Summary

Eligibility
for people ages 12 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

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.

Official Title

A Phase 1b/2, Multicenter Study of Vorasidenib in Combination With Temozolomide (TMZ) in Participants With IDH1- or IDH2-mutant Glioma

Keywords

IDH1-mutant Glioma, IDH2-mutant Glioma, IDH-mutant glioma, IDH mutation, vorasidenib, S95032, Phase 1/2, pediatric, Glioma, Temozolomide, Temozolomide (TMZ), Vorasidenib and Temozolomide (TMZ)

Eligibility

Locations

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Institut de Recherches Internationales Servier
ID
NCT06478212
Phase
Phase 1/2 Glioma Research Study
Study Type
Interventional
Participants
Expecting 42 study participants
Last Updated