| March 20, 2008 |
| November 4, 2009 |
| July 2008 |
| March 2009 (final data collection date for 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 ] |
| 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 ] |
| Complete list of historical versions of study NCT00644488 on ClinicalTrials.gov Archive Site |
- 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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- 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 ]
- To identify the dose(s) of BMS-641988 for Phase II [ Time Frame: at the end of study ]
- To assess any preliminary evidence of anti-tumor activity by PSA decline, tumor shrinkage, radionuclide bone scans [ Time Frame: 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) [ Time Frame: throughout the study ]
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| |
| A Phase I Study of BMS-641988 in Japanese Patients With Castration Resistant Prostate Cancer |
| A Phase I Study of BMS-641988 in Japanese Patients With Castration Resistant Prostate Cancer |
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 |
| |
| Phase I |
| Interventional |
| Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study |
| Prostate Cancer |
| Drug: BMS-641988 (AR#2) |
| Experimental: Active |
| |
| |
| Completed |
| 7 |
| March 2009 |
| March 2009 (final data collection date for primary outcome measure) |
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
|
| Male |
| 20 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Japan |
| |
| NCT00644488 |
| Study Director, Bristol-Myers Squibb |
| CA185-005 |
| Bristol-Myers Squibb |
|
| Study Director: |
Bristol-Myers Squibb |
Bristol-Myers Squibb |
|
|
| Bristol-Myers Squibb |
| May 2009 |