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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Prostate Cancer

Treatments: Drug: AR Antagonist (BMS-641988)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00326586

CA185-002

Details and patient eligibility

About

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

Enrollment: 54 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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54 participants in 1 patient group

1

Experimental group

Treatment:

Drug: AR Antagonist (BMS-641988)