OncoMatch/Clinical Trials/NCT04485559
Trametinib and Everolimus for Treatment of Pediatric and Young Adult Patients With Recurrent Gliomas (PNOC021)
Is NCT04485559 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1 trial studies multiple treatments including Everolimus and Trametinib for recurrent world health organization (who) grade ii glioma.
Treatment: Everolimus · Trametinib — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Cancer type
Glioblastoma
Demographics
Prior therapy
Must have received: anticancer therapy (biologic, chemotherapy, or radiation therapy)
recurrent or progressive after prior treatment (biologic, chemotherapy or radiation therapy)
Cannot have received: MEK inhibitor in combination with mTOR inhibitor
Participants that have received prior therapy with a MEK inhibitor in combination with an mTOR inhibitor
Lab requirements
Blood counts
Peripheral absolute neutrophil count (ANC) >= 1000/mm^3 (unsupported); Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment); Hemoglobin >= 8 m/dL (may be supported); INR <= 1.5
Kidney function
Creatinine clearance or radioisotope GFR >= 70 mL/min/1.73 m^2 or a serum creatinine based on age/gender
Liver function
Bilirubin (sum of conjugated + unconjugated) <= 1.5 x ULN for age; Serum glutamate pyruvate transaminase (SGPT) alanine aminotransferase (ALT) <= 3 x ULN; Serum albumin >= 2 g/dL
Cardiac function
Corrected QT (QTc) interval <= 450 msecs; Left ventricular ejection fraction (LVEF) >= 50%
See inclusion criteria: ANC >= 1000/mm^3, Platelet count >= 100,000/mm^3, Hemoglobin >= 8 m/dL, INR <= 1.5, Creatinine clearance or radioisotope GFR >= 70 mL/min/1.73 m^2 or a serum creatinine based on age/gender, Bilirubin <= 1.5 x ULN for age, ALT <= 3 x ULN, Albumin >= 2 g/dL, Sodium, potassium, calcium and magnesium within 1.5 x institutional LLN or ULN, cholesterol < 350 mg/dL, triglycerides < 400 mg/dL, QTc <= 450 msecs, LVEF >= 50%, Pulse Ox > 93% on room air
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Alabama at Birmingham, Children's of Alabama · Birmingham, Alabama
- Children's Hospital Los Angeles · Los Angeles, California
- University of California, San Diego Rady Children's Hospital · San Diego, California
- University of California, San Francisco · San Francisco, California
- Children's National Medical Center · Washington D.C., District of Columbia
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT04485559 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior MEK inhibitor in combination with mTOR inhibitor disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 25 years or younger and at least 1 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages