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

Sponsor:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00644488

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 I

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:

MedlinePlus related topics: Cancer Prostate Cancer

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

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 February 12, 2012