A Study in Japan and Ex-Japan to Characterize the Pharmacokinetic and Pharmacodynamic Response to Orteronel (TAK-700) in Chemotherapy-Naive Patients With Castration-Resistant Prostate Cancer
Phase 1
- Conditions
- Chemotherapy-naive castration-resistant prostate cancer
- Registration Number
- JPRN-jRCT2080221877
- Lead Sponsor
- Takeda Pharmaceutical Company Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Male
- Target Recruitment
- 72
Inclusion Criteria
Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma
- Progressive disease
- Prior surgical castration or concurrent use of an agent for medical castration
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Exclusion Criteria
- Received prior chemotherapy for prostate cancer
- Documented central nervous system metastases
- Current spinal cord compression, bilateral hydronephrosis or current bladder neck outlet obstruction
- Uncontrolled cardiovascular condition as specified in study protocol
- Uncontrolled nausea, vomiting or diarrhea
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Serum Testosterone
- Secondary Outcome Measures
Name Time Method 50% prostate specific antigen (PSA) response