Ivosidenib Expanded Access Program in Relapsed/Refractory AML With an IDH1 Mutation
NCT03245424 · Status: APPROVED_FOR_MARKETING · Type: EXPANDED_ACCESS
Last updated 2018-07-24
Summary
To provide access to ivosidenib monotherapy to patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase 1 (IDH1) mutation.
Conditions
- Acute Myeloid Leukemia
- Relapsed Adult AML
- Relapsed Pediatric AML
Interventions
- DRUG
-
ivosidenib (AG-120)
Patients will receive ivosidenib 500 mg by mouth once daily on 28-day cycles
Sponsors & Collaborators
-
Agios Pharmaceuticals, Inc.
lead INDUSTRY
Eligibility
- Min Age
- 12 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
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