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
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
- 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.