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 range12 Years – 17 Years

SexALL

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…

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)

Average age of menarche

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 range12 Years – 17 Years

SexALL

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)

Average age of menarche

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