8 completed, 7 recruiting, 5 active not recruiting, 3 terminated. 25 Phase 1, 6 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 25 | Completed 8, Recruiting 7, Active not recruiting 5, Terminated 3, Withdrawn 2 |
| Phase 2 | 6 | Recruiting 3, Active not recruiting 2, Terminated 1 |
Follow ivosidenib: new trials by email Literature Review of ivosidenib trials Research Report on ivosidenib
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Study of an IDH1m Inhibitor in Participants With IDH1-Mutated Malignancies and Hepatic or Renal Impairment Ivosidenib Oral Tablet - IDH1-Mutated Malignancies | Phase 1 | Recruiting | Servier Bio-Innovation LLC | 30 | 2026-01-14 | 2026-08-06 |
| Venetoclax in Combination With Ivosidenib and Azacitidine for Newly Diagnosed IDH1-Mutated AML Ivosidenib, Venetoclax, Azacitidine - AML, IDH1 Mutation | Phase 1 / Phase 2 | Recruiting | Institute of Hematology & Blood Diseases Hospital, China | 23 | 2025-10-17 | 2026-05-13 |
| Ivosidenib Plus Durvalumab and Gemcitabine/Cisplatin as First-Line Therapy in Participants With Locally Advanced or Metastatic Cholangiocarcinoma With an IDH1 Mutation Ivosidenib, Durvalumab (for the first 8, 21-day, cycles), Gemcitabine (for the first 8, 21-day, cycles) - Locally Advanced, Unresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation | Phase 1 / Phase 2 | Active not recruiting | Institut de Recherches Internationales Servier | 55 | 2024-12-16 | 2026-10-13 |
| Ivosidenib and Ruxolitinib in Patients With Advanced Myeloproliferative Neoplasms (MPNs) That Have an IDH1 Gene Mutation Ivosidenib, Ruxolitinib - Myeloproliferative Neoplasms | Phase 1 | Recruiting | University of Chicago | 18 | 2024-09-19 | 2026-09-01 |
| A Study of Gilteritinib in Combination With Ivosidenib or Enasidenib in People With Acute Myeloid Leukemia (AML) Gilteritinib, Ivosidenib, Enasidenib - Acute Myeloid Leukemia (AML) | Phase 1 | Active not recruiting | Memorial Sloan Kettering Cancer Center | 8 | 2023-10-25 | 2026-10-15 |
| Ivosidenib, Nivolumab, and Ipilimumab Combination in Previously Treated Subjects With Nonresectable or Metastatic IDH1 Mutant Cholangiocarcinoma Ivosidenib, Nivolumab, Ipilimumab - IDH1-mutant Cholangiocarcinoma | Phase 1 / Phase 2 | Terminated | Servier Bio-Innovation LLC | 7 | 2023-10-23 | 2026-04-20 |
| Ivosidenib + mFOLFIRINOX in Patients With Resectable Pancreatic Adenocarcinoma Ivosidenib, mFOLFIRINOX - Pancreatic Ductal Adenocarcinoma, Resectable Pancreatic Cancer | Phase 1 | Active not recruiting | Case Comprehensive Cancer Center | 16 | 2022-09-08 | 2025-09-05 |
| Glasdegib-Based Treatment Combinations for the Treatment of Patients With Relapsed Acute Myeloid Leukemia Who Have Undergone Hematopoietic Cell Transplantation Bosutinib Monohydrate, Decitabine, Enasidenib Mesylate - Recurrent Acute Myeloid Leukemia | Phase 1 | Withdrawn | City of Hope Medical Center | 2022-06-25 | 2022-06-09 | |
| A Study of Fedratinib With IDH Inhibition in Advanced-Phase, IDH-Mutated Ph-Negative Myeloproliferative Neoplasms Ivosidenib, Enasidenib, Fedratinib - IDH Mutation, IDH1 Mutation | Phase 1 | Withdrawn | University of Chicago | 2021-10-29 | 2024-07-31 | |
| Decitabine Alone or in Combination With Venetoclax, Gilteritinib, Enasidenib, or Ivosidenib as Maintenance Therapy for the Treatment of Acute Myeloid Leukemia in Remission Decitabine and Cedazuridine, Enasidenib, Gilteritinib - Acute Myeloid Leukemia | Phase 1 | Recruiting | M.D. Anderson Cancer Center | 125 | 2021-10-25 | 2026-10-09 |
| Decitabine/Cedazuridine and Venetoclax in Combination With Ivosidenib or Enasidenib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia Decitabine and Cedazuridine, Enasidenib, Ivosidenib - Acute Myeloid Leukemia, Recurrent Acute Myeloid Leukemia | Phase 1 / Phase 2 | Recruiting | M.D. Anderson Cancer Center | 84 | 2021-05-24 | 2026-05-20 |
