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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

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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: 23 Jan 2024

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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; Jazz Pharmaceuticals Inc

    • Most Recent Events

    • 12 Dec 2023 Results of a PopPKPD model analysis using data from three clinical studies: NCT00389428, NCT02238925 and NCT01696084 presented at the 65th American Society of Hematology Annual Meeting and Exposition
    • 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
    • 23 Feb 2016 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov record.
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