participants who came off-treatment before cycle 8.
Time Frame Baseline, C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and EOT
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title PF-04691502 8 mg PF-04691502 11 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 13 1
Mean (Standard Deviation)
Unit of Measure: nanogram per milliliter (ng/mL)
Baseline (n=13, 1) 3.1  (1.79) 3.7
Change at C1D8 (n=13, 1) 5.2  (3.36) 2.0
Change at C1D15 (n=12, 0) 4.4  (3.58) NA [1] 
Change at C2D1 (n=10, 0) 6.2  (3.33) NA [1] 
Change at C2D15 (n=8, 0) 4.5  (3.62) NA [1] 
Change at C3D1 (n=3, 0) 2.0  (1.35) NA [1] 
Change at C4D1 (n=1, 0) 4.9 [2]   (NA) NA [1] 
Change at C5D1 (n=1, 0) 4.8 [2]   (NA) NA [1] 
Change at C6D1 (n=1, 0) 0.7 [2]   (NA) NA [1] 
Change at C7D1 (n=1, 0) 5.8 [2]   (NA) NA [1] 
Change at C8D1 (n=1, 0) 1.5 [2]   (NA) NA [1] 
Change at End of Treatment (n=6, 1) 3.4  (2.21) 0.9
[1]
Results not reported because none of the participants were evaluable.
[2]
Standard deviation was not estimable since only 1 participant was evaluable.
15.Secondary Outcome
Title Change From Baseline in Fresh Tumor Biopsy Biomarkers at Cycle 1 Day 21
Hide Description 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.
Time Frame Baseline; 4 hours post-dose on C1D21
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title PF-04691502 8 mg
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: NFC
Baseline: AKT S473 (n=5) 98.5  (100.19)
Baseline: AKT T308 (n=4) 102.9  (61.87)
Baseline: FKHR T24 FKHRL1 T32 (n=5) 193.4  (120.50)
Baseline: STAT3 (n=5) 260.9  (192.49)
Change at C1D21: AKT S473 (n=5) -72.6  (82.26)
Change at C1D21: AKT T308 (n=4) -48.6  (40.37)
Change at C1D21: FKHR T24 FKHRL1 T32 (n=5) -81.5  (47.70)
Change at C1D21: STAT3 (n=5) -112.2  (78.14)
16.Secondary Outcome
Title Change From Baseline in Hair Follicle Biopsy Biomarkers at Cycle 1 Day 21
Hide Description 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.
Time Frame Baseline; pre-dose, 2, 4, 24 hours post-dose on C1D21
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title PF-04691502 8 mg
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: NFU
Baseline: AKT S473 (n=10) 21.7  (10.47)
Baseline: AKT T308 (n=7) 50.3  (14.33)
Baseline: KI67 (n=6) 117.9  (41.19)
Baseline: PRAS40 (T246) (n=7) 136.7  (37.37)
Baseline: STAT3 (Y705) (n=7) 189.8  (46.52)
Change at 0 hour: AKT S473 (n=6) -3.0  (8.63)
Change at 0 hour: AKT T308 (n=5) -5.9  (12.21)
Change at 0 hour: KI67 (n=4) 2.0  (36.24)
Change at 0 hour: PRAS40 (T246) (n=6) -3.7  (39.12)
Change at 0 hour: STAT3 (Y705) (n=4) 2.5  (39.98)
Change at 2 hours: AKT S473 (n=9) -2.5  (5.47)
Change at 2 hours: AKT T308 (n=6) -10.9  (13.00)
Change at 2 hours: KI67 (n=5) -8.6  (32.67)
Change at 2 hours: PRAS40 (T246) (n=5) -21.2  (28.91)
Change at 2 hours: STAT3 (Y705) (n=5) 21.4  (62.76)
Change at 4 hours: AKT S473 (n=7) -2.9  (6.15)
Change at 4 hours: AKT T308 (n=5) 13.6  (29.98)
Change at 4 hours: KI67 (n=3) 27.0  (18.39)
Change at 4 hours: PRAS40 (T246) (n=5) -15.7  (23.74)
Change at 4 hours: STAT3 (Y705) (n=5) -9.3  (48.67)
Change at 24 hours: AKT S473 (n=7) 3.2  (9.46)
Change at 24 hours: AKT T308 (n=3) 7.1  (14.89)
Change at 24 hours: KI67 (n=4) -12.2  (31.68)
Change at 24 hours: PRAS40 (T246) (n=6) 10.4  (45.68)
Change at 24 hours: STAT3 (Y705) (n=5) -10.8  (65.89)
17.Secondary Outcome
Title Number of Participants With Mutation, Deletion, Amplification in Phosphatidylinositol 3-kinase (PI3K) Pathway Signaling Related Genes and/or Proteins in Biopsied Tumor Tissue
Hide Description 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.