| Gemcitabine and Cisplatin With Ivosidenib or Pemigatinib for the Treatment of Unresectable or Metastatic Cholangiocarcinoma Cisplatin, Gemcitabine, Ivosidenib - Advanced Cholangiocarcinoma, Metastatic Cholangiocarcinoma | Phase 1 | Terminated | Academic and Community Cancer Research United | 8 | 2021-01-25 | 2024-05-06 |
| Ivosidenib and Combination Chemotherapy for the Treatment of IDH1 Mutant Relapsed or Refractory Acute Myeloid Leukemia Cytarabine, Filgrastim, Fludarabine - Recurrent Acute Myeloid Leukemia, Recurrent Myelodysplastic Syndrome | Phase 1 | Terminated | Northwestern University | 2 | 2020-12-21 | 2026-06-01 |
| A China Bridging Study of Ivosidenib in r/r AML Subjects With an IDH1 Mutation ivosidenib - Relapsed or Refractory Acute Myeloid Leukemia | Phase 1 | Completed | CStone Pharmaceuticals | 30 | 2019-11-12 | 2023-02-13 |
| IDH1 Inhibition Using Ivosidenib as Maintenance Therapy for IDH1-mutant Myeloid Neoplasms Following Allogeneic Stem Cell Transplantation Ivosidenib - IDH1 Mutation Myeloid Neoplasms | Phase 1 | Completed | Massachusetts General Hospital | 18 | 2019-01-16 | 2025-11-04 |
| Study of AG-120 and AG-881 in Subjects With Low Grade Glioma AG-120, AG881 - Glioma | Phase 1 | Completed | Institut de Recherches Internationales Servier | 49 | 2018-03-20 | 2026-02-17 |
| Ivosidenib and Venetoclax With or Without Azacitidine in Treating Patients With IDH1 Mutated Hematologic Malignancies Azacitidine, Ivosidenib, Venetoclax - Acute Myeloid Leukemia, Hematopoietic and Lymphoid System Neoplasm | Phase 1 / Phase 2 | Recruiting | M.D. Anderson Cancer Center | 96 | 2018-03-19 | 2026-09-14 |
| A Study of AG-120 (Ivosidenib) in Subjects With Mild or Moderate Hepatic Impairment or Normal Hepatic Function AG-120 (Ivosidenib) - Hepatic Impairment | Phase 1 | Completed | Agios Pharmaceuticals, Inc. | 33 | 2017-09-26 | 2018-04-27 |
| Japanese Bridging Study of Ivosidenib (AG-120) in Healthy Subjects ivosidenib (AG-120) - Healthy | Phase 1 | Completed | Agios Pharmaceuticals, Inc. | 60 | 2017-03-31 | 2018-01-11 |
| A Study to Assess the Safety and Efficacy of Two Combinations of Isocitrate Dehydrogenase (IDH) Mutant Targeted Therapies Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) Harboring IDH Mutations Who Are Not Candidates to Receive Intensive Induction Chemotherapy AG-120, Azacitidine, AG-221 - Leukemia, Myeloid, Acute | Phase 1 / Phase 2 | Active not recruiting | Celgene | 130 | 2016-06-03 | 2026-02-19 |
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Leukemia, Myeloid, Acute (10) · Myeloproliferative Disorders (4) · Myelodysplastic Syndromes (3) · Cholangiocarcinoma (2) · Glioma (2) · Hematologic Neoplasms (2) · Leukemia (2) · Recurrence (2) · Chondrosarcoma (1)
Institut de Recherches Internationales Servier (5) · Agios Pharmaceuticals, Inc. (4) · M.D. Anderson Cancer Center (3) · Servier Bio-Innovation LLC (2) · University of Chicago (2) · Academic and Community Cancer Research United (1) · CStone Pharmaceuticals (1) · Case Comprehensive Cancer Center (1) · Celgene (1) · City of Hope Medical Center (1) · Institute of Hematology & Blood Diseases Hospital, China (1) · Massachusetts General Hospital (1) · Memorial Sloan Kettering Cancer Center (1) · Northwestern University (1)
United States (23) · France (4) · Australia (3) · Germany (3) · South Korea (3) · Spain (3) · Brazil (2) · Canada (2) · China (2) · Netherlands (2) · United Kingdom (2) · Belgium (1) · Czechia (1) · Italy (1) · Japan (1)
Courtney DiNardo, MD (2) · Amir T Fathi, MD (1) · Anand Patel (1) · David Bajor, MD (1) · Eytan Stein, MD (1) · Guido Marcucci (1) · Hui Wei, MD (1) · Olatoyosi Odenike, MD (1) · Sam Agresta, MD (1) · Shira N Dinner, M.D. (1) · Shubham Pant (1) · Tapan M Kadia, MD (1)
PMID 33394722, PMID 38507688, PMID 40513054, PMID 27245312, PMID 29860938, PMID 31028664, PMID 31300360, PMID 31841594, PMID 32208957, PMID 32296873, PMID 32380538, PMID 32530764, PMID 32648303, PMID 33119479, PMID 33493392, PMID 33709779, PMID 34672961, PMID 34751786, PMID 34889407, PMID 35166065, PMID 37034685, PMID 38010220, PMID 38640348, PMID 40073835, PMID 41678089
2015 (2), P30CA015083 (1), P30CA033572 (1), P30CA060553 (1)