Conditions: Prostate Cancer
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 77
Healthy volunteers: no

Brief summary:
Protocol G200712 is a Phase II, exploratory study to assess the effects of GTx-758 on serum prostate specific antigen (PSA) response ans serum PSA progression in men with Metastatic Castration Resistant Prostate Cancer (mCRPC) on Androgen Deprivation Therapy (ADT) with luteinizing hormone-releasing hormone (LHRH) agonists, LHRH antagonists, or orchidectomy. This study will also assess the venous thromboembolism (VTE) risk of lower doses of GTx-758.

Detailed description:

Arms:
arm 1: one GTx-758 tablet orally administered daily arm 2: two GTx-758 tablets orally administered daily

Interventions: intervention 1: GTx-758 125 mg intervention 2: GTx-758 250 mg
Intervention descriptions: intervention 1: One 125 mg tablet once a day intervention 2: two 125 mg tablets once daily

Protocol document: