drugset / Trial / NCT04827069

A Clinical Trial to Evaluate Clifutinib in Patients with Relapsed or Refractory Acute Myeloid Leukemia(AML)

NCT04827069

Phase 1 Completed 75 enrolled Sunshine Lake Pharma Co., Ltd.
Non-randomizedSequentialOpen-labelTreatment

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of Clifutinib Besylate in Relapsed/refractory AML patients with FLT3-ITD mutation.

Timeline

Start
2018-05-18
Primary completion
2023-08-21
Completion
2023-08-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Clifutinib Unknown 10 mg Oral
Subject Clifutinib Unknown 20 mg Oral
Subject Clifutinib Unknown 40 mg Oral
Subject Clifutinib Unknown 55 mg Oral
Subject Clifutinib Unknown 70 mg Oral
Subject Clifutinib Unknown 100 mg Oral