Status:

COMPLETED

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

Lead Sponsor:

Pfizer

Conditions:

Non-Small Cell Lung Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

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.

Eligibility Criteria

Inclusion

  • 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

  • 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)

Key Trial Info

Start Date :

January 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2014

Estimated Enrollment :

27 Patients enrolled

Trial Details

Trial ID

NCT00965731

Start Date

January 1 2010

End Date

January 1 2014

Last Update

October 28 2015

Active Locations (16)

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Page 1 of 4 (16 locations)

1

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35233

2

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35294

3

University of California, Irvine Medical Center Pharmacy

Orange, California, United States, 92868-3298

4

University of California, Irving - Medical Center

Orange, California, United States, 92868-3298