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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 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.

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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.

Conditions Studied

High Grade Glioma Low Grade Glioma Recurrent World Health Organization (WHO) Grade II Glioma

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

FieldValue
Enrollment Target 50 participants
Start Date 2020-12-09
Est. Completion 2027-12-31
Phase Phase 1

Sponsor

University of California, San Francisco

1,713 total trials

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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, categorized as Phase 1. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 65-participant average among 42 other High Grade Glioma trials with a reported enrollment target (23% lower). The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.

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 reports 17 study locations spanning 15 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.