Trial Outcomes & Findings for Trial Of PF-00299804 In Patients With Advanced Refractory Lung Cancer (NCT NCT00553254)

Last Updated: 2020-10-19

Results Overview

The highest dose at which less than (\<) 33 percent (%) of participants experienced dose-limiting toxicities (DLT) was to be designated as the maximum tolerated dose (MTD) as well as the RP2D. DLT was defined as any of the following events: Grade 3/4 (severe or life-threatening/ disabling adverse event \[AE\]) nausea, vomiting, or diarrhea (despite the use of adequate/maximal medical intervention and/or prophylaxis); Grade greater than or equal to (\>=) 3 (severe or life-threatening/disabling AE or death related to AE) non-hematological toxicity; delayed (which delayed scheduled treatment for \>14 days) recovery from toxicity related to treatment with PF-00299804; Grade 4 neutropenia (absolute neutrophil count \[ANC\] \<500 cells per cubic millimeter \[cells/mm\^3\] for 5 or more consecutive days or febrile neutropenia \[fever \>=38.5 degrees Celsius with ANC \<1000 cells/mm\^3\]); and Grade 4 thrombocytopenia (\<25,000 cells/mm\^3) or bleeding which required platelet transfusion.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

55 participants

Primary outcome timeframe

Baseline up to Day 21

Results posted on

2020-10-19

Participant Flow

Participant milestones

Participant milestones
Measure	PF-00299804 30 mg - Phase 1 A single dose of PF-00299804 30 milligram (mg) tablet orally on or before Day -9 followed by PF-00299804 30 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.	PF-00299804 45 mg - Phase 1 A single dose of PF-00299804 45 mg tablet orally on or before Day -9 followed by PF-00299804 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.	PF-00299804 45 mg - Phase 2 PF-00299804 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	6	6	43
Overall Study STARTED	6	6	43

Reasons for withdrawal

Reasons for withdrawal
Measure	PF-00299804 30 mg - Phase 1 A single dose of PF-00299804 30 milligram (mg) tablet orally on or before Day -9 followed by PF-00299804 30 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.	PF-00299804 45 mg - Phase 1 A single dose of PF-00299804 45 mg tablet orally on or before Day -9 followed by PF-00299804 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.	PF-00299804 45 mg - Phase 2 PF-00299804 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.
Overall Study Death	3	6	25
Overall Study Lost to Follow-up	0	0	2
Overall Study Withdrawal by Subject	2	0	2
Overall Study Study terminated by Sponsor	0	0	1
Overall Study Other	1	0	13

Baseline Characteristics

Trial Of PF-00299804 In Patients With Advanced Refractory Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PF-00299804 - Phase 1 All Participants n=12 Participants A single dose of PF-00299804 30 mg or 45 mg tablet orally on or before Day -9 followed by PF-00299804 30 mg or 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.	PF-00299804 45 mg - Phase 2 n=43 Participants PF-00299804 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.	Total n=55 Participants Total of all reporting groups
Age, Continuous	52.6 years STANDARD_DEVIATION 12.3 • n=5 Participants	57.0 years STANDARD_DEVIATION 8.7 • n=7 Participants	56.0 years STANDARD_DEVIATION 9.6 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	23 Participants n=7 Participants	32 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	20 Participants n=7 Participants	23 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline up to Day 21

Population: As-treated population included all enrolled participants who received at least 1 dose of study medication.

Outcome measures

Outcome measures
Measure	PF-00299804 - Phase 1 All Participants n=12 Participants A single dose of PF-00299804 30 mg or 45 mg tablet orally on or before Day -9 followed by PF-00299804 30 mg or 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.	PF-00299804 45 mg - Phase 1 A single dose of PF-00299804 45 mg tablet orally on or before Day -9 followed by PF-00299804 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.	PF-00299804 45 mg - Phase 2 PF-00299804 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.
Recommended Phase 2 Dose (RP2D) - Phase 1	45 mg	—	—

PRIMARY outcome

Timeframe: Month 4

Population: Full analysis set (FAS) included all enrolled participants.

PFS4m was defined as percent chance of being event free (event defined as progressive disease \[PD\] or death due to any cause, whichever occurred first) at 4 months. Progression was defined using Response Evaluation Criteria in Solid Tumors (RECIST), as at least 20 percent (%) increase in the sum of longest dimensions (LD) of target lesions, taking as reference the smallest sum of LD recorded since the treatment started and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.

Outcome measures

Outcome measures
Measure	PF-00299804 - Phase 1 All Participants n=43 Participants A single dose of PF-00299804 30 mg or 45 mg tablet orally on or before Day -9 followed by PF-00299804 30 mg or 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.	PF-00299804 45 mg - Phase 1 A single dose of PF-00299804 45 mg tablet orally on or before Day -9 followed by PF-00299804 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.	PF-00299804 45 mg - Phase 2 PF-00299804 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.
Progression-Free Survival (PFS) at Month 4 (PFS4m) - Phase 2	47.2 percent chance of being event-free Interval 31.6 to 61.3	—	—

SECONDARY outcome

Timeframe: Month 6

Population: FAS included all enrolled participants.

PFS6m was defined as percent chance of being event free (event defined as PD or death due to any cause, whichever occurred first) at 6 months. Progression was defined using RECIST, as at least 20% increase in the sum of longest dimensions (LD) of target lesions, taking as reference the smallest sum of LD recorded since the treatment started and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.

Outcome measures

Outcome measures
Measure	PF-00299804 - Phase 1 All Participants n=43 Participants A single dose of PF-00299804 30 mg or 45 mg tablet orally on or before Day -9 followed by PF-00299804 30 mg or 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.	PF-00299804 45 mg - Phase 1 A single dose of PF-00299804 45 mg tablet orally on or before Day -9 followed by PF-00299804 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.	PF-00299804 45 mg - Phase 2 PF-00299804 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.
Progression-Free Survival (PFS) at Month 6 (PFS6m) - Phase 2	24.8 percent chance of being event-free Interval 12.9 to 38.7	—	—

SECONDARY outcome

Timeframe: Month 6

Population: FAS included all enrolled participants.

OS6m was defined as percent chance of being alive at Month 6.

