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Phase 2, open-label, single-arm study of Quizartinib (AC220) monotherapy in Japanese patients with FLT3-ITD positive refractory or relapsed acute myeloid leukemia

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Trial Profile

Phase 2, open-label, single-arm study of Quizartinib (AC220) monotherapy in Japanese patients with FLT3-ITD positive refractory or relapsed acute myeloid leukemia

Status: Discontinued
Phase of Trial: Phase II

Latest Information Update: 21 Feb 2024

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At a glance

  • Drugs Quizartinib (Primary)
  • Indications Acute myeloid leukaemia
  • Focus Registrational; Therapeutic Use
  • Sponsors Daiichi Sankyo Company

Most Recent Events

  • 18 Jun 2019 According to a Daiichi Sankyo Company media release, based on the results of this study and a phase III study (NCT02039726), the the Ministry of Health, Labor and Welfare (MHLW) of Japan has approved VANFLYTA (quizartinib), an oral FLT3 inhibitor, for the treatment of adult patients with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML), as detected by an MHLW-approved test.
  • 17 Oct 2018 Status changed from active, no longer recruiting to discontinued.
  • 17 Oct 2018 According to a Daiichi Sankyo Company media release, primary endpoint of achieving a predetermined composite complete remission rate has been met at interim analysis, triggering an early stop of the study due to efficacy.

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