DAY101 vs. Chemotherapy for Pediatric Brain Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines a new treatment called tovorafenib (also known as DAY101) for children and young adults with low-grade glioma, a specific type of brain tumor. Researchers aim to determine if tovorafenib is more effective and safer than standard chemotherapy treatments. Participants must have a confirmed diagnosis of this tumor type with an activating RAF alteration. This trial is for individuals who have not yet begun any systemic cancer treatment. As a Phase 3 trial, it represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking treatment advancements.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does exclude those who have had prior or ongoing nonsurgical anticancer therapy for this condition.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have shown that tovorafenib is generally well-tolerated. Research indicates that children taking tovorafenib may experience slower growth, but the treatment remains safe. The FDA has approved tovorafenib for treating certain brain tumors in children, confirming its safety for those cases. This approval provides additional confidence in its safety.12345
Why do researchers think this study treatment might be promising for brain cancer?
Researchers are excited about Tovorafenib because it offers a new approach to treating pediatric brain cancer. Unlike traditional chemotherapy, which attacks rapidly dividing cells indiscriminately, Tovorafenib specifically targets a mutated protein called BRAF, which is involved in cell growth and division. This targeted mechanism may lead to fewer side effects and improved effectiveness. By honing in on the root cause of certain brain tumors, Tovorafenib has the potential to revolutionize treatment options and improve outcomes for young patients.
What evidence suggests that this trial's treatments could be effective for pediatric low-grade glioma?
Research shows that tovorafenib, a new medication, holds promise for treating a specific brain tumor in children called low-grade glioma (LGG) with certain genetic changes. In earlier studies, about 46% of children who took tovorafenib experienced tumor shrinkage within three months. The U.S. FDA has approved tovorafenib for treating some children with low-grade glioma, indicating confidence in its effectiveness. In this trial, participants will receive either tovorafenib or the investigator's choice of standard chemotherapy. These findings suggest that tovorafenib could be a promising treatment option for children with this type of brain cancer.12456
Are You a Good Fit for This Trial?
This trial is for children and young adults under 25 with a type of brain tumor called low-grade glioma that has a specific genetic change (RAF alteration). They should have a measurable tumor but can't have had any previous cancer treatments like chemo or radiation, and shouldn't have certain other medical conditions or additional genetic changes in their tumors.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either tovorafenib monotherapy or standard of care chemotherapy. Treatment cycles repeat every 28 days until disease progression, unacceptable toxicity, or withdrawal.
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants may continue therapy beyond progressive disease if deemed beneficial
What Are the Treatments Tested in This Trial?
Interventions
- Chemotherapeutic Agent
- DAY101
Chemotherapeutic Agent is already approved in United States for the following indications:
- Pediatric low-grade glioma with BRAF gene mutations
Find a Clinic Near You
Who Is Running the Clinical Trial?
Day One Biopharmaceuticals, Inc.
Lead Sponsor
SIOPe Brain Tumor Group LOGGIC Consortium
Collaborator