MedTrace Logo

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

NCT06478212 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2026-04-06

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Institut de Recherches Internationales Servier

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-22
Primary Completion
2027-11-30
Completion
2028-06-30
FDA Drug
Yes

Countries

  • United States
  • Austria
  • China
  • France
  • Germany
  • Israel
  • Italy
  • Japan
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06478212 on ClinicalTrials.gov