Vorasidenib Study in Pediatric Participants With Grade 2 Astrocytoma or Oligodendroglioma With an IDH1 or IDH2 Mutation

Recruiting Phase 2 Interventional Study
Grade 2 Astrocytoma or Oligodendroglioma With an IDH1 or IDH2 Mutation
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
12 – 17
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
10 (estimated)
Sponsor
Institut de Recherches Internationales Servier (I.R.I.S.) · Industry
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About This Trial
The objective of this study is to evaluate the safety, tolerability, efficacy profile, and effect on growth and development of vorasidenib in pediatric participants aged 12 to \< 18 years old with grade 2 glioma with an IDH1 or IDH2 mutation. The study includes a screening period, a treatment period consisting of continuous 28-day cycles of treatment, a safety follow-up period and a long-term foll…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Weigh ≥ 25 kg at Screening. * Written informed consent/assent must be obtained from a legally authorized representative, and assent must be obtained from the participant in accordance with local regulations. Participants and their families must be willing and able to comply wi…
Contacts

Institut de Recherches Internationales Servier (I.R.I.S.)

+33 1 55 72 60 00

scientificinformation@servier.com

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