Trial · NCT01121575

A Study Of Combined C- MET Inhibitor And PAN-HER Inhibitor (PF-02341066 And PF-00299804) In Patients With Non- Small Cell Lung Cancer

NCT01121575, Phase 1, Completed, Pfizer; results first posted 2015-03-30

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Study Of Combined C- MET Inhibitor And PAN-HER Inhibitor (PF-02341066 And PF-00299804) In Patients With Non- Small Cell Lung Cancer. Trials, record NCT01121575. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01121575

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study Of Combined C- MET Inhibitor And PAN-HER Inhibitor (PF-02341066 And PF-00299804) In Patients With Non- Small Cell Lung Cancer
NCT number: NCT01121575
Status: Completed
Phases: Phase 1
Enrollment: 70 participants, actual
Lead sponsor: Pfizer
Conditions: Non Small Cell Lung Cancer
Interventions: PF-02341066, PF-00299804, PF-02341066, PF-00299804
First posted: 2010-05-12
Last updated: 2015-10-28
Results first posted: 2015-03-30

Source ClinicalTrials.gov

Registered outcomes42

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Overview of Treatment-emergent All Causalities Adverse Events (AEs) in Escalation Phase	Up to Maximum of treatment duration + 28 days for each participant (could be 295 days)	AE was any untoward medical occurrence with study drug/ device in a trial participant. Serious adverse event (SAE) was an AE resulting in death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, congenital anomaly. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of study medication. AEs were reported from signing of informed consent until 28 days after the last dose of study medication. SAEs were reported after this time frame if considered to be treatment related. The severity of AEs were graded by the investigator using National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) v.4.02 and was assessed as Grade 0: no change from normal or reference range; Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: life-threatening or disabling; Grade 5: death related to AE. However the below table included Grade 3, 4, and 5 AEs.
Primary	Overview of Treatment-emergent All Causalities AEs in Expansion Phase	Up to Maximum of treatment duration + 28 days for each participant (could be 295 days)	AE was any untoward medical occurrence with study drug/ device in a trial participant. SAE was an AE resulting in death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, congenital anomaly. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of study medication. AEs were reported from signing of informed consent until 28 days after the last dose of study medication. SAEs were reported after this time frame if considered to be treatment related. The severity of AEs were graded by the investigator using NCI CTCAE v.4.02 and was assessed as Grade 0: no change from normal or reference range; Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: life-threatening or disabling; Grade 5: death related to AE. However the below table included Grade 3, 4, and 5 AEs.
Primary	Overview of Treatment-emergent, Treatment-related AEs in Escalation Phase	Up to Maximum of treatment duration + 28 days for each participant (could be 295 days)	An AE was any untoward medical occurrence attributed to study treatment in a participant who received study treatment. SAE was an AE resulting in death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, congenital anomaly. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of study medication. AEs were reported from signing of informed consent until 28 days after the last dose of study medication. SAEs were reported after this time frame if considered to be treatment related. The severity of AEs were graded by the investigator using NCI CTCAE v.4.02 and was assessed as Grade 0: no change from normal or reference range; Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: life-threatening or disabling; Grade 5: death related to AE. However the below table included Grade 3, 4, and 5 AEs.
Primary	Overview of Treatment-emergent, Treatment-related AEs in Expansion Phase	Up to Maximum of treatment duration + 28 days for each participant (could be 295 days)	An AE was any untoward medical occurrence attributed to study treatment in a participant who received study treatment. SAE was an AE resulting in death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, congenital anomaly. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of study medication. AEs were reported from signing of informed consent until 28 days after the last dose of study medication. SAEs were reported after this time frame if considered to be treatment related. The severity of AEs were graded by the investigator using NCI CTCAE v.4.02 and was assessed as Grade 0: no change from normal or reference range; Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: life-threatening or disabling; Grade 5: death related to AE. However the below table included Grade 3, 4, and 5 AEs.
