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Genentech and OSI Pharmaceuticals Initiate Phase IIIB Clinical Trial of Tarceva

Genentech and OSI Pharmaceuticals Initiate Phase IIIB Clinical Trial of Tarceva
Breast cancer treatment Breast cancer main What is new?  

Genentech, Inc. and OSI Pharmaceuticals, Inc. jointly announced the plan to initiate Phase IIIB clinical study to investigate the efficiency of Tarceva(erlotinib HCl) in patients who had received one or more prior chemotherapies. This clinical trial is named as ACT (Access to Care, Tarceva) trial, will be a multi-center, open-label study of once-daily oral Tarceva, with endpoints of survival and response rate. Total study population will be consistent with the pivotal Tarceva trial, which is the basis for the New Drug Application (NDA) that was filed with the U.S. Food and Drug Administration (FDA) earlier this year. Patient enrollment for the trial has already begun and will end when the FDA issues an approval decision regarding whether Tarceva is safe and effective as a monotherapy for the treatment of patients with advanced NSCLC after failure of at least one prior chemotherapy regimen. Patients interested in learning about the ACT trial can call 888-662-6728.

MedicineWorl.Org: Genentech and OSI Pharmaceuticals Initiate Phase IIIB Clinical Trial of Tarceva

 
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