A Phase I Study of BMS-641988 in Japanese Patients With Castration Resistant Prostate Cancer
Phase 1
Completed
- Conditions
- Prostate Cancer
- Interventions
- Drug: BMS-641988 (AR#2)
- Registration Number
- NCT00644488
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this clinical study is to assess the safety and tolerability of BMS-641988 once daily orally in Japanese patients with castration resistant prostate cancer
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 7
Inclusion Criteria
- Patients with castration-resistant prostate cancer and serum testosterone ≤50 ng/dL progressive to current therapy who satisfy the inclusion and exclusion criteria
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Exclusion Criteria
Not provided
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A1 BMS-641988 (AR#2) Active
- Primary Outcome Measures
Name Time Method To assess the safety and tolerability of BMS-641988 once daily orally in Japanese patients with castration resistant prostate cancer throughout the study
- Secondary Outcome Measures
Name Time Method To evaluate the pharmacokinetics of BMS-641988 and the metabolites BMS-501949 and BMS-570511 at cycle 1 day 1, day 15 and day 29 To identify the dose(s) of BMS-641988 for Phase II at the end of study To assess any preliminary evidence of anti-tumor activity by PSA decline, tumor shrinkage, radionuclide bone scans throughout the study To assess the effects of BMS-641988 on pharmacodynamic markers (LH, total and free testosterone, 5(alpha)-DHT, estradiol, prolactin, FSH, and SHBG) throughout the study
Trial Locations
- Locations (1)
Local Institution
🇯🇵Koto-Ku, Tokyo, Japan