Outcome measures

Outcome measures
Measure	PF-00299804 - Phase 1 All Participants n=43 Participants A single dose of PF-00299804 30 mg or 45 mg tablet orally on or before Day -9 followed by PF-00299804 30 mg or 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.	PF-00299804 45 mg - Phase 1 A single dose of PF-00299804 45 mg tablet orally on or before Day -9 followed by PF-00299804 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.	PF-00299804 45 mg - Phase 2 PF-00299804 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.
Overall Survival (OS) at Month 6 (OS6m) - Phase 2	80.7 percent chance of being alive Interval 65.1 to 89.9	—	—

SECONDARY outcome

Timeframe: Baseline until disease progression or initiation of new anti-cancer therapy or death, assessed every 2 (odd-numbered) cycles up to 12 months after end of treatment (EOT) (EOT: up to Day 506)

Population: Response-evaluable population included all enrolled participants who received at least 1 dose of study medication, had an adequate baseline tumor assessment, and had at least 1 on-study tumor assessment after first dosing.

Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. CR: disappearance of all target and non-target lesions. PR: at least 30 % decrease in sum of the longest dimensions (LDs) of target lesion, taking as reference the baseline sum LD, associated to non-progressive disease response for non-target lesions. Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response.

Outcome measures

Outcome measures
Measure	PF-00299804 - Phase 1 All Participants n=6 Participants A single dose of PF-00299804 30 mg or 45 mg tablet orally on or before Day -9 followed by PF-00299804 30 mg or 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.	PF-00299804 45 mg - Phase 1 n=6 Participants A single dose of PF-00299804 45 mg tablet orally on or before Day -9 followed by PF-00299804 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.	PF-00299804 45 mg - Phase 2 PF-00299804 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.
Percentage of Participants With Objective Response - Phase 1	0.0 percentage of participants Interval 0.0 to 45.9	33.3 percentage of participants Interval 4.3 to 77.7	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 (C1D1, Baseline), Day 1 of each odd-numbered cycle up to Cycle 17 for both Phase 1 and Phase 2

Population: Biomarker analysis set: all enrolled participants who had baseline samples submitted as per Institutional Review Board/Independent Ethics Committee approval and participant consent. Data was pre-specified in statistical analysis plan to be analyzed and summarized per phase. Number analyzed = participants evaluable at specified time-point.

Blood specimens were analyzed at a sponsor-designated laboratory for analysis of shed proteins/receptors related to Human Epidermal Growth Factor Receptor (HER) signaling (epidermal growth factor receptor \[EGFR\], HER2). These measurements were determined by enzyme-linked immunosorbent assay (ELISA). The data for all Phase 1 participants was combined for this outcome.

Outcome measures

SECONDARY outcome

Timeframe: Screening

Tumor tissue was analyzed at a sponsor-designated laboratory to investigate EGFR, KRAS and HER2 status (wild type or mutated). Participants who did not provide samples for central laboratory analysis confirmation were classified as "unknown". The data for all Phase 1 participants was combined for this outcome.

Outcome measures

Outcome measures
Measure	PF-00299804 - Phase 1 All Participants n=12 Participants A single dose of PF-00299804 30 mg or 45 mg tablet orally on or before Day -9 followed by PF-00299804 30 mg or 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.	PF-00299804 45 mg - Phase 1 n=43 Participants A single dose of PF-00299804 45 mg tablet orally on or before Day -9 followed by PF-00299804 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.	PF-00299804 45 mg - Phase 2 PF-00299804 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.
Number of Participants With Epidermal Growth Factor Receptor (EGFR), Kirsten Rat Sarcoma (KRAS), and Human Epidermal Growth Factor Receptor-2 (HER2) Mutation Status EGFR Status: Wild Type	3 participants	3 participants	—
Number of Participants With Epidermal Growth Factor Receptor (EGFR), Kirsten Rat Sarcoma (KRAS), and Human Epidermal Growth Factor Receptor-2 (HER2) Mutation Status EGFR Status: Mutant	2 participants	12 participants	—
Number of Participants With Epidermal Growth Factor Receptor (EGFR), Kirsten Rat Sarcoma (KRAS), and Human Epidermal Growth Factor Receptor-2 (HER2) Mutation Status EGFR Status: Unknown	7 participants	28 participants	—
Number of Participants With Epidermal Growth Factor Receptor (EGFR), Kirsten Rat Sarcoma (KRAS), and Human Epidermal Growth Factor Receptor-2 (HER2) Mutation Status KRAS Status: Wild Type	9 participants	29 participants	—
Number of Participants With Epidermal Growth Factor Receptor (EGFR), Kirsten Rat Sarcoma (KRAS), and Human Epidermal Growth Factor Receptor-2 (HER2) Mutation Status KRAS Status: Mutant	0 participants	0 participants	—
Number of Participants With Epidermal Growth Factor Receptor (EGFR), Kirsten Rat Sarcoma (KRAS), and Human Epidermal Growth Factor Receptor-2 (HER2) Mutation Status KRAS Status: Unknown	3 participants	14 participants	—
Number of Participants With Epidermal Growth Factor Receptor (EGFR), Kirsten Rat Sarcoma (KRAS), and Human Epidermal Growth Factor Receptor-2 (HER2) Mutation Status HER2 Status: Wild Type	0 participants	9 participants	—
Number of Participants With Epidermal Growth Factor Receptor (EGFR), Kirsten Rat Sarcoma (KRAS), and Human Epidermal Growth Factor Receptor-2 (HER2) Mutation Status HER2 Status: Mutant	0 participants	1 participants	—
Number of Participants With Epidermal Growth Factor Receptor (EGFR), Kirsten Rat Sarcoma (KRAS), and Human Epidermal Growth Factor Receptor-2 (HER2) Mutation Status HER2 Status: Unknown	12 participants	33 participants	—

SECONDARY outcome

Timeframe: 0 (pre-dose), 2, 4, 6, 8, 24, 72, 144, 216 hours post-dose on C0D-9 for Phase 1, 0 (pre-dose), 2, 4, 6, 8, 24 hours post-dose on C1D14 for Phase 1 and 2

Population: Pharmacokinetic (PK): all participants who received at least 1 dose of study drug and had at least 1 measured plasma concentration. "number analyzed"=participants evaluable for specified time-point. PK analysis was done by dose level instead of by phase. Participants started from the same dose level were combined together for PK analysis.

Data in "PF-00299804 45 mg" treatment arm at Cycle 0 Day -9 (C0D-9) represents participants from Phase 1 only and at C1D14 represents participants from both Phase 1 and Phase 2.

