Study of Quizartinib in Combination With Standard Therapies in Chinese Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)
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- STATUS
- Recruiting
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- End date
- Sep 30, 2022
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- participants needed
- 18
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- sponsor
- Daiichi Sankyo Co., Ltd.
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 Identifier | NCT03723681 |
| Sponsor | Daiichi Sankyo Co., Ltd. |
| Last Modified on | 25 April 2022 |
Eligibility
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
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