US drugmaker Medivation has received written permission from the Food and Drug Administration to begin a pivotal Phase III trial of MDV3100, its novel androgen receptor antagonist, in patients with metastatic castration-resistant prostate cancer who have failed docetaxel-based chemotherapy.
The placebo-controlled, double-blind, multinational study will enroll approximately 1,200 patients who will be randomized to receive either MDV3100 or placebo. The primary endpoint of the trial will be overall survival. The firm says it will work to begin the Phase III clinical development of MDV3100 "as quickly as possible this year."
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