{"id":"ivosidenib-oral-tablet","safety":{"commonSideEffects":[{"rate":null,"effect":"Differentiation syndrome"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Elevated transaminases"},{"rate":null,"effect":"Leukocytosis"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"IDH1 mutations are found in certain hematologic malignancies and solid tumors, where they produce elevated levels of 2-hydroxyglutarate, an oncometabolite that drives malignant transformation. 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Untreated or Previously Treated With 1 Systemic Treatment Regimen","enrollment":136},{"nctId":"NCT05010772","phase":"PHASE1","title":"Decitabine Alone or in Combination With Venetoclax, Gilteritinib, Enasidenib, or Ivosidenib as Maintenance Therapy for the Treatment of Acute Myeloid Leukemia in Remission","status":"RECRUITING","sponsor":"M.D. Anderson Cancer Center","startDate":"2021-10-25","conditions":"Acute Myeloid Leukemia","enrollment":125},{"nctId":"NCT06501625","phase":"PHASE1, PHASE2","title":"Ivosidenib Plus Durvalumab and Gemcitabine/Cisplatin as First-Line Therapy in Participants With Locally Advanced or Metastatic Cholangiocarcinoma With an IDH1 Mutation","status":"RECRUITING","sponsor":"Institut de Recherches Internationales Servier","startDate":"2024-12-16","conditions":"Locally Advanced, Unresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation","enrollment":52},{"nctId":"NCT03013998","phase":"PHASE1, PHASE2","title":"Study of Biomarker-Based Treatment of Acute 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(MDS)","enrollment":146},{"nctId":"NCT04774393","phase":"PHASE1, PHASE2","title":"Decitabine/Cedazuridine and Venetoclax in Combination With Ivosidenib or Enasidenib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia","status":"RECRUITING","sponsor":"M.D. Anderson Cancer Center","startDate":"2021-05-24","conditions":"Acute Myeloid Leukemia, Recurrent Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia","enrollment":84},{"nctId":"NCT05907057","phase":"PHASE3","title":"An Open-label Phase 3b Study of Ivosidenib in Combination With Azacitidine in Adult Patients Newly Diagnosed With IDH1m Acute Myeloid Leukemia (AML) Ineligible for Intensive Induction Chemotherapy.","status":"RECRUITING","sponsor":"Servier Affaires Médicales","startDate":"2023-06-14","conditions":"Acute Myeloid Leukemia (AML)","enrollment":245},{"nctId":"NCT04056910","phase":"PHASE2","title":"Ivosidenib (AG-120) With Nivolumab in IDH1 Mutant Tumors","status":"COMPLETED","sponsor":"Jason J. 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Used for Acute myeloid leukemia (AML) with IDH1 mutation, Cholangiocarcinoma with IDH1 mutation, Other IDH1-mutant solid tumors (in development).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}