Adenocarcinoma of the Prostate Clinical Trial
Official title:
Phase 2 Trial of TAK-700 (Orteronel) Without Prednisone for Metastatic Castration-Resistant Prostate Cancer
This phase II trial studies how well orteronel works in treating patients with metastatic hormone-resistant prostate cancer. Orteronel may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. To assess the relationship between circulating tumor cell (CTC)-based androgen receptor
(AR) expression level and >=-50% prostate-specific antigen (PSA) decline following 12 weeks
of therapy with TAK-700 (orteronel).
SECONDARY OBJECTIVES:
I. To assess changes in PSA and CTC levels and time to PSA progression (best response,
decline at 12 weeks as continuous variable, etc.) with or without prior docetaxel-based
treatment.
II. To assess measurable disease response and time to radiographic disease progression for
castration-resistant prostate cancer (CRPC) with or without prior docetaxel-based treatment.
III. To explore relationships between endocrine and clinical responses.
IV. To confirm the safety of TAK-700 administered without prednisone in patients with
metastatic CRPC.
OUTLINE: Patients receive orteronel orally (PO) twice daily (BID) on days 1-28. Courses
repeat every 28 days in the absence of disease progression or unacceptable toxicity.
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