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

NCT ID: NCT00965731

Last Updated: 2015-10-28

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

PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2014-01-31

Brief Summary

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This is a Phase 1/2 study comparing the safety and anti-tumor activity of erlotinib alone versus erlotinib in combination with PF-02341066 in patients with advanced non-small cell lung cancer.

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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Erlotinib

Group Type ACTIVE_COMPARATOR

Erlotinib

Intervention Type DRUG

Erlotinib, 150 mg, QD will be administered orally on a continuous schedule (Phase 2 only)

Erlotinib + PF-02341066

Group Type EXPERIMENTAL

Erlotinib

Intervention Type DRUG

For Phase 1 - escalating doses of erlotinib will be administered orally on a continuous schedule. The planned doses to be evaluated are 100 and 150 mg QD. The dose determined in Phase 1 will be used in Phase 2

PF-02341066

Intervention Type DRUG

For Phase 1 - escalating doses of PF-02341066 will be administered orally on a continuous schedule. The planned doses to be evaluated are 200 and 250 mg BID. The dose determined in Phase 1 will be used in Phase 2

Interventions

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Erlotinib

Erlotinib, 150 mg, QD will be administered orally on a continuous schedule (Phase 2 only)

Intervention Type DRUG

Erlotinib

For Phase 1 - escalating doses of erlotinib will be administered orally on a continuous schedule. The planned doses to be evaluated are 100 and 150 mg QD. The dose determined in Phase 1 will be used in Phase 2

Intervention Type DRUG

PF-02341066

For Phase 1 - escalating doses of PF-02341066 will be administered orally on a continuous schedule. The planned doses to be evaluated are 200 and 250 mg BID. The dose determined in Phase 1 will be used in Phase 2

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* histologically proven diagnosis of Non-Small Cell Lung Cancer (NSCLC) that is locally advanced or metastatic and of the adenocarcinoma subtype (including mixed adenosquamous histology)
* evident disease progression by Response Evaluation Criterion in Solid Tumors (RECIST) after at least one but no more than 2 chemotherapy regimens for advanced disease
* tumors must have measurable disease as per RECIST

Exclusion Criteria

* known interstitial lung disease
* prior treatment with an agent that is known or proposed to be active by action on EGFR tyrosine kinase or c-Met/HGF (Phase 2 Portion)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

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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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

University of California, Irvine Medical Center Pharmacy

Orange, California, United States

Site Status

University of California, Irving - Medical Center

Orange, California, United States

Site Status

University of California Irvin

Orange, California, United States

Site Status

Holy Cross Hospital

Fort Lauderdale, Florida, United States

Site Status

Siteman Cancer Center

City of Saint Peters, Missouri, United States

Site Status

Siteman Cancer Center -West County

Creve Coeur, Missouri, United States

Site Status

Barnes-Jewish Hospital

St Louis, Missouri, United States

Site Status

Washington University, School of Medicine

St Louis, Missouri, United States

Site Status

OSU East

Columbus, Ohio, United States

Site Status

The Ohio State University James Cancer Hospital

Columbus, Ohio, United States

Site Status

James Care in Kenny

Columbus, Ohio, United States

Site Status

Cancer Therapy & Research Center @ UTHSCSA

San Antonio, Texas, United States

Site Status

Seattle Cancer Care Alliance

Seattle, Washington, United States

Site Status

University of Washington Medical Center

Seattle, Washington, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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2009-012377-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

A8081002

Identifier Type: -

Identifier Source: org_study_id

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