ARMOR2: A 2 Part, Phase 2 Trial of Galeterone in the Treatment of Castration Resistant Prostate Cancer.
To further evaluate the safety profile of galeterone, to confirm the recommended dose and patient population for expansion arm (Part 2) of the trial, to determine efficacy of galeterone in terms of changes from baseline in PSA concentration
At least 18 years of age, confirmed adenocarcinoma of the prostate, Ongoing androgen blockade (therapy with gonadotropin-releasing hormone (GnRH) analogues, or orchiectomy), Demonstration of progression while on androgen blockade, good physical status, able to swallow multiple tablets, must not have liver metastasis, must not have received any chemotherapy, must not be on long term steroids, must not be using Coumadin or spironolactone, must have good blood/liver/kidney functions, must not have significant heart disease, must not have/had Hepatitis B or C or know HIV infection, must not have uncontrolled hypertension
Patients will receive a minimum of 3 (28 day) cycles. In Part 1, patients will receive one of 3 dose levels (1700mg, 2550 mg or 3400 mg) to be taken orally once every day. If patients tolerate their treatment well, they may continue treatment in an optional extension period. In Part 2, patients will receive the selected dose from Part I in one of several potential expansion schemas to be determined.
09/20/2014 04:03 AM