A Phase I Dose-Escalation Study of BMS-641988 in Patients With Castration-Resistant Prostate Cancer
Phase 1
Completed
- Conditions
- Prostate Cancer
- Interventions
- Drug: AR Antagonist (BMS-641988)
- Registration Number
- NCT00326586
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
This is a Phase I Dose-Escalation Study of BMS641988 in Patients with Castration-Resistant Prostate Cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 54
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
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 AR Antagonist (BMS-641988) -
- Primary Outcome Measures
Name Time Method To assess safety and tolerability and to identify a dose for Phase II evaluation during the dose escalation phase
- Secondary Outcome Measures
Name Time Method To evaluate pharmacokinetics throughout the study To describe preliminary evidence of anit-tumor activity throughout the study
Trial Locations
- Locations (3)
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
University Of Wisconsin Hospital And Clinics Laboratory
🇺🇸Madison, Wisconsin, United States
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
🇺🇸Baltimore, Maryland, United States