Trial purpose
Cancer treatment
Tumor type
Brain and Spinal
Age
0 - 25
Clinical summary
Summary
Approximately 400 treatment-naïve people with low-grade glioma will be randomly allocated (by chance) to one of two treatment arms.
In Arm 1 (Experimental), participants will receive tovorafenib, which is an oral pan-RAF inhibitor.
In Arm 2 (Active Comparator), participants will receive the Investigator's choice of one of the following standard of care chemotherapy regimens:
- Children's Oncology Group - Vincristine/Carboplatin (COG-V/C) regimen
- International Society for Paediatric Oncology - Low-Grade Glioma Vincristine/Carboplatin (SIOPe-LGG-V/C) regimen
- Vinblastine (VBL) regimen
- or monthly Carboplatin.
The choice of chemotherapy regimen will be selected prior to patient randomisation.
Conditions
This trial is treating people with low-grade glioma who have not had prior treatment with a known activating RAF alteration
Eligibility
Inclusion
- Less than 25 years of age with LGG with known activating RAF alteration
- Histopathologic diagnosis of glioma or glioneuronal tumor
- At least one measurable lesion as defined by RANO criteria
- Meet indication for first-line systemic therapy
Inclusion
- You have been diagnosed with cancer, but have not received any treatment.
- You are able to swallow medication by mouth.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:
Trial sponsor
Day One Biopharmaceuticals, Inc.
Scientific Title
A Phase 3, Randomized, International Multicenter Trial of DAY101 Monotherapy Versus Standard of Care Chemotherapy in Patients With Pediatric Low-Grade Glioma Harboring an Activating RAF Alteration Requiring First-Line Systemic Therapy
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