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

Tracking Information

First Received Date ^ICMJE

March 20, 2008

Last Updated Date

November 4, 2009

Start Date ^ICMJE

July 2008

Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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 ]

Change History

Complete list of historical versions of study NCT00644488 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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 ]

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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

Detailed Description

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study

Condition ^ICMJE

Prostate Cancer

Intervention ^ICMJE

Drug: BMS-641988 (AR#2)

Study Arms / Comparison Groups

Experimental: Active

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2009

Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

20 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT ID ^ICMJE

NCT00644488

Responsible Party

Study Director, Bristol-Myers Squibb

Study ID Numbers ^ICMJE

CA185-005

Study Sponsor ^ICMJE

Bristol-Myers Squibb

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Bristol-Myers Squibb

Information Provided By

Bristol-Myers Squibb

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP