Status:
COMPLETED
An Investigational Drug, PF-02341066, Is Being Studied In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene
Lead Sponsor:
Pfizer
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a Phase 2 trial that will evaluate the safety and efficacy of PF-02341066 in patients with advanced non-small cell lung cancer with a specific gene profile involving the ALK gene. This trial w...
Eligibility Criteria
Inclusion
- histologically or cytologically proven diagnosis of non-small cell lung cancer
- positive for the ALK fusion gene (test provided by either a central laboratory. Local laboratory may be used for certain cases)
- may have received pemetrexed or docetaxel from previous Phase 3 trial (A8081007) and discontinued treatment due to Response Evaluation Criterion in Solid Tumors (RECIST)-defined progression. or, once the primary endpoint of Study A8081007 has been analyzed and the results made available, at any time without RECIST-defined progression.
- Tumors can be measurable or non measurable
Exclusion
- prior treatment with PF-02341066
- received no prior systemic treatment, chemotherapy or EGFR tyrosine kinase inhibitor, for advanced non-small cell lung cancer
- current enrollment in another therapeutic clinical trial
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
1069 Patients enrolled
Trial Details
Trial ID
NCT00932451
Start Date
January 1 2010
End Date
December 1 2015
Last Update
January 13 2017
Active Locations (280)
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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 Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
4
Comprehensive Blood and Cancer Center
Bakersfield, California, United States, 93309