Outcome measures

Outcome measures
Measure	PF-00299804 - Phase 1 All Participants n=6 Participants A single dose of PF-00299804 30 mg or 45 mg tablet orally on or before Day -9 followed by PF-00299804 30 mg or 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.	PF-00299804 45 mg - Phase 1 n=40 Participants A single dose of PF-00299804 45 mg tablet orally on or before Day -9 followed by PF-00299804 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.	PF-00299804 45 mg - Phase 2 PF-00299804 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.
Maximum Observed Plasma Concentration (Cmax) of PF-00299804 30 mg and PF-00299804 45 mg C0D-9	13.34 nanogram per milliliter (ng/mL) Standard Deviation 4.8205	21.30 nanogram per milliliter (ng/mL) Standard Deviation 12.356	—
Maximum Observed Plasma Concentration (Cmax) of PF-00299804 30 mg and PF-00299804 45 mg C1D14	56.96 nanogram per milliliter (ng/mL) Standard Deviation 20.572	82.71 nanogram per milliliter (ng/mL) Standard Deviation 38.788	—

SECONDARY outcome

Timeframe: 0 (pre-dose), 2, 4, 6, 8, 24, 72, 144, 216 hours post-dose on Cycle 0 Day -9 (C0D-9) for Phase 1, 0 (pre-dose), 2, 4, 6, 8, 24 hours post-dose on C1D14 for Phase 1 and 2

Population: PK analysis set included all participants who received at least 1 dose of study drug and had at least 1 measured plasma concentration. "number analyzed"=participants evaluable for specified time-point. PK analysis was done by dose level instead of by phase. Participants started from the same dose level were combined together for PK analysis.

Data in "PF-00299804 45 mg" treatment arm at C0D-9 represents participants from Phase 1 only and at C1D14 represents participants from both Phase 1 and Phase 2.

Outcome measures

Outcome measures
Measure	PF-00299804 - Phase 1 All Participants n=6 Participants A single dose of PF-00299804 30 mg or 45 mg tablet orally on or before Day -9 followed by PF-00299804 30 mg or 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.	PF-00299804 45 mg - Phase 1 n=40 Participants A single dose of PF-00299804 45 mg tablet orally on or before Day -9 followed by PF-00299804 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.	PF-00299804 45 mg - Phase 2 PF-00299804 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-00299804 30 mg and PF-00299804 45 mg C0D-9	8.00 hours Interval 4.17 to 24.0	4.96 hours Interval 1.98 to 8.0	—
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-00299804 30 mg and PF-00299804 45 mg C1D14	5.03 hours Interval 0.0 to 24.0	6.10 hours Interval 0.0 to 24.0	—

SECONDARY outcome

Timeframe: 0 (pre-dose), 2, 4, 6, 8, 24, 72, 144, 216 hours post-dose on Cycle 0 Day -9 (C0D-9)

Population: PK analysis set for Phase 1 included all participants who received at least 1 dose of study medication and had at least 1 measured plasma concentration.

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Outcome measures

Outcome measures
Measure	PF-00299804 - Phase 1 All Participants n=6 Participants A single dose of PF-00299804 30 mg or 45 mg tablet orally on or before Day -9 followed by PF-00299804 30 mg or 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.	PF-00299804 45 mg - Phase 1 n=6 Participants A single dose of PF-00299804 45 mg tablet orally on or before Day -9 followed by PF-00299804 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.	PF-00299804 45 mg - Phase 2 PF-00299804 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.
Plasma Decay Half-Life (t1/2) of PF-00299804 30 mg and PF-00299804 45 mg - Phase 1	63.60 hours Standard Deviation 30.271	54.02 hours Standard Deviation 13.461	—

SECONDARY outcome

Timeframe: 0 (pre-dose), 2, 4, 6, 8, 24 hours post-dose on Cycle 0 Day -9 (C0D-9) for Phase 1, 0 (pre-dose), 2, 4, 6, 8, 24 hours post-dose on C1D14 for Phase 1 and 2

AUC0-24: Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post dose. Data in "PF- 00299804 45 mg" treatment arm at C0D-9 represents participants from Phase 1 only and at C1D14 represents participants from both Phase 1 and Phase 2.

Outcome measures

Outcome measures
Measure	PF-00299804 - Phase 1 All Participants n=6 Participants A single dose of PF-00299804 30 mg or 45 mg tablet orally on or before Day -9 followed by PF-00299804 30 mg or 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.	PF-00299804 45 mg - Phase 1 n=40 Participants A single dose of PF-00299804 45 mg tablet orally on or before Day -9 followed by PF-00299804 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.	PF-00299804 45 mg - Phase 2 PF-00299804 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.
Area Under the Curve From Time Zero to 24 Hour Post-Dose (AUC0-24) of PF-00299804 30 mg and PF-00299804 45 mg C0D-9	221.6 nanogramhour per milliliter (nghr/mL) Standard Deviation 87.063	354.8 nanogramhour per milliliter (nghr/mL) Standard Deviation 153.31	—
Area Under the Curve From Time Zero to 24 Hour Post-Dose (AUC0-24) of PF-00299804 30 mg and PF-00299804 45 mg C1D14	1075 nanogramhour per milliliter (nghr/mL) Standard Deviation 515.66	1621 nanogramhour per milliliter (nghr/mL) Standard Deviation 664.87	—

SECONDARY outcome

Timeframe: 0 (pre-dose), 2, 4, 6, 8, 24, 72, 144, 216 hours post-dose on C0D-9

Population: PK analysis set for Phase 1 included all participants who received at least 1 dose of study medication and had at least 1 measured plasma concentration.

AUClast: Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration.

Outcome measures

Outcome measures
Measure	PF-00299804 - Phase 1 All Participants n=6 Participants A single dose of PF-00299804 30 mg or 45 mg tablet orally on or before Day -9 followed by PF-00299804 30 mg or 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.	PF-00299804 45 mg - Phase 1 n=6 Participants A single dose of PF-00299804 45 mg tablet orally on or before Day -9 followed by PF-00299804 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.	PF-00299804 45 mg - Phase 2 PF-00299804 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-00299804 30 mg and PF-00299804 45 mg- Phase 1	893.4 ng*hr/mL Standard Deviation 516.50	1248 ng*hr/mL Standard Deviation 522.11	—

SECONDARY outcome

Timeframe: 0 (pre-dose), 2, 4, 6, 8, 24, 72, 144, 216 hours post-dose on C0D-9

Population: PK analysis set for Phase 1 included all participants who received at least 1 dose of study medication and had at least 1 measured plasma concentration.

AUCinf: Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).

