Phase I Study of Dasatinib (BMS-354825) and Imatinib in Subjects With Chronic Myeloid Leukemia in Chronic Phase
| Status: | Withdrawn |
|---|---|
| Conditions: | Blood Cancer, Blood Cancer, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | August 2006 |
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.
is safe, and whether the combination of the two drugs will help decrease the number of cells
that contain the Philadelphia chromosome.
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
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