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Trametinib and Everolimus for Treatment of Pediatric and Young Adult Patients With Recurrent Gliomas (PNOC021)
NCT04485559 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04485559
The ClinicalTrials.gov registry entry for NCT04485559 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francis, which has 1,574 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04485559 reports 17 study locations spanning 15 distinct geographic areas — top geographies include California, Alabama, District of Columbia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04485559?
The interventions under investigation include: Everolimus (DRUG), Trametinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04485559?
This trial is sponsored by University of California, San Francis, which has 1,574 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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