In light of favorable results from the Phase 1-2 trial of MDV 3100 for advanced prostate cancer, a Phase 3 trial is enrolling at sites in the US, Canada, South America, UK, Europe, Australia, and South Africa. Results from the earlier trial are published online by the UK medical journal The Lancet.
Phase 3 Trial of MDV 3100 Underway
Medivation and Astellas are enrolling patients in a Phase 3 clinical trial of MDV3100 in men with progressive disease following docetaxel treatment. Known as AFFIRM, the randomized, placebo-controlled, double-blind, multi-national trial is evaluating MDV3100 at a dose of 160 mg taken orally once daily in men with metastatic prostate cancer who were previously treated with docetaxel-based chemotherapy.
The primary endpoint of the trial is overall survival; secondary endpoints include progression-free survival, safety and tolerability. The AFFIRM study is being conducted at sites in Argentina, Austria, Australia, Belgium, Canada, Chile, France, Germany, Italy, Netherlands, Poland, South Africa, Spain, UK and U.S. Information about patient eligibility and enrollment can be obtained by visiting www.affirmtrial.com or calling the AFFIRM study hotline toll-free in the U.S. and Canada at 1-888-782-3256.
Details of the Phase 3 trial can also be seen by visiting the US government site: http://clinicaltrials.gov/ct2/results?term=MDV3100
Check this page for updated search results for MDV100 at clinicaltrials.gov
How Does this Drug Work?
MDV 3100 is a “novel triple-acting oral androgen receptor antagonist.” The trial whose results are reported in the Lancet April 15 was for men with progressive, metastatic castration-resistant prostate cancer. According to the published results, MDV3100 demonstrated anti-tumor activity in patients with late-stage prostate cancer as evaluated by reductions in prostate specific antigen (PSA) levels, radiographic findings and circulating tumor cell (CTC) counts. Anti-tumor effects were observed in patients who were resistant to standard anti-androgen treatments, as well as in patients who had progressed following chemotherapy.
More details about results so far in our MedNews pages: New Targeted Therapy MDV100 Safe, Effective