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Clinical Trials/NCT00349518
NCT00349518
Withdrawn
Phase 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 Squibb2 sites in 2 countriesDecember 2006
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ConditionsChronic Myeloid LeukemiaAcute Lymphoblastic Leukemia
DrugsDasatinib

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Chronic Myeloid Leukemia
Sponsor
Bristol-Myers Squibb
Locations
2
Primary Endpoint
Incidence and severity of drug-related adverse events.
Status
Withdrawn
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

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.

Registry
clinicaltrials.gov
Start Date
December 2006
End Date
January 2007
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Eligibility Criteria

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

Study Sites (2)

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