Time Frame Baseline; 4 hours post-dose on C1D21
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title PF-04691502
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: participants
PTEN status: Present (n=18) 9
PTEN status: Absent (n=18) 9
PIK3CA amplification: Positive (n=17) 2
PIK3CA amplification: Negative (n=17) 15
PIK3CA mutation status: Detectable (n=17) 3
PIK3CA mutation status: Undetectable (n=17) 14
18.Secondary Outcome
Title Number of Participants With Objective Response
Hide Description 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.
Time Frame Baseline, prior to Day 1 of Cycle every odd-numbered cycle or when progressive disease was suspected
Hide Outcome Measure Data
Hide Analysis Population Description
Response analysis set included all participants who started treatment and had an adequate baseline tumor assessment.
Arm/Group Title PF-04691502 2 mg PF-04691502 4 mg PF-04691502 8 mg PF-04691502 11 mg
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 3 3 26 4
Measure Type: Number
Unit of Measure: participants
0 0 0 0
Time Frame [Not Specified]
Adverse Event Reporting Description 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.
 
Arm/Group Title PF-04691502 2 mg PF-04691502 4 mg PF-04691502 8 mg PF-04691502 11 mg
Hide Arm/Group Description 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. 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. 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. 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.
All-Cause Mortality
PF-04691502 2 mg PF-04691502 4 mg PF-04691502 8 mg PF-04691502 11 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
PF-04691502 2 mg PF-04691502 4 mg PF-04691502 8 mg PF-04691502 11 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/3 (66.67%)   1/3 (33.33%)   15/26 (57.69%)   3/5 (60.00%) 
Gastrointestinal disorders         
Colitis * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Intestinal obstruction * 1  1/3 (33.33%)  0/3 (0.00%)  0/26 (0.00%)  0/5 (0.00%) 
Small intestinal obstruction * 1  1/3 (33.33%)  0/3 (0.00%)  2/26 (7.69%)  0/5 (0.00%) 
Vomiting * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
General disorders         
Disease progression * 1  0/3 (0.00%)  0/3 (0.00%)  5/26 (19.23%)  1/5 (20.00%) 
Infections and infestations         
Bacteraemia * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Pneumonia * 1  0/3 (0.00%)  1/3 (33.33%)  2/26 (7.69%)  1/5 (20.00%) 
Metabolism and nutrition disorders         
Hypercalcaemia * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Nervous system disorders         
Transient ischaemic attack * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Acute respiratory distress syndrome * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Dyspnoea * 1  0/3 (0.00%)  0/3 (0.00%)  2/26 (7.69%)  0/5 (0.00%) 
Pneumonitis * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Pulmonary embolism * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Skin and subcutaneous tissue disorders         
Rash * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  1/5 (20.00%) 
Vascular disorders         
Embolism * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v15.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
PF-04691502 2 mg PF-04691502 4 mg PF-04691502 8 mg PF-04691502 11 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/3 (100.00%)   3/3 (100.00%)   24/26 (92.31%)   5/5 (100.00%) 
Blood and lymphatic system disorders         
Anaemia * 1  1/3 (33.33%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Leukocytosis * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Leukopenia * 1  0/3 (0.00%)  0/3 (0.00%)  0/26 (0.00%)  1/5 (20.00%) 
Lymphopenia * 1  0/3 (0.00%)  0/3 (0.00%)  5/26 (19.23%)  0/5 (0.00%) 
Neutropenia * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Thrombocytopenia * 1  0/3 (0.00%)  0/3 (0.00%)  2/26 (7.69%)  1/5 (20.00%) 
Cardiac disorders         
Nodal rhythm * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Palpitations * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Sinus bradycardia * 1  0/3 (0.00%)  0/3 (0.00%)  2/26 (7.69%)  0/5 (0.00%) 
Sinus tachycardia * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Tachycardia * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Ear and labyrinth disorders         
