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Trial record 1 of 1 for:    NCT00965731
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Erlotinib Is Being Studied With Or Without An Investigational Drug, PF-02341066, In Patients With Lung Cancer

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: NCT00965731
Recruitment Status : Completed
First Posted : August 26, 2009
Results First Posted : January 14, 2013
Last Update Posted : October 28, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non-Small Cell Lung Cancer
Interventions Drug: Erlotinib
Drug: PF-02341066
Enrollment 27
Recruitment Details  
Pre-assignment Details This study was planned to include 2 phases; phase 1 was a dose escalation safety and pharmacokinetic (PK) study followed by a randomized phase 2 efficacy and safety study. The study was discontinued and phase 2 not started; no participants were enrolled in that phase of the study.
Arm/Group Title PF-02341066 (200 mg) and Erlotinib (100 mg) PF-02341066 (150 mg) and Erlotinib (100 mg)
Hide Arm/Group Description PF-02341066 200 milligrams (mg) administered orally twice daily (BID) in combination with erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD. PF-02341066 150 mg administered orally BID in combination with erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
Period Title: Overall Study
Started 7 20 [1]
Completed 0 0
Not Completed 7 20
Reason Not Completed
Death             0             4
Withdrawal by Subject             0             1
Other             7             15
[1]
Dose level given only after lower dose was successfully administered
Arm/Group Title PF-02341066 (200 mg) and Erlotinib (100 mg) PF-02341066 (150 mg) and Erlotinib (100 mg) Total
Hide Arm/Group Description PF-02341066 200 milligrams (mg) administered orally twice daily (BID) in combination with erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD. PF-02341066 150 mg administered orally BID in combination with erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD. Total of all reporting groups
Overall Number of Baseline Participants 7 20 27
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 7 participants 20 participants 27 participants
18 to 44 years 1 0 1
45 to 64 years 5 11 16
greater than or equal to (≥) 65 1 9 10
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 20 participants 27 participants
Female
6
  85.7%
13
  65.0%
19
  70.4%
Male
1
  14.3%
7
  35.0%
8
  29.6%
1.Primary Outcome
Title Number of Participants With Dose-Limiting Toxicities (DLT) (Phase 1)
Hide Description Phase 1, first cycle DLT includes Grade (Gr) ≥4 hematologic possible drug-related toxicities and Gr ≥3 possible drug-related febrile neutropenia. Gr ≥3 non-hematological possible drug-related toxicities (except asymptomatic lab value elevation). Gr 3/4 nausea, vomiting or diarrhea. Gr 3 hypertension considered DLT if event unmanageable by approved pharmacologic agents or symptomatic sequelae despite medical intervention. Diagnosis of interstitial lung disease. Inability to deliver at least 80 percent (%) of planned dose during cycle 1 due to possible drug-related adverse events (AEs).
Time Frame Baseline up to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
DLT evaluable population: all participants in dose escalation phase receiving at least 1 dose of study medication who did not have a major treatment deviation during the first cycle (for example, less than 80% of planned dose of PF-02341066 or erlotinib in cycle 1 for reasons other than treatment-related toxicities)
Arm/Group Title PF-02341066 (200 mg) and Erlotinib (100 mg) PF-02341066 (150 mg) and Erlotinib (100 mg)
Hide Arm/Group Description:
PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
Overall Number of Participants Analyzed 6 16
Measure Type: Number
Unit of Measure: participants
2 3
2.Primary Outcome
Title Progression-Free Survival (Phase 2)
Hide Description Time in weeks from phase 2 study randomization to first documentation of objective disease progression or death due to any cause. Progression-Free Survival was calculated as (first event date minus randomization date plus 1) divided by 7.02. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from AE data (where the outcome was "Death"; date of death reported in notice of death was used).
Time Frame Baseline, every 42 days up to 20 months, disease progression, or unacceptable toxicity
Hide Outcome Measure Data
Hide Analysis Population Description
Not analyzed due to phase 2 study termination
Arm/Group Title PF-02341066 and Erlotinib Erlotinib
Hide Arm/Group Description:
PF-02341066 (BID) and erlotinib (QD) administered at the recommended Phase 2 dose (RP2D) in continuous 21-day cycles.
Erlotinib 150 mg was to be administered orally QD in continuous 21-day cycles
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title PF-02341066 (Crizotinib) Area Under the Concentration-Time Curve During Dosing Interval (AUCtau) (Phase 1)
Hide Description AUCtau is a measure of the plasma exposure to PF-02341066. In this study, it is used to characterize PF-02341066 exposure after a single dose (Cycle 1 Day 1) and multiple doses (Cycle1 Day 15) of PF-02341066 were administered in combination of Erlotinib.
Time Frame Cycle 1 (C1) Day 1 (D1) i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) parameter analysis population included all participants in safety analysis set 1 who had at least 1 of the PK parameters of interest. Number of participants analyzed section in below table includes number of participants in PK analysis population. N=number of participants in treatment group contributing to summary statistics.
Arm/Group Title PF-02341066 (200 mg) and Erlotinib (100 mg) PF-02341066 (150 mg) and Erlotinib (100 mg)
Hide Arm/Group Description:
PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
Overall Number of Participants Analyzed 7 19
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*hr/mL
C1D1 Crizotinib (N=7, 19)
581.9
(49%)
400.3
(40%)
C1D15 Crizotinib (N=5, 14)
2274
(43%)
1720
(40%)
4.Secondary Outcome
Title PF-02341066 (Crizotinib) Maximum Observed Plasma Concentration (Cmax) (Phase 1)
Hide Description Cmax is a measure of the plasma exposure to PF-02341066. In this study, it is used to characterize PF-02341066 exposure after a single dose (Cycle 1 Day 1) and multiple doses (Cycle 1 Day 15) of PF-02341066 were administered in combination of Erlotinib
Time Frame C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) parameter analysis population included all participants in safety analysis set 1 who had at least 1 of the PK parameters of interest. Number of participants analyzed section in below table includes number of participants in PK analysis population. N=number of participants in treatment group contributing to summary statistics.
