Trial Outcomes & Findings for Erlotinib Is Being Studied With Or Without An Investigational Drug, PF-02341066, In Patients With Lung Cancer (NCT NCT00965731)

Last Updated: 2015-10-28

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

27 participants

Primary outcome timeframe

Baseline up to Day 28

Results posted on

2015-10-28

Participant Flow

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.

Participant milestones

Participant milestones
Measure	PF-02341066 (200 mg) and Erlotinib (100 mg) 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) and Erlotinib (100 mg) 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.
Overall Study STARTED	7	20
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	7	20

Reasons for withdrawal

Reasons for withdrawal
Measure	PF-02341066 (200 mg) and Erlotinib (100 mg) 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) and Erlotinib (100 mg) 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.
Overall Study Death	0	4
Overall Study Withdrawal by Subject	0	1
Overall Study Other	7	15

Baseline Characteristics

Erlotinib Is Being Studied With Or Without An Investigational Drug, PF-02341066, In Patients With Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PF-02341066 (200 mg) and Erlotinib (100 mg) n=7 Participants 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) and Erlotinib (100 mg) n=20 Participants 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 n=27 Participants Total of all reporting groups
Age, Customized 18 to 44 years	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Age, Customized 45 to 64 years	5 participants n=5 Participants	11 participants n=7 Participants	16 participants n=5 Participants
Age, Customized greater than or equal to (≥) 65	1 participants n=5 Participants	9 participants n=7 Participants	10 participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	13 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline up to Day 28

Population: 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)

Outcome measures

Outcome measures
Measure	PF-02341066 (150 mg) and Erlotinib (100 mg) n=16 Participants 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.	PF-02341066 (200 mg) and Erlotinib (100 mg) n=6 Participants 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.
Number of Participants With Dose-Limiting Toxicities (DLT) (Phase 1)	3 participants	2 participants

PRIMARY outcome

Timeframe: Baseline, every 42 days up to 20 months, disease progression, or unacceptable toxicity

Population: Not analyzed due to phase 2 study termination

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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Outcome measures
Measure	PF-02341066 (150 mg) and Erlotinib (100 mg) n=19 Participants 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.	PF-02341066 (200 mg) and Erlotinib (100 mg) n=7 Participants 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 (Crizotinib) Area Under the Concentration-Time Curve During Dosing Interval (AUCtau) (Phase 1) C1D1 Crizotinib (N=7, 19)	400.3 ng*hr/mL Geometric Coefficient of Variation 40	581.9 ng*hr/mL Geometric Coefficient of Variation 49
PF-02341066 (Crizotinib) Area Under the Concentration-Time Curve During Dosing Interval (AUCtau) (Phase 1) C1D15 Crizotinib (N=5, 14)	1720 ng*hr/mL Geometric Coefficient of Variation 40	2274 ng*hr/mL Geometric Coefficient of Variation 43

SECONDARY outcome

Timeframe: C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib

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

Outcome measures

Outcome measures
Measure	PF-02341066 (150 mg) and Erlotinib (100 mg) n=19 Participants 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.	PF-02341066 (200 mg) and Erlotinib (100 mg) n=7 Participants 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 (Crizotinib) Maximum Observed Plasma Concentration (Cmax) (Phase 1) C1D1 Crizotinib (N=7, 19)	65.31 ng/mL Geometric Coefficient of Variation 50	86.75 ng/mL Geometric Coefficient of Variation 37
PF-02341066 (Crizotinib) Maximum Observed Plasma Concentration (Cmax) (Phase 1) C1D15 Crizotinib (N=5, 14)	185.9 ng/mL Geometric Coefficient of Variation 40	251.0 ng/mL Geometric Coefficient of Variation 46

SECONDARY outcome

Timeframe: C1D15 i.e., 15 days of giving crizotinib and erlotinib

Population: 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.

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.

Outcome measures

Outcome measures
Measure	PF-02341066 (150 mg) and Erlotinib (100 mg) n=14 Participants 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.	PF-02341066 (200 mg) and Erlotinib (100 mg) n=5 Participants 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 (Crizotinib) Apparent Oral Clearance (CL/F) (Phase 1)	87.20 L/hr Geometric Coefficient of Variation 40	88.02 L/hr Geometric Coefficient of Variation 43

SECONDARY outcome

Timeframe: C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib

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.

