- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00326586
A Phase I Dose-Escalation Study of BMS-641988 in Patients With Castration-Resistant Prostate Cancer
January 24, 2011 updated by: Bristol-Myers Squibb
This is a Phase I Dose-Escalation Study of BMS641988 in Patients with Castration-Resistant Prostate Cancer.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
54
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21231
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
-
-
New York
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New York, New York, United States, 10021
- Memorial Sloan-Kettering Cancer Center
-
-
Wisconsin
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Madison, Wisconsin, United States, 53792
- University Of Wisconsin Hospital And Clinics Laboratory
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To assess safety and tolerability and to identify a dose for Phase II evaluation
Time Frame: during the dose escalation phase
|
during the dose escalation phase
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To evaluate pharmacokinetics
Time Frame: throughout the study
|
throughout the study
|
To describe preliminary evidence of anit-tumor activity
Time Frame: throughout the study
|
throughout the study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2006
Primary Completion (Actual)
March 1, 2009
Study Completion (Actual)
March 1, 2009
Study Registration Dates
First Submitted
May 15, 2006
First Submitted That Met QC Criteria
May 15, 2006
First Posted (Estimate)
May 17, 2006
Study Record Updates
Last Update Posted (Estimate)
January 25, 2011
Last Update Submitted That Met QC Criteria
January 24, 2011
Last Verified
July 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CA185-002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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