A Phase I Study of BMS-641988 in Japanese Patients With Castration Resistant Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

A Phase I Study of BMS-641988 in Japanese Patients With Castration Resistant Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00644488
• Other study ID #: CA185-005
• Status: Completed
• Phase: Phase 1
• First received: March 20, 2008
• Last updated: January 24, 2011
• Start date: July 2008
• Est. completion date: March 2009

Study information

• Verified date: May 2009
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• BMS-641988 (AR#2)
Tablets, Oral, 20 mg, 40 mg, 60 mg, 100 mg, once daily, 24 weeks

Locations

Country	Name	City	State
Japan	Local Institution	Hamamatsu-Shi	Shizuoka
Japan	Local Institution	Hidaka	Saitama
Japan	Local Institution	Koto-Ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the safety and tolerability of BMS-641988 once daily orally in Japanese patients with castration resistant prostate cancer		throughout the study	Yes
Secondary	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	No
Secondary	To identify the dose(s) of BMS-641988 for Phase II		at the end of study	No
Secondary	To assess any preliminary evidence of anti-tumor activity by PSA decline, tumor shrinkage, radionuclide bone scans		throughout the study	No
Secondary	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	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form