Outcome measures

Outcome measures
Measure	PF-02341066 (150 mg) and Erlotinib (100 mg) n=19 Participants 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.	PF-02341066 (200 mg) and Erlotinib (100 mg) n=7 Participants 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-06260182 Area Under the Concentration-Time Curve During Dosing Interval (AUCtau) (Phase 1) C1D1 PF-06260182 (N=7, 19)	14.03 ng*hr/mL Geometric Coefficient of Variation 72	16.48 ng*hr/mL Geometric Coefficient of Variation 58
PF-06260182 Area Under the Concentration-Time Curve During Dosing Interval (AUCtau) (Phase 1) C1D15 PF-06260182 (N=5, 14)	57.77 ng*hr/mL Geometric Coefficient of Variation 66	60.36 ng*hr/mL Geometric Coefficient of Variation 63

SECONDARY outcome

Timeframe: C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib

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.

Outcome measures

Outcome measures
Measure	PF-02341066 (150 mg) and Erlotinib (100 mg) n=19 Participants 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.	PF-02341066 (200 mg) and Erlotinib (100 mg) n=7 Participants 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-06260182 Maximum Observed Plasma Concentration (Cmax) (Phase 1) C1D1 PF-06260182 (N=7, 19)	2.087 ng/mL Geometric Coefficient of Variation 63	2.625 ng/mL Geometric Coefficient of Variation 49
PF-06260182 Maximum Observed Plasma Concentration (Cmax) (Phase 1) C1D15 PF-06260182 (N=5, 14)	6.508 ng/mL Geometric Coefficient of Variation 63	7.093 ng/mL Geometric Coefficient of Variation 54

SECONDARY outcome

Timeframe: C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib

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.

Outcome measures

Outcome measures
Measure	PF-02341066 (150 mg) and Erlotinib (100 mg) n=19 Participants 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.	PF-02341066 (200 mg) and Erlotinib (100 mg) n=7 Participants 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.
Molecular Weight Adjusted PF-06260182-to-PF-02341006 Ratio of AUCtau (Phase 1) C1D1 (N=7, 19)	0.03395 Ratio Geometric Coefficient of Variation 45	0.02748 Ratio Geometric Coefficient of Variation 23
Molecular Weight Adjusted PF-06260182-to-PF-02341006 Ratio of AUCtau (Phase 1) C1D15 (N=5, 14)	0.03258 Ratio Geometric Coefficient of Variation 31	0.02574 Ratio Geometric Coefficient of Variation 27

SECONDARY outcome

Timeframe: 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

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).

Outcome measures

Outcome measures
Measure	PF-02341066 (150 mg) and Erlotinib (100 mg) n=19 Participants 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.	PF-02341066 (200 mg) and Erlotinib (100 mg) n=7 Participants 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.
Erlotinib Area Under the Concentration-Time Curve During Dosing Interval (AUCtau) (Phase 1) C1D-1 Erlotinib Alone (N=7,19)	26880 ng*hr/mL Geometric Coefficient of Variation 39	23490 ng*hr/mL Geometric Coefficient of Variation 31
Erlotinib Area Under the Concentration-Time Curve During Dosing Interval (AUCtau) (Phase 1) C1D1 Erlotinib+Crizotinib Single Dose (N=7,19)	30040 ng*hr/mL Geometric Coefficient of Variation 39	26520 ng*hr/mL Geometric Coefficient of Variation 25
Erlotinib Area Under the Concentration-Time Curve During Dosing Interval (AUCtau) (Phase 1) C1D15 Erlotinib+Crizotinib Multiple Doses (N=5,14)	38910 ng*hr/mL Geometric Coefficient of Variation 49	41770 ng*hr/mL Geometric Coefficient of Variation 27

SECONDARY outcome

Timeframe: 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

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).

Outcome measures

Outcome measures
Measure	PF-02341066 (150 mg) and Erlotinib (100 mg) n=19 Participants 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.	PF-02341066 (200 mg) and Erlotinib (100 mg) n=7 Participants 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.
Erlotinib Maximum Observed Plasma Concentration (Cmax) (Phase 1) C1D-1 Erlotinib Alone (N=7,19)	1797 ng/mL Geometric Coefficient of Variation 36	1593 ng/mL Geometric Coefficient of Variation 26
Erlotinib Maximum Observed Plasma Concentration (Cmax) (Phase 1) C1D1 Erlotinib+Crizotinib Single Dose (N=7,19)	1723 ng/mL Geometric Coefficient of Variation 38	1452 ng/mL Geometric Coefficient of Variation 21
Erlotinib Maximum Observed Plasma Concentration (Cmax) (Phase 1) C1D15 Erlotinib+Crizotinib Multiple Doses (N=5,14)	2346 ng/mL Geometric Coefficient of Variation 43	2546 ng/mL Geometric Coefficient of Variation 24

SECONDARY outcome

Timeframe: C1D15 i.e., 15 days of giving crizotinib and erlotinib

Population: 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.

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).