Arm/Group Title PF-02341066 (200 mg) and Erlotinib (100 mg) PF-02341066 (150 mg) and Erlotinib (100 mg)
Hide Arm/Group Description:
PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
Overall Number of Participants Analyzed 7 19
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
C1D1 Crizotinib (N=7, 19)
86.75
(37%)
65.31
(50%)
C1D15 Crizotinib (N=5, 14)
251.0
(46%)
185.9
(40%)
5.Secondary Outcome
Title PF-02341066 (Crizotinib) Apparent Oral Clearance (CL/F) (Phase 1)
Hide Description Apparent oral Clearance is a measure of combination of the rate at which a drug is removed from the blood (CL) and the bioavailability (F) after oral dose. In this study, It is used to characterize PF-02341066 CL/F after multiple doses (Cycle 1 Day 15) of PF-02341066 were administered in combination of Erlotinib.
Time Frame C1D15 i.e., 15 days of giving crizotinib and erlotinib
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic (PK) parameter analysis population was defined as all participants in the safety analysis set 1 who had at least 1 of the PK parameters of interest.
Arm/Group Title PF-02341066 (200 mg) and Erlotinib (100 mg) PF-02341066 (150 mg) and Erlotinib (100 mg)
Hide Arm/Group Description:
PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
Overall Number of Participants Analyzed 5 14
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: L/hr
88.02
(43%)
87.20
(40%)
6.Secondary Outcome
Title PF-06260182 Area Under the Concentration-Time Curve During Dosing Interval (AUCtau) (Phase 1)
Hide Description AUCtau is a measure of the plasma exposure to PF-06260182, a PF-02341066 metabolite. In this study, it is used to characterize the metabolite exposure after a single dose (Cycle 1 Day 1) and multiple doses (Cycle 1 Day 15) of PF-02341066 were administered in combination of Erlotinib.
Time Frame C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) parameter analysis population included all participants in safety analysis set 1 who had at least 1 of the PK parameters of interest. Number of participants analyzed section in below table includes number of participants in PK analysis population. N=number of participants in treatment group contributing to summary statistics.
Arm/Group Title PF-02341066 (200 mg) and Erlotinib (100 mg) PF-02341066 (150 mg) and Erlotinib (100 mg)
Hide Arm/Group Description:
PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
Overall Number of Participants Analyzed 7 19
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*hr/mL
C1D1 PF-06260182 (N=7, 19)
16.48
(58%)
14.03
(72%)
C1D15 PF-06260182 (N=5, 14)
60.36
(63%)
57.77
(66%)
7.Secondary Outcome
Title PF-06260182 Maximum Observed Plasma Concentration (Cmax) (Phase 1)
Hide Description Cmax is a measure of the plasma exposure to PF-06260182, a PF-02341066 metabolite. In this study, it is used to characterize the metabolite exposure after a single dose (Cycle 1 Day 1) and multiple doses (Cycle 1 Day 15) of PF-02341066 were administered in combination of Erlotinib.
Time Frame C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) parameter analysis population included all participants in safety analysis set 1 who had at least 1 of the PK parameters of interest. Number of participants analyzed section in below table includes number of participants in PK analysis population. N=number of participants in treatment group contributing to summary statistics.
Arm/Group Title PF-02341066 (200 mg) and Erlotinib (100 mg) PF-02341066 (150 mg) and Erlotinib (100 mg)
Hide Arm/Group Description:
PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
Overall Number of Participants Analyzed 7 19
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
C1D1 PF-06260182 (N=7, 19)
2.625
(49%)
2.087
(63%)
C1D15 PF-06260182 (N=5, 14)
7.093
(54%)
6.508
(63%)
8.Secondary Outcome
Title Molecular Weight Adjusted PF-06260182-to-PF-02341006 Ratio of AUCtau (Phase 1)
Hide Description Molecular weight adjusted PF-06260182-to-PF-02341006 ratio of AUCtau is a measure of how much PF-02341066 (parent drug) was converted to the metabolite PF-06260182 after PF-02341066 dosing. In this study, it is used to characterize the metabolite-to-parent ratio exposure after a single dose (Cycle 1 Day 1) and multiple doses (Cycle 1 Day 15) of PF-02341066 were administered in combination of Erlotinib.
Time Frame C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) parameter analysis population included all participants in safety analysis set 1 who had at least 1 of the PK parameters of interest. Number of participants analyzed section in below table includes number of participants in PK analysis population. N=number of participants in treatment group contributing to summary statistics.
Arm/Group Title PF-02341066 (200 mg) and Erlotinib (100 mg) PF-02341066 (150 mg) and Erlotinib (100 mg)
Hide Arm/Group Description:
PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
Overall Number of Participants Analyzed 7 19
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio
C1D1 (N=7, 19)
0.02748
(23%)
0.03395
(45%)
C1D15 (N=5, 14)
0.02574
(27%)
0.03258
(31%)
9.Secondary Outcome
Title Erlotinib Area Under the Concentration-Time Curve During Dosing Interval (AUCtau) (Phase 1)
Hide Description AUCtau is a measure of the plasma exposure to erlotinib. In this study, it is used to characterize erlotinib exposure after multiple doses of erlotinib were administered alone (Day -1) and in combination of PF-02341066 (Cycle 1 Day 1 and Day 15).
Time Frame C1D-1 i.e., 1 day prior to initiation of continuous dosing of crizotinib; C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) parameter analysis population included all participants in safety analysis set 1 who had at least 1 of the PK parameters of interest. Number of participants analyzed section in below table includes number of participants in PK analysis population. N=number of participants in treatment group contributing to summary statistics.
