Tokai enrolls first patient into Phase II trial of galeterone in CRPC

According to a media release issued earlier today by Tokai Pharmaceuticals, the company has started treating men with castration-resistant prostate cancer (CRPC) in the Phase II ARMOR2 trial of galeterone (TOK-001).

Details about this trial are available on the web site. Basically, eligible patients must:

  • Have a rising PSA level while on androgen deprivation therapy (ADT, either by using an LHRH analog or as a consequence of orchiectomy)
  • Have a serum testosterone concentration of < 50 ng/dl
  • Have not received any form of androgen-directed hormonal therapy (such as TAK-700, ARN-509, ketoconazole, or enzalutamide) for the treatment of prostate cancer
  • Have not demonstrated disease progression while on treatment with abiraterone acetate (Zytiga®)

However, there are a number of other enrollment criteria that must be met, so do look through the full inclusion and and exclusion criteria if you are interested in participating in this trial.

This is a two-part, Phase II trial that will enroll about 170 patients. Unfortunately, at least as yet, there is no list of centers at which trial participation is possible listed on line. If you are interested in getting additional information about where patients can enroll in this trial, we can only suggest that you contact the office of the Chief Medical Officer of Tokai Pharmaceuticals (Adrian Senderowicz, MD) by calling Tokai Pharmaceuticals in Cambridge, Massachusetts, at 1-617-225-4305 — although it is clear from the media release that patients are being enrolled at a center in Omaha, Nebraska.

Information about the mechanism of action of galeterone can be found on the Tokai Pharmaceuticals web site.

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