Deafness * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Ear pain * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Hypoacusis * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Tinnitus * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Endocrine disorders         
Hypothyroidism * 1  1/3 (33.33%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Eye disorders         
Conjunctivitis * 1  0/3 (0.00%)  0/3 (0.00%)  2/26 (7.69%)  0/5 (0.00%) 
Dry eye * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Vision blurred * 1  0/3 (0.00%)  0/3 (0.00%)  2/26 (7.69%)  0/5 (0.00%) 
Visual acuity reduced * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Visual impairment * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Gastrointestinal disorders         
Abdominal discomfort * 1  0/3 (0.00%)  0/3 (0.00%)  2/26 (7.69%)  0/5 (0.00%) 
Abdominal hernia * 1  1/3 (33.33%)  0/3 (0.00%)  0/26 (0.00%)  0/5 (0.00%) 
Abdominal pain * 1  2/3 (66.67%)  0/3 (0.00%)  3/26 (11.54%)  1/5 (20.00%) 
Abdominal pain upper * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  1/5 (20.00%) 
Anorectal discomfort * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Chapped lips * 1  0/3 (0.00%)  0/3 (0.00%)  0/26 (0.00%)  1/5 (20.00%) 
Constipation * 1  2/3 (66.67%)  0/3 (0.00%)  3/26 (11.54%)  1/5 (20.00%) 
Diarrhoea * 1  2/3 (66.67%)  1/3 (33.33%)  8/26 (30.77%)  1/5 (20.00%) 
Dry mouth * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  1/5 (20.00%) 
Dyspepsia * 1  2/3 (66.67%)  0/3 (0.00%)  3/26 (11.54%)  1/5 (20.00%) 
Dysphagia * 1  0/3 (0.00%)  0/3 (0.00%)  2/26 (7.69%)  0/5 (0.00%) 
Gastritis * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Gastrointestinal pain * 1  1/3 (33.33%)  0/3 (0.00%)  0/26 (0.00%)  0/5 (0.00%) 
Gastrooesophageal reflux disease * 1  2/3 (66.67%)  1/3 (33.33%)  2/26 (7.69%)  0/5 (0.00%) 
Glossodynia * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Haemorrhoids * 1  2/3 (66.67%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Irritable bowel syndrome * 1  1/3 (33.33%)  0/3 (0.00%)  0/26 (0.00%)  0/5 (0.00%) 
Melaena * 1  1/3 (33.33%)  0/3 (0.00%)  0/26 (0.00%)  0/5 (0.00%) 
Nausea * 1  3/3 (100.00%)  3/3 (100.00%)  15/26 (57.69%)  2/5 (40.00%) 
Oral pain * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Tongue disorder * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Toothache * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Vomiting * 1  3/3 (100.00%)  1/3 (33.33%)  8/26 (30.77%)  2/5 (40.00%) 
General disorders         
Asthenia * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  1/5 (20.00%) 
Chills * 1  0/3 (0.00%)  1/3 (33.33%)  3/26 (11.54%)  1/5 (20.00%) 
Disease progression * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Early satiety * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  1/5 (20.00%) 
Fatigue * 1  1/3 (33.33%)  1/3 (33.33%)  17/26 (65.38%)  4/5 (80.00%) 
Feeling hot * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Local swelling * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Mucosal inflammation * 1  0/3 (0.00%)  0/3 (0.00%)  5/26 (19.23%)  2/5 (40.00%) 
Oedema * 1  0/3 (0.00%)  0/3 (0.00%)  2/26 (7.69%)  1/5 (20.00%) 
Oedema peripheral * 1  0/3 (0.00%)  0/3 (0.00%)  4/26 (15.38%)  0/5 (0.00%) 
Pain * 1  1/3 (33.33%)  0/3 (0.00%)  4/26 (15.38%)  0/5 (0.00%) 
Pyrexia * 1  0/3 (0.00%)  0/3 (0.00%)  5/26 (19.23%)  1/5 (20.00%) 
Thirst * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Hepatobiliary disorders         
Hyperbilirubinaemia * 1  1/3 (33.33%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Immune system disorders         
Seasonal allergy * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Infections and infestations         
Bacteraemia * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Candidiasis * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Chronic sinusitis * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Infection * 1  0/3 (0.00%)  1/3 (33.33%)  0/26 (0.00%)  1/5 (20.00%) 
Liver abscess * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Oral candidiasis * 1  0/3 (0.00%)  0/3 (0.00%)  0/26 (0.00%)  1/5 (20.00%) 
