A Phase 3 Open-label Randomized Study of Quizartinib (AC220) Monotherapy Versus Salvage Chemotherapy in Subjects With Tyrosine Kinase 3 - Internal Tandem Duplication (FLT3-ITD) Positive Acute Myeloid Leukemia (AML) Refractory to or Relapsed After First-line Treatment With or Without Hematopoietic Stem Cell Transplantation (HSCT) Consolidation

Trial Profile

A Phase 3 Open-label Randomized Study of Quizartinib (AC220) Monotherapy Versus Salvage Chemotherapy in Subjects With Tyrosine Kinase 3 - Internal Tandem Duplication (FLT3-ITD) Positive Acute Myeloid Leukemia (AML) Refractory to or Relapsed After First-line Treatment With or Without Hematopoietic Stem Cell Transplantation (HSCT) Consolidation

Recruiting
Phase of Trial: Phase III

Latest Information Update: 14 Aug 2017

At a glance

  • Drugs Quizartinib (Primary) ; Cytarabine; Etoposide; Fludarabine; Granulocyte colony-stimulating factors; Idarubicin; Mitoxantrone
  • Indications Acute myeloid leukaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms QUANTUM-R
  • Sponsors Ambit Biosciences Corporation; Daiichi Sankyo Inc
  • Most Recent Events

    • 10 Jun 2017 Biomarkers information updated
    • 09 Dec 2016 Planned End Date changed from 1 Jul 2017 to 1 Apr 2018.
    • 09 Dec 2016 Planned primary completion date changed from 1 May 2017 to 1 Feb 2018.
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