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A Phase 2, Randomized, Open-Label Study of the Safety and Efficacy of Two Doses of Quizartinib (AC220; ASP2689) in Subjects With FLT3-ITD Positive Relapsed or Refractory Acute Myeloid Leukemia

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Trial Profile

A Phase 2, Randomized, Open-Label Study of the Safety and Efficacy of Two Doses of Quizartinib (AC220; ASP2689) in Subjects With FLT3-ITD Positive Relapsed or Refractory Acute Myeloid Leukemia

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 19 Feb 2024

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At a glance

  • Drugs Quizartinib (Primary)
  • Indications Acute myeloid leukaemia
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Ambit Biosciences Corporation; Astellas Pharma; Daiichi Sankyo Inc
  • Most Recent Events

    • 29 Jun 2020 Results evaluating the population pharmacokinetics (PK) of quizartinib and its active metabolite published in the Journal of Clinical Pharmacology
    • 06 Nov 2019 Results of analysis of two clinical studies: a phase 3 QuANTUM-R trial and a phase 2 study APS2689-CL-2004, evaluating exposure response relationships across various efficacy endpoints of quizartinib, release in 61st Annual Meeting and Exposition of the American Society of Hematology
    • 06 Nov 2019 Results of pooled data from four studies: one phase 3 (QuANTUM-R), two phase 2, (ACC220-002 and 2689-CL-2004), and one phase 1 (CP0001), released at the 61st Annual Meeting and Exposition of the American Society of Hematology.
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