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Phase 1-2 Safety and Efficacy Study of DACOGEN in Sequential Administration With Cytarabine in Children With Relapsed or Refractory Acute Myeloid Leukemia

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Trial Profile

Phase 1-2 Safety and Efficacy Study of DACOGEN in Sequential Administration With Cytarabine in Children With Relapsed or Refractory Acute Myeloid Leukemia

Status: Discontinued
Phase of Trial: Phase I/II

Latest Information Update: 18 Jun 2019

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At a glance

  • Drugs Decitabine (Primary) ; Cytarabine
  • Indications Acute myeloid leukaemia
  • Focus Adverse reactions; Pharmacokinetics; Therapeutic Use
  • Sponsors Janssen Research & Development; Janssen-Cilag
  • Most Recent Events

    • 18 Jun 2019 Status changed from completed to discontinued.
    • 11 Dec 2018 A population pharmacokinetic model was developed by pooling decitabine concentration-time data from 5 adult (AML and MDS) and 2 pediatric (AML) studies (DACO-018, DACO-017, DACO-020, DACO-016, E7373-A001-101, E7373-G000-202 and DACOGENAML2004 trial); results published in the Journal of Clinical Pharmacology
    • 31 Jan 2018 Status changed from suspended to completed.
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