Back to resultsA Phase I Dose-Escalation Study of BMS-641988 in Patients With Castration-Resistant Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
AR Antagonist (BMS-641988)
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer
Eligibility Criteria
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
Sites / Locations
- Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
- Memorial Sloan-Kettering Cancer Center
- University Of Wisconsin Hospital And Clinics Laboratory
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
To assess safety and tolerability and to identify a dose for Phase II evaluation
Secondary Outcome Measures
To evaluate pharmacokinetics
To describe preliminary evidence of anit-tumor activity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00326586
Brief Title
A Phase I Dose-Escalation Study of BMS-641988 in Patients With Castration-Resistant Prostate Cancer
Official Title
A Phase I Dose-Escalation Study of BMS-641988 in Patients With Castration-Resistant Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
5. Study Description
Brief Summary
This is a Phase I Dose-Escalation Study of BMS641988 in Patients with Castration-Resistant Prostate Cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
AR Antagonist (BMS-641988)
Intervention Description
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
Primary Outcome Measure Information:
Title
To assess safety and tolerability and to identify a dose for Phase II evaluation
Time Frame
during the dose escalation phase
Secondary Outcome Measure Information:
Title
To evaluate pharmacokinetics
Time Frame
throughout the study
Title
To describe preliminary evidence of anit-tumor activity
Time Frame
throughout the study
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
University Of Wisconsin Hospital And Clinics Laboratory
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Phase I Dose-Escalation Study of BMS-641988 in Patients With Castration-Resistant Prostate Cancer
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