Back to resultsA Phase I Study of BMS-641988 in Japanese Patients With Castration Resistant Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
BMS-641988 (AR#2)
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer
Eligibility Criteria
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
Sites / Locations
- Local Institution
- Local Institution
- Local Institution
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A1
Arm Description
Active
Outcomes
Primary Outcome Measures
To assess the safety and tolerability of BMS-641988 once daily orally in Japanese patients with castration resistant prostate cancer
Secondary Outcome Measures
To evaluate the pharmacokinetics of BMS-641988 and the metabolites BMS-501949 and BMS-570511
To identify the dose(s) of BMS-641988 for Phase II
To assess any preliminary evidence of anti-tumor activity by PSA decline, tumor shrinkage, radionuclide bone scans
To assess the effects of BMS-641988 on pharmacodynamic markers (LH, total and free testosterone, 5(alpha)-DHT, estradiol, prolactin, FSH, and SHBG)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00644488
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A1
Arm Type
Experimental
Arm Description
Active
Intervention Type
Drug
Intervention Name(s)
BMS-641988 (AR#2)
Intervention Description
Tablets, Oral, 20 mg, 40 mg, 60 mg, 100 mg, once daily, 24 weeks
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
To identify the dose(s) of BMS-641988 for Phase II
Time Frame
at the end of study
Title
To assess any preliminary evidence of anti-tumor activity by PSA decline, tumor shrinkage, radionuclide bone scans
Time Frame
throughout the study
Title
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Hidaka
State/Province
Saitama
ZIP/Postal Code
3501298
Country
Japan
Facility Name
Local Institution
City
Hamamatsu-Shi
State/Province
Shizuoka
ZIP/Postal Code
431-3192
Country
Japan
Facility Name
Local Institution
City
Koto-Ku
State/Province
Tokyo
ZIP/Postal Code
1358550
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
A Phase I Study of BMS-641988 in Japanese Patients With Castration Resistant Prostate Cancer
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