Primary	Number of Participants With Dose Limiting Toxicities (DLTs) in Escalation Phase	Cycle 1 (4 weeks)	DLTs were those AEs which occurred in Cycle 1 of treatment in Dose Escalation Phase which may be attributed to study drug \[combined Crizotinib (PF-02341066) plus Dacomitinib (PF-00299804)\] without a clear alternative explanation and despite the use of adequate/maximal medical intervention as dictated by local institutional clinical practices or the judgment of the investigator. The following events were considered DLTs (using CTCAE version 4.02);1. Grade ≥4 hematologic events. 2. Grade ≥3 non-hematological events (except Grade 3/4 asymptomatic hypophosphatemia and Grade 3/4 hyperuricemia without signs and symptoms of gout). Nausea, vomiting or diarrhea had to have persisted at Grade 3 or 4 despite maximal medical therapy. Grade 3 hypertension will be considered a DLT only if the event is unmanageable by standard approved pharmacologic agents or if the symptomatic sequelae are identified despite appropriate medical intervention.
Secondary	Number of Participants With Stable Disease and Stable Disease Duration in Escalation Phase	From objective response to date of progression or death due to any cause, whichever occurs first (up to post treatment follow-up as 28-35 days after last dose of study treatment)	If a participant had not achieved an objective response with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) - 1.1 as determined by the investigators, relative to the response evaluable population, but remained stable for at least 6 weeks after first dose, then the best overall response for such a participant was considered as stable disease.
Secondary	Number of Participants With Stable Disease and Stable Disease Duration in Expansion Phase	From objective response to date of progression or death due to any cause, whichever occurs first (up to post treatment follow-up as 28-35 days after last dose of study treatment)	If a participant had not achieved an objective response with confirmed complete response (CR) or partial response (PR) according to RECIST (1.1) as determined by the investigators, relative to the response evaluable population, but remained stable for at least 6 weeks after first dose, then the best overall response for such a participant was considered as stable disease.
Secondary	Number of Participants With Objective Response Rate (ORR) in Escalation Phase	From objective response to date of progression or death due to any cause, whichever occurs first (up to post treatment follow-up as 28-35 days after last dose of study treatment)	ORR was defined as the percent of participants with CR or PR according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) determined by study physicians, relative to the response evaluable population. Participants were considered non-responders until proven otherwise. Thus, participants who: 1) Did not have CR or PR while on study, or 2) Did not have a post-baseline tumor evaluation, or 3) Received anti-tumor treatment other than the study medication prior to reaching a CR or PR, or 4) Died, in progress, or drop out for any reason prior to reaching a CR or PR, were counted as non-responders in the assessment of ORR. To be assigned a status of PR or CR, changes in tumor measurements in participants with responding tumors were confirmed by repeated tumor assessment that were performed 4 weeks after the criteria for response were first met.
Secondary	Number of Participants With ORR in Expansion Phase	From objective response to date of progression or death due to any cause, whichever occurs first (up to post treatment follow-up as 28-35 days after last dose of study treatment)	ORR was defined as the percent of participants with CR or PR according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) determined by study physicians, relative to the response evaluable population. Participants were considered non-responders until proven otherwise. Thus, participants who: 1) Did not have CR or PR while on study, or 2) Did not have a post-baseline tumor evaluation, or 3) Received anti-tumor treatment other than the study medication prior to reaching a CR or PR, or 4) Died, in progress, or drop out for any reason prior to reaching a CR or PR, were counted as non-responders in the assessment of ORR. To be assigned a status of PR or CR, changes in tumor measurements in participants with responding tumors were confirmed by repeated tumor assessment that were performed 4 weeks after the criteria for response were first met.
Secondary	Duration of Response for the Only Participant Shown Partial Response in Expansion Phase	From objective response to date of progression or death due to any cause, whichever occurs first (up to post treatment follow-up as 28-35 days after last dose of study treatment)	This outcome measure presented the duration of response for one participant in expansion cohort 1 who showed partial response.

