Prostate Cancer
Conditions
Brief summary
This is a Phase I Dose-Escalation Study of BMS641988 in Patients with Castration-Resistant Prostate Cancer.
Interventions
DRUGAR 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
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess safety and tolerability and to identify a dose for Phase II evaluation | during the dose escalation phase |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate pharmacokinetics | throughout the study |
| To describe preliminary evidence of anit-tumor activity | throughout the study |
Countries
United States
Outcome results
None listed