Study of Quizartinib in Combination With Standard Therapies in Chinese Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)

  • STATUS
    Not Recruiting
  • days left to enroll
    4
  • participants needed
    18
  • sponsor
    Daiichi Sankyo Co., Ltd.
Updated on 8 August 2022
cytarabine

Summary

20 mg or 40 mg of quizartinib will be given to Chinese patients who were just diagnosed with AML. The study drug will be given to them along with standard therapies. The purpose is to find out the highest dose they can stand.

Description

This is a Phase 1, multicenter, open-label study to evaluate the safety and pharmacokinetics (PK) of quizartinib in combination with standard induction therapy and consolidation therapy in Chinese patients with newly diagnosed AML.

The quizartinib doses will be Level 1: 20 mg and Level 2: 40 mg. No increase in the quizartinib dose will be made in the same subject.

Dose-limiting toxicity associated with quizartinib occurring at each level will be assessed, and the maximum tolerated dose (MTD) will be decided using a 3 + 3 design.

Details
Condition Acute Myeloid Leukemia (AML)
Treatment Quizartinib
Clinical Study IdentifierNCT03723681
SponsorDaiichi Sankyo Co., Ltd.
Last Modified on8 August 2022

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