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Vorasidenib for Brain Tumor

Recruiting at 4 trial locations
Id
Overseen ByInstitut de Recherches Internationales Servier (I.R.I.S.)
Age: < 18
Sex: Any
Trial Phase: Phase 2
Sponsor: Institut de Recherches Internationales Servier (I.R.I.S.)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of 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 follow-up period. The long-term follow-up period will assess participants for growth, development, and long-term safety impacts for approximately 5 years after the start of treatment or until Tanner Stage V is reached (whichever is later). Participants may undergo blood tests, heart tests (electrocardiogram (ECG)), imaging (MRI, X-ray), vital sign checks, and physical exams.

Are You a Good Fit for This Trial?

This trial is for children and teens aged 12 to under 18 with grade 2 astrocytoma or oligodendroglioma brain tumors that have an IDH1 or IDH2 mutation. Participants must weigh at least 25 kg, have had surgery but no prior chemo or radiation, and be able to attend regular study visits.

Inclusion Criteria

Participants and their families must be willing and able to comply with scheduled visits, treatment plans, procedures, and laboratory tests, including serial peripheral blood sampling
My astrocytoma does not have a 1p19q co-deletion or has an ATRX loss or mutation.
Have MRI-evaluable, measurable, non-enhancing disease
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Exclusion Criteria

Features assessed as high-risk by Investigator
Pregnant or breastfeeding
Any other acute or chronic medical or psychiatric condition
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What Are the Treatments Tested in This Trial?

Interventions

  • Vorasidenib

Trial Overview

The study tests vorasidenib, a new drug taken in repeating monthly cycles, to see if it is safe and effective for treating certain low-grade brain tumors in young people. The trial includes long-term follow-up on growth and development over about five years.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Open Label VorasidenibExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

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

Lead Sponsor

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