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www.fdanews.com/articles/61493-gpc-begins-trial-of-satraplatin-plus-tarceva-for-lung-cancer

GPC BEGINS TRIAL OF SATRAPLATIN PLUS TARCEVA FOR LUNG CANCER

August 7, 2006

GPC Biotech has initiated a Phase II randomized trial evaluating the company's lead drug candidate, satraplatin, in combination with Tarceva (erlotinib) as a first-line therapy in patients with inoperable advanced non-small-cell lung cancer who are 70 years of age and older. A Phase III trial exploring satraplatin in combination with prednisone as a second-line chemotherapy treatment for patients with hormone-refractory prostate cancer has also completed patient enrollment.

The Phase II study is a randomized trial that is expected to involve more than 20 centers in the U.S. and Europe and enroll approximately 120 patients. The primary objective of this study is to evaluate progression-free survival. The study will also examine overall survival, response rates and safety. Patients will be randomized to receive satraplatin plus Tarceva or Tarceva alone. A sequential dosing regimen will be used in the satraplatin arm. The treatment cycle for both arms is 28 days. Patients will be stratified according to smoking history and gender.