drugset / Trial / NCT07629089
VorAsidenib With Lomustine In Patients With rEcurrent IDH-mutaNT Glioma Harboring IDH1 and/or IDH2 Mutations
Phase 1
Not yet recruiting
24 enrolled
Megan Mantica
Institut de Recherches Internationales Servier · collab
NaSingle-groupOpen-labelTreatment
Summary
This study will test the hypothesis that vorasidenib in combination with lomustine will be safe and tolerable. The overall goal of this study is to identify the optimal vorasidenib dose that can be tested in a subsequent phase 2 study to determine the efficacy of vorasidenib in combination with lomustine in patients with recurrent IDH mutant gliomas.
Timeline
- Start
- 2026-06-30
- Primary completion
- 2030-06-30
- Completion
- 2035-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vorasidenib | Small molecule | 10 mg | Oral |
| Subject | Vorasidenib | Small molecule | 20 mg | Oral |
| Subject | Vorasidenib | Small molecule | 40 mg | Oral |
| Background | Lomustine | Small molecule | 110 mg/m2 | Oral |