Phase I Study of Dasatinib (BMS-354825) and Imatinib in Subjects With Chronic Myeloid Leukemia in Chronic Phase
Phase 1
Withdrawn
- Conditions
- Myeloid Leukemia, Chronic, Chronic-Phase
- Registration Number
- NCT00324077
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method To determine the maximum tolerated dose (MTD) and recommended dose of dasatinib when combined with imatinib in chronic phase CML patients.
- Secondary Outcome Measures
Name Time Method identify dose limiting toxicities evaluate progressive free survival and overall survival assess safety and tolerability of dasatinib and imatinib administered in combination throughout study characterize mutations in the BCR-ABL gene characterize plasma pharmacokinetics of dasatinib and imatinib in month 1 measure major molecular response rate measure the major cytogenetic response rate
Trial Locations
- Locations (1)
Local Institution
🇺🇸New York, New York, United States