5 completed, 2 active not recruiting, 2 not yet recruiting, 2 recruiting. 11 Phase 1, 1 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 11 | Completed 5, Active not recruiting 2, Not yet recruiting 2, Recruiting 2 |
| Phase 2 | 1 | Active not recruiting 1 |
Follow vorasidenib: new trials by email Literature Review of vorasidenib trials Research Report on vorasidenib
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 Multicenter Safety and Immunogenicity Window-of-opportunity Phase 1 Interventional Trial Assessing the Combination of IDH1 Vaccine (IDH1-vac) and Vorasidenib in Adult Patients With Recurrent IDH1R132H-mutant Astrocytoma, Grade 2 - 4 (iVOCAL) IDH1R132H-vac, Vorasidenib 40 mg Oral Tablet, Aldara - Imiquimod 5% - Recurrent IDH1R132H-mutant Astrocytoma, Grade 2 - 4 | Phase 1 | Not yet recruiting | Heidelberg University | 45 | 2027-01-01 | 2026-10-16 |
| VorAsidenib With Lomustine In Patients With rEcurrent IDH-mutaNT Glioma Harboring IDH1 and/or IDH2 Mutations Vorasidenib, Lomustine - Recurrent Glioma, IDH-mutant Gliomas | Phase 1 | Not yet recruiting | Megan Mantica | 36 | 2026-11-30 | 2026-10-22 |
| Pharmacokinetic Study of Vorasidenib in Severe Hepatically Impaired and Matched-Control Participants Vorasidenib 20mg - Severe Hepatic Impairment, Normal Hepatic Function | Phase 1 | Recruiting | Institut de Recherches Internationales Servier (I.R.I.S.) | 20 | 2026-04-23 | 2026-06-05 |
| A Drug-drug Interaction Study of Vorasidenib and a Combined Oral Contraceptive in Healthy Female Participants Vorasidenib, DRSP/EE - Healthy Adult Female Participants | Phase 1 | Completed | Institut de Recherches Internationales Servier (I.R.I.S.) | 28 | 2025-11-05 | 2026-05-12 |
| Drug-drug Interaction Study of Vorasidenib With Bupropion, Repaglinide, Flurbiprofen, Omeprazole, Midazolam, and Rosuvastatin in Healthy Adult Participants Vorasidenib, Bupropion, Flurbiprofen - Healthy Adult Participants | Phase 1 | Completed | Institut de Recherches Internationales Servier (I.R.I.S.) | 28 | 2025-10-07 | 2026-02-17 |
| ViCToRy: Vorasidenib in Combination With Tumor Specific Peptide Vaccine for Recurrent IDH1 Mutant Lower Grade Gliomas PEPIDH1M vaccine + vorasidenib - Low Grade Glioma of Brain | Phase 1 | Recruiting | Katy Peters, MD, PhD | 48 | 2025-07-15 | 2026-08-24 |
| Vorasidenib in Combination With Temozolomide (TMZ) in IDH-mutant Glioma Vorasidenib, Temozolomide (TMZ) - IDH1-mutant Glioma, IDH2-mutant Glioma | Phase 1 / Phase 2 | Active not recruiting | Institut de Recherches Internationales Servier | 51 | 2025-01-22 | 2026-07-08 |
| A Phase 1, Open-Label Study to Evaluate the Effect of a Low-Fat Meal and Multiple Doses of Ciprofloxacin on the Pharmacokinetics of Vorasidenib in Healthy Subjects Vorasidenib 40 mg Oral Tablet, Ciprofloxacin 500 mg Oral Tablet, Vorasidenib 10 mg Oral Tablet - Healthy Subjects | Phase 1 | Completed | Servier Bio-Innovation LLC | 64 | 2023-04-14 | 2025-02-14 |
| A Study of Vorasidenib in Participants With Moderate or Mild Hepatic Impairment and Matched Participants With Normal Hepatic Function Vorasidenib - Hepatic Impairment | Phase 1 | Completed | Institut de Recherches Internationales Servier | 16 | 2023-03-14 | 2024-02-08 |
| Study of Vorasidenib and Pembrolizumab Combination in Recurrent or Progressive IDH-1 Mutant Glioma Vorasidenib, Pembrolizumab - Astrocytoma, Oligodendroglioma | Phase 1 | Active not recruiting | Institut de Recherches Internationales Servier | 60 | 2023-01-20 | 2026-03-12 |
| A Study to Evaluate AG-881 in Healthy Japanese and Non-Asian Participants AG881 - Healthy Volunteers | Phase 1 | Completed | Agios Pharmaceuticals, Inc. | 32 | 2019-10-02 | 2020-04-02 |
Astrocytoma (2) · Glioma (2) · Brain Neoplasms (1) · Oligodendroglioma (1)
Institut de Recherches Internationales Servier (3) · Institut de Recherches Internationales Servier (I.R.I.S.) (3) · Agios Pharmaceuticals, Inc. (1) · Heidelberg University (1) · Katy Peters, MD, PhD (1) · Megan Mantica (1) · Servier Bio-Innovation LLC (1)
United States (8) · United Kingdom (3) · Austria (1) · China (1) · France (1) · Germany (1) · Israel (1) · Italy (1) · Japan (1) · Netherlands (1) · Spain (1)
Katherine Peters, MD, PhD (1) · Megan Mantica, MD (1) · Michael Platten, Prof. Dr. med. (1)