What side effects are associated with this type of intervention?

Common treatments for Low Grade Glioma (LGG) include surgery, radiation therapy, and chemotherapy. For treatments targeting the RAF pathway, such as Tovorafenib, side effects may include fatigue, skin rash, diarrhea, and liver enzyme abnormalities. These side effects are consistent with those observed in other targeted therapies that inhibit specific molecular pathways involved in tumor growth.

What prior FDA approvals exist?

There is limited specific information on prior FDA approvals for the treatment of Low Grade Glioma (LGG) focusing on RAF pathway inhibition. However, targeted therapies and inhibitors of related pathways, such as BRAF inhibitors, have been explored in various cancers. For instance, drugs like vemurafenib and dabrafenib, which target BRAF mutations, have shown efficacy in other tumor types and are being investigated for their potential in treating gliomas. Tovorafenib, currently under study, represents a similar approach by targeting RAF pathway alterations in pediatric LGG.

What other types of research exist?

Promising alternatives to Tovorafenib for Low Grade Glioma patients include Bevacizumab, which has shown efficacy in various neuro-oncological conditions, and Everolimus, which has been studied in Phase II trials for neurofibromatosis type 2 and progressive vestibular schwannomas. Additionally, Lapatinib, an EGFR and HER2 inhibitor, has shown potential in treating brain metastases and could be considered for LGG treatment.

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DAY101 vs. Chemotherapy for Pediatric Brain Cancer

Phase 3

Recruiting

Research Sponsored by Day One Biopharmaceuticals, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 60 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing tovorafenib, a medication given alone, in children with a specific type of brain tumor. The drug works by blocking a protein that helps cancer cells grow.

Who is the study for?

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.

What is being tested?

The study compares DAY101, which is an experimental drug, to the standard chemotherapy drugs usually given for this condition. It's designed to see which treatment works better as the first line of attack against these brain tumors in kids and young adults.

What are the potential side effects?

While specific side effects are not listed here, DAY101 and standard chemotherapies can cause various reactions. These might include nausea, fatigue, hair loss, increased risk of infections due to lowered immunity, and possible damage to organs over time.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 60 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 60 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 60 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Compare the objective response rate (ORR) assessed per RANO-LGG criteria by Independent Review Committee (IRC) of tovorafenib monotherapy versus standard of care (SoC) chemotherapy

Secondary study objectives

Compare changes in visual function outcomes of tovorafenib monotherapy versus SoC chemotherapy in patients with optic pathway glioma (OPG)

Compare the DOR of tovorafenib monotherapy versus SoC chemotherapy as assessed by IRC per RAPNO-LGG and RANO-HGG criteria

Compare the ORR of tovorafenib monotherapy versus SoC chemotherapy as assessed by IRC per RANO-HGG and Response Assessment in Pediatric Neuro-Oncology (RAPNO-LGG) criteria

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm #1Experimental Treatment1 Intervention

Tovorafenib

Group II: Arm #2Active Control1 Intervention

Investigator's choice of one of the following current standard of care for pediatric patients with low-grade gliomas: 1. Children's Oncology Group - Vincristine/Carboplatin (COG-V/C) 2. International Society for Paediatric Oncology - Low-Grade Glioma Vincristine/Carboplatin (SIOPe-LGG-V/C) 3. Vinblastine (VBL)

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Low Grade Glioma (LGG) treatments often target specific molecular pathways involved in tumor growth and survival. Tovorafenib, for example, inhibits the RAF pathway, which is crucial in cell division and tumor proliferation. By blocking this pathway, Tovorafenib can potentially halt or slow down tumor growth. Other common treatments include chemotherapy agents like temozolomide, which damages the DNA of cancer cells, leading to cell death, and radiation therapy, which uses high-energy particles to destroy cancer cells. These treatments are significant for LGG patients as they offer targeted approaches to manage tumor growth, potentially improving outcomes and quality of life.