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DAY101 vs. Standard of Care Chemotherapy in Pediatric Participants With Low-Grade Glioma Requiring First-Line Systemic Therapy (LOGGIC/FIREFLY-2)
NCT05566795 · View on ClinicalTrials.gov ↗
Study Summary
This is a 2-arm, randomized, open-label, multicenter, global, Phase 3 trial to evaluate the efficacy, safety, and tolerability of tovorafenib monotherapy versus standard of care (SoC) chemotherapy in participants with pediatric low-grade glioma (LGG) harboring an activating rapidly accelerated fibrosarcoma (RAF) alteration requiring first-line systemic therapy.
Conditions Studied
Interventions
- DRUG Tovorafenib
- DRUG Chemotherapeutic Agent
Study Locations (20)
California
- Children's Hospital Los Angeles — Los Angeles
- Children's Hospital of Orange County Main Campus - Orange — Orange
- Packard Children's Hospital Stanford — Palo Alto
- UCSF Benioff Children's Hospital — San Francisco
Florida
- University of Florida Health — Gainesville
- Nicklaus Children's Hospital — Miami
- Arnold Palmer Hospital for Children — Orlando
- Johns Hopkins All Children's Hospital — St. Petersburg
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago
- University of Chicago — Chicago
Alabama
- Children's of Alabama — Birmingham
Arizona
- Phoenix Children's Hospital — Phoenix
Colorado
- Children's Hospital Colorado — Aurora
Connecticut
- Connecticut Children's Medical Center — Hartford
District of Columbia
- Children's National Medical Center — Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2023-02-27 |
| Est. Completion | 2031-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05566795
The ClinicalTrials.gov registry entry for NCT05566795 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Day One Biopharmaceuticals, which has 30 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Low-grade Glioma appearing as the primary indexed condition, and to 2 interventions — of which Tovorafenib is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05566795 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, Florida, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05566795 about?
NCT05566795 is a clinical study titled "DAY101 vs. Standard of Care Chemotherapy in Pediatric Participants With Low-Grade Glioma Requiring First-Line Systemic Therapy (LOGGIC/FIREFLY-2)". This is a 2-arm, randomized, open-label, multicenter, global, Phase 3 trial to evaluate the efficacy, safety, and tolerability of tovorafenib monotherapy versus standard of care (SoC) chemotherapy in participants with pediatric low-grade glioma (LGG) harboring an activating rapidly accelerated fibro...
What is the current status of trial NCT05566795?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 400 participants. The study started on 2023-02-27. Estimated completion is 2031-06.
What conditions does trial NCT05566795 study?
This clinical trial studies the following conditions: Low-grade Glioma, Rapidly Accelerated Fibrosarcoma (RAF) Altered Glioma, Pediatric Low-grade Glioma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05566795?
The interventions under investigation include: Tovorafenib (DRUG), Chemotherapeutic Agent (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05566795?
This trial is sponsored by Day One Biopharmaceuticals, which has 30 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05566795 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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