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Sponsored by: |
Bristol-Myers Squibb |
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Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00326586 |
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 |
Estimated Enrollment: | 60 |
Study Start Date: | May 2006 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | September 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
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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. |
United States, California | |
Local Institution | Not yet recruiting |
Los Angeles, California, United States, 90046 | |
Contact: Site 004 | |
United States, Maryland | |
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins | Recruiting |
Baltimore, Maryland, United States, 21231 | |
Contact: Michael A. Carducci, Site 003 410-614-3977 | |
United States, New York | |
Memorial Sloan-Kettering Cancer Center | Recruiting |
New York, New York, United States, 10021 | |
Contact: Howard I. Scher, Site 001 | |
United States, Wisconsin | |
University Of Wisconsin Hospital And Clinics Laboratory | Recruiting |
Madison, Wisconsin, United States, 53792 | |
Contact: George Wilding, Site 002 608-263-8610 |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Bristol-Myers Squibb ( Study Director ) |
Study ID Numbers: | CA185-002 |
Study First Received: | May 15, 2006 |
Last Updated: | January 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00326586 |
Health Authority: | United States: Food and Drug Administration |
Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
Neoplasms Neoplasms by Site |