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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00644488
First received: March 20, 2008
Last updated: January 24, 2011
Last verified: May 2009
History of Changes
  Purpose

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


Condition Intervention Phase
Prostate Cancer
 Drug: BMS-641988 (AR#2)
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of BMS-641988 in Japanese Patients With Castration Resistant Prostate Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 Measures:
  • 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 ]

Enrollment: 7
Study Start Date: July 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A1
Active
 Drug: BMS-641988 (AR#2)
Tablets, Oral, 20 mg, 40 mg, 60 mg, 100 mg, once daily, 24 weeks

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00644488

Locations
Japan
Local Institution
Hidaka, Saitama, Japan, 3501298
Local Institution
Hamamatsu-Shi, Shizuoka, Japan, 431-3192
Local Institution
Koto-Ku, Tokyo, Japan, 1358550
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

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

No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00644488     History of Changes
Other Study ID Numbers: CA185-005
Study First Received: March 20, 2008
Last Updated: January 24, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 22, 2013