Arm/Group Title PF-02341066 (200 mg) and Erlotinib (100 mg) PF-02341066 (150 mg) and Erlotinib (100 mg)
Hide Arm/Group Description:
PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
Overall Number of Participants Analyzed 7 19
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*hr/mL
C1D-1 Erlotinib Alone (N=7,19)
23490
(31%)
26880
(39%)
C1D1 Erlotinib+Crizotinib Single Dose (N=7,19)
26520
(25%)
30040
(39%)
C1D15 Erlotinib+Crizotinib Multiple Doses (N=5,14)
41770
(27%)
38910
(49%)
10.Secondary Outcome
Title Erlotinib Maximum Observed Plasma Concentration (Cmax) (Phase 1)
Hide Description Cmax is a measure of the plasma exposure to erlotinib. In this study, it is used to characterize erlotinib exposure after multiple doses of erlotinib were administered alone (Day -1) and in combination of PF-02341066 (Cycle 1 Day 1 and Day 15).
Time Frame C1D-1 i.e., 1 day prior to initiation of continuous dosing of crizotinib; C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) parameter analysis population included all participants in safety analysis set 1 who had at least 1 of the PK parameters of interest. Number of participants analyzed section in below table includes number of participants in PK analysis population. N=number of participants in treatment group contributing to summary statistics.
Arm/Group Title PF-02341066 (200 mg) and Erlotinib (100 mg) PF-02341066 (150 mg) and Erlotinib (100 mg)
Hide Arm/Group Description:
PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
Overall Number of Participants Analyzed 7 19
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
C1D-1 Erlotinib Alone (N=7,19)
1593
(26%)
1797
(36%)
C1D1 Erlotinib+Crizotinib Single Dose (N=7,19)
1452
(21%)
1723
(38%)
C1D15 Erlotinib+Crizotinib Multiple Doses (N=5,14)
2546
(24%)
2346
(43%)
11.Secondary Outcome
Title Erlotinib Apparent Oral Clearance (CL/F) (Phase 1)
Hide Description Apparent oral Clearance is a measure of combination of the rate at which a drug is removed from the blood (CL) and the bioavailability (F) after oral dose. In this study, it is used to characterize erlotinib CL/F after multiple doses in combination with PF-02341066 (Cycle 1 Day 15).
Time Frame C1D15 i.e., 15 days of giving crizotinib and erlotinib
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic (PK) parameter analysis population was defined as all participants in the safety analysis set 1 who had at least 1 of the PK parameters of interest.
Arm/Group Title PF-02341066 (200 mg) and Erlotinib (100 mg) PF-02341066 (150 mg) and Erlotinib (100 mg)
Hide Arm/Group Description:
PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
Overall Number of Participants Analyzed 5 14
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: L/hr
2.395
(27%)
2.572
(49%)
12.Secondary Outcome
Title Ratio of Adjusted Means of Erlotinib AUCtau (Crizotinib + Erlotinib / Erlotinib Alone) (Phase 1)
Hide Description Ratio of adjusted means of Erlotinib AUCtau (Crizotinib + Erlotinib / Erlotinib Alone) is a measure of the plasma exposure to erlotinib after erlotinib dosing with crizotinib compared with that after erlotinib dosing alone. In this study, it is used to characterize the effect magnitude of crizotinib on the erlotinib exposure after combinational use of crizotinib and erlotinib.
Time Frame C1D-1 (i.e., 1 day prior to initiation of continuous dosing of crizotinib) to C1D15 (i.e., 15 days of giving crizotinib and erlotinib)
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis population was defined as all participants in the safety analysis set 1 who had at least 1 of the PK parameters of interest.
Arm/Group Title PF-02341066 (200 mg) and Erlotinib (100 mg) PF-02341066 (150 mg) and Erlotinib (100 mg)
Hide Arm/Group Description:
PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
Overall Number of Participants Analyzed 7 19
Geometric Mean (90% Confidence Interval)
Unit of Measure: Ratio in percentage
184.80
(149.67 to 228.18)
149.41
(125.87 to 177.36)
13.Secondary Outcome
Title Ratio of Adjusted Means of Erlotinib Cmax (Crizotinib + Erlotinib / Erlotinib Alone) (Phase 1)
Hide Description Ratio of adjusted means of Erlotinib Cmax (Crizotinib + Erlotinib / Erlotinib Alone) is a measure of the plasma exposure to erlotinib after erlotinib dosing with crizotinib compared with that after erlotinib dosing alone. In this study, it is used to characterize the effect magnitude of crizotinib on the erlotinib exposure after combinational use of crizotinib and erlotinib.
Time Frame C1D-1 (i.e., 1 day prior to initiation of continuous dosing of crizotinib) to C1D15 (i.e., 15 days of giving crizotinib and erlotinib)
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic (PK) parameter analysis population was defined as all participants in the safety analysis set 1 who had at least 1 of the PK parameters of interest.
Arm/Group Title PF-02341066 (200 mg) and Erlotinib (100 mg) PF-02341066 (150 mg) and Erlotinib (100 mg)
Hide Arm/Group Description:
PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
Overall Number of Participants Analyzed 7 19
Geometric Mean (90% Confidence Interval)
Unit of Measure: Ratio in percentage
160.15
(121.06 to 211.86)
134.60
(115.23 to 157.22)
14.Secondary Outcome
Title Progression-Free Survival (Phase 1)
Hide Description Time in weeks from phase 1 randomization to first documentation of objective disease progression or death due to any cause. Progression-Free Survival was calculated as (first event date minus randomization date plus 1) divided by 7.02. Tumor progression was determined from oncologic assessment data (where data meet the criteria for PD), or from AE data (where the outcome was "Death"; date of death reported in notice of death was used).