Outcome measures

Outcome measures
Measure	PF-00299804 - Phase 1 All Participants n=6 Participants A single dose of PF-00299804 30 mg or 45 mg tablet orally on or before Day -9 followed by PF-00299804 30 mg or 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.	PF-00299804 45 mg - Phase 1 n=6 Participants A single dose of PF-00299804 45 mg tablet orally on or before Day -9 followed by PF-00299804 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.	PF-00299804 45 mg - Phase 2 PF-00299804 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-00299804 30 mg and PF-00299804 45 mg - Phase 1	1018 ng*hr/mL Standard Deviation 593.51	1348 ng*hr/mL Standard Deviation 599.34	—

SECONDARY outcome

Timeframe: 0 (pre-dose), 2, 4, 6, 8, 24 hours post-dose on C0D-9, 0 (pre-dose), 2, 4, 6, 8, 24 hours post-dose on C1D14

Population: PK analysis set for Phase 1 included all participants who received at least 1 dose of study medication and had at least 1 measured plasma concentration.

Rac was calculated by dividing AUC0-24 (C1D14) by AUC0-24 (C0D-9).

Outcome measures

Outcome measures
Measure	PF-00299804 - Phase 1 All Participants n=6 Participants A single dose of PF-00299804 30 mg or 45 mg tablet orally on or before Day -9 followed by PF-00299804 30 mg or 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.	PF-00299804 45 mg - Phase 1 n=6 Participants A single dose of PF-00299804 45 mg tablet orally on or before Day -9 followed by PF-00299804 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.	PF-00299804 45 mg - Phase 2 PF-00299804 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.
Accumulation Ratio (Rac) of PF-00299804 30 mg and PF-00299804 45 mg - Phase 1	5.265 ratio Standard Deviation 2.2958	5.682 ratio Standard Deviation 2.5752	—

SECONDARY outcome

Timeframe: 0 (pre-dose), 2, 4, 6, 8, 24 hours post-dose on C1D14 for Phase 1 and 2

Population: PK analysis set included all participants who received at least 1 dose of study drug and had at least 1 measured plasma concentration. PK analysis was done by dose level instead of by phase. Participants started from the same dose level were combined together for PK analysis.

Data in "PF-00299804 45 mg" treatment arm represents participants from both Phase 1 and Phase 2.

Outcome measures

Outcome measures
Measure	PF-00299804 - Phase 1 All Participants n=6 Participants A single dose of PF-00299804 30 mg or 45 mg tablet orally on or before Day -9 followed by PF-00299804 30 mg or 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.	PF-00299804 45 mg - Phase 1 n=40 Participants A single dose of PF-00299804 45 mg tablet orally on or before Day -9 followed by PF-00299804 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.	PF-00299804 45 mg - Phase 2 PF-00299804 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.
Average Plasma Concentration (Cavg) of PF-00299804 30 mg and PF-00299804 45 mg	44.78 ng/mL Standard Deviation 21.439	67.52 ng/mL Standard Deviation 27.643	—

SECONDARY outcome

Timeframe: 0 (pre-dose), 2, 4, 6, 8, 24, 72, 144, 216 hours post-dose on C0D-9, 0 (pre-dose), 2, 4, 6, 8, 24 hours post-dose on C1D14

Population: PK analysis set for Phase 1 included all participants who received at least 1 dose of study medication and had at least 1 measured plasma concentration.

Rss was calculated by dividing AUC0-24 (C1D14) by AUCinf (C0D-9).

Outcome measures

Outcome measures
Measure	PF-00299804 - Phase 1 All Participants n=6 Participants A single dose of PF-00299804 30 mg or 45 mg tablet orally on or before Day -9 followed by PF-00299804 30 mg or 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.	PF-00299804 45 mg - Phase 1 n=6 Participants A single dose of PF-00299804 45 mg tablet orally on or before Day -9 followed by PF-00299804 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.	PF-00299804 45 mg - Phase 2 PF-00299804 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.
Linearity Ratio (Rss) of PF-00299804 30 mg and PF-00299804 45 mg - Phase 1	1.093 ratio Standard Deviation 0.3100	1.442 ratio Standard Deviation 0.5661	—

SECONDARY outcome

Timeframe: 0 hours (pre-dose) on C2D1, C3D1, C4D1

Data in "PF-00299804 45 mg" treatment arm represents participants from both Phase 1 and Phase 2.

Outcome measures

Outcome measures
Measure	PF-00299804 - Phase 1 All Participants n=6 Participants A single dose of PF-00299804 30 mg or 45 mg tablet orally on or before Day -9 followed by PF-00299804 30 mg or 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.	PF-00299804 45 mg - Phase 1 n=40 Participants A single dose of PF-00299804 45 mg tablet orally on or before Day -9 followed by PF-00299804 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.	PF-00299804 45 mg - Phase 2 PF-00299804 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.
Minimum Observed Plasma Trough Concentration (Ctrough) of PF-00299804 30 mg and PF-00299804 45 mg C2D1	45.96 ng/mL Standard Deviation 31.061	65.11 ng/mL Standard Deviation 33.673	—
Minimum Observed Plasma Trough Concentration (Ctrough) of PF-00299804 30 mg and PF-00299804 45 mg C3D1	46.52 ng/mL Standard Deviation 23.329	66.98 ng/mL Standard Deviation 32.354	—
Minimum Observed Plasma Trough Concentration (Ctrough) of PF-00299804 30 mg and PF-00299804 45 mg C4D1	40.34 ng/mL Standard Deviation 24.527	69.75 ng/mL Standard Deviation 37.584	—

SECONDARY outcome

Timeframe: Baseline up to end of treatment (up to Day 889)

Population: FAS included all enrolled participants. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.

EORTC QLQ-C30: included global health status/quality of life (QoL), functional (Fn) scales (physical, role, cognitive, emotional, and social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulties). Scores were averaged, transformed to 0-100 scale; higher score for Global Qol/Fn scales=better level of QoL/functioning or higher score for symptom scales/items=greater degree of symptoms. Overall scale change is categorized as Improved (if average scales change from baseline: for Global QoL/Fn scales \>=10; for symptom scale/item \<=-10), Worsened (if average scales change from baseline: for Global QoL/Fn scales \<=-10; for symptom scale/item \>=10), and Stable (if average scales change from baseline \>-10 but \<10 for Global QoL/Fn scales and symptom scale/item) and participants in each category are reported.

