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Clinical Trials/NCT00349518
NCT00349518WithdrawnPhase 2

A Phase II Study of Dasatinib (BMS-354825) in Subjects With Chronic or Advanced Phase Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Who Are Resistant or Intolerant to Imatinib

Bristol-Myers Squibb20 sites in 6 countriesStarted: December 2006Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Withdrawn
Sponsor
Locations
20
Primary Endpoint
Incidence and severity of drug-related adverse events.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this study is to further assess the safety of dasatinib in imatinib intolerant or resistant patients with chronic phase chronic myeloid leukemia, advanced phase chronic myeloid leukemia or Philadelphia chromosome positive acute lymphoblastic leukemia. The efficacy of the drug in this kind of patients will also further be documented.

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
  • •CP or AD CML or Ph+ ALL
  • •Intolerant of resistant to imatinib
  • •ECOG PS 0-2 (CP CML)
  • •ECOG PS 0-3 (AD CML and Ph+ ALL)
  • •Adequate hepatic and renal function

Exclusion Criteria

  • •Pregnant or breastfeeding females
  • •History of significant cardiac disease
  • •History of significant bleeding disorder (not CML)

Outcomes

Primary Outcomes

Incidence and severity of drug-related adverse events.

Secondary Outcomes

  • Chronic Phase CML: Cytogenetic and Hematologic Response
  • Time to and duration of Cytogenetic and Hematologic Response
  • Advanced Phase CML and Philadelphia positive ALL: Hematologic Response

Investigators

Sponsor
Bristol-Myers Squibb
Sponsor Class
Industry

Study Sites (20)

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