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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 July 13, 2014