Vorasidenib Maintenance for IDH Mutant Astrocytoma
Recruiting
Phase 3
Interventional Study
IDH-mutant Grade 2 or 3 Astrocytoma
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 468 (estimated)
- Sponsor
- European Organisation for Research and Treatment of Cancer - EORTC · Research network
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About This Trial
The main goal of VIGOR is to demonstrate that vorasidenib maintenance therapy improves locally assessed progression-free survival (PFS) from enrolment compared to placebo in patients with IDH-mutant, CNS5 WHO Grade 2 or 3 astrocytoma following the completion of first-line chemoradiotherapy.
The primary endpoint is Progression-free survival (PFS), as assessed locally from the date of enrolment usi…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Before participant's enrolment, written informed consent must be given according to ICH/GCP, and national/local regulations.
* Age ≥ 18 years
* Integrated diagnosis of astrocytoma, IDH-mutant, WHO CNS5 grade 2 or 3, per local assessment
* Documented IDH1 or IDH2 mutation based…
Contacts