1 to 10 of 42Source ClinicalTrials.gov

See all 42 registered outcomes

Outcomes42

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Overview of Treatment-emergent All Causalities Adverse Events (AEs) in Escalation Phase	Up to Maximum of treatment duration + 28 days for each participant (could be 295 days)	The safety analysis population included all enrolled participants who had received at least 1 dose of study medication.	participants	NUMBER
PRIMARY	Overview of Treatment-emergent All Causalities AEs in Expansion Phase	Up to Maximum of treatment duration + 28 days for each participant (could be 295 days)	The safety analysis population included all enrolled participants who had received at least 1 dose of study medication.	Participants	NUMBER
PRIMARY	Overview of Treatment-emergent, Treatment-related AEs in Escalation Phase	Up to Maximum of treatment duration + 28 days for each participant (could be 295 days)	The safety analysis population included all enrolled participants who had received at least 1 dose of study medication.	participants	NUMBER
PRIMARY	Overview of Treatment-emergent, Treatment-related AEs in Expansion Phase	Up to Maximum of treatment duration + 28 days for each participant (could be 295 days)	The safety analysis population included all enrolled participants who had received at least 1 dose of study medication.	Participants	NUMBER
PRIMARY	Number of Participants With Dose Limiting Toxicities (DLTs) in Escalation Phase	Cycle 1 (4 weeks)	The DLT evaluable population was defined as safety analysis (SA) participants in the Dose Escalation phase who did not have a major treatment deviation during the first cycle.	Participants	NUMBER
SECONDARY	Number of Participants With Stable Disease and Stable Disease Duration in Escalation Phase	From objective response to date of progression or death due to any cause, whichever occurs first (up to post treatment follow-up as 28-35 days after last dose of study treatment)	The response evaluable population included participants in safety analysis population who had an adequate Baseline tumor assessment.	Participants	NUMBER
SECONDARY	Number of Participants With Stable Disease and Stable Disease Duration in Expansion Phase	From objective response to date of progression or death due to any cause, whichever occurs first (up to post treatment follow-up as 28-35 days after last dose of study treatment)	The response evaluable population included participants in safety analysis population who had an adequate Baseline tumor assessment.	Participants	NUMBER
SECONDARY	Number of Participants With Objective Response Rate (ORR) in Escalation Phase	From objective response to date of progression or death due to any cause, whichever occurs first (up to post treatment follow-up as 28-35 days after last dose of study treatment)	The response evaluable population included participants in safety analysis population who had an adequate Baseline tumor assessment.	Participants	NUMBER
SECONDARY	Number of Participants With ORR in Expansion Phase	From objective response to date of progression or death due to any cause, whichever occurs first (up to post treatment follow-up as 28-35 days after last dose of study treatment)	The response evaluable population included participants in safety analysis population who had an adequate Baseline tumor assessment.	Participants	NUMBER
SECONDARY	Duration of Response for the Only Participant Shown Partial Response in Expansion Phase	From objective response to date of progression or death due to any cause, whichever occurs first (up to post treatment follow-up as 28-35 days after last dose of study treatment)	This Outcome Measure was only assessed for participants with response.	Weeks	NUMBER

1 to 10 of 42Source ClinicalTrials.gov

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Results by group357

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Overview of Treatment-emergent All Causalities Adverse Events (AEs) in Escalation Phase	Crizotinib 200 mg BID/ Dacomitinib 30 mg QD	Participants with AEs	14	participants
Overview of Treatment-emergent All Causalities Adverse Events (AEs) in Escalation Phase	Crizotinib 200 mg BID/ Dacomitinib 45 mg QD	Participants with AEs	6	participants
Overview of Treatment-emergent All Causalities Adverse Events (AEs) in Escalation Phase	Crizotinib 250 mg BID/ Dacomitinib 30 mg QD	Participants with AEs	7	participants
Overview of Treatment-emergent All Causalities Adverse Events (AEs) in Escalation Phase	Crizotinib 250 mg QD/ Dacomitinib 45 mg QD	Participants with AEs	6	participants
Overview of Treatment-emergent All Causalities Adverse Events (AEs) in Escalation Phase	Crizotinib 200 mg BID/ Dacomitinib 30 mg QD	Participants with Grade 3 or 4 AEs	9	participants
Overview of Treatment-emergent All Causalities Adverse Events (AEs) in Escalation Phase	Crizotinib 200 mg BID/ Dacomitinib 45 mg QD	Participants with Grade 3 or 4 AEs	4	participants
Overview of Treatment-emergent All Causalities Adverse Events (AEs) in Escalation Phase	Crizotinib 250 mg BID/ Dacomitinib 30 mg QD	Participants with Grade 3 or 4 AEs	5	participants
Overview of Treatment-emergent All Causalities Adverse Events (AEs) in Escalation Phase	Crizotinib 250 mg QD/ Dacomitinib 45 mg QD	Participants with Grade 3 or 4 AEs	5	participants
Overview of Treatment-emergent All Causalities Adverse Events (AEs) in Escalation Phase	Crizotinib 200 mg BID/ Dacomitinib 30 mg QD	Participants with Grade 5 AEs	3	participants
Overview of Treatment-emergent All Causalities Adverse Events (AEs) in Escalation Phase	Crizotinib 200 mg BID/ Dacomitinib 45 mg QD	Participants with Grade 5 AEs	0	participants

