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drugset / Trial / NCT02834390

Study of Quizartinib in Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)

NCT02834390 ↗

Phase 1 Completed 7 enrolled Daiichi Sankyo
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is a phase 1b, dose escalation, study of quizartinib to evaluate the safety profile, the pharmacokinetics, and the recommended dose of quizartinib for subsequent clinical studies of the combination of quizartinib and induction and consolidation chemotherapy.

Timeline

Start
2016-08-12
Primary completion
2017-10-19
Completion
2017-10-19

Drugs

EvaluationDrugModalityDoseRoute
Subject Quizartinib Small molecule 20 mg Oral
Subject Quizartinib Small molecule 40 mg Oral
Background Cytarabine Small molecule 100 mg/m2 Intravenous
Background Cytarabine Small molecule 3 g Intravenous
Background Daunorubicin Small molecule 60 mg/m2 Intravenous
Background Idarubicin Small molecule 12 mg/m2 Intravenous

Indications

acute myeloid leukemia