Outcome measures

Outcome measures
Measure	PF-00299804 - Phase 1 All Participants n=39 Participants A single dose of PF-00299804 30 mg or 45 mg tablet orally on or before Day -9 followed by PF-00299804 30 mg or 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.	PF-00299804 45 mg - Phase 1 A single dose of PF-00299804 45 mg tablet orally on or before Day -9 followed by PF-00299804 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.	PF-00299804 45 mg - Phase 2 PF-00299804 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.
Number of Participants With Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Phase 2 Global QoL: Improved	5 participants	—	—
Number of Participants With Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Phase 2 Global QoL: Worsened	18 participants	—	—
Number of Participants With Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Phase 2 Global QoL: Stable	16 participants	—	—
Number of Participants With Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Phase 2 Physical Functioning: Improved	2 participants	—	—
Number of Participants With Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Phase 2 Physical Functioning: Worsened	20 participants	—	—
Number of Participants With Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Phase 2 Physical Functioning: Stable	17 participants	—	—
Number of Participants With Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Phase 2 Role Functioning: Improved	2 participants	—	—
Number of Participants With Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Phase 2 Role Functioning: Worsened	22 participants	—	—
Number of Participants With Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Phase 2 Role Functioning: Stable	15 participants	—	—
Number of Participants With Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Phase 2 Cognitive Functioning: Improved	4 participants	—	—
Number of Participants With Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Phase 2 Cognitive Functioning: Worsened	17 participants	—	—
Number of Participants With Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Phase 2 Cognitive Functioning: Stable	18 participants	—	—
Number of Participants With Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Phase 2 Emotional Functioning: Improved	2 participants	—	—
Number of Participants With Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Phase 2 Emotional Functioning: Worsened	16 participants	—	—
Number of Participants With Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Phase 2 Emotional Functioning: Stable	21 participants	—	—
Number of Participants With Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Phase 2 Social Functioning: Improved	6 participants	—	—
Number of Participants With Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Phase 2 Social Functioning: Worsened	15 participants	—	—
Number of Participants With Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Phase 2 Social Functioning: Stable	18 participants	—	—
Number of Participants With Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Phase 2 Fatigue: Improved	3 participants	—	—
Number of Participants With Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Phase 2 Fatigue: Worsened	20 participants	—	—
Number of Participants With Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Phase 2 Fatigue: Stable	16 participants	—	—
Number of Participants With Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Phase 2 Pain: Improved	8 participants	—	—
Number of Participants With Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Phase 2 Pain: Worsened	15 participants	—	—
Number of Participants With Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Phase 2 Pain: Stable	16 participants	—	—
Number of Participants With Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Phase 2 Nausea and Vomiting: Improved	4 participants	—	—
Number of Participants With Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Phase 2 Nausea and Vomiting: Worsened	10 participants	—	—
Number of Participants With Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Phase 2 Nausea and Vomiting: Stable	25 participants	—	—
Number of Participants With Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Phase 2 Dyspnea: Improved	7 participants	—	—
Number of Participants With Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Phase 2 Dyspnea: Worsened	16 participants	—	—
Number of Participants With Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Phase 2 Dyspnea: Stable	16 participants	—	—
Number of Participants With Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Phase 2 Loss of Appetite: Improved	6 participants	—	—
Number of Participants With Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Phase 2 Loss of Appetite: Worsened	24 participants	—	—
Number of Participants With Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Phase 2 Loss of Appetite: Stable	9 participants	—	—
Number of Participants With Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Phase 2 Insomnia: Improved	9 participants	—	—
Number of Participants With Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Phase 2 Insomnia: Worsened	12 participants	—	—
Number of Participants With Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Phase 2 Insomnia: Stable	18 participants	—	—
Number of Participants With Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Phase 2 Constipation: Improved	9 participants	—	—
Number of Participants With Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Phase 2 Constipation: Worsened	8 participants	—	—
Number of Participants With Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Phase 2 Constipation: Stable	22 participants	—	—
Number of Participants With Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Phase 2 Diarrhea: Improved	0 participants	—	—
Number of Participants With Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Phase 2 Diarrhea: Worsened	36 participants	—	—
Number of Participants With Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Phase 2 Diarrhea: Stable	3 participants	—	—
Number of Participants With Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Phase 2 Financial Difficulties: Improved	10 participants	—	—
Number of Participants With Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Phase 2 Financial Difficulties: Worsened	9 participants	—	—
Number of Participants With Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Phase 2 Financial Difficulties: Stable	20 participants	—	—

SECONDARY outcome

Timeframe: Baseline up to end of treatment (up to Day 889)

Population: FAS included all enrolled participants. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure. Medicine for pain was not summarized because a more comprehensive and reliable summary of concomitant medications was reported separately.

EORTC 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, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, and medicine for pain). Scores averaged, transformed to 0-100 scale; higher symptom score = greater degree of symptoms. Overall scale change is categorized as Improved (if average scales change from baseline \<=-10), Worsened (if average scales change from baseline \>=10), and Stable (if average scales change from baseline \>-10 but \<10) and participants in each category are reported.

