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NCT04485559 · ClinicalTrials.gov registry record · Phase 1
Trametinib and Everolimus for Treatment of Pediatric and Young Adult Patients With Recurrent Gliomas (PNOC021)
A Phase 1 study of High Grade Glioma and Low Grade Glioma, sponsored by University of California, San Francisco.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
- 17
- Study locations
NCT04485559: Recruiting Phase 1 study of High Grade Glioma and Low Grade Glioma, sponsored by University of California, San Francisco.
NCT04485559 is a Phase 1 study of High Grade Glioma and Low Grade Glioma that is actively recruiting participants, run by University of California, San Francisco. The registered enrollment target is 50 participants, below the 65-participant average among 42 other High Grade Glioma trials with a reported enrollment target (23% lower). The trial reports 17 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04485559, a Phase 1 study of High Grade Glioma and Low Grade Glioma, is actively recruiting participants, sponsored by University of California, San Francisco.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
- 17
- Study locations
Study Summary
This phase I trial studies the side effects and best dose of trametinib and everolimus in treating pediatric and young adult patients with gliomas that have come back (recurrent). Trametinib acts by targeting a protein in cells called MEK and disrupting tumor growth. Everolimus is a drug that may block another pathway in tumor cells that can help tumors grow. Giving trametinib and everolimus may work better to treat low and high grade gliomas compared to trametinib or everolimus alone.
Primary Outcome
We will employ the Bayesian optimal interval (BOIN) design to find the MTD for both continuous and intermittent dosing schedules. The BOIN design is implemented in a simple way similar to the traditional 3+3 design, but is more flexible and possesses superior operating characteristics that are comparable to those of the more complex model-based designs, such as the continual reassessment method (CRM).
Conditions Studied
Interventions
- DRUG Everolimus
- DRUG Trametinib
Study Locations (17)
California
- Children's Hospital Los Angeles - Los Angeles
- University of California, San Diego Rady Children's Hospital - San Diego
- University of California, San Francisco - San Francisco
Alabama
- University of Alabama at Birmingham, Children's of Alabama - Birmingham
District of Columbia
- Children's National Medical Center - Washington D.C.
Florida
- University of Florida - Gainesville
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago
Indiana
- Riley Hospital for Children - Indianapolis
Maryland
- John Hopkins University - Baltimore
Massachusetts
- Dana Farber Cancer Institute - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2020-12-09 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 1 |
What NCT04485559 shows while recruiting
NCT04485559 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 65-participant average among 42 other High Grade Glioma trials with a reported enrollment target (23% lower).
The record links to 3 conditions, with High Grade Glioma appearing as the primary indexed condition, and to 2 interventions - of which Everolimus is the first listed.
NCT04485559 lists 17 locations in 15 states (California, Alabama, District of Columbia).
Frequently Asked Questions
What is clinical trial NCT04485559 about?
NCT04485559 is a clinical study titled "Trametinib and Everolimus for Treatment of Pediatric and Young Adult Patients With Recurrent Gliomas (PNOC021)". This phase I trial studies the side effects and best dose of trametinib and everolimus in treating pediatric and young adult patients with gliomas that have come back (recurrent). Trametinib acts by targeting a protein in cells called MEK and disrupting tumor growth. Everolimus is a drug that may bl...
What is the current status of trial NCT04485559?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2020-12-09. Estimated completion is 2027-12-31.
What conditions does trial NCT04485559 study?
This clinical trial studies the following conditions: High Grade Glioma, Low Grade Glioma, Recurrent World Health Organization (WHO) Grade II Glioma.
What interventions are being tested in trial NCT04485559?
The interventions under investigation include: Everolimus (DRUG), Trametinib (DRUG).
Who is sponsoring clinical trial NCT04485559?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04485559 being conducted?
This trial has 17 study locations across Alabama, California, District of Columbia, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for High Grade Glioma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04485559's enrollment target sits among peer trials
50 14th of 42 higher than 28 of 42 other High Grade Glioma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other High 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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