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

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

MedlinePlus related topics:

Cancer Prostate Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study

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

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 ]

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 ]
To identify the dose(s) of BMS-641988 for Phase II [ Time Frame: 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 ]
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 ]

Estimated Enrollment:	15
Study Start Date:	June 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A1: Experimental 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

Contacts


Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:		Clinical.Trials@bms.com

Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Locations


Japan, Saitama
	Local Institution	Not yet recruiting
	Hidaka, Saitama, Japan, 3501298
	Contact: Site 001

Japan, Shizuoka
	Local Institution	Not yet recruiting
	Hamamatsu-Shi, Shizuoka, Japan, 431-3192
	Contact: Site 003

Japan, Tokyo
	Local Institution	Not yet recruiting
	Koto-Ku, Tokyo, Japan, 1358550
	Contact: Site 002

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators


Study Director:	Bristol-Myers Squibb	Bristol-Myers Squibb

More Information

BMS Clinical Trials Disclosure 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

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CA185-005
First Received:	March 20, 2008
Last Updated:	June 27, 2008
ClinicalTrials.gov Identifier:	NCT00644488
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Study placed in the following topic categories:

Prostatic Diseases

Genital Neoplasms, Male

Urogenital Neoplasms

Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

Genital Diseases, Male

ClinicalTrials.gov processed this record on July 03, 2008

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