- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00644488
A Phase I Study of BMS-641988 in Japanese Patients With Castration Resistant Prostate Cancer
January 24, 2011 updated by: Bristol-Myers Squibb
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
Study Overview
Study Type
Interventional
Enrollment (Actual)
7
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Saitama
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Hidaka, Saitama, Japan, 3501298
- Local Institution
-
-
Shizuoka
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Hamamatsu-Shi, Shizuoka, Japan, 431-3192
- Local Institution
-
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Tokyo
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Koto-Ku, Tokyo, Japan, 1358550
- Local Institution
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A1
Active
|
Tablets, Oral, 20 mg, 40 mg, 60 mg, 100 mg, once daily, 24 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
throughout the study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
at cycle 1 day 1, day 15 and day 29
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To identify the dose(s) of BMS-641988 for Phase II
Time Frame: at the end of study
|
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
|
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
|
throughout the study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2008
Primary Completion (Actual)
March 1, 2009
Study Completion (Actual)
March 1, 2009
Study Registration Dates
First Submitted
March 20, 2008
First Submitted That Met QC Criteria
March 20, 2008
First Posted (Estimate)
March 26, 2008
Study Record Updates
Last Update Posted (Estimate)
January 25, 2011
Last Update Submitted That Met QC Criteria
January 24, 2011
Last Verified
May 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CA185-005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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