Outcome measures

Outcome measures
Measure	PF-00299804 - Phase 1 All Participants n=39 Participants A single dose of PF-00299804 30 mg or 45 mg tablet orally on or before Day -9 followed by PF-00299804 30 mg or 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.	PF-00299804 45 mg - Phase 1 A single dose of PF-00299804 45 mg tablet orally on or before Day -9 followed by PF-00299804 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.	PF-00299804 45 mg - Phase 2 PF-00299804 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.
Number of Participants With Change in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) - Phase 2 Dyspnoea: Improved	10 participants	—	—
Number of Participants With Change in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) - Phase 2 Dyspnoea: Worsened	16 participants	—	—
Number of Participants With Change in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) - Phase 2 Dyspnoea: Stable	13 participants	—	—
Number of Participants With Change in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) - Phase 2 Coughing: Improved	9 participants	—	—
Number of Participants With Change in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) - Phase 2 Coughing: Worsened	11 participants	—	—
Number of Participants With Change in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) - Phase 2 Coughing: Stable	19 participants	—	—
Number of Participants With Change in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) - Phase 2 Haemoptysis: Improved	0 participants	—	—
Number of Participants With Change in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) - Phase 2 Haemoptysis: Worsened	5 participants	—	—
Number of Participants With Change in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) - Phase 2 Haemoptysis: Stable	34 participants	—	—
Number of Participants With Change in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) - Phase 2 Sore mouth: Improved	1 participants	—	—
Number of Participants With Change in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) - Phase 2 Sore mouth: Worsened	33 participants	—	—
Number of Participants With Change in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) - Phase 2 Sore mouth: Stable	5 participants	—	—
Number of Participants With Change in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) - Phase 2 Dysphagia: Improved	4 participants	—	—
Number of Participants With Change in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) - Phase 2 Dysphagia: Worsened	19 participants	—	—
Number of Participants With Change in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) - Phase 2 Dysphagia: Stable	16 participants	—	—
Number of Participants With Change in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) - Phase 2 Peripheral: Improved	9 participants	—	—
Number of Participants With Change in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) - Phase 2 Peripheral: Worsened	10 participants	—	—
Number of Participants With Change in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) - Phase 2 Peripheral: Stable	20 participants	—	—
Number of Participants With Change in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) - Phase 2 Alopecia: Improved	7 participants	—	—
Number of Participants With Change in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) - Phase 2 Alopecia: Worsened	11 participants	—	—
Number of Participants With Change in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) - Phase 2 Alopecia: Stable	21 participants	—	—
Number of Participants With Change in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) - Phase 2 Pain in chest: Improved	10 participants	—	—
Number of Participants With Change in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) - Phase 2 Pain in chest: Worsened	10 participants	—	—
Number of Participants With Change in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) - Phase 2 Pain in chest: Stable	19 participants	—	—
Number of Participants With Change in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) - Phase 2 Pain in arm or Shoulder: Improved	16 participants	—	—
Number of Participants With Change in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) - Phase 2 Pain in arm or Shoulder: Worsened	11 participants	—	—
Number of Participants With Change in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) - Phase 2 Pain in arm or Shoulder: Stable	12 participants	—	—
Number of Participants With Change in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) - Phase 2 Pain in other parts: Improved	10 participants	—	—
Number of Participants With Change in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) - Phase 2 Pain in other parts: Worsened	14 participants	—	—
Number of Participants With Change in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) - Phase 2 Pain in other parts: Stable	15 participants	—	—

SECONDARY outcome

Timeframe: C1D1 (baseline), D1 of each subsequent cycle up to C44

Population: FAS included all enrolled participants. Here "number analyzed" signifies participants who were evaluable for specified time-point for each treatment arm, respectively.

DLQI: 10-item questionnaire to measure how much the participant's skin problem has impacted their life over the previous week. All questions were answered on a 4-point Likert scale ranging from 0 (not at all/not relevant) to 3 (very much/prevented work or studying). The DLQI was calculated by summing the score of each question and ranged from 0 to 30, where higher scores indicate more quality of life impairment.

Outcome measures

Outcome measures
Measure	PF-00299804 - Phase 1 All Participants n=43 Participants A single dose of PF-00299804 30 mg or 45 mg tablet orally on or before Day -9 followed by PF-00299804 30 mg or 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.	PF-00299804 45 mg - Phase 1 A single dose of PF-00299804 45 mg tablet orally on or before Day -9 followed by PF-00299804 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.	PF-00299804 45 mg - Phase 2 PF-00299804 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.
Dermatology Life Quality Index (DLQI) Total Score - Phase 2 C2D1	6.54 units on a scale Standard Deviation 5.51	—	—
Dermatology Life Quality Index (DLQI) Total Score - Phase 2 C1D1	0.81 units on a scale Standard Deviation 1.99	—	—
Dermatology Life Quality Index (DLQI) Total Score - Phase 2 C3D1	9.51 units on a scale Standard Deviation 7.88	—	—
Dermatology Life Quality Index (DLQI) Total Score - Phase 2 C4D1	10.85 units on a scale Standard Deviation 7.49	—	—
Dermatology Life Quality Index (DLQI) Total Score - Phase 2 C5D1	11.04 units on a scale Standard Deviation 6.77	—	—
Dermatology Life Quality Index (DLQI) Total Score - Phase 2 C6D1	10.76 units on a scale Standard Deviation 8.04	—	—
Dermatology Life Quality Index (DLQI) Total Score - Phase 2 C7D1	9.47 units on a scale Standard Deviation 6.27	—	—
Dermatology Life Quality Index (DLQI) Total Score - Phase 2 C8D1	9.92 units on a scale Standard Deviation 5.56	—	—
Dermatology Life Quality Index (DLQI) Total Score - Phase 2 C9D1	9.58 units on a scale Standard Deviation 4.44	—	—
Dermatology Life Quality Index (DLQI) Total Score - Phase 2 C10D1	10.22 units on a scale Standard Deviation 6.10	—	—
Dermatology Life Quality Index (DLQI) Total Score - Phase 2 C11D1	11.25 units on a scale Standard Deviation 6.09	—	—
Dermatology Life Quality Index (DLQI) Total Score - Phase 2 C12D1	9.00 units on a scale Standard Deviation 4.36	—	—
Dermatology Life Quality Index (DLQI) Total Score - Phase 2 C13D1	8.71 units on a scale Standard Deviation 6.05	—	—
Dermatology Life Quality Index (DLQI) Total Score - Phase 2 C14D1	9.80 units on a scale Standard Deviation 6.76	—	—
Dermatology Life Quality Index (DLQI) Total Score - Phase 2 C15D1	9.60 units on a scale Standard Deviation 5.94	—	—
Dermatology Life Quality Index (DLQI) Total Score - Phase 2 C16D1	9.25 units on a scale Standard Deviation 7.04	—	—
Dermatology Life Quality Index (DLQI) Total Score - Phase 2 C17D1	11.50 units on a scale Standard Deviation 10.28	—	—
Dermatology Life Quality Index (DLQI) Total Score - Phase 2 C18D1	9.00 units on a scale Standard Deviation 7.07	—	—
Dermatology Life Quality Index (DLQI) Total Score - Phase 2 C19D1	8.75 units on a scale Standard Deviation 6.18	—	—
Dermatology Life Quality Index (DLQI) Total Score - Phase 2 C20D1	7.00 units on a scale Standard Deviation 6.48	—	—
Dermatology Life Quality Index (DLQI) Total Score - Phase 2 C21D1	7.00 units on a scale Standard Deviation 6.98	—	—
Dermatology Life Quality Index (DLQI) Total Score - Phase 2 C22D1	7.75 units on a scale Standard Deviation 5.56	—	—
Dermatology Life Quality Index (DLQI) Total Score - Phase 2 C23D1	7.75 units on a scale Standard Deviation 5.50	—	—
Dermatology Life Quality Index (DLQI) Total Score - Phase 2 C24D1	10.00 units on a scale Standard Deviation 2.83	—	—
Dermatology Life Quality Index (DLQI) Total Score - Phase 2 C25D1	11.00 units on a scale Standard Deviation 1.41	—	—
Dermatology Life Quality Index (DLQI) Total Score - Phase 2 C26D1	12.00 units on a scale Standard Deviation NA No measure of dispersion calculated as there is only 1 participant.	—	—
Dermatology Life Quality Index (DLQI) Total Score - Phase 2 C27D1	13.00 units on a scale Standard Deviation NA No measure of dispersion calculated as there is only 1 participant.	—	—
Dermatology Life Quality Index (DLQI) Total Score - Phase 2 C28D1	12.00 units on a scale Standard Deviation NA No measure of dispersion calculated as there is only 1 participant.	—	—
Dermatology Life Quality Index (DLQI) Total Score - Phase 2 C29D1	12.00 units on a scale Standard Deviation NA No measure of dispersion calculated as there is only 1 participant.	—	—
Dermatology Life Quality Index (DLQI) Total Score - Phase 2 C30D1	12.00 units on a scale Standard Deviation NA No measure of dispersion calculated as there is only 1 participant.	—	—
Dermatology Life Quality Index (DLQI) Total Score - Phase 2 C31D1	12.00 units on a scale Standard Deviation NA No measure of dispersion calculated as there is only 1 participant.	—	—
Dermatology Life Quality Index (DLQI) Total Score - Phase 2 C32D1	12.00 units on a scale Standard Deviation NA No measure of dispersion calculated as there is only 1 participant.	—	—
Dermatology Life Quality Index (DLQI) Total Score - Phase 2 C33D1	12.00 units on a scale Standard Deviation NA No measure of dispersion calculated as there is only 1 participant.	—	—
Dermatology Life Quality Index (DLQI) Total Score - Phase 2 C34D1	12.00 units on a scale Standard Deviation NA No measure of dispersion calculated as there is only 1 participant.	—	—
Dermatology Life Quality Index (DLQI) Total Score - Phase 2 C35D1	14.00 units on a scale Standard Deviation NA No measure of dispersion calculated as there is only 1 participant.	—	—
Dermatology Life Quality Index (DLQI) Total Score - Phase 2 C36D1	12.00 units on a scale Standard Deviation NA No measure of dispersion calculated as there is only 1 participant.	—	—
Dermatology Life Quality Index (DLQI) Total Score - Phase 2 C37D1	10.00 units on a scale Standard Deviation NA No measure of dispersion calculated as there is only 1 participant.	—	—
Dermatology Life Quality Index (DLQI) Total Score - Phase 2 C38D1	11.00 units on a scale Standard Deviation NA No measure of dispersion calculated as there is only 1 participant.	—	—
Dermatology Life Quality Index (DLQI) Total Score - Phase 2 C39D1	13.00 units on a scale Standard Deviation NA No measure of dispersion calculated as there is only 1 participant.	—	—
Dermatology Life Quality Index (DLQI) Total Score - Phase 2 C40D1	12.00 units on a scale Standard Deviation NA No measure of dispersion calculated as there is only 1 participant.	—	—
Dermatology Life Quality Index (DLQI) Total Score - Phase 2 C41D1	13.00 units on a scale Standard Deviation NA No measure of dispersion calculated as there is only 1 participant.	—	—
Dermatology Life Quality Index (DLQI) Total Score - Phase 2 C42D1	12.00 units on a scale Standard Deviation NA No measure of dispersion calculated as there is only 1 participant.	—	—
Dermatology Life Quality Index (DLQI) Total Score - Phase 2 C43D1	12.00 units on a scale Standard Deviation NA No measure of dispersion calculated as there is only 1 participant.	—	—
Dermatology Life Quality Index (DLQI) Total Score - Phase 2 C44D1	12.00 units on a scale Standard Deviation NA No measure of dispersion calculated as there is only 1 participant.	—	—

