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. 2018 Sep 12;78(14):1509–1516. doi: 10.1007/s40265-018-0978-3

Key clinical trials of Ivosidenib

Drug(s) Indication Phase Status Location(s) Identifier Sponsor
Ivosidenib, placebo Untreated AML 3 Recruiting Multnational NCT03173248; AGILE; AG120-C-009 Agios Pharmaceuticals, Inc
Ivosidenib, placebo Advanced cholangiocarcinoma 3 Recruiting Multinational NCT02989857; A G120-C-005 Agios Pharmaceuticals, Inc
Ivosidenib R/R AML EA Approved for marketing NA NCT03245424; AG120-C-010 Agios Pharmaceuticals, Inc
Ivosidenib Myelodysplastic syndrome 2 Planned NA NCT03503409; IDIOME-STUDY Groupe Francophone des Myelodysplasies
Ivosidenib, other targeted agents Untreated AML 1b/2 Recruiting USA NCT03013998; BAML-16-001 Beat AML, LLC
Ivosidenib/enasidenib (with azacitidine) Newly diagnosed AML 1b/2 Recruiting Multinational NCT02677922; AG-221-AML-005 Celgene
Ivosidenib, venetoclax Haematologic malignancies 1b/2 Recruiting NA NCT03471260; 2017-0490 MD Anderson Cancer Center
Ivosidenib Myeloid neoplasms 1 Planned USA NCT03564821; 18-123 Massachusetts General Hospital
Ivosidenib, enasidenib (with chemotherapy) Newly diagnosed AML 1 Recruiting USA, Germany, Netherlands NCT02632708; AG120-221-C-001 Agios Pharmaceuticals, Inc
Ivosidenib Advanced haematological malignancies (including R/R AML) 1 Ongoing USA, France NCT02074839; AG120-C-001 Agios Pharmaceuticals, Inc
Ivosidenib Advanced solid tumors 1 Ongoing USA, France NCT02073994; AG120-C-002 Agios Pharmaceuticals, Inc
Ivosidenib, vorasidenib Recurrent, non-enhancing, low-grade glioma 1 Recruiting USA NCT03343197; AG120-881-C-001 Agios Pharmaceuticals, Inc

AML acute myeloid leukaemia, EA expanded access, NA not available, R/R relapsed or refractory