A Randomized Two-by-Two, Multicenter, Open-Label Phase III Study of BMS-354825 Administered Orally at a Dose of 50 mg or 70 mg Twice Daily or 100 mg or 140 mg Once Daily in Subjects with Chronic Phase Philadelphia Chromosome or BCR-ABL Positive Chronic Myelogenous Leukemia Who are Resistant or Intolerant to Imatinib Mesylate (Gleevec).

Trial Profile

A Randomized Two-by-Two, Multicenter, Open-Label Phase III Study of BMS-354825 Administered Orally at a Dose of 50 mg or 70 mg Twice Daily or 100 mg or 140 mg Once Daily in Subjects with Chronic Phase Philadelphia Chromosome or BCR-ABL Positive Chronic Myelogenous Leukemia Who are Resistant or Intolerant to Imatinib Mesylate (Gleevec).

Completed
Phase of Trial: Phase III

Latest Information Update: 01 Aug 2017

At a glance

  • Drugs Dasatinib (Primary)
  • Indications Chronic myeloid leukaemia
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Bristol-Myers Squibb
  • Most Recent Events

    • 01 Aug 2017 Results evaluating cardiovascular ischaemic event rates in dasatinib treated patients using patient data from NCT00103701, NCT00101647, NCT00101816, NCT00101660, NCT00101595, NCT00103844, NCT00123474, NCT00123487, NCT00481247, NCT00529763, NCT01357655, NCT00744497 trials and and comparing it with external reference populations published in the Annals of Hematology
    • 10 Jun 2017 Biomarkers information updated
    • 12 Mar 2016 Results of DASISION, CA180-034 and CA180-035 trials assessing incidence of lymphocytosis and its association with response, survival, and side effects published in the Cancer
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