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USA trial of MDV3100


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MDV3100 is an investigational novel small molecule androgen receptor antagonist produced by Medivation Inc. and being developed to treat castration-resistant and hormone-refractory prostate cancer. It’s currently being evaluated in patients who have failed standard therapies to assess its safety, tolerability, pharmacokinetics, effect on PSA and disease progression. To date MDV3100 has shown significant PSA reductions in most evaluable patients.

An increased number of androgen receptors present on prostate cancer cells are believed to play a major role in the growth of castrate-resistant prostate cancer. Unlike currently available agents, MDV3100 has two modes of activity; (1) preventing the androgen receptor from entering the cell’s nucleus and triggering further growth of the tumour and importantly (2) continuing to inhibit the growth of the cancer even when the androgen receptor is overexpressed, as is the case in castrate-resistant prostate cancer. Trials to date have shown encouraging and durable anti-tumour activity in the three expanded dose groups tested thus far, as measured by PSA declines, radiographic findings, circulating tumour cell changes and time on treatment.

In the U.S.A. applicants are currently being recruited for a nationwide phase III clinical trial for patients with castrate-resistant prostate cancer who have been previously treated with docetaxel-based chemotherapy. To be eligible to participate men must have progressive prostate cancer, testosterone levels less than 50ng/dl, one or two prior chemotherapy regimes with at least one containing docetaxel, the ability to swallow the study drug and comply with study requirements and adequate bone marrow, hepatic and renal functioning.

The clinical trial will involve 1,200 men in around 60 separate sites.

Zero – The Project to End Prostate Cancer

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