Phase I Study of Dasatinib (BMS-354825) and Imatinib in Subjects With Chronic Myeloid Leukemia in Chronic Phase

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Dasatinib; Imatinib Mesylate

Criteria

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