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An Open Label Phase II Pharmacokinetic and Pharmacodynamic Assessment of the Potential for QTc Prolongation Following First Induction Treatment With CPX-351 (Cytarabine:Daunorubicin) Liposome Injection in Acute Leukemias and MDS Patients

Trial Profile

An Open Label Phase II Pharmacokinetic and Pharmacodynamic Assessment of the Potential for QTc Prolongation Following First Induction Treatment With CPX-351 (Cytarabine:Daunorubicin) Liposome Injection in Acute Leukemias and MDS Patients

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 19 Dec 2018

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At a glance

  • Drugs Cytarabine/daunorubicin (Primary)
  • Indications Acute myeloid leukaemia; Myelodysplastic syndromes; Precursor cell lymphoblastic leukaemia-lymphoma
  • Focus Adverse reactions; Registrational
  • Sponsors Celator Pharmaceuticals
  • Most Recent Events

    • 19 Dec 2018 Results of the population pharmacokinetics analysis based on pooled data from Study 101, 206 and 301 (n=195) published in the Journal of Clinical Pharmacology
    • 31 Aug 2018 Biomarkers information updated
    • 23 Feb 2016 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov record.
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