Not Yet RecruitingPhase 2

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

10 participantsStarted 2026-03-15

Plain-language summary

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.

Who can participate

Age range

12 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 with the scheduled visits, treatment plans, procedures, and laboratory tests, including serial peripheral blood sampling, during the study. * Have Grade 2 astrocytoma or oligodendroglioma per World Health Organisation (WHO) 2021 criteria. * Have had at least 1 prior surgery for glioma (biopsy, sub-total resection, gross-total resection) and no other prior anticancer therapy, including chemotherapy and radiotherapy, and do not need immediate chemotherapy or radiotherapy in the opinion of the Investigator. * Have: * Confirmed IDH1 or IDH2 gene mutation, as well as known 1p19q and/or ATRX (Alpha Thalassemia/Mental Retardation Syndrome X-linked) status based on local testing of tumor tissue by an accredited laboratory. * For astrocytoma: Absence of 1p19q co-deletion and/or documented loss of nuclear ATRX expression or ATRX mutation by local testing. * For oligodendroglioma: Presence of 1p19q co-deletion by local testing. * Have magnetic resonance imaging (MRI)-evaluable, measurable, non-enhancing disease * Have a Karnofsky Performance Score (KPS; for participants ≥ 16 years of age) or Lansky Play-Performance Scale (LPPS; for participants \< 16 years of age) score of ≥ 70. Karnofsky Perfo…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Events (AEs) leading to discontinuation, or Adverse Events (AEs) leading to death

Timeframe: 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)

Severity of AEs

Height and Weight Percentiles at Study Visits

Timeframe: From start of treatment through long-term follow-up (approximately 5 years per participant for a total study duration of approximately 7 years)

Change in Height and Weight Percentiles from Cycle 1 Day 1 (C1D1)

Timeframe: From start of treatment through long-term follow-up (approximately 5 years per participant for a total study duration of approximately 7 years)

Tanner staging

Timeframe: From start of treatment through long-term follow-up (approximately 5 years per participant for a total study duration of approximately 7 years)

Trial details

NCT IDNCT07286292

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

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2033-05-02

Contact for this trial

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

+33 1 55 72 60 00 scientificinformation@servier.com

View on ClinicalTrials.gov More Grade 2 Astrocytoma or Oligodendroglioma With an IDH1 or IDH2 Mutation trials

Plain-language summary

Who can participate

Age range

12 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Events (AEs) leading to discontinuation, or Adverse Events (AEs) leading to death

Severity of AEs

Height and Weight Percentiles at Study Visits

Timeframe: From start of treatment through long-term follow-up (approximately 5 years per participant for a total study duration of approximately 7 years)

Change in Height and Weight Percentiles from Cycle 1 Day 1 (C1D1)

Timeframe: From start of treatment through long-term follow-up (approximately 5 years per participant for a total study duration of approximately 7 years)

Tanner staging

Timeframe: From start of treatment through long-term follow-up (approximately 5 years per participant for a total study duration of approximately 7 years)