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Phase II open-label global study to evaluate the effect of dabrafenib in combination with trametinib in children and adolescent patients with BRAF V600 mutation positive Low Grade Glioma (LGG) or relapsed or refractory High Grade Glioma (HGG)

Study on Investigational Medications for Glioma with BRAF V600 Mutation

Recruiting
1-17 years
All
Phase N/A

This study investigates the use of investigational medications in children and adolescents with a specific type of brain tumor called glioma. Glioma is a type of tumor that occurs in the brain and spinal cord. The study focuses on patients who have a BRAF V600 mutation, which is a change in the gene that can affect cell growth. The study is looking at two types of glioma: low grade glioma (LGG) and high grade glioma (HGG) that has come back or is not responding to treatment.

Participants in the study will receive either the investigational medications or a placebo. A placebo is an inactive substance that looks like the investigational medicine but does not contain any medicine. The study will assess the safety and effects of these treatments on the tumors.

  • Who can participate: Children and adolescents with glioma and a BRAF V600 mutation can participate. They must have relapsed or unresponsive tumors or progressive disease, without prior similar treatments or recent cancer therapies.
  • Study details: Participants will receive either the investigational medications or a placebo. The study will monitor the safety and effects of these treatments on the tumors.
Study details
    Zanthiastrocytoma
    Rosette-forming Glioneurona Tumor
    Glioma
    Astrocytoma
    Iponeurocytoma
    Gangliocytoma
    High Grade Glioma
    Glioblastoma
    BRAF mutation
    Papillary Glioneuronal Tumor
    Oligodenroglioma
    Low Grade Glioma
    Neurocytoma

TX8998

19 February 2024

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