Time Frame Baseline, every 42 days until disease progression or unacceptable toxicity
Hide Outcome Measure Data
Hide Analysis Population Description
not analyzed due to small number of study participants
Arm/Group Title PF-02341066 (200 mg) and Erlotinib (100 mg) PF-02341066 (150 mg) and Erlotinib (100 mg)
Hide Arm/Group Description:
PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
15.Secondary Outcome
Title Duration of Response (Phase 1)
Hide Description Median duration (50 percent [%]) of tumor response. Duration of response (DR) defined as time from start of first documented objective tumor response [Complete Response (CR) or Partial Response (PR)] to first documented objective tumor progression or death due to any cause, whichever occurs first. DR calculated as (Weeks) = (the end date for DR minus first subsequent confirmed CR or PR plus 1) divided by 7.02. CR: disappearance of a target lesions. PR: at least 30% decrease in the sum of diameters of target lesions.
Time Frame Baseline, every 42 days until disease progression or unacceptable toxicity
Hide Outcome Measure Data
Hide Analysis Population Description
not analyzed due to small number of responses
Arm/Group Title PF-02341066 (200 mg) and Erlotinib (100 mg) PF-02341066 (150 mg) and Erlotinib (100 mg)
Hide Arm/Group Description:
PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
16.Secondary Outcome
Title Percentage of Participants With Objective Response (Phase 1)
Hide Description Percentage of participants during phase 1 with objective response based assessment of confirmed CR or confirmed PR according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Confirmed responses: persist on repeat imaging study at least 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 and disappearance of all non-target 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 nontarget disease. No new lesions.
Time Frame Baseline, every 42 days until disease progression or unacceptable toxicity
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Response Evaluable Population: all participants enrolled into the Phase 1 portion of the study who receive at least one dose of study medication (either PF-02341066 or erlotinib) and have an adequate baseline tumor assessment.
Arm/Group Title PF-02341066 (200 mg) and Erlotinib (100 mg) PF-02341066 (150 mg) and Erlotinib (100 mg)
Hide Arm/Group Description:
PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
Overall Number of Participants Analyzed 7 18
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
14.3
(0.4 to 57.9)
5.6
(0.1 to 27.3)
17.Secondary Outcome
Title Plasma Level of Soluble Marker: c-Met Ectodomain (Phase 1)
Hide Description Levels of soluble protein biomarker c-MET was analyzed at Baseline and at Day 50.
Time Frame Baseline and Day 50 (Cycle 3, Day 1)
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Hide Analysis Population Description
The soluble biomarker evaluable population was defined as participants from the safety analysis set of phase 1 who had a soluble protein blood sample taken prior to dosing on Cycle 3 Day 1 and 1 soluble biomarker evaluation after dosing on Cycle 3 Day 1.
Arm/Group Title PF-02341066 (200 mg) and Erlotinib (100 mg) PF-02341066 (150 mg) and Erlotinib (100 mg)
Hide Arm/Group Description:
PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
Overall Number of Participants Analyzed 1 7
Mean (Standard Deviation)
Unit of Measure: nanogram per milliliter (ng/mL)
Baseline 1560.0 [1]   (NA) 1454.6  (303.93)
C3D1 0 Hour 1870.0 [1]   (NA) 1525.9  (442.01)
C3D1 6 Hour 1660.0 [1]   (NA) 1600.0  (369.05)
[1]
Not available as there is only one participant.
18.Secondary Outcome
Title Plasma Level of Soluble Marker: Hepatocyte Growth Factor (HGF) Scatter Factor (Phase 1)
Hide Description [Not Specified]
Time Frame Baseline and Day 50 (Cycle 3, Day 1)
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Hide Analysis Population Description
Plasma level of soluble marker HGF scatter factor not analyzed due to prior experience with high levels of intra participant variability
Arm/Group Title PF-02341066 (200 mg) and Erlotinib (100 mg) PF-02341066 (150 mg) and Erlotinib (100 mg)
Hide Arm/Group Description:
PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
19.Secondary Outcome
Title Plasma Level of Soluble Marker: c-Met Ectodomain (Phase 2)
Hide Description [Not Specified]
Time Frame Baseline and Day 50 (Cycle 3, Day 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Not analyzed due to phase 2 study termination
Arm/Group Title PF-02341066 and Erlotinib Erlotinib
Hide Arm/Group Description:
PF-02341066 (BID) and erlotinib (QD) administered at the recommended Phase 2 dose (RP2D) in continuous 21-day cycles.
Erlotinib 150 mg was to be administered orally QD in continuous 21-day cycles.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
20.Secondary Outcome
Title Plasma Level of Soluble Marker: HGF Scatter Factor (Phase 2)
Hide Description [Not Specified]
Time Frame Baseline and Day 50 (Cycle 3, Day 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Not analyzed due to phase 2 study termination
Arm/Group Title PF-02341066 and Erlotinib Erlotinib
Hide Arm/Group Description:
PF-02341066 (BID) and erlotinib (QD) administered at the recommended Phase 2 dose (RP2D) in continuous 21-day cycles.
Erlotinib 150 mg was to be administered orally QD in continuous 21-day cycles.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
21.Secondary Outcome
Title Duration of Response (Phase 2)
Hide Description Median duration (50%) of tumor response. DR defined as time from start of first documented objective tumor response (CR or PR) to first documented objective tumor progression or death due to any cause, whichever occurs first. DR calculated as (Weeks) = (the end date for DR minus first subsequent confirmed CR or PR plus 1) divided by 7.02. 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 and disappearance of all non-target 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 nontarget disease. No new lesions.
Time Frame Baseline, every 42 days up to 20 months, disease progression, or unacceptable toxicity
Hide Outcome Measure Data
Hide Analysis Population Description
Not analyzed due to phase 2 study termination
Arm/Group Title PF-02341066 and Erlotinib Erlotinib
Hide Arm/Group Description:
PF-02341066 (BID) and erlotinib (QD) administered at the recommended Phase 2 dose (RP2D) in continuous 21-day cycles.
