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A Phase 1b, Open-Label, Dose-Escalation Study of MLN4924 Plus Azacitidine in Treatment-Naive Patients With Acute Myelogenous Leukemia Who Are 60 Years or Older

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Trial Profile

A Phase 1b, Open-Label, Dose-Escalation Study of MLN4924 Plus Azacitidine in Treatment-Naive Patients With Acute Myelogenous Leukemia Who Are 60 Years or Older

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 07 Aug 2021

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At a glance

  • Drugs Pevonedistat (Primary) ; Azacitidine; Azacitidine
  • Indications Acute myeloid leukaemia
  • Focus Adverse reactions
  • Sponsors Takeda Oncology

    • Most Recent Events

    • 17 Jun 2021 Results of an exposure-efficacy pooled analysis from three clinical studies: NCT01814826, NCT02782468 and NCT02610777 assessing impact of Pevonedistat exposure on efficacy and safety presented at the 26th Congress of the European Haematology Association
    • 08 Jun 2021 Results of pooled analysis from 3 studies (NCT01814826, NCT02782468 and NCT02610777) were used evaluate the impact of PEV exposure on safety and efficacy, presented at the 57th Annual Meeting of the American Society of Clinical Oncology.
    • 29 Jul 2019 A population pharmacokinetic analysis was conducted to quantify the impact of patient-specific and concurrent medication factors on pevonedistat pharmacokinetics using pooled data from 6 clinical studies ; results published in the British Journal of Clinical Pharmacology
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