Status:
WITHDRAWN
Phase I Study of Dasatinib (BMS-354825) and Imatinib in Subjects With Chronic Myeloid Leukemia in Chronic Phase
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Myeloid Leukemia, Chronic, Chronic-Phase
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00324077
Start Date
August 1 2006
Last Update
February 17 2016
Active Locations (3)
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1
Local Institution
Los Angeles, California, United States
2
Local Institution
San Francisco, California, United States
3
Local Institution
New York, New York, United States