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

This study has been completed.

First Received: May 15, 2006 Last Updated: August 19, 2009 History of Changes

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00326586

Purpose

This is a Phase I Dose-Escalation Study of BMS641988 in Patients with Castration-Resistant Prostate Cancer.

Condition	Intervention	Phase
Prostate Cancer	Drug: AR Antagonist (BMS-641988)	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety Study
Official Title:	A Phase I Dose-Escalation Study of BMS-641988 in Patients With Castration-Resistant Prostate Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

To assess safety and tolerability and to identify a dose for Phase II evaluation [ Time Frame: during the dose escalation phase ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To evaluate pharmacokinetics [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
To describe preliminary evidence of anit-tumor activity [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

Enrollment:	54
Study Start Date:	May 2006
Study Completion Date:	March 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: AR Antagonist (BMS-641988) Tablets, Oral, 6 Patients will be randomized in a 1:1 ratio and in a double-blinded fashion to achieve a single dose of the study drug or Placebo on C1D1. Once daily, at least 3 cycles until the disease progresses

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00326586

Locations

United States, Maryland
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
Baltimore, Maryland, United States, 21231
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
United States, Wisconsin
University Of Wisconsin Hospital And Clinics Laboratory
Madison, Wisconsin, United States, 53792

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

No publications provided

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CA185-002
Study First Received:	May 15, 2006
Last Updated:	August 19, 2009
ClinicalTrials.gov Identifier:	NCT00326586 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on September 01, 2009