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

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Trial phase: 
Phase I
Recruitment status: 
Active, not recruiting

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

Background information
Trial ID: 
NCT00326586
Other unique IDs: 
CA185-002
Official title: 

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

Detailed description: 

 

Number to be enrolled: 
60 patients
Clinical information
Age groups: 
Adult
Senior
Gender: 
Male
Eligibility 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

Study design: 
Treatment
Randomized
Placebo Control
Safety Study
Crossover Assignment
Double Blind (Subject, Investigator)
Interventions: 
AR Antagonist (BMS-641988)
Conditions treated: 
Prostate Cancer
Outcome measurements: 

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 ]

Funding
Funding types: 
INDUSTRY
Sponsor: 
Bristol-Myers Squibb
Dates
Date the data was first received: 
Mon, 2006-05-15
Trial start date: 
Mon, 2006-05-01
Trial completion date: 
Tue, 2009-09-01
Trial last updated: 
Wed, 2009-05-20