Erlotinib 150 mg was to be administered orally QD in continuous 21-day cycles.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
22.Secondary Outcome
Title Percentage of Participants With Confirmed CR, PR or Stable Disease (SD) at Phase 2
Hide Description Percentage of participants during phase 2 with confirmed CR, confirmed PR or SD according to RECIST 1.1. Also known as Disease Control Rate (DCR). 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 and disappearance of all non-target 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 nontarget disease. No new lesions. SD: neither sufficient shrinkage or increase to qualify for PR or PD.
Time Frame Week 6 and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Not analyzed due to phase 2 study termination
Arm/Group Title PF-02341066 and Erlotinib Erlotinib
Hide Arm/Group Description:
PF-02341066 (BID) and erlotinib (QD) administered at the recommended Phase 2 dose (RP2D) in continuous 21-day cycles.
Erlotinib 150 mg was to be administered orally QD in continuous 21-day cycles.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
23.Secondary Outcome
Title Percentage of Participants With Objective Response (Phase 2)
Hide Description Percentage of participants during phase 2 with objective response based assessment of confirmed CR or confirmed PR according to RECIST (1.1). Confirmed responses: persist on repeat imaging study at least 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 and disappearance of all non-target 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 nontarget disease. No new lesions.
Time Frame Baseline, every 42 days up to 20 months, disease progression, or unacceptable toxicity
Hide Outcome Measure Data
Hide Analysis Population Description
Not analyzed due to phase 2 study termination
Arm/Group Title PF-02341066 and Erlotinib Erlotinib
Hide Arm/Group Description:
PF-02341066 (BID) and erlotinib (QD) administered at the recommended Phase 2 dose (RP2D) in continuous 21-day cycles.
Erlotinib 150 mg was to be administered orally QD in continuous 21-day cycles.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
24.Secondary Outcome
Title Overall Survival (OS) at Phase 2
Hide Description Time in months from randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 30.4.
Time Frame Baseline until death, up to 20 months
Hide Outcome Measure Data
Hide Analysis Population Description
Not analyzed due to phase 2 study termination
Arm/Group Title PF-02341066 and Erlotinib Erlotinib
Hide Arm/Group Description:
PF-02341066 (BID) and erlotinib (QD) administered at the recommended Phase 2 dose (RP2D) in continuous 21-day cycles.
Erlotinib 150 mg was to be administered orally QD in continuous 21-day cycles.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
25.Secondary Outcome
Title European Organization for Research and Treatment of Cancer (EORTC), Quality of Life Questionnaire (QLQ-C30) Score at Phase 2
Hide Description Phase 2 EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms.
Time Frame Baseline and every 21 days, up to 20 months
Hide Outcome Measure Data
Hide Analysis Population Description
Not analyzed due to phase 2 study termination
Arm/Group Title PF-02341066 and Erlotinib Erlotinib
Hide Arm/Group Description:
PF-02341066 (BID) and erlotinib (QD) administered at the recommended Phase 2 dose (RP2D) in continuous 21-day cycles.
Erlotinib 150 mg was to be administered orally QD in continuous 21-day cycles.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
26.Secondary Outcome
Title EORTC Quality of Life Questionnaire -Lung Cancer 13 (QLQ-LC13) Score at Phase 2
Hide Description QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, neuropathy, alopecia, and medicine for pain). Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.
Time Frame Baseline and every 21 days, up to 20 months
Hide Outcome Measure Data
Hide Analysis Population Description
Not analyzed due to phase 2 study termination
Arm/Group Title PF-02341066 and Erlotinib Erlotinib
Hide Arm/Group Description:
PF-02341066 (BID) and erlotinib (QD) administered at the recommended Phase 2 dose (RP2D) in continuous 21-day cycles.
Erlotinib 150 mg was to be administered orally QD in continuous 21-day cycles.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
27.Secondary Outcome
Title Plasma Concentration of PF-02341066 and Erlotinib (Phase 2)
Hide Description Plasma concentration of PF-02341066 and erlotinib when administered in combination during phase 2
Time Frame Day 1 of cycles 1, 3, and 5 (i.e., up to 15 weeks) at 0 (pre-dose) and 2 to 6 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Not analyzed due to phase 2 study termination
Arm/Group Title PF-02341066 and Erlotinib Erlotinib
Hide Arm/Group Description:
PF-02341066 (BID) and erlotinib (QD) administered at the recommended Phase 2 dose (RP2D) in continuous 21-day cycles.
Erlotinib 150 mg was to be administered orally QD in continuous 21-day cycles.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
28.Secondary Outcome
Title Plasma Concentration of Erlotinib (Phase 2)
Hide Description Plasma concentration of erlotinib when administered as a single agent during phase 2
Time Frame Day 1 of cycles 1, 3, and 5 (i.e., up to 15 weeks) at 0 hours (pre-dose)
Hide Outcome Measure Data
Hide Analysis Population Description
Not analyzed due to phase 2 study termination
Arm/Group Title PF-02341066 and Erlotinib Erlotinib
Hide Arm/Group Description:
PF-02341066 (BID) and erlotinib (QD) administered at the recommended Phase 2 dose (RP2D) in continuous 21-day cycles.
Erlotinib 150 mg was to be administered orally QD in continuous 21-day cycles.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
29.Secondary Outcome
Title Percentage of Participants With Mutations in Tumor Tissue (Phase 2)
Hide Description Tumor tissue samples collected for molecular profiling were to be analyzed to assess Kirsten rat sarcoma (KRAS) mutations, mutations, amplification and expression of Epidermal Growth Factor Receptor (EGFR) and c-Met, and echinoderm microtubule-associated protein-like 4-anaplastic large cell receptor kinase (EML4-ALK) fusion in tumors.
