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
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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COMPLETED
PHASE1
54 participants
INTERVENTIONAL
2006-05-31
2009-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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1
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
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
MALE
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
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
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
University Of Wisconsin Hospital And Clinics Laboratory
Madison, Wisconsin, United States
Countries
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Related Links
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Investigator Inquiry form
Other Identifiers
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CA185-002
Identifier Type: -
Identifier Source: org_study_id
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