SECONDARY outcome

Timeframe: Baseline until disease progression or initiation of new anti-cancer therapy or death, assessed every 2 (odd-numbered) cycles up to 12 months after EOT (EOT: up to Day 1723)

Number of participants with BOR according to RECIST: CR= disappearance of all target and non-target lesions. PR= at least 30% decrease in sum of LDs of target lesion, taking as reference baseline sum LD, associated to non-progressive disease response for non-target lesions. Stable/no response= neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Objective progression= at least a 20% increase in sum of LDs of target lesions, taking as reference the smallest sum of LD recorded since treatment started and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.

Outcome measures

Outcome measures
Measure	PF-00299804 - Phase 1 All Participants n=41 Participants A single dose of PF-00299804 30 mg or 45 mg tablet orally on or before Day -9 followed by PF-00299804 30 mg or 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.	PF-00299804 45 mg - Phase 1 A single dose of PF-00299804 45 mg tablet orally on or before Day -9 followed by PF-00299804 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.	PF-00299804 45 mg - Phase 2 PF-00299804 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.
Best Overall Response (BOR) - Phase 2 Complete Response	0 participants	—	—
Best Overall Response (BOR) - Phase 2 Partial Response	7 participants	—	—
Best Overall Response (BOR) - Phase 2 Stable/No Response	21 participants	—	—
Best Overall Response (BOR) - Phase 2 Objective Progression	13 participants	—	—
Best Overall Response (BOR) - Phase 2 Indeterminate	0 participants	—	—

SECONDARY outcome

Timeframe: Baseline until disease progression or initiation of new anti-cancer therapy or death, assessed every 2 (odd-numbered) cycles up to 12 months after EOT (EOT: up to Day 506 for Phase 1 and up to Day 1723 for Phase 2)

Population: Analysis population included sub-set of participants from response-evaluable population, who had a confirmed objective tumor response (CR or PR).

Time in weeks from first documentation of objective tumor response to objective tumor progression or death due to any cause, whichever occurred first. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR \[which ever occurred first\] that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.

Outcome measures

Outcome measures
Measure	PF-00299804 - Phase 1 All Participants A single dose of PF-00299804 30 mg or 45 mg tablet orally on or before Day -9 followed by PF-00299804 30 mg or 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.	PF-00299804 45 mg - Phase 1 n=2 Participants A single dose of PF-00299804 45 mg tablet orally on or before Day -9 followed by PF-00299804 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.	PF-00299804 45 mg - Phase 2 n=7 Participants PF-00299804 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.
Duration of Response (DR)	—	41.9 weeks Interval 15.1 to 68.7	60.6 weeks Interval 10.1 to The upper limit of 95% confidence interval was not reached.

