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

Completed · Phase 2

Conditions studied: Carcinoma, Non-Small-Cell Lung

In brief

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 will also allow patients from a Phase 3 trial who received standard of care chemotherapy (Study A8081007) to receive PF-02341066.

Key facts

Study ID

NCT00932451

Run by

Pfizer

People needed

1069

Starts

2010-01-01

Expected to finish

2015-12-01

Last updated by the study team

2017-01-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Comprehensive Blood and Cancer Center — Bakersfield, California, United States
• Tower Cancer Research Foundation — Beverly Hills, California, United States
• Tower Hematology Oncology Medical Group — Beverly Hills, California, United States
• Moores UCSD Cancer Center — La Jolla, California, United States
• UCSD Medical Center - La Jolla — La Jolla, California, United States
• Drug Shipping Address: Ronald Reagen University of California-Los Angeles — Los Angeles, California, United States
• Ronald Reagen University of California-Los Angeles Medical Center — Los Angeles, California, United States
• UCLA Opthalmic Oncology Center — Los Angeles, California, United States
• University of California-Los Angeles — Los Angeles, California, United States
• University of California, Irvine-Medical Center — Orange, California, United States
• University of California, Irvine-Pharmacy — Orange, California, United States
• Stanford University-Cancer Center — Palo Alto, California, United States
• UC Davis Cancer Center — Sacramento, California, United States
• University of California Davis Medical Center — Sacramento, California, United States
• UCSD Medical Center - Hillcrest — San Diego, California, United States
• Santa Monica-UCLA Medical Center & Orthopaedic Hospital Clinical Laboratory — Santa Monica, California, United States
• UCLA Hematology Oncology-Santa Monica — Santa Monica, California, United States
• University of California-Los Angeles — Santa Monica, California, United States
• Redwood Regional Medical Group Inc — Santa Rosa, California, United States
• DRUG SHIPMENT: University of Colorado Cancer Center — Aurora, Colorado, United States
• Rocky Mountain Lions Eye Institute — Aurora, Colorado, United States
• University of Colorado Hospital — Aurora, Colorado, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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