According to a media release from Medivation, Inc. earlier today, the company has treated the first patient in a Phase III clinical trial of the novel androgen receptor antagonist MDV3100 in advanced prostate cancer.
This trial, known as AFFIRM, will evaluate the effectiveness and safety of the investigational drug MDV3100 in men with castration-resistant prostate cancer who were previously treated with docetaxel-based chemotherapy.
The randomized, placebo-controlled, double-blind, multi-national AFFIRM trial is expected to enroll approximately 1,200 patients at sites in the United States, Canada, Europe, South America, Australia, and South Africa. The primary endpoint of the trial is overall survival; secondary endpoints include progression-free survival, safety, and tolerability. This trial will evaluate MDV3100 at a dose of 160 mg taken orally once daily versus placebo.
Information about patient eligibility and enrollment can be obtained by calling the toll-free AFFIRM study hotline at 1-888-782-3256 or by looking at the trial protocol on line at the ClinicalTrials.gov web site. At present, only trial sites in the USA are open for patient enrollment.
Filed under: Drugs in development Tagged: | castration-resistant prostate cancer, CRPC, MDV3100
Search for new and
ongoing trials on the
CTAG PCa web site
I am sure that I would qualify for this clinical trial. Please contact me. I would be very interested in joining your group.
Thank you so much
Jeffrey E. Kanne
Dear Mr. Kanne:
There is a study site for this trial in Chicago, IL. For additional information you should contact Mohammad Hirmand, MD, at 415-543-3470