Outcome measures

Outcome measures
Measure	PF-02341066 (150 mg) and Erlotinib (100 mg) n=14 Participants 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.	PF-02341066 (200 mg) and Erlotinib (100 mg) n=5 Participants 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.
Erlotinib Apparent Oral Clearance (CL/F) (Phase 1)	2.572 L/hr Geometric Coefficient of Variation 49	2.395 L/hr Geometric Coefficient of Variation 27

SECONDARY outcome

Timeframe: 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)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	PF-02341066 (150 mg) and Erlotinib (100 mg) n=19 Participants 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.	PF-02341066 (200 mg) and Erlotinib (100 mg) n=7 Participants 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.
Ratio of Adjusted Means of Erlotinib AUCtau (Crizotinib + Erlotinib / Erlotinib Alone) (Phase 1)	149.41 Ratio in percentage 90% Confidence Interval 43 • Interval 125.87 to 177.36	184.80 Ratio in percentage 90% Confidence Interval 40 • Interval 149.67 to 228.18

SECONDARY outcome

Timeframe: 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)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	PF-02341066 (150 mg) and Erlotinib (100 mg) n=19 Participants 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.	PF-02341066 (200 mg) and Erlotinib (100 mg) n=7 Participants 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.
Ratio of Adjusted Means of Erlotinib Cmax (Crizotinib + Erlotinib / Erlotinib Alone) (Phase 1)	134.60 Ratio in percentage 90% Confidence Interval 27 • Interval 115.23 to 157.22	160.15 Ratio in percentage 90% Confidence Interval 49 • Interval 121.06 to 211.86

SECONDARY outcome

Timeframe: Baseline, every 42 days until disease progression or unacceptable toxicity

Population: not analyzed due to small number of study participants

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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, every 42 days until disease progression or unacceptable toxicity

Population: not analyzed due to small number of responses

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, every 42 days until disease progression or unacceptable toxicity

Population: 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.

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.

Outcome measures

Outcome measures
Measure	PF-02341066 (150 mg) and Erlotinib (100 mg) n=18 Participants 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.	PF-02341066 (200 mg) and Erlotinib (100 mg) n=7 Participants 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.
Percentage of Participants With Objective Response (Phase 1)	5.6 percentage of participants Interval 0.1 to 27.3	14.3 percentage of participants Interval 0.4 to 57.9

SECONDARY outcome

Timeframe: Baseline and Day 50 (Cycle 3, Day 1)

Population: 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.

Levels of soluble protein biomarker c-MET was analyzed at Baseline and at Day 50.

Outcome measures

Outcome measures
Measure	PF-02341066 (150 mg) and Erlotinib (100 mg) n=7 Participants 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.	PF-02341066 (200 mg) and Erlotinib (100 mg) n=1 Participants 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.
Plasma Level of Soluble Marker: c-Met Ectodomain (Phase 1) Baseline	1454.6 nanogram per milliliter (ng/mL) Standard Deviation 303.93	1560.0 nanogram per milliliter (ng/mL) Standard Deviation NA Not available as there is only one participant.
Plasma Level of Soluble Marker: c-Met Ectodomain (Phase 1) C3D1 0 Hour	1525.9 nanogram per milliliter (ng/mL) Standard Deviation 442.01	1870.0 nanogram per milliliter (ng/mL) Standard Deviation NA Not available as there is only one participant.
Plasma Level of Soluble Marker: c-Met Ectodomain (Phase 1) C3D1 6 Hour	1600.0 nanogram per milliliter (ng/mL) Standard Deviation 369.05	1660.0 nanogram per milliliter (ng/mL) Standard Deviation NA Not available as there is only one participant.

SECONDARY outcome

Timeframe: Baseline and Day 50 (Cycle 3, Day 1)

Population: Plasma level of soluble marker HGF scatter factor not analyzed due to prior experience with high levels of intra participant variability

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and Day 50 (Cycle 3, Day 1)

Population: Not analyzed due to phase 2 study termination

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and Day 50 (Cycle 3, Day 1)

Population: Not analyzed due to phase 2 study termination

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, every 42 days up to 20 months, disease progression, or unacceptable toxicity

Population: Not analyzed due to phase 2 study termination

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 6 and Week 12

Population: Not analyzed due to phase 2 study termination

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, every 42 days up to 20 months, disease progression, or unacceptable toxicity

Population: Not analyzed due to phase 2 study termination

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline until death, up to 20 months

Population: Not analyzed due to phase 2 study termination

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and every 21 days, up to 20 months

Population: Not analyzed due to phase 2 study termination

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and every 21 days, up to 20 months

Population: Not analyzed due to phase 2 study termination

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

Population: Not analyzed due to phase 2 study termination

Plasma concentration of PF-02341066 and erlotinib when administered in combination during phase 2

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 of cycles 1, 3, and 5 (i.e., up to 15 weeks) at 0 hours (pre-dose)

Population: Not analyzed due to phase 2 study termination

Plasma concentration of erlotinib when administered as a single agent during phase 2

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Screening

Population: Not analyzed due to phase 2 study termination

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to 28 days (Cycle 1)

Population: DLT evaluable population

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.

