Ignite Creation Date:
2024-07-17 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06478212
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-06-17
Brief Title:
Vorasidenib in Combination With Temozolomide TMZ in IDH-mutant Glioma
Sponsor:
Institut de Recherches Internationales Servier
Organization:
Servier
Study Overview
Official Title:
A Phase 1b2 Multicenter Study of Vorasidenib in Combination With Temozolomide TMZ in Participants With IDH1- or IDH2-mutant Glioma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT05592743
Has Expanded Access, NCT# Status:
AVAILABLE
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None