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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00326586
First received: May 15, 2006
Last updated: January 24, 2011
Last verified: July 2009
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase I Dose-Escalation Study of BMS-641988 in Patients With Castration-Resistant Prostate Cancer

Resource links provided by NLM:


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
Experimental: 1 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Advanced castration-resistant prostate carcinoma with progressive disease
  • At least 4 weeks must have elapsed from major surgery
  • Patient must be available for follow-up
  • Adequate liver and kidney function
  • Adequate blood values

Exclusion Criteria:

  • Uncontrolled or significant heart disease
  • History of seizures
  • History of head injury, loss of consciousness, or stroke
  • Patients undergoing alcohol withdrawal
  • Any concurrent cancer
  • A serious uncontrolled medical disorder or active infection
  • Inability to swallow tablets
  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 Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00326586     History of Changes
Other Study ID Numbers: CA185-002
Study First Received: May 15, 2006
Last Updated: January 24, 2011
Health Authority: United States: Food and Drug Administration

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 April 16, 2014