Dasatinib (BMS-354825) in Subjects With Myeloid Blast Phase Chronic Myeloid Leukemia Resistant to or Intolerant of Imatinib Mesylate

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IITreatmentCompleted18 and overPharmaceutical / IndustryCA180-006
NCT00101816

Trial Description

Summary

The purpose of this study is to see what effect an investigational drug (BMS-354825) has on subjects who are currently in the myeloid blast phase of chronic myeloid leukemia (CML) and who are either resistant to or intolerant of imatinib mesylate. Another purpose of the study is to see what side effects this drug may have on subjects.

Eligibility Criteria

Inclusion Criteria:

  • Subjects with myeloid blast phase chronic myeloid leukemia
  • Subjects who are either resistant or intolerant of imatinib mesylate

Exclusion Criteria:

  • Subjects who are eligible and willing to undergo transplantation
  • Serious uncontrolled medical disorder or active infection
  • Uncontrolled or significant heart problems, such as congestive heart failure, recent heart attack, etc
  • Subjects receiving medications that may affect heart rhythm
  • Other malignancy/cancer other than CML
  • History of significant bleeding disorder unrelated to CML
  • Pregnant or breastfeeding women (subjects must avoid becoming pregnant)
  • Subjects received imatinib within 7 days, interferon or cytarabine within 14 days, a targeted anticancer medication within 14 days, an antineoplastic agent (other than hydroxyurea or anagrelide) within 28 days, or any other investigation medication in 28 days
  • Subject is receiving medications that affect platelet function or an anticoagulant

Trial Contact Information

Trial Lead Organizations/Sponsors

Bristol-Myers Squibb Company - New York

    Bristol-Myers Squibb, Study Director

    Link to the current ClinicalTrials.gov record.
    NLM Identifier NCT00101816
    ClinicalTrials.gov processed this data on April 09, 2015

    Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.