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

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 Performance Score and LPPS \< 70 due to functional limitations as a result of prior surgical resections or due to the anatomical location of the tumor will be permitted.
• •Have adequate bone marrow function as evidenced by:
• •Absolute neutrophil count ≥ 1500/mm3 or ≥ 1.5 × 109/L
• •Hemoglobin ≥ 9 g/dL
• •Platelets ≥ 100,000/mm3 or ≥ 100 × 109/L
• •Have adequate hepatic function as evidenced by:
• •Serum total bilirubin ≤ 1.5 × ULN; if \> 1.5 ULN and due to Gilbert syndrome, total bilirubin ≤ 3 × ULN with direct bilirubin ≤ ULN
• •AST at or below ULN and ALT at or below ULN
• •Alkaline phosphatase (ALP) ≤ 2.5 × ULN
• •Have adequate renal function as evidenced by:
• •Serum creatinine ≤ 2.5 × ULN, OR
• •eGFR \> 40 mL/min/1.73 m2 based on the Bedside Schwartz method 0.413 × (Height in cm/Serum Creatinine in mg/dL)
• •Have recovered from any clinically relevant toxicities associated with any prior surgery for the treatment of glioma unless stabilized under medical management (functional limitations as a result of prior surgical resections or due to the anatomical location of the tumor will be permitted).
• •Female participants of reproductive potential must have a negative serum pregnancy test before starting investigational medicinal product (IMP).
• •Women of childbearing potential as well as fertile male participants with female partners of reproductive potential, must agree to abstain from sexual intercourse or to use 2 effective methods of contraception from screening until at least 90 days after the last dose of IMP.