Time Frame Screening
Hide Outcome Measure Data
Hide Analysis Population Description
Not analyzed due to phase 2 study termination
Arm/Group Title PF-02341066 and Erlotinib Erlotinib
Hide Arm/Group Description:
PF-02341033 (BID) and erlotinib (QD) administered at the recommended Phase 2 dose (RP2D) in continuous 21-day cycles
Erlotinib 150 mg was to be administered orally QD in continuous 21-day cycles.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
30.Other Pre-specified Outcome
Title Maximum Tolerated Dose (MTD) of PF-02341066 When Administered in Combination With Erlotinib (Phase 1)
Hide Description MTD: the combination dose level of PF-02341066 and erlotinib in which 0/6 or 1/6 participants experienced DLT after 28 days of treatment (Cycle 1) with the next higher dose level having at least 2/3 or 2/6 participants with DLT during Cycle 1 of treatment.
Time Frame Baseline up to 28 days (Cycle 1)
Hide Outcome Measure Data
Hide Analysis Population Description
DLT evaluable population
Arm/Group Title All Treated Participants (Phase 1)
Hide Arm/Group Description:
All participants who received PF-02341066 (200 mg or 150 mg) administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
Overall Number of Participants Analyzed 22
Measure Type: Number
Unit of Measure: mg
PF-02341066 (BID) 150
Erlotinib (QD) 100
31.Other Pre-specified Outcome
Title Recommended Phase 2 Dose (RP2D) of PF-02341066 When Administered in Combination With Erlotinib (Phase 1)
Hide Description If no more than 1/6 participants presented with a DLT during Cycle 1 at the MTD, then this dose level was considered the RP2D. If >1/6 participants experienced a DLT, then the previous lower level was considered the MTD and RP2D.
Time Frame Baseline up to 28 days (Cycle 1)
Hide Outcome Measure Data
Hide Analysis Population Description
DLT evaluable population
Arm/Group Title All Treated Participants (Phase 1)
Hide Arm/Group Description:
All participants who received PF-02341066 (200 mg or 150 mg) administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
Overall Number of Participants Analyzed 22
Measure Type: Number
Unit of Measure: mg
PF-02341066 (BID) 150
Erlotinib (QD) 100
Time Frame Up to 28 days after the last dose of study treatment (up to approximately 20 months)
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-02341066 (200 mg) and Erlotinib (100 mg) PF-02341066 (150 mg) and Erlotinib (100 mg)
Hide Arm/Group Description PF-02341066 200 milligrams (mg) administered orally twice daily (BID) in combination with erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD. PF-02341066 150 mg administered orally BID in combination with erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
All-Cause Mortality
PF-02341066 (200 mg) and Erlotinib (100 mg) PF-02341066 (150 mg) and Erlotinib (100 mg)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
PF-02341066 (200 mg) and Erlotinib (100 mg) PF-02341066 (150 mg) and Erlotinib (100 mg)
Affected / at Risk (%) Affected / at Risk (%)
Total   2/7 (28.57%)   8/20 (40.00%) 
Blood and lymphatic system disorders     
Pancytopenia * 1  0/7 (0.00%)  1/20 (5.00%) 
Gastrointestinal disorders     
Abdominal pain * 1  0/7 (0.00%)  1/20 (5.00%) 
Diarrhoea * 1  0/7 (0.00%)  1/20 (5.00%) 
Oesophagitis * 1  1/7 (14.29%)  0/20 (0.00%) 
General disorders     
Disease progression * 1  0/7 (0.00%)  4/20 (20.00%) 
Infections and infestations     
Pneumonia * 1  0/7 (0.00%)  2/20 (10.00%) 
Viral infection * 1  0/7 (0.00%)  1/20 (5.00%) 
Metabolism and nutrition disorders     
Dehydration * 1  0/7 (0.00%)  1/20 (5.00%) 
Nervous system disorders     
Aphasia * 1  0/7 (0.00%)  1/20 (5.00%) 
Psychiatric disorders     
Anxiety * 1  0/7 (0.00%)  1/20 (5.00%) 
Respiratory, thoracic and mediastinal disorders     
Hypoxia * 1  0/7 (0.00%)  1/20 (5.00%) 
Pleural effusion * 1  0/7 (0.00%)  1/20 (5.00%) 
Pulmonary embolism * 1  1/7 (14.29%)  0/20 (0.00%) 
Vascular disorders     
Deep vein thrombosis * 1  0/7 (0.00%)  2/20 (10.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v16.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
