Study of Quizartinib in Combination With Standard Therapies in Chinese Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Acute Myeloid Leukemia (AML)
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 70 years
- Gender
- Both males and females
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 ...
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.
Tracking Information
- NCT #
- NCT03723681
- Collaborators
- Not Provided
- Investigators
- Study Director: Global Clinical Leader Daiichi Sankyo, Inc.
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