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NCT07286292

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

StatusRecruiting
PhasePhase 2
Primary completion (estimated)
Track this trial

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Record History

All 4 versions: 4 with changes below. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 40 words
    • Primary endpoints: details revised at 1 of 16 entries
    • Trial sites expanded: 5 → 8 locations
  2. Trial sites expanded: 1 → 5 locationsv3
  3. Recruitment opened
    • Start date changed from estimate of Mar 15, 2026 to Jul 23, 2026
    • Study sites: 0 to 1
    v2
  4. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

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
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)
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)
Change from C1D1 to the worst on-treatment value of leutenizing hormone (LH)
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 from C1D1 to the worst on-treatment value of follicle-stimulating hormone (FSH)
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 from C1D1 to the worst on-treatment value of anti-Müllerian hormone (AMH)
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 from C1D1 to the worst on-treatment value of estradiol
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 from C1D1 to the worst on-treatment value of testosterone
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 from C1D1 to the worst on-treatment value of Insulin-like growth factor 1 (IGF-1)
Timeframe: Cycle 1 Day 1 (C1D1) (each cycle is 28 days long)
Change from C1D1 to the worst on-treatment value of Insulin-Like Growth Factor-Binding Protein 3 (IGFBP-3)
Timeframe: Cycle 1 Day 1 (C1D1) (each cycle is 28 days long)
Change from C1D1 to the worst on-treatment value of thyroid stimulating hormone (TSH)
Timeframe: Cycle 1 Day 1 (C1D1) (each cycle is 28 days long)
Change from C1D1 to the worst on-treatment value of Free T4 (thyroxine)
Timeframe: Cycle 1 Day 1 (C1D1) (each cycle is 28 days long)
Change from C1D1 to the worst on-treatment hand/wrist bone age as determined by X-ray
Timeframe: From start of treatment through long-term follow-up (approximately 5 years per participant for a total study duration of approximately 7 years)

Secondary (9)

Progression-free survival (PFS)
Objective response (OR)
Best overall response of complete response (CR), partial response (PR), or minor response (mR)
Time to response (TTR)
Time to CR, PR, or mR
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Duration of response (DoR)
Duration of CR, PR, or mR
Plasma concentration of vorasidenib
Plasma concentration of AGI-69460

Arms and interventions

Open Label VorasidenibExperimental

Drugs: Vorasidenib

Sites

8 sites in 3 countries

United States 6, Australia 1, Canada 1