PF-02341066 (200 mg) and Erlotinib (100 mg) PF-02341066 (150 mg) and Erlotinib (100 mg)
Affected / at Risk (%) Affected / at Risk (%)
Total   7/7 (100.00%)   19/20 (95.00%) 
Blood and lymphatic system disorders     
Anaemia * 1  1/7 (14.29%)  3/20 (15.00%) 
Lymphadenopathy * 1  0/7 (0.00%)  1/20 (5.00%) 
Neutropenia * 1  0/7 (0.00%)  1/20 (5.00%) 
Cardiac disorders     
Pericardial effusion * 1  1/7 (14.29%)  0/20 (0.00%) 
Tachycardia * 1  0/7 (0.00%)  1/20 (5.00%) 
Endocrine disorders     
Adrenal disorder * 1  0/7 (0.00%)  1/20 (5.00%) 
Eye disorders     
Cataract * 1  1/7 (14.29%)  0/20 (0.00%) 
Conjunctival haemorrhage * 1  1/7 (14.29%)  0/20 (0.00%) 
Conjunctivitis * 1  1/7 (14.29%)  1/20 (5.00%) 
Dry eye * 1  1/7 (14.29%)  0/20 (0.00%) 
Eye pruritus * 1  1/7 (14.29%)  1/20 (5.00%) 
Eyelid pain * 1  1/7 (14.29%)  0/20 (0.00%) 
Lacrimation increased * 1  1/7 (14.29%)  0/20 (0.00%) 
Photopsia * 1  0/7 (0.00%)  1/20 (5.00%) 
Scotoma * 1  1/7 (14.29%)  1/20 (5.00%) 
Trichiasis * 1  1/7 (14.29%)  0/20 (0.00%) 
Vision blurred * 1  0/7 (0.00%)  1/20 (5.00%) 
Visual acuity reduced * 1  0/7 (0.00%)  1/20 (5.00%) 
Visual impairment * 1  0/7 (0.00%)  3/20 (15.00%) 
Gastrointestinal disorders     
Abdominal discomfort * 1  0/7 (0.00%)  2/20 (10.00%) 
Abdominal pain * 1  0/7 (0.00%)  1/20 (5.00%) 
Abdominal pain upper * 1  1/7 (14.29%)  3/20 (15.00%) 
Constipation * 1  0/7 (0.00%)  5/20 (25.00%) 
Diarrhoea * 1  6/7 (85.71%)  16/20 (80.00%) 
Dyspepsia * 1  1/7 (14.29%)  3/20 (15.00%) 
Dysphagia * 1  1/7 (14.29%)  2/20 (10.00%) 
Flatulence * 1  0/7 (0.00%)  1/20 (5.00%) 
Food poisoning * 1  1/7 (14.29%)  0/20 (0.00%) 
Gastritis * 1  1/7 (14.29%)  0/20 (0.00%) 
Gingival pain * 1  0/7 (0.00%)  1/20 (5.00%) 
Haematochezia * 1  1/7 (14.29%)  0/20 (0.00%) 
Nausea * 1  3/7 (42.86%)  11/20 (55.00%) 
Oesophageal pain * 1  1/7 (14.29%)  0/20 (0.00%) 
Oesophageal stenosis * 1  1/7 (14.29%)  0/20 (0.00%) 
Oesophagitis * 1  1/7 (14.29%)  1/20 (5.00%) 
Stomatitis * 1  0/7 (0.00%)  2/20 (10.00%) 
Toothache * 1  0/7 (0.00%)  1/20 (5.00%) 
Vomiting * 1  4/7 (57.14%)  8/20 (40.00%) 
General disorders     
Asthenia * 1  0/7 (0.00%)  2/20 (10.00%) 
Catheter site swelling * 1  0/7 (0.00%)  1/20 (5.00%) 
Chest discomfort * 1  0/7 (0.00%)  1/20 (5.00%) 
Chills * 1  0/7 (0.00%)  2/20 (10.00%) 
Fatigue * 1  3/7 (42.86%)  14/20 (70.00%) 
Malaise * 1  1/7 (14.29%)  1/20 (5.00%) 
Mucosal inflammation * 1  0/7 (0.00%)  3/20 (15.00%) 
Non-cardiac chest pain * 1  1/7 (14.29%)  0/20 (0.00%) 
Oedema * 1  0/7 (0.00%)  1/20 (5.00%) 
Oedema peripheral * 1  1/7 (14.29%)  1/20 (5.00%) 
Pain * 1  2/7 (28.57%)  0/20 (0.00%) 
Pyrexia * 1  1/7 (14.29%)  3/20 (15.00%) 
Local swelling * 1  1/7 (14.29%)  0/20 (0.00%) 
Hepatobiliary disorders     
Hepatic steatosis * 1  1/7 (14.29%)  0/20 (0.00%) 
Infections and infestations     
Abscess * 1  1/7 (14.29%)  0/20 (0.00%) 
Herpes zoster * 1  1/7 (14.29%)  0/20 (0.00%) 
Localised infection * 1  0/7 (0.00%)  1/20 (5.00%) 
Nasopharyngitis * 1  1/7 (14.29%)  0/20 (0.00%) 
Paronychia * 1  1/7 (14.29%)  0/20 (0.00%) 
Pneumonia * 1  0/7 (0.00%)  1/20 (5.00%) 
Rash pustular * 1  2/7 (28.57%)  0/20 (0.00%) 
Rhinitis * 1  0/7 (0.00%)  1/20 (5.00%) 
Sepsis * 1  0/7 (0.00%)  1/20 (5.00%) 
Sinusitis * 1  1/7 (14.29%)  0/20 (0.00%) 
Upper respiratory tract infection * 1  0/7 (0.00%)  1/20 (5.00%) 
Urinary tract infection * 1  1/7 (14.29%)  1/20 (5.00%) 
Nail bed infection * 1  1/7 (14.29%)  0/20 (0.00%) 
Injury, poisoning and procedural complications     
Fall * 1  0/7 (0.00%)  1/20 (5.00%) 
Ligament sprain * 1  1/7 (14.29%)  0/20 (0.00%) 
Wrist fracture * 1  0/7 (0.00%)  1/20 (5.00%) 
Investigations     
Alanine aminotransferase increased * 1  0/7 (0.00%)  1/20 (5.00%) 
Aspartate aminotransferase increased * 1  1/7 (14.29%)  2/20 (10.00%) 
Blood alkaline phosphatase decreased * 1  1/7 (14.29%)  0/20 (0.00%) 
Blood alkaline phosphatase increased * 1  0/7 (0.00%)  2/20 (10.00%) 
Blood creatinine increased * 1  1/7 (14.29%)  0/20 (0.00%) 
Breath sounds abnormal * 1  1/7 (14.29%)  2/20 (10.00%) 
Breath sounds absent * 1  1/7 (14.29%)  0/20 (0.00%) 
Electrocardiogram QT prolonged * 1  0/7 (0.00%)  1/20 (5.00%) 