Adverse Events

PF-00299804 30 mg - Phase 1

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

PF-00299804 45 mg - Phase 1

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

PF-00299804 45 mg - Phase 2

Serious events: 9 serious events

Other events: 41 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	PF-00299804 30 mg - Phase 1 n=6 participants at risk A single dose of PF-00299804 30 milligram (mg) tablet orally on or before Day -9 followed by PF-00299804 30 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.	PF-00299804 45 mg - Phase 1 n=6 participants at risk A single dose of PF-00299804 45 mg tablet orally on or before Day -9 followed by PF-00299804 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.	PF-00299804 45 mg - Phase 2 n=43 participants at risk PF-00299804 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/6 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product. The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product. The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.3% 1/43 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product. The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Diarrhoea	0.00% 0/6 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product. The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product. The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.3% 1/43 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product. The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders Disease progression	0.00% 0/6 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product. The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product. The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	11.6% 5/43 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product. The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Pneumonia	0.00% 0/6 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product. The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product. The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.3% 1/43 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product. The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Hydrocephalus	0.00% 0/6 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product. The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product. The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.3% 1/43 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product. The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Pleural effusion	16.7% 1/6 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product. The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product. The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/43 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product. The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Vascular disorders Hypotension	0.00% 0/6 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product. The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product. The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.3% 1/43 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product. The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.

Other adverse events

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

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

Restriction type: OTHER

Measure	PF-00299804 - Phase 1 All Participants n=12 Participants A single dose of PF-00299804 30 mg or 45 mg tablet orally on or before Day -9 followed by PF-00299804 30 mg or 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.	PF-00299804 45 mg - Phase 1 n=43 Participants A single dose of PF-00299804 45 mg tablet orally on or before Day -9 followed by PF-00299804 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.	PF-00299804 45 mg - Phase 2 PF-00299804 45 mg tablet orally once daily continuously in 21-day cycles starting from Day 1 until unacceptable toxicity, disease progression, withdrawal from the trial, or death.
Soluble Protein Biomarkers Level EGFR: C1D1	58.57 nanogram per milliliter (ng/mL) Standard Deviation 7.498	57.41 nanogram per milliliter (ng/mL) Standard Deviation 13.146	—
Soluble Protein Biomarkers Level EGFR: C3D1	47.46 nanogram per milliliter (ng/mL) Standard Deviation 7.845	50.81 nanogram per milliliter (ng/mL) Standard Deviation 11.465	—
Soluble Protein Biomarkers Level EGFR: C5D1	46.76 nanogram per milliliter (ng/mL) Standard Deviation 5.395	58.87 nanogram per milliliter (ng/mL) Standard Deviation 13.627	—
Soluble Protein Biomarkers Level EGFR: C7D1	48.58 nanogram per milliliter (ng/mL) Standard Deviation NA No measure of dispersion calculated as there is only 1 participant	55.83 nanogram per milliliter (ng/mL) Standard Deviation 19.34	—
Soluble Protein Biomarkers Level EGFR: C9D1	42.83 nanogram per milliliter (ng/mL) Standard Deviation NA No measure of dispersion calculated as there is only 1 participant	50.32 nanogram per milliliter (ng/mL) Standard Deviation 26.214	—
Soluble Protein Biomarkers Level EGFR: C11D1	40.98 nanogram per milliliter (ng/mL) Standard Deviation NA No measure of dispersion calculated as there is only 1 participant	63.69 nanogram per milliliter (ng/mL) Standard Deviation 28.908	—
Soluble Protein Biomarkers Level EGFR: C13D1	67.34 nanogram per milliliter (ng/mL) Standard Deviation NA No measure of dispersion calculated as there is only 1 participant	73.26 nanogram per milliliter (ng/mL) Standard Deviation 29.487	—
Soluble Protein Biomarkers Level EGFR: C15D1	52 nanogram per milliliter (ng/mL) Standard Deviation NA No measure of dispersion calculated as there is only 1 participant	49.45 nanogram per milliliter (ng/mL) Standard Deviation 14.358	—
Soluble Protein Biomarkers Level EGFR: C17D1	66.62 nanogram per milliliter (ng/mL) Standard Deviation NA No measure of dispersion calculated as there is only 1 participant	57.95 nanogram per milliliter (ng/mL) Standard Deviation 24.923	—
Soluble Protein Biomarkers Level HER2: C1D1	9.51 nanogram per milliliter (ng/mL) Standard Deviation 2.418	9.54 nanogram per milliliter (ng/mL) Standard Deviation 5.859	—
Soluble Protein Biomarkers Level HER2: C3D1	8.85 nanogram per milliliter (ng/mL) Standard Deviation 1.125	8.36 nanogram per milliliter (ng/mL) Standard Deviation 4.284	—
Soluble Protein Biomarkers Level HER2: C5D1	9.63 nanogram per milliliter (ng/mL) Standard Deviation 2.542	9.29 nanogram per milliliter (ng/mL) Standard Deviation 5.138	—
Soluble Protein Biomarkers Level HER2: C7D1	6.7 nanogram per milliliter (ng/mL) Standard Deviation NA No measure of dispersion calculated as there is only 1 participant	11.57 nanogram per milliliter (ng/mL) Standard Deviation 5.342	—
Soluble Protein Biomarkers Level HER2: C9D1	5.6 nanogram per milliliter (ng/mL) Standard Deviation NA No measure of dispersion calculated as there is only 1 participant	8.49 nanogram per milliliter (ng/mL) Standard Deviation 4.124	—
Soluble Protein Biomarkers Level HER2: C11D1	6.3 nanogram per milliliter (ng/mL) Standard Deviation NA No measure of dispersion calculated as there is only 1 participant	8.2 nanogram per milliliter (ng/mL) Standard Deviation 4.122	—
Soluble Protein Biomarkers Level HER2: C13D1	11.7 nanogram per milliliter (ng/mL) Standard Deviation NA No measure of dispersion calculated as there is only 1 participant	9.51 nanogram per milliliter (ng/mL) Standard Deviation 5.97	—
Soluble Protein Biomarkers Level HER2: C15D1	7.4 nanogram per milliliter (ng/mL) Standard Deviation NA No measure of dispersion calculated as there is only 1 participant	5.43 nanogram per milliliter (ng/mL) Standard Deviation 1.99	—
Soluble Protein Biomarkers Level HER2: C17D1	8.9 nanogram per milliliter (ng/mL) Standard Deviation NA No measure of dispersion calculated as there is only 1 participant	6.27 nanogram per milliliter (ng/mL) Standard Deviation 2.626	—