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NCT06478212 · ClinicalTrials.gov registry record · Phase 1
Vorasidenib in Combination With Temozolomide (TMZ) in IDH-mutant Glioma
A Phase 1 study of IDH1-mutant Glioma and IDH2-mutant Glioma, sponsored by Institut de Recherches Internationales Servier.
- Active
- Registry status
- Phase 1
- Development phase
- 51
- Enrollment target
- 20
- Study locations
NCT06478212 is a Phase 1 study of IDH1-mutant Glioma and IDH2-mutant Glioma that is active but no longer recruiting, run by Institut de Recherches Internationales Servier. The registered enrollment target is 51 participants. The trial reports 20 study locations across 8 states.
The verdict
NCT06478212, a Phase 1 study of IDH1-mutant Glioma and IDH2-mutant Glioma, is active but no longer recruiting, sponsored by Institut de Recherches Internationales Servier.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 51 participants
- Enrollment target
- 20
- Study locations
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 Studied
Interventions
- DRUG Temozolomide (TMZ)
- DRUG Vorasidenib
Study Locations (20)
Other
- Medical University of Vienna - AKH - Vienna
- Beijing Tiantan Hospital, Capital Medical University - Beijing
- Huashan Hospital, Fudan University - Shanghai
- Hôpital Pierre Wertheimer - Lyon
- Hôpital Pitié-Salpêtrière - Paris
- IUCT-Oncopole Institut Universitaire du Cancer - Toulouse
- Universitätsklinikum Heidelberg - Heidelberg
- Medizinische Fakultät Mannheim, Universität Heidelberg - Mannheim
- Universitätsklinikum Regensburg - Regensburg
- The Tel Aviv Sourasky Medical Center (TASMC) (Ichilov Hospital) - Tel Aviv
- IOV - Ospedale Busonera - Padua
- Ospedale Molinette - Centro Oncologico Ematologico - Turin
- Kumamoto University Hospital - Kumamoto
California
- University of California Los Angeles - Los Angeles
Florida
- University of Miami - Miami
Massachusetts
- Dana Farber Cancer Institute - Boston
New York
- Memorial Sloan Kettering Cancer Center - New York
North Carolina
- Duke University Medical Center - Durham
Texas
- MD Anderson Cancer Center - Houston
Milan
- Instituto Clinico Humanitas IRCCS - Rozzano
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2025-01-22 |
| Est. Completion | 2028-06 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06478212
The ClinicalTrials.gov registry entry for NCT06478212 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Institut de Recherches Internationales Servier, which has 27 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with IDH1-mutant Glioma appearing as the primary indexed condition, and to 2 interventions - of which Temozolomide (TMZ) is the first listed.
NCT06478212 reports 20 study locations spanning 8 distinct geographic areas - top geographies include Other, California, Florida.
Frequently Asked Questions
What is clinical trial NCT06478212 about?
NCT06478212 is a clinical study titled "Vorasidenib in Combination With Temozolomide (TMZ) in IDH-mutant Glioma". 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 s...
What is the current status of trial NCT06478212?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 51 participants. The study started on 2025-01-22. Estimated completion is 2028-06.
What conditions does trial NCT06478212 study?
This clinical trial studies the following conditions: IDH1-mutant Glioma, IDH2-mutant Glioma.
What interventions are being tested in trial NCT06478212?
The interventions under investigation include: Temozolomide (TMZ) (DRUG), Vorasidenib (DRUG).
Who is sponsoring clinical trial NCT06478212?
This trial is sponsored by Institut de Recherches Internationales Servier, which has 27 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06478212 being conducted?
This trial has 20 study locations across California, Florida, Massachusetts, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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