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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Olutasidenib: Oral administration
Research Site
Tokyo and Other Japanese Cities, Japan
RECRUITINGIncidence of adverse events and adverse drug reactions
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.
Time frame: From the start of IMP administration to 28 days after the final dose of the IMP
CR/CRh rate
The number and proportion of patients who achieve CR or CRh
Time frame: Through study completion, approximately up to 3 years
Duration of CR/CRh
The duration from the achievement of the first CR or CRh to relapse or death, whichever occurs first
Time frame: Through study completion, approximately up to 3 years
Time to CR/CRh
The duration from the start of IMP administration to the achievement of CR or CRh
Time frame: Through study completion, approximately up to 3 years
Transfusion independence
The number and proportion of patients who have been transfusion-free for 28 days and 56 days after the start of IMP
Time frame: Through study completion, approximately up to 3 years
Overall survival (OS)
The duration from the start of IMP administration to death for any reason
Time frame: Through study completion, approximately up to 3 years
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