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news.Cougar Biotechnology has reached agreement with the FDA under a special protocol assessment for its planned Phase III clinical trial of the company's lead drug candidate CB7630.
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Pursuant to the special protocol assessment, the Phase III trial will be a randomized, double-blind, placebo-controlled trial of CB7630 plus prednisone in patients with metastatic castration-resistant prostate cancer who have failed docetaxel-based chemotherapy.
Similar to the patient populations in the company’s Phase II trials COU-AA-003 and COU-AA-004, patients are allowed to have received up to two prior chemotherapy regimens before entering the trial. The trial is expected to enroll approximately 1160 patients who will be randomized (2:1) to receive either CB7630 plus prednisone or placebo plus prednisone. The trial will be conducted at approximately 150 sites in North America, Europe and Australia. The primary endpoint of the trial will be overall survival. The company expects to begin patient enrollment in late April 2008.
Alan Auerbach, CEO and president of Cougar, said: “Obtaining FDA agreement on our overall Phase III trial design, patient population and endpoints represents an important milestone in the global development of CB7630 and for Cougar as a company.”