- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00324077
Phase I Study of Dasatinib (BMS-354825) and Imatinib in Subjects With Chronic Myeloid Leukemia in Chronic Phase
February 16, 2016 updated by: Bristol-Myers Squibb
A Phase I Dose Escalation Study of the Combination of Dasatinib (BMS-354825) and Imatinib in Subjects With Chronic Myeloid Leukemia in Chronic Phase
The purpose of this study is to find out whether adding a new drug, dasatinib, to imatinib is safe, and whether the combination of the two drugs will help decrease the number of cells that contain the Philadelphia chromosome.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
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
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California
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Los Angeles, California, United States
- Local Institution
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San Francisco, California, United States
- Local Institution
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New York
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New York, New York, United States
- Local Institution
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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
N/A
Genders Eligible for Study
All
Description
Inclusion Criteria:
- males and females, 18 or older
- chronic phase Ph+ or BCR-ABL positive CML
- current complete hematologic response to imatinib
- lack of major molecular response
- on imatinib for at least one year
- on the same imatinib dose for at least 6 months
- adequate hepatic and renal function
Exclusion Criteria:
- History of accelerated or blast phase CML
- Serious uncontrolled medical disorder or active infection
- Significant cardiovascular disease or bleeding disorder
- Concurrent use of medications at risk of causing Torsades de Pointe
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: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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To determine the maximum tolerated dose (MTD) and recommended dose of dasatinib when combined with imatinib in chronic phase CML patients.
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Secondary Outcome Measures
Outcome Measure |
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assess safety and tolerability of dasatinib and imatinib administered in combination throughout study
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identify dose limiting toxicities
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characterize plasma pharmacokinetics of dasatinib and imatinib in month 1
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measure major molecular response rate
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measure the major cytogenetic response rate
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characterize mutations in the BCR-ABL gene
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evaluate progressive free survival and overall survival
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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
August 1, 2006
Primary Completion (Actual)
February 1, 2007
Study Registration Dates
First Submitted
May 9, 2006
First Submitted That Met QC Criteria
May 9, 2006
First Posted (Estimate)
May 10, 2006
Study Record Updates
Last Update Posted (Estimate)
February 17, 2016
Last Update Submitted That Met QC Criteria
February 16, 2016
Last Verified
April 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Bone Marrow Diseases
- Hematologic Diseases
- Myeloproliferative Disorders
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Leukemia, Myeloid, Chronic-Phase
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Imatinib Mesylate
- Dasatinib
Other Study ID Numbers
- CA180-011
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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