Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| jRCT2051260041 | Registry Identifier | jRCT |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Olutasidenib | Experimental | Olutasidenib will be administered orally twice daily under fasting condition. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olutasidenib | Drug | Olutasidenib: Oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence 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. | From the start of IMP administration to 28 days after the final dose of the IMP |
| Measure | Description | Time Frame |
|---|---|---|
| CR/CRh rate | The number and proportion of patients who achieve CR or CRh | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kissei Pharmaceutical Co., Ltd | Contact | Email only | rinsyousiken@pharm.kissei.co.jp |
| Name | Affiliation | Role |
|---|---|---|
| Yumi Ikezaki | Kissei Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Recruiting | Tokyo and Other Japanese Cities | Japan |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000710173 | olutasidenib |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 | 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 | Through study completion, approximately up to 3 years |
| Overall survival (OS) | The duration from the start of IMP administration to death for any reason | Through study completion, approximately up to 3 years |