FindTrial
Sign In

A Phase 1b/2, multicenter study of vorasidenib in combination with temozolomide (TMZ) in participants with IDH1- or IDH2-mutant glioma

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-513738-39-00
Acronym
S095032-211
Enrollment
17
Registered
2025-02-24
Start date
2025-03-18
Completion date
Unknown
Last updated
2025-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IDH1-mutant Glioma, IDH2-mutant Glioma

Brief summary

DLTs (for Phase 1b only), incidence and severity of AEs, SAEs, and AESIs, Progression-free Survival (PFS) status at 12 months

Detailed description

PFS, OS, OR, and clinical benefit (CR+ PR+SD), Plasma concentrations and PK parameters of vorasidenib and its metabolite AGI-69460 and TMZ

Interventions

DRUGTemozolomide Accord 5 mg hard capsules.
DRUGTemozolomide ratiopharm 20 mg
DRUGcapsules
DRUGhard
DRUGTemozolomide ratiopharm 250 mg
DRUGTemozolomide SUN 100 mg hard capsules
DRUGTemozolomide SUN 180 mg hard capsules
DRUGTemozolomide Accord 140 mg hard capsules.
DRUGTEMOZOLOMIDE VIATRIS 180 mg
DRUGgélule
DRUGTemozolomide ratiopharm 180 mg
DRUGTemozolomide SUN 5 mg hard capsules
DRUGTEMOZOLOMIDE VIATRIS 140 mg
DRUGTemozolomide Accord 20 mg hard capsules
DRUGTemozolomide Accord 180 mg hard capsules.
DRUGS95032/AG-881
DRUGTEMOZOLOMIDE VIATRIS 250 mg
DRUGTemozolomide ratiopharm 100 mg
DRUGTemozolomide ratiopharm 5 mg
DRUGTemozolomide SUN 20 mg hard capsules
DRUGTemozolomide SUN 140 mg hard capsules
DRUGTemozolomide ratiopharm 140 mg
DRUGTemozolomide Accord 250 mg hard capsules.
DRUGTEMOZOLOMIDE VIATRIS 5 mg
DRUGTemozolomide SUN 250 mg hard capsules
DRUGTemozolomide Accord 100 mg hard capsules.
DRUGTEMOZOLOMIDE VIATRIS 20 mg
DRUGTEMOZOLOMIDE VIATRIS 100 mg

Sponsors

Institut De Recherches Internationales Servier IRIS
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
DLTs (for Phase 1b only), incidence and severity of AEs, SAEs, and AESIs, Progression-free Survival (PFS) status at 12 months—

Secondary

MeasureTime frame
PFS, OS, OR, and clinical benefit (CR+ PR+SD), Plasma concentrations and PK parameters of vorasidenib and its metabolite AGI-69460 and TMZ—

Countries

Austria, France, Germany, Italy, Netherlands, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026