1 to 10 of 357Source ClinicalTrials.gov

See all 357 results by group

Participant flow24

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Crizotinib 200 mg BID/ Dacomitinib 30 mg QD	14
Overall Study	STARTED	Crizotinib 200 mg BID/ Dacomitinib 45 mg QD	6
Overall Study	STARTED	Crizotinib 250 mg BID/ Dacomitinib 30 mg QD	7
Overall Study	STARTED	Crizotinib 250 mg QD/ Dacomitinib 45 mg QD	6
Overall Study	STARTED	Expansion Cohort 1	25
Overall Study	STARTED	Expansion Cohort 2	12
Overall Study	Treated	Crizotinib 200 mg BID/ Dacomitinib 30 mg QD	14
Overall Study	Treated	Crizotinib 200 mg BID/ Dacomitinib 45 mg QD	6
Overall Study	Treated	Crizotinib 250 mg BID/ Dacomitinib 30 mg QD	7
Overall Study	Treated	Crizotinib 250 mg QD/ Dacomitinib 45 mg QD	6

1 to 10 of 24Source ClinicalTrials.gov

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Adverse events1,284

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anaemia	Blood and lymphatic system disorders	PF-02341066, 200 mg BID/ PF-00299804, 30 mg QD	4	14
other	Anaemia	Blood and lymphatic system disorders	PF-02341066, 200 mg BID/ PF-00299804, 45 mg QD	1	6
other	Anaemia	Blood and lymphatic system disorders	PF-02341066, 250 mg BID/ PF-00299804, 30 mg QD	1	7
other	Anaemia	Blood and lymphatic system disorders	PF-02341066, 250 mg QD/ PF-00299804, 45 mg QD	0	6
other	Anaemia	Blood and lymphatic system disorders	Expansion Cohort 1	2	25
other	Anaemia	Blood and lymphatic system disorders	Expansion Cohort 2	1	12
other	Neutropenia	Blood and lymphatic system disorders	PF-02341066, 200 mg BID/ PF-00299804, 30 mg QD	1	14
other	Neutropenia	Blood and lymphatic system disorders	PF-02341066, 200 mg BID/ PF-00299804, 45 mg QD	0	6
other	Neutropenia	Blood and lymphatic system disorders	PF-02341066, 250 mg BID/ PF-00299804, 30 mg QD	1	7
other	Neutropenia	Blood and lymphatic system disorders	PF-02341066, 250 mg QD/ PF-00299804, 45 mg QD	1	6

1 to 10 of 1,284Source ClinicalTrials.gov

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Adverse event totals18

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	PF-02341066, 200 mg BID/ PF-00299804, 30 mg QD
Total, all-cause mortality	PF-02341066, 200 mg BID/ PF-00299804, 45 mg QD
Total, all-cause mortality	PF-02341066, 250 mg BID/ PF-00299804, 30 mg QD
Total, all-cause mortality	PF-02341066, 250 mg QD/ PF-00299804, 45 mg QD
Total, all-cause mortality	Expansion Cohort 1
Total, all-cause mortality	Expansion Cohort 2
Total, other adverse events	PF-02341066, 200 mg BID/ PF-00299804, 30 mg QD	14	14
Total, other adverse events	PF-02341066, 200 mg BID/ PF-00299804, 45 mg QD	6	6
Total, other adverse events	PF-02341066, 250 mg BID/ PF-00299804, 30 mg QD	7	7
Total, other adverse events	PF-02341066, 250 mg QD/ PF-00299804, 45 mg QD	6	6

1 to 10 of 18Source ClinicalTrials.gov

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Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Expansion Cohort 1 vs Expansion Cohort 2: Number of Participants With KRAS Mutation (GLY12CYS) at Baseline	Trial comparisons
Expansion Cohort 1 vs Expansion Cohort 2: Number of Participants With ORR in Expansion Phase	Trial comparisons
Expansion Cohort 1 vs Expansion Cohort 2: Number of Participants With ROS1 Gene Translocation at Baseline	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01121575

GET https://conductscience.org/api/trials/v1/NCT01121575/registered?page=2

API reference For AI assistants