Trial intelligence / Profile preview

Vorasidenib + Temozolomide in IDH-mutant Glioma

NCT06478212Phase 2

Key facts

Status: Active, not recruiting
Start: Jan 2025
Primary completion: Nov 2027
Countries: 11
Sponsor: Servier
Modality: Small Molecules

Drugs: vorasidenib
Conditions: glioma

Overview

Phase 2, open-label trial of vorasidenib in glioma (2 arms), sponsored by Servier. Primary endpoints: Dose-limiting toxicities at 28 days, Adverse Events up to 3 years and 1 more. Started Jan 2025; status: active, not recruiting.

Design

2 arms

Study design: Non-randomizedOpen-label

Phase 1b
Vorasidenib + Temozolomide (dose finding)
Phase 2
Vorasidenib (RCD) + Temozolomide

Who it enrols

Participants must be >=12 years old, weigh >=40 kg, have IDH1- or IDH2-mutant glioma, adequate organ function, and KPS >=70. Excludes those with prior IDH inhibitor therapy, significant cardiac disease, or active uncontrolled infections.

Endpoints

Primary

Dose-limiting toxicities28 days
Adverse Eventsup to 3 years
Progression-free Survival status at 12 months12 months

Secondary

Progression-free Survivalup to 3 years
Overall Survivalup to 3 years
Objective Response Rateup to 3 years
Clinical Benefit Rateup to 3 years
Pharmacokinetic Parametersup to 13 cycles

Beyond the preview

Go deeper on NCT06478212.

Full results, competitive context and analysis are in the Gosset platform.

Full results & analysis

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on NCT06478212.