This study investigates the safety and effects of an investigational medication in children with high-grade gliomas, a type of brain tumor that is difficult to treat. High-grade gliomas are classified as WHO grade III or IV tumors, which are aggressive and fast-growing. The study focuses on pediatric patients who have already undergone radiation therapy and are experiencing tumor recurrence or persistence.
Participants in this study will receive either the investigational medication or a placebo, which is an inactive substance that looks like the investigational medicine but does not contain any medicine. The study will assess how well the investigational medication is tolerated and whether it affects the tumor's growth rate after 6 months.
- Who can participate: Children with relapsed or refractory high-grade glioma, who have had radiation therapy, can participate. They need measurable disease, good organ function, and cannot be pregnant or breastfeeding.
- Study details: Participants will take the investigational medication or a placebo. An inactive substance that looks like the investigational medicine but does not contain any medicine. They must be able to swallow tablets and will need to provide tumor tissue samples for analysis.
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