Finding studies
Finding studies
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Lead
University of Southern California
With
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.
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
