Clinical Trials in Japan / NCT07604064
Recruiting
Phase 2
A Clinical Trial of Olutasidenib in Patients With Acute Myeloid Leukemia
NCT07604064 · tracked via the Priya Life Science Japan tracker
Condition(s) studied
Relapsed or Refractory IDH1 Mutation-Positive Acute Myeloid Leukemia
Investigational drug(s) / intervention(s)
Olutasidenib: Olutasidenib: Oral administration
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.
Eligibility
Inclusion Criteria:
* Japanese patients who personally provide written informed consent to participate in this clinical trial
* Patients with a confirmed diagnosis of AML based on WHO classification (2022 edition) (except acute promyelocytic leukemia with t (15:17) translocation)
* Patients with relapsed or refractory AML who may or may not have undergone allogeneic hematopoietic stem cell transplantation.
* Patients with IDH1 gene mutation confirmed by central confirmation after relapse or refractoriness
Exclusion Criteria:
* Patients with IDH2 mutations or patients with a history of IDH2 inhibitor treatment
* Patients who are intolerant to IDH1 inhibitors
* Patients who are deemed inappropriate for the clinical trial by the investigator or sub-investigator
Primary outcome measure(s)
- Incidence of adverse events and adverse drug reactions — From the start of IMP administration to 28 days after the final dose of the IMP
The number of events, number of patients, and incidence will be presented for all events, Grade 3 or higher events, Grade 4 or higher events, events resulting in death, serious events excluding death, events resulting in drug withdrawal, and events resulting in drug interruption.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Tokyo and Other Japanese Cities | Japan | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07604064 on ClinicalTrials.gov ↗ ← All trials in Japan