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

May 15, 2006
January 24, 2011
May 2006
March 2009   (final data collection date for primary outcome measure)
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 ]
To assess safety and tolerability and to identify a dose for Phase II evaluation
Complete list of historical versions of study NCT00326586 on ClinicalTrials.gov Archive Site
  • 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 ]
  • To evaluate pharmacokinetics
  • To describe preliminary evidence of anit-tumor activity
Not Provided
Not Provided
 
A Phase I Dose-Escalation Study of BMS-641988 in Patients With Castration-Resistant Prostate Cancer
A Phase I Dose-Escalation Study of BMS-641988 in Patients With Castration-Resistant Prostate Cancer

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Prostate Cancer
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
Experimental: 1
Intervention: Drug: AR Antagonist (BMS-641988)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
March 2009
March 2009   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00326586
CA185-002
Not Provided
Study Director, Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
July 2009

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