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

Acute Myeloid Leukemia (AML) Clinical Trial

Official title:
A Study to Evaluate the Safety and Pharmacokinetics of Quizartinib in Combination With Standard Induction Therapy and Consolidation Therapy in Chinese Patients With Newly Diagnosed Acute Myeloid Leukemia

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03723681
Study type Interventional
Source Daiichi Sankyo, Inc.
Contact
Status Completed
Phase Phase 1
Start date November 5, 2018
Completion date March 3, 2022
View Details
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