A Phase I Dose Escalation Study of the Combination of Dasatinib (BMS-354825) and Imatinib in Subjects With Chronic Myeloid Leukemia in Chronic Phase

Bristol-Myers Squibb1 site in 1 countryAugust 2006

ConditionsMyeloid Leukemia, Chronic, Chronic-Phase

DrugsDasatinib in combination with imatinib

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Myeloid Leukemia, Chronic, Chronic-Phase
Sponsor: Bristol-Myers Squibb
Locations: 1
Primary Endpoint: To determine the maximum tolerated dose (MTD) and recommended dose of dasatinib when combined with imatinib in chronic phase CML patients.
Status: Withdrawn
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2006

End Date

February 2007

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

Eligibility 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

Outcomes

Primary Outcomes

To determine the maximum tolerated dose (MTD) and recommended dose of dasatinib when combined with imatinib in chronic phase CML patients.

Secondary Outcomes

evaluate progressive free survival and overall survival
identify dose limiting toxicities
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