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

Phase 1CompletedNCT00326586

Bristol-Myers Squibb54 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Prostate Cancer

Interventions

AR Antagonist (BMS-641988)DRUG

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

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins

Baltimore, Maryland, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

University Of Wisconsin Hospital And Clinics Laboratory

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

To assess safety and tolerability and to identify a dose for Phase II evaluation

Time frame: during the dose escalation phase

Secondary Outcomes

To evaluate pharmacokinetics

Time frame: throughout the study

To describe preliminary evidence of anit-tumor activity

Time frame: throughout the study

Data from ClinicalTrials.gov

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