drugset / Trial / NCT02984995
Phase 2 Study of Quizartinib in Participants With Acute Myeloid Leukemia (AML) FLT3 Internal Tandem Duplication (FLT3/ITD) Mutation
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a Phase 2, multi-center, open-label study to evaluate the efficacy, safety and pharmacokinetics of quizartinib monotherapy in Japanese subjects with FLT3-ITD positive refractory or relapsed acute myeloid leukemia.
Timeline
- Start
- 2016-12-08
- Primary completion
- 2018-03-28
- Completion
- 2018-09-14
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Quizartinib | Small molecule | 30 mg | Oral |
| Subject | Quizartinib | Small molecule | 60 mg | Oral |