A Phase I Dose-Escalation Study of BMS-641988 in Patients With Castration-Resistant Prostate Cancer
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Male
Prostate Cancer
Male
Prostate Cancer
Trial Information
A Phase I Dose-Escalation Study of BMS-641988 in Patients With Castration-Resistant Prostate Cancer
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
To assess safety and tolerability and to identify a dose for Phase II evaluation
Outcome Time Frame:
during the dose escalation phase
Safety Issue:
Yes
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
United States: Food and Drug Administration
Study ID:
CA185-002
NCT ID:
NCT00326586
Start Date:
May 2006
Completion Date:
March 2009
Related Keywords:
- Prostate Cancer
- Prostatic Neoplasms
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
| University Of Wisconsin Hospital And Clinics Laboratory | Madison, Wisconsin 53792 |