Oral herpes * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Pneumonia * 1  0/3 (0.00%)  0/3 (0.00%)  3/26 (11.54%)  0/5 (0.00%) 
Urinary tract infection * 1  0/3 (0.00%)  0/3 (0.00%)  3/26 (11.54%)  2/5 (40.00%) 
Viral infection * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Injury, poisoning and procedural complications         
Contusion * 1  0/3 (0.00%)  0/3 (0.00%)  2/26 (7.69%)  0/5 (0.00%) 
Fall * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Mouth injury * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Post procedural fistula * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Post procedural haemorrhage * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Procedural pain * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Investigations         
Activated partial thromboplastin time prolonged * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Alanine aminotransferase increased * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Aspartate aminotransferase increased * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Blood alkaline phosphatase increased * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Blood creatinine increased * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Blood lactate dehydrogenase increased * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Breath sounds abnormal * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Electrocardiogram QT prolonged * 1  1/3 (33.33%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Eosinophil count increased * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Glycosylated haemoglobin increased * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
International normalised ratio increased * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Platelet count decreased * 1  1/3 (33.33%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Troponin increased * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Urine output decreased * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Weight decreased * 1  1/3 (33.33%)  0/3 (0.00%)  3/26 (11.54%)  0/5 (0.00%) 
Metabolism and nutrition disorders         
Decreased appetite * 1  1/3 (33.33%)  2/3 (66.67%)  11/26 (42.31%)  3/5 (60.00%) 
Dehydration * 1  0/3 (0.00%)  0/3 (0.00%)  2/26 (7.69%)  1/5 (20.00%) 
Hypercholesterolaemia * 1  1/3 (33.33%)  0/3 (0.00%)  0/26 (0.00%)  0/5 (0.00%) 
Hyperglycaemia * 1  2/3 (66.67%)  0/3 (0.00%)  10/26 (38.46%)  1/5 (20.00%) 
Hypoalbuminaemia * 1  1/3 (33.33%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Hypokalaemia * 1  1/3 (33.33%)  0/3 (0.00%)  6/26 (23.08%)  0/5 (0.00%) 
Hyponatraemia * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  2/5 (40.00%) 
Hypophosphataemia * 1  0/3 (0.00%)  0/3 (0.00%)  0/26 (0.00%)  1/5 (20.00%) 
Iron deficiency * 1  1/3 (33.33%)  0/3 (0.00%)  0/26 (0.00%)  0/5 (0.00%) 
Lactic acidosis * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Polydipsia * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Musculoskeletal and connective tissue disorders         
Arthralgia * 1  0/3 (0.00%)  0/3 (0.00%)  3/26 (11.54%)  0/5 (0.00%) 
Arthritis * 1  1/3 (33.33%)  0/3 (0.00%)  0/26 (0.00%)  0/5 (0.00%) 
Arthropathy * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Back pain * 1  0/3 (0.00%)  0/3 (0.00%)  2/26 (7.69%)  0/5 (0.00%) 
Bone pain * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Flank pain * 1  0/3 (0.00%)  0/3 (0.00%)  0/26 (0.00%)  1/5 (20.00%) 
Intervertebral disc degeneration * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Muscle spasms * 1  0/3 (0.00%)  0/3 (0.00%)  3/26 (11.54%)  0/5 (0.00%) 
Musculoskeletal chest pain * 1  0/3 (0.00%)  1/3 (33.33%)  1/26 (3.85%)  0/5 (0.00%) 
Musculoskeletal discomfort * 1  0/3 (0.00%)  0/3 (0.00%)  2/26 (7.69%)  0/5 (0.00%) 
Musculoskeletal pain * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Myalgia * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Neck pain * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Osteoarthritis * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Osteoporosis * 1  1/3 (33.33%)  0/3 (0.00%)  0/26 (0.00%)  0/5 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Cancer pain * 1  0/3 (0.00%)  0/3 (0.00%)  0/26 (0.00%)  1/5 (20.00%) 
Malignant pleural effusion * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Nervous system disorders         
Balance disorder * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Convulsion * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Dizziness * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  1/5 (20.00%) 
Dysgeusia * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Headache * 1  1/3 (33.33%)  1/3 (33.33%)  4/26 (15.38%)  2/5 (40.00%) 
Hypoaesthesia * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Neuropathy peripheral * 1  2/3 (66.67%)  0/3 (0.00%)  3/26 (11.54%)  1/5 (20.00%) 
Paraesthesia * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Sinus headache * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Trigeminal neuralgia * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Psychiatric disorders         
Agitation * 1  0/3 (0.00%)  0/3 (0.00%)  0/26 (0.00%)  1/5 (20.00%) 
Anxiety * 1  1/3 (33.33%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Depression * 1  1/3 (33.33%)  0/3 (0.00%)  3/26 (11.54%)  0/5 (0.00%) 
Insomnia * 1  1/3 (33.33%)  0/3 (0.00%)  5/26 (19.23%)  0/5 (0.00%) 
Renal and urinary disorders         
Dysuria * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Nocturia * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Polyuria * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Proteinuria * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  1/5 (20.00%) 
Renal failure acute * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Reproductive system and breast disorders         
Sexual dysfunction * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Asthma * 1  1/3 (33.33%)  0/3 (0.00%)  0/26 (0.00%)  0/5 (0.00%) 
Cough * 1  0/3 (0.00%)  0/3 (0.00%)  3/26 (11.54%)  1/5 (20.00%) 
Dysphonia * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Dyspnoea * 1  0/3 (0.00%)  0/3 (0.00%)  4/26 (15.38%)  2/5 (40.00%) 
Dyspnoea exertional * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Epistaxis * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  1/5 (20.00%) 
Haemoptysis * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Hypoxia * 1  0/3 (0.00%)  0/3 (0.00%)  2/26 (7.69%)  0/5 (0.00%) 
Oropharyngeal pain * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Pulmonary congestion * 1  0/3 (0.00%)  0/3 (0.00%)  0/26 (0.00%)  1/5 (20.00%) 
Skin and subcutaneous tissue disorders         
Cold sweat * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Dermatitis acneiform * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Dry skin * 1  0/3 (0.00%)  0/3 (0.00%)  4/26 (15.38%)  0/5 (0.00%) 
Generalised erythema * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Hair texture abnormal * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Hyperhidrosis * 1  0/3 (0.00%)  0/3 (0.00%)  0/26 (0.00%)  1/5 (20.00%) 
Palmar-plantar erythrodysaesthesia syndrome * 1  0/3 (0.00%)  0/3 (0.00%)  0/26 (0.00%)  1/5 (20.00%) 
Pruritus * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Rash * 1  0/3 (0.00%)  0/3 (0.00%)  7/26 (26.92%)  2/5 (40.00%) 
Rash generalised * 1  0/3 (0.00%)  0/3 (0.00%)  2/26 (7.69%)  0/5 (0.00%) 
Rash macular * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Rash maculo-papular * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Rash papular * 1  0/3 (0.00%)  0/3 (0.00%)  0/26 (0.00%)  1/5 (20.00%) 
Skin discolouration * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Skin lesion * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Swelling face * 1  0/3 (0.00%)  0/3 (0.00%)  2/26 (7.69%)  0/5 (0.00%) 
Vascular disorders         
Deep vein thrombosis * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
Flushing * 1  0/3 (0.00%)  0/3 (0.00%)  2/26 (7.69%)  0/5 (0.00%) 
Hypertension * 1  1/3 (33.33%)  0/3 (0.00%)  3/26 (11.54%)  0/5 (0.00%) 
Hypotension * 1  0/3 (0.00%)  0/3 (0.00%)  2/26 (7.69%)  1/5 (20.00%) 
Thrombosis * 1  0/3 (0.00%)  0/3 (0.00%)  1/26 (3.85%)  0/5 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v15.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00927823     History of Changes
Other Study ID Numbers: B1271001
First Submitted: June 23, 2009
First Posted: June 25, 2009
Results First Submitted: July 18, 2014
Results First Posted: August 12, 2014
Last Update Posted: August 12, 2014