Conditions: Prostate Cancer Hormone Refractory Prostate Cancer
Keywords: Prostate Cancer Hormone Refractory Castration
Enrollment: 140
Healthy volunteers: no

Brief summary:
This is a multi-center open-label dose-escalation study of a novel compound (MDV3100) to treat patients with castration-resistant (hormone-refractory) prostate cancer. Additional patients will be enrolled in expanded cohorts at doses determined to be tolerable. Patients who tolerate the drug and do not progress will be allowed to continue to look for PSA response.

Detailed description:
This is a Phase 1, open-label, uncontrolled, dose-escalation study with dose-expansion at doses determined to be tolerated. Patients who tolerate the drug and do not progress will be allowed to continue treatment. The study endpoints are safety and tolerability and pharmacokinetics. PSA values will also be collected to look for PSA response.

Arms:
arm 1: MDV3100

Interventions: intervention 1: MDV3100
Intervention descriptions: intervention 1: MDV3100 daily until progression or dose-limiting toxicity

Protocol document: