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NCT04201457 · ClinicalTrials.gov registry record · Phase 1
A Trial of Dabrafenib, Trametinib and Hydroxychloroquine for Patients With Recurrent LGG or HGG With a BRAF Aberration
A Phase 1 study of Low Grade Glioma (LGG) of Brain With BRAF Aberration and High Grade Glioma (HGG) of the Brain With BRAF Aberration, sponsored by Pediatric Brain Tumor Consortium.
- Active
- Registry status
- Phase 1
- Development phase
- 57
- Enrollment target
- 15
- Study locations
NCT04201457: Active Phase 1 study of Low Grade Glioma (LGG) of Brain With BRAF Aberration and High Grade Glioma (HGG) of the Brain With BRAF Aberration, sponsored by Pediatric Brain Tumor Consortium.
NCT04201457 is a Phase 1 study of Low Grade Glioma (LGG) of Brain With BRAF Aberration and High Grade Glioma (HGG) of the Brain With BRAF Aberration that is active but no longer recruiting, run by Pediatric Brain Tumor Consortium. The registered enrollment target is 57 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. The trial reports 15 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04201457, a Phase 1 study of Low Grade Glioma (LGG) of Brain With BRAF Aberration and High Grade Glioma (HGG) of the Brain With BRAF Aberration, is active but no longer recruiting, sponsored by Pediatric Brain Tumor Consortium.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 57 participants
- Enrollment target
- 15
- Study locations
Study Summary
This phase I/II trial is designed to study the side effects, best dose and efficacy of adding hydroxychloroquine to dabrafenib and/or trametinib in children with low grade or high grade brain tumors previously treated with similar drugs that did not respond completely (progressive) or tumors that came back while receiving a similar agent (recurrent). Patients must also have specific genetic mutations including BRAF V600 mutations or BRAF fusion/duplication, with or without neurofibromatosis type 1. Neurofibromatosis type 1 is an inherited genetic condition that causes tumors to grow on nerve tissue. Hydroxychloroquine, works in different ways to stop the growth of tumor cells by killing the cells or stopping them from dividing. Trametinib and dabrafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving hydroxychloroquine with trametinib and/or dabrafenib may lower the chance of brain tumors growing or spreading compared to usual treatments.
Primary Outcome
Testing the safety/tolerability of adding HCQ to Dabrafenib + Trametinib or to Trametinib
Conditions Studied
Interventions
- DRUG Trametinib
- DRUG Dabrafenib
- DRUG Hydroxychloroquine
Study Locations (15)
California
- Children's Hospital Los Angeles - Los Angeles
- Lucile Packard Children's Hospital at Stanford University Medical Center - Palo Alto
Ohio
- Cincinnati Children Hospital Medical Center - Cincinnati
- Nationwide Children's Hospital - Columbus
Arizona
- Phoenix Children's Hospital - Phoenix
Colorado
- Children's Hospital Colorado - Aurora
District of Columbia
- Children's National Medical Center - Washington D.C.
Florida
- University of Florida - Gainesville
Georgia
- Children's Healthcare of Atlanta - Atlanta
Illinois
- Lurie Children's Hospital-Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2020-01-17 |
| Est. Completion | 2026-03-31 |
| Phase | Phase 1 |
What the registry record for NCT04201457 still lists
NCT04201457 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 3 conditions, with Low Grade Glioma (LGG) of Brain With BRAF Aberration appearing as the primary indexed condition, and to 3 interventions - of which Trametinib is the first listed.
NCT04201457 lists 15 locations in 13 states (California, Ohio, Arizona).
Frequently Asked Questions
What is clinical trial NCT04201457 about?
NCT04201457 is a clinical study titled "A Trial of Dabrafenib, Trametinib and Hydroxychloroquine for Patients With Recurrent LGG or HGG With a BRAF Aberration". This phase I/II trial is designed to study the side effects, best dose and efficacy of adding hydroxychloroquine to dabrafenib and/or trametinib in children with low grade or high grade brain tumors previously treated with similar drugs that did not respond completely (progressive) or tumors that ca...
What is the current status of trial NCT04201457?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 57 participants. The study started on 2020-01-17. Estimated completion is 2026-03-31.
What conditions does trial NCT04201457 study?
This clinical trial studies the following conditions: Low Grade Glioma (LGG) of Brain With BRAF Aberration, High Grade Glioma (HGG) of the Brain With BRAF Aberration, Low Grade Glioma of Brain With Neurofibromatosis Type 1.
What interventions are being tested in trial NCT04201457?
The interventions under investigation include: Trametinib (DRUG), Dabrafenib (DRUG), Hydroxychloroquine (DRUG).
Who is sponsoring clinical trial NCT04201457?
This trial is sponsored by Pediatric Brain Tumor Consortium, which has 27 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04201457 being conducted?
This trial has 15 study locations across Arizona, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04201457's enrollment target sits among peer trials
57 901st of 2000 higher than 1,099 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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