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

Sponsor
Institut de Recherches Internationales Servier (I.R.I.S.)
Study ID
NCT07286292
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Grade 2 Astrocytoma or Oligodendroglioma With an IDH1 or IDH2 Mutation

Eligibility Criteria

Sex
ALL
Age
12 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Vorasidenib — DRUG
    40mg taken orally daily for participants weighing ≥ 40 kg OR 20mg taken orally daily for participants weighing ≥ 25 kg to \< 40 kg

Study Details

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.

Key Dates

Start date
Mar 15, 2026
Status verified
Dec 2025
Primary completion
May 2, 2033
Completion
May 2, 2033

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Open Label Vorasidenib

Primary Outcome Measure

Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Events (AEs) leading to discontinuation, or Adverse Events (AEs) leading to death [ Time Frame: From start of treatment through 28 days after last dose for AEs (Safety follow-up), study-related SAEs will be reported through long-term follow-up (approximately 5 years per participant for a total study duration of approximately 7 years) ]

Central Contacts

  • Institut de Recherches Internationales Servier (I.R.I.S.)
    +33 1 55 72 60 00
    [email protected]