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Clinical Trials/NCT00324077
NCT00324077WithdrawnPhase 1

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 Squibb3 sites in 1 countryStarted: August 2006Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Withdrawn
Sponsor
Locations
3
Primary Endpoint
To determine the maximum tolerated dose (MTD) and recommended dose of dasatinib when combined with imatinib in chronic phase CML patients.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Investigators

Sponsor
Bristol-Myers Squibb
Sponsor Class
Industry

Study Sites (3)

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