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

NCT ID: NCT00326586

Last Updated: 2011-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2009-03-31

Brief Summary

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

Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

AR Antagonist (BMS-641988)

Intervention Type 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

Interventions

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AR 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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Bristol-Myers Squibb

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins

Baltimore, Maryland, United States

Site Status

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Site Status

University Of Wisconsin Hospital And Clinics Laboratory

Madison, Wisconsin, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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CA185-002

Identifier Type: -

Identifier Source: org_study_id

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