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A Phase II Clinical Trial of Olutasidenib in Patients With Acute Myeloid Leukemia

NCT07604064 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2026-05-22

No results posted yet for this study

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.

Conditions

  • Relapsed or Refractory IDH1 Mutation-Positive Acute Myeloid Leukemia

Interventions

DRUG

Olutasidenib

Olutasidenib: Oral administration

Sponsors & Collaborators

  • Kissei Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yumi Ikezaki · Kissei Pharmaceutical Co., Ltd.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2030-09-30
Completion
2030-09-30

Countries

  • Japan

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07604064 on ClinicalTrials.gov