Medivation, a biopharmaceutical company, has received the FDA approval 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 trial will enroll approximately 1,200 patients who will be randomized (2:1) to receive either MDV3100 or placebo. The primary endpoint of the trial will be overall survival.
The FDA informed the company that it could test a dose of MDV3100 up to 240mg/day. There are no driving or other restrictions placed on the activities of participants in the trial. Final trial specifics will be announced when the first patient is enrolled.
MDV3100 is being evaluated in an ongoing open-label, US, Phase I-II study of a total of 140 men with castration-resistant prostate cancer (CRPC). Patients in this trial were heavily pretreated, with all having failed standard hormonal therapies and many having also failed docetaxel-based chemotherapy.
MDV3100 has consistently demonstrated encouraging anti-tumor activity across dose levels and endpoints for both chemo-naive and post-chemo patients. MDV3100 has been generally well tolerated at doses of up to and including 240mg/day, the company said.
David Hung, president and CEO of Medivation, said: This is a significant milestone in the development of this important novel investigational drug. We look forward to starting the trial and rapidly executing a comprehensive Phase III development program for MDV3100. Given the encouraging results seen to date in our ongoing Phase I-II trial and the limited life expectancy of men with CRPC who have failed chemotherapy, we will work to begin the Phase III clinical development of MDV3100 as quickly as possible in 2009.