Outcome measures

Outcome measures
Measure	PF-02341066 (150 mg) and Erlotinib (100 mg) 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.	PF-02341066 (200 mg) and Erlotinib (100 mg) n=22 Participants 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.
Maximum Tolerated Dose (MTD) of PF-02341066 When Administered in Combination With Erlotinib (Phase 1) PF-02341066 (BID)	—	150 mg
Maximum Tolerated Dose (MTD) of PF-02341066 When Administered in Combination With Erlotinib (Phase 1) Erlotinib (QD)	—	100 mg

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to 28 days (Cycle 1)

Population: DLT evaluable population

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.

Outcome measures

Outcome measures
Measure	PF-02341066 (150 mg) and Erlotinib (100 mg) 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.	PF-02341066 (200 mg) and Erlotinib (100 mg) n=22 Participants 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.
Recommended Phase 2 Dose (RP2D) of PF-02341066 When Administered in Combination With Erlotinib (Phase 1) PF-02341066 (BID)	—	150 mg
Recommended Phase 2 Dose (RP2D) of PF-02341066 When Administered in Combination With Erlotinib (Phase 1) Erlotinib (QD)	—	100 mg

Adverse Events

PF-02341066 (200 mg) and Erlotinib (100 mg)

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

PF-02341066 (150 mg) and Erlotinib (100 mg)

Serious events: 8 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	PF-02341066 (200 mg) and Erlotinib (100 mg) n=7 participants at risk 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) and Erlotinib (100 mg) n=20 participants at risk 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.
General disorders Disease progression	0.00% 0/7 • Up to 28 days after the last dose of study treatment (up to approximately 20 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	20.0% 4/20 • Up to 28 days after the last dose of study treatment (up to approximately 20 months) 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.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/7 • Up to 28 days after the last dose of study treatment (up to approximately 20 months) 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.	5.0% 1/20 • Up to 28 days after the last dose of study treatment (up to approximately 20 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal pain	0.00% 0/7 • Up to 28 days after the last dose of study treatment (up to approximately 20 months) 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.	5.0% 1/20 • Up to 28 days after the last dose of study treatment (up to approximately 20 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Diarrhoea	0.00% 0/7 • Up to 28 days after the last dose of study treatment (up to approximately 20 months) 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.	5.0% 1/20 • Up to 28 days after the last dose of study treatment (up to approximately 20 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Oesophagitis	14.3% 1/7 • Up to 28 days after the last dose of study treatment (up to approximately 20 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/20 • Up to 28 days after the last dose of study treatment (up to approximately 20 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Pneumonia	0.00% 0/7 • Up to 28 days after the last dose of study treatment (up to approximately 20 months) 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.	10.0% 2/20 • Up to 28 days after the last dose of study treatment (up to approximately 20 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Viral infection	0.00% 0/7 • Up to 28 days after the last dose of study treatment (up to approximately 20 months) 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.	5.0% 1/20 • Up to 28 days after the last dose of study treatment (up to approximately 20 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Dehydration	0.00% 0/7 • Up to 28 days after the last dose of study treatment (up to approximately 20 months) 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.	5.0% 1/20 • Up to 28 days after the last dose of study treatment (up to approximately 20 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Aphasia	0.00% 0/7 • Up to 28 days after the last dose of study treatment (up to approximately 20 months) 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.	5.0% 1/20 • Up to 28 days after the last dose of study treatment (up to approximately 20 months) 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.
Psychiatric disorders Anxiety	0.00% 0/7 • Up to 28 days after the last dose of study treatment (up to approximately 20 months) 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.	5.0% 1/20 • Up to 28 days after the last dose of study treatment (up to approximately 20 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/7 • Up to 28 days after the last dose of study treatment (up to approximately 20 months) 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.	5.0% 1/20 • Up to 28 days after the last dose of study treatment (up to approximately 20 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/7 • Up to 28 days after the last dose of study treatment (up to approximately 20 months) 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.	5.0% 1/20 • Up to 28 days after the last dose of study treatment (up to approximately 20 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	14.3% 1/7 • Up to 28 days after the last dose of study treatment (up to approximately 20 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/20 • Up to 28 days after the last dose of study treatment (up to approximately 20 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Deep vein thrombosis	0.00% 0/7 • Up to 28 days after the last dose of study treatment (up to approximately 20 months) 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.	10.0% 2/20 • Up to 28 days after the last dose of study treatment (up to approximately 20 months) 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.

Other adverse events

Additional Information

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Results disclosure agreements

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