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NCT03919071 · ClinicalTrials.gov registry record · Phase 2
Dabrafenib Combined With Trametinib After Radiation Therapy in Treating Patients With Newly-Diagnosed High-Grade Glioma
A Phase 2 study of Glioblastoma and Malignant Glioma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 58
- Enrollment target
- 20
- Study locations
NCT03919071: Active Phase 2 study of Glioblastoma and Malignant Glioma, sponsored by National Cancer Institute (NCI).
NCT03919071 is a Phase 2 study of Glioblastoma and Malignant Glioma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 58 participants, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (47% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03919071, a Phase 2 study of Glioblastoma and Malignant Glioma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 58 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial studies how well the combination of dabrafenib and trametinib works after radiation therapy in children and young adults with high grade glioma who have a genetic change called BRAF V600 mutation. Radiation therapy uses high energy rays to kill tumor cells and reduce the size of tumors. Dabrafenib and trametinib may stop the growth of tumor cells by blocking BRAF and MEK, respectively, which are enzymes that tumor cells need for their growth. Giving dabrafenib with trametinib after radiation therapy may work better than treatments used in the past in patients with newly-diagnosed BRAF V600-mutant high-grade glioma.
Primary Outcome
The EFS curve for the new treatment cohort (stratum 1) will be estimated by Kaplan Meier estimates. A 2-sample, 1 sided log-rank test will be used to test whether the EFS distribution is better in new treatment compared with historical control. Calculation of the EFS will be based on the site determination as central review will be performed retrospectively.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Lumbar Puncture
- PROCEDURE Magnetic Resonance Imaging
- RADIATION Radiation Therapy
- DRUG Dabrafenib Mesylate
Study Locations (20)
California
- Kaiser Permanente Downey Medical Center - Downey
- Loma Linda University Medical Center - Loma Linda
- Miller Children's and Women's Hospital Long Beach - Long Beach
- Children's Hospital Los Angeles - Los Angeles
- Cedars Sinai Medical Center - Los Angeles
- Kaiser Permanente-Oakland - Oakland
- Children's Hospital of Orange County - Orange
- Lucile Packard Children's Hospital Stanford University - Palo Alto
- University of California Davis Comprehensive Cancer Center - Sacramento
- UCSF Medical Center-Mission Bay - San Francisco
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center - Torrance
Arizona
- Banner Children's at Desert - Mesa
- Phoenix Childrens Hospital - Phoenix
Connecticut
- Connecticut Children's Medical Center - Hartford
- Yale University - New Haven
Alabama
- Children's Hospital of Alabama - Birmingham
Arkansas
- Arkansas Children's Hospital - Little Rock
Colorado
- Children's Hospital Colorado - Aurora
Delaware
- Alfred I duPont Hospital for Children - Wilmington
District of Columbia
- MedStar Georgetown University Hospital - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2020-02-20 |
| Est. Completion | 2027-09-30 |
| Phase | Phase 2 |
What the registry record for NCT03919071 still lists
NCT03919071 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (47% lower).
The record links to 8 conditions, with Glioblastoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT03919071 names 20 study sites across 8 states, led by California, Arizona, Connecticut.
Frequently Asked Questions
What is clinical trial NCT03919071 about?
NCT03919071 is a clinical study titled "Dabrafenib Combined With Trametinib After Radiation Therapy in Treating Patients With Newly-Diagnosed High-Grade Glioma". This phase II trial studies how well the combination of dabrafenib and trametinib works after radiation therapy in children and young adults with high grade glioma who have a genetic change called BRAF V600 mutation. Radiation therapy uses high energy rays to kill tumor cells and reduce the size of ...
What is the current status of trial NCT03919071?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 58 participants. The study started on 2020-02-20. Estimated completion is 2027-09-30.
What conditions does trial NCT03919071 study?
This clinical trial studies the following conditions: Glioblastoma, Malignant Glioma, Anaplastic Astrocytoma, WHO Grade 3 Glioma, WHO Grade 4 Glioma.
What interventions are being tested in trial NCT03919071?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Lumbar Puncture (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Radiation Therapy (RADIATION), Dabrafenib Mesylate (DRUG).
Who is sponsoring clinical trial NCT03919071?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03919071 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03919071's enrollment target sits among peer trials
58 80th of 199 higher than 119 of 199 other Glioblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioblastoma 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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