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NCT04775485 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate Tovorafenib in Pediatric and Young Adult Participants With Relapsed or Progressive Low-Grade Glioma and Advance Solid Tumors
A Phase 2 study of Advanced Solid Tumor and Low Grade Glioma, sponsored by Day One Biopharmaceuticals.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 141
- Enrollment target
- 20
- Study locations
NCT04775485 is a Phase 2 study of Advanced Solid Tumor and Low Grade Glioma that is actively recruiting participants, run by Day One Biopharmaceuticals. The registered enrollment target is 141 participants, below the 192-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (27% lower). The trial reports 20 study locations across 16 states.
The verdict
NCT04775485, a Phase 2 study of Advanced Solid Tumor and Low Grade Glioma, is actively recruiting participants, sponsored by Day One Biopharmaceuticals.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 141 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Phase 2, multi center, open-label study to evaluate the safety and efficacy of Type II RAF (tovorafenib) in pediatric participants with low-grade glioma or advanced solid tumors. Qualifying genomic alterations will be identified through molecular assays as routinely performed at Clinical Laboratory Improvement Amendments (CLIA) of 1988 or other similarly certified laboratories prior to enrollment into any of the arms. The study will consist of a screening period, a treatment period, a long-term extension phase, end of treatment (EOT) visit(s), a safety follow-up visit, and long-term follow-up assessments.
Conditions Studied
Interventions
- DRUG Tovorafenib
Study Locations (20)
Other
- Queensland Children's Hospital - Brisbane
- Royal Children's Hospital - Parkville
- Perth Children's Hospital - Perth
- Sydney Children's Hospital - Randwick
- The Children's Hospital at Westmead - Westmead
California
- UCSF Benioff Children's Hospital - San Francisco
District of Columbia
- Children's National Medical Center - Washington D.C.
Illinois
- Lurie Children's Hospital of Chicago - Chicago
Maryland
- Johns Hopkins Hospital - Baltimore
Massachusetts
- Dana-Farber Cancer Institute - Boston
Michigan
- CS Mott Children's Hospital - Ann Arbor
Missouri
- St. Louis Children's Hospital - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 141 participants |
| Start Date | 2021-04-22 |
| Est. Completion | 2027-05-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04775485
The ClinicalTrials.gov registry entry for NCT04775485 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 141 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 192-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (27% lower). The listed sponsor is Day One Biopharmaceuticals, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Advanced Solid Tumor appearing as the primary indexed condition, and to 1 intervention - of which Tovorafenib is the first listed.
NCT04775485 reports 20 study locations spanning 16 distinct geographic areas - top geographies include Other, California, District of Columbia.
Frequently Asked Questions
What is clinical trial NCT04775485 about?
NCT04775485 is a clinical study titled "A Study to Evaluate Tovorafenib in Pediatric and Young Adult Participants With Relapsed or Progressive Low-Grade Glioma and Advance Solid Tumors". This is a Phase 2, multi center, open-label study to evaluate the safety and efficacy of Type II RAF (tovorafenib) in pediatric participants with low-grade glioma or advanced solid tumors. Qualifying genomic alterations will be identified through molecular assays as routinely performed at Clinical L...
What is the current status of trial NCT04775485?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 141 participants. The study started on 2021-04-22. Estimated completion is 2027-05-31.
What conditions does trial NCT04775485 study?
This clinical trial studies the following conditions: Advanced Solid Tumor, Low Grade Glioma.
What interventions are being tested in trial NCT04775485?
The interventions under investigation include: Tovorafenib (DRUG).
Who is sponsoring clinical trial NCT04775485?
This trial is sponsored by Day One Biopharmaceuticals, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04775485 being conducted?
This trial has 20 study locations across California, District of Columbia, Illinois, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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