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A Randomized Trial Of PF-0029...

A Randomized Trial Of PF-00299804 Taken Orally Versus Erlotinib Taken Orally For Treatment Of Advanced Non-Small Cell Lung Cancer That Has Progressed After One Or Two Prior Chemotherapy Regimen

Last Updated: 2015-10-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

188 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2014-08-31

Brief Summary

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This study will compare PF-00299804 given orally on continuous schedule to the approved drug, erlotinib, in patients whose non-small cell lung cancer has progressed after chemotherapy; patients will be randomized to receive one of these drugs, and followed for efficacy and tolerance of each.

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Detailed Description

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Conditions

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Non-small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type ACTIVE_COMPARATOR

Erlotinib

Intervention Type DRUG

Continuous oral dosing at 150 mg daily.

B

Group Type EXPERIMENTAL

PF-00299804

Intervention Type DRUG

Continuous oral dosing at 45mg daily

Interventions

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Erlotinib

Continuous oral dosing at 150 mg daily.

Intervention Type DRUG

PF-00299804

Continuous oral dosing at 45mg daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* advanced measurable Non-Small Cell Lung Cancer (NSCLC);
* progressed after 1-2 prior chemotherapy;
* Eastern Cooperative Oncology Group (ECOG) 0-2;
* tissue available for future KRAS/ EGFR testing

Exclusion Criteria

* prior Epidermal Growth Factor Receptor (EGFR) targeted therapy;
* active or untreated Central Nervous System (CNS) metastases;

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Northwest Alabama Cancer Center

Muscle Shoals, Alabama, United States

Site Status

Agajanian Institute of Oncology and Hematology

Montebello, California, United States

Site Status

Bridgeport Hospital

Bridgeport, Connecticut, United States

Site Status

Wittingham Cancer Center @ Norwalk Hospital

Norwalk, Connecticut, United States

Site Status