DAY101 Monotherapy Versus Standard Of Care Chemotherapy In Patients With Pediatric Low-Grade Glioma Harboring An Activating RAF Alteration Requiring First-Line Systemic Therapy
Summary
The purpose of this study is to evaluate if DAY101 is safe, well-tolerated and how well it works compared to SoC chemotherapy in treating children, adolescent, and young adult patients with low-grade gliomas with RAF alteration.
Eligibility
Eligible gender: Male, Female, Transgender, Other
Inclusion criteria:
Inclusion Criteria:
1. Less than 25 years of age with LGG with known activating RAF alteration
2. Histopathologic diagnosis of glioma or glioneuronal tumor
3. At least one measurable lesion as defined by RANO criteria
4. Meet indication for first-line systemic therapy
5. Additional criteria will be evaluated by the physician to ensure that you are eligible for the study
Exclusion criteria:
Exclusion Criteria:
1. Patient has any of the following tumor-histological findings:
Schwannoma
Subependymal giant cell astrocytoma (Tuberous Sclerosis)
Diffuse intrinsic pontine glioma, even if histologically diagnosed as World Health Organization (WHO) Grade I-II
2. Patient's tumor has additional activating molecular alterations
3. Known or suspected diagnosis of neurofibromatosis Type 1 or 2 (NF-1/NF-2)
4. Prior or ongoing nonsurgical anticancer therapy for this indication (eg, chemotherapy, oral/intravenous targeted therapy) including radiation
Participate
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Additional information
Contact information
Dr. Lucie Lafay-Cousin Pediatric Oncologist, Alberta Children's Hospital Professor of Pediatrics and Oncology University of Calgary, Faculty of Medicine Phone: 403-955-2554 E-mail lucie.lafay-cousin@ahs.ca
Principal investigator:
Lucie Lafay-Cousin
Clinical trial:
Yes
REB-ID:
HREBA.CC-22-0359