OncoMatch/Clinical Trials/NCT06188741
Selumetinib for the Prevention of Plexiform Neurofibroma Growth in NF Type 1
Is NCT06188741 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Selumetinib for neurofibromatosis 1.
Treatment: Selumetinib — Plexiform neurofibromas (PN) are known to cause significant morbidity in children with NF1. The recent FDA approval for selumetinib in children 2 years and older with inoperable symptomatic PN was based on the finding that selumetinib shrinks the majority of PN in children with NF1 and results in clinically meaningful benefit such as improvement in pain or range of motion. However, many morbidities, such as blindness or nerve damage, cannot be fully reversed with PN shrinkage. Therefore, there remains a critical need in this patient population to determine if young participants with PN in high-risk locations may benefit from early medical intervention prior to the development of clinical problems. This study will determine whether participants with asymptomatic PN in high-risk locations can potentially benefit from early treatment with selumetinib.
Check if I qualifyExtracted eligibility criteria
Prior therapy
Cannot have received: MEK inhibitor (selumetinib)
Prior treatment with selumetinib or another specific MEK1/2 inhibitor
Cannot have received: chemotherapy
Ongoing radiation therapy, chemotherapy, hormonal therapy directed at a tumor, immunotherapy, or biologic therapy
Cannot have received: biologic therapy
Ongoing radiation therapy, chemotherapy, hormonal therapy directed at a tumor, immunotherapy, or