NCT06478212

Vorasidenib in Combination With Temozolomide (TMZ) in IDH-mutant Glioma

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
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Institut de Recherches Internationales Servier · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to determine the safety and tolerability of vorasidenib in combination with temozolomide (TMZ) and to establish the recommended combination dose (RCD) of vorasidenib. The study will begin as a Phase Ib study to determine the RCD and then will transition to a Phase II study to assess the clinical efficacy of vorasidenib at the RCD in combination with TMZ. During the treatment period participants will have study visits on day 1 and 22 of each cycle, with additional visits occurring during the first cycle of the Phase 1b study. Approximately 30 days after treatment has ended, a safety follow-up visit will occur and then participants will be followed for survival every 3 months. Study visits may include questionnaires, blood tests, ECG, vital signs, and a physical examination.

Conditions

• IDH1-mutant Glioma
• IDH2-mutant Glioma

Interventions

Type	Name	Description
DRUG	Vorasidenib	To be taken by mouth once daily in 28-day cycles with no break between cycles
DRUG	Temozolomide (TMZ)	To be taken by mouth once daily for the first 5 days of each 28-day cycle, for a maximum of 12 cycles

Timeline

• Start date: 2025-01-22
• Primary completion: 2027-11-01
• Completion: 2028-06-01
• First posted: 2024-06-27
• Last updated: 2026-04-06

Locations

28 sites across 11 countries: United States, Austria, China, France, Germany, Israel, Italy, Japan, Netherlands, Spain, United Kingdom

Regulatory

• FDA-regulated drug study