drugset / Trial / NCT07604064

A Clinical Trial of Olutasidenib in Patients With Acute Myeloid Leukemia

NCT07604064

Phase 2 Recruiting 3 enrolled Kissei Pharmaceutical Co., Ltd.
NaSingle-groupOpen-labelTreatment

Summary

This clinical trial is a multicenter, single-arm, open-label study to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of olutasidenib administered orally twice daily under fasting conditions for one cycle of 28 days in at least 3 Japanese patients with relapsed or refractory IDH1 mutation-positive AML.

Timeline

Start
2026-06
Primary completion
2030-09
Completion
2030-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Olutasidenib Small molecule Oral