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

Bristol-Myers Squibb (BMS)

Status and phase: Withdrawn; Phase 1

Conditions: Myeloid Leukemia, Chronic, Chronic-Phase

Treatments: Drug: Dasatinib in combination with imatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00324077

CA180-011

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)