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The Phase III trial is a randomized, double-blind, placebo-controlled trial of CB7630 plus prednisone in patients with metastatic castration-resistant prostate cancer (CRPC) who have not yet received treatment with chemotherapy. The trial is expected to enroll approximately 1,000 patients who will be randomized (1:1) 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 co-primary endpoints of the trial are progression free survival and overall survival.
The company plans to use the progression free survival data from the trial as the basis for submission of a new drug application and a marketing authorization application for accelerated and conditional approval from the regulatory agencies.
Arturo Molina, chief medical officer and executive vice president of clinical R&D at Cougar, said: "The interim results of our Phase II trials of CB7630 have shown strong evidence of antitumor activity in patients with metastatic CRPC who have not yet received chemotherapy; therefore, we are pleased to initiate the COU-AA-302 Phase III trial in this patient population. Due to the high level of awareness of CB7630 in the urology and medical oncology communities, we look forward to aggressively enrolling this Phase III trial."
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