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
Status: Recruiting
Phase:
Diagnosis: Lung Cancer
NCT ID: NCT00932451
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 09-303
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 allow patients from a Phase 3 trial who received standard of care chemotherapy (Study A8081007) to receive PF-02341066.
Conducting Institutions:
Dana-Farber Cancer Institute, Massachusetts General Hospital, Beth-Israel Deaconess Medical Center, Brigham and Women's Hospital
Overall PI:
Pasi Janne, MD, PhD,
Dana-Farber Cancer Institute
Site-responsible Investigators:
Daniel Costa, MD,
Beth Israel Deaconess Medical Center
Alice Shaw, MD, PhD,
Massachusetts General Hospital
Contacts:
Dana-Farber Cancer Institute:
Kelly Masone, 617-632-3383,
kmasone@partners.org
Massachusetts General Hospital:
Cancer Trials Call Center, 877-789-6100
Beth-Israel Deaconess Medical Center:
Cancer Trials Call Center, 617-667-3060
Eligibility Criteria
Inclusion Criteria:
- histologically or cytologically proven diagnosis of non-small cell lung cancer
- positive for ALK gene
- received pemetrexed or docetaxel from previous Phase 3 trial (A8081007) and
discontinued treatment due to Response Evaluation Criterion in Solid Tumors
(RECIST)-defined progression
Exclusion Criteria:
- prior treatment with PF-02341066
- received no prior chemotherapy for advanced non-small cell lung cancer
- current enrollment in another therapeutic clinical trial