Weight decreased * 1  0/7 (0.00%)  3/20 (15.00%) 
White blood cell count decreased * 1  0/7 (0.00%)  1/20 (5.00%) 
Metabolism and nutrition disorders     
Decreased appetite * 1  3/7 (42.86%)  12/20 (60.00%) 
Dehydration * 1  1/7 (14.29%)  4/20 (20.00%) 
Fluid retention * 1  0/7 (0.00%)  1/20 (5.00%) 
Hypercreatininaemia * 1  0/7 (0.00%)  1/20 (5.00%) 
Hyperglycaemia * 1  0/7 (0.00%)  2/20 (10.00%) 
Hyperkalaemia * 1  0/7 (0.00%)  1/20 (5.00%) 
Hypoalbuminaemia * 1  1/7 (14.29%)  5/20 (25.00%) 
Hypokalaemia * 1  2/7 (28.57%)  0/20 (0.00%) 
Hypomagnesaemia * 1  0/7 (0.00%)  2/20 (10.00%) 
Hyponatraemia * 1  0/7 (0.00%)  2/20 (10.00%) 
Hypophosphataemia * 1  1/7 (14.29%)  1/20 (5.00%) 
Metabolic disorder * 1  0/7 (0.00%)  1/20 (5.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  1/7 (14.29%)  1/20 (5.00%) 
Flank pain * 1  1/7 (14.29%)  0/20 (0.00%) 
Joint swelling * 1  1/7 (14.29%)  1/20 (5.00%) 
Limb discomfort * 1  1/7 (14.29%)  0/20 (0.00%) 
Muscle spasms * 1  2/7 (28.57%)  0/20 (0.00%) 
Musculoskeletal pain * 1  1/7 (14.29%)  1/20 (5.00%) 
Musculoskeletal stiffness * 1  0/7 (0.00%)  1/20 (5.00%) 
Myalgia * 1  1/7 (14.29%)  0/20 (0.00%) 
Neck pain * 1  1/7 (14.29%)  0/20 (0.00%) 
Pain in extremity * 1  1/7 (14.29%)  0/20 (0.00%) 
Nervous system disorders     
Ataxia * 1  0/7 (0.00%)  1/20 (5.00%) 
Dizziness * 1  0/7 (0.00%)  2/20 (10.00%) 
Dysgeusia * 1  2/7 (28.57%)  0/20 (0.00%) 
Headache * 1  2/7 (28.57%)  1/20 (5.00%) 
Hyperaesthesia * 1  1/7 (14.29%)  0/20 (0.00%) 
Paraesthesia * 1  1/7 (14.29%)  0/20 (0.00%) 
Tremor * 1  0/7 (0.00%)  1/20 (5.00%) 
Vocal cord paralysis * 1  1/7 (14.29%)  0/20 (0.00%) 
Psychiatric disorders     
Confusional state * 1  0/7 (0.00%)  1/20 (5.00%) 
Depression * 1  0/7 (0.00%)  1/20 (5.00%) 
Insomnia * 1  1/7 (14.29%)  1/20 (5.00%) 
Renal and urinary disorders     
Dysuria * 1  1/7 (14.29%)  0/20 (0.00%) 
Urinary tract pain * 1  1/7 (14.29%)  0/20 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  1/7 (14.29%)  4/20 (20.00%) 
Dysphonia * 1  0/7 (0.00%)  1/20 (5.00%) 
Dyspnoea * 1  2/7 (28.57%)  4/20 (20.00%) 
Dyspnoea exertional * 1  1/7 (14.29%)  2/20 (10.00%) 
Epistaxis * 1  1/7 (14.29%)  2/20 (10.00%) 
Haemoptysis * 1  1/7 (14.29%)  0/20 (0.00%) 
Oropharyngeal pain * 1  0/7 (0.00%)  2/20 (10.00%) 
Pleural effusion * 1  1/7 (14.29%)  1/20 (5.00%) 
Pleuritic pain * 1  0/7 (0.00%)  1/20 (5.00%) 
Productive cough * 1  0/7 (0.00%)  1/20 (5.00%) 
Pulmonary congestion * 1  0/7 (0.00%)  1/20 (5.00%) 
Sinus congestion * 1  0/7 (0.00%)  1/20 (5.00%) 
Tonsillar disorder * 1  1/7 (14.29%)  0/20 (0.00%) 
Skin and subcutaneous tissue disorders     
Dermatitis acneiform * 1  1/7 (14.29%)  2/20 (10.00%) 
Dry skin * 1  5/7 (71.43%)  4/20 (20.00%) 
Erythema * 1  1/7 (14.29%)  0/20 (0.00%) 
Hypertrichosis * 1  1/7 (14.29%)  0/20 (0.00%) 
Palmar-plantar erythrodysaesthesia syndrome * 1  0/7 (0.00%)  1/20 (5.00%) 
Pruritus * 1  0/7 (0.00%)  3/20 (15.00%) 
Pruritus generalised * 1  0/7 (0.00%)  1/20 (5.00%) 
Rash * 1  4/7 (57.14%)  13/20 (65.00%) 
Rash erythematous * 1  0/7 (0.00%)  1/20 (5.00%) 
Rash macular * 1  0/7 (0.00%)  1/20 (5.00%) 
Skin disorder * 1  0/7 (0.00%)  1/20 (5.00%) 
Skin fissures * 1  1/7 (14.29%)  1/20 (5.00%) 
Skin lesion * 1  1/7 (14.29%)  0/20 (0.00%) 
Skin toxicity * 1  1/7 (14.29%)  0/20 (0.00%) 
Vascular disorders     
Hypotension * 1  0/7 (0.00%)  2/20 (10.00%) 
Phlebitis superficial * 1  1/7 (14.29%)  0/20 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v16.1
The sponsor terminated phase 2 of this study; no data was collected during phase 2, leading to phase 2 outcomes not analyzed. The decision was based on strategic considerations regarding the clinical program only; there were no safety concerns.
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
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00965731    
Other Study ID Numbers: A8081002
2009-012377-35 ( EudraCT Number )
First Submitted: August 24, 2009
First Posted: August 26, 2009
Results First Submitted: December 7, 2012
Results First Posted: January 14, 2013
Last Update Posted: October 28, 2015