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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
Not Recruiting
Trial ID: NCT00932451
Purpose
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.
Official Title
Phase 2, Open-label Single Arm Study Of The Efficacy And Safety Of Pf-02341066 In Patients With Advanced Non-small Cell Lung Cancer (Nsclc) Harboring A Translocation Or Inversion Involving The Anaplastic Lymphoma Kinase (Alk) Gene Locus
Stanford Investigator(s)
Heather Wakelee
Winston Chen and Phyllis Huang Professor
Joel Neal, MD, PhD
Associate Professor of Medicine (Oncology)
A. Dimitrios Colevas, MD
Professor of Medicine (Oncology) and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Radiation Oncology (Radiation Therapy)
George A. Fisher Jr.
Colleen Haas Chair in the School of Medicine
Eligibility
Inclusion Criteria:
- 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 Criteria:
- 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
Intervention(s):
drug: PF-02341066
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Cancer Clinical Trials Office
650-498-7061