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| Descriptive Information Fields | |||||||||
| Brief Title † | A Phase I Study of BMS-641988 in Japanese Patients With Castration Resistant Prostate Cancer | ||||||||
| Official Title † | A Phase I Study of BMS-641988 in Japanese Patients With Castration Resistant Prostate Cancer | ||||||||
| 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 |
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| Detailed Description | |||||||||
| Study Phase | Phase I | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study | ||||||||
| Primary Outcome Measure † | To assess the safety and tolerability of BMS-641988 once daily orally in Japanese patients with castration resistant prostate cancer [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ] | ||||||||
| Secondary Outcome Measure † | To evaluate the pharmacokinetics of BMS-641988 and the metabolites BMS-501949 and BMS-570511 [ Time Frame: at cycle 1 day 1, day 15 and day 29 ] [ Designated as safety issue: No ] To identify the dose(s) of BMS-641988 for Phase II [ Time Frame: at the end of study ] [ Designated as safety issue: No ] To assess any preliminary evidence of anti-tumor activity by PSA decline, tumor shrinkage, radionuclide bone scans [ Time Frame: throughout the study ] [ Designated as safety issue: No ] To assess the effects of BMS-641988 on pharmacodynamic markers (LH, total and free testosterone, 5(alpha)-DHT, estradiol, prolactin, FSH, and SHBG) [ Time Frame: throughout the study ] [ Designated as safety issue: No ] |
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| Condition † | Prostate Cancer | ||||||||
| Intervention † | Drug: BMS-641988 (AR#2) | ||||||||
| MEDLINE PMIDs | |||||||||
| Links | BMS Clinical Trials Disclosure  For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm |
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 15 | ||||||||
| Start Date † | July 2008 | ||||||||
| Completion Date | December 2009 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
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| Gender | Male | ||||||||
| Ages | 20 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | Japan | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00644488 | ||||||||
| Organization ID | CA185-005 | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | Bristol-Myers Squibb | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | Bristol-Myers Squibb | ||||||||
| Verification Date | August 2008 | ||||||||
| First Received Date † | March 20, 2008 | ||||||||
| Last Updated Date | September 26, 2008 | ||||||||
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