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NCT05566795 · ClinicalTrials.gov registry record · Phase 3
DAY101 vs. Standard of Care Chemotherapy in Pediatric Participants With Low-Grade Glioma Requiring First-Line Systemic Therapy (LOGGIC/FIREFLY-2)
A Phase 3 study of Low Grade Glioma and Rapidly Accelerated Fibrosarcoma (RAF) Altered Glioma, sponsored by Day One Biopharmaceuticals.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 400
- Enrollment target
- 20
- Study locations
NCT05566795: Recruiting Phase 3 study of Low Grade Glioma and Rapidly Accelerated Fibrosarcoma (RAF) Altered Glioma, sponsored by Day One Biopharmaceuticals.
NCT05566795 is a Phase 3 study of Low Grade Glioma and Rapidly Accelerated Fibrosarcoma (RAF) Altered Glioma that is actively recruiting participants, run by Day One Biopharmaceuticals. The registered enrollment target is 400 participants, above the 96-participant average among 23 other Low Grade Glioma trials with a reported enrollment target (317% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05566795, a Phase 3 study of Low Grade Glioma and Rapidly Accelerated Fibrosarcoma (RAF) Altered Glioma, is actively recruiting participants, sponsored by Day One Biopharmaceuticals.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 400 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
ORR assessed per Response Assessment in Pediatric Neuro Oncology (RAPNO) criteria by Independent Review Committee (IRC), and defined as the proportion of participants with overall confirmed response of complete response (CR), partial response (PR), or minor response (MR).
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 |
What NCT05566795 shows while recruiting
NCT05566795 is an interventional study that assigns participants to a tested intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, above the 96-participant average among 23 other Low Grade Glioma trials with a reported enrollment target (317% higher).
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.
NCT05566795 names 20 study sites across 13 states, led by California, Florida, Illinois.
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.
What interventions are being tested in trial NCT05566795?
The interventions under investigation include: Tovorafenib (DRUG), Chemotherapeutic Agent (DRUG).
Who is sponsoring clinical trial NCT05566795?
This trial is sponsored by Day One Biopharmaceuticals, which has 5 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT05566795's enrollment target sits among peer trials
400 1st of 23 higher than 23 of 23 other Low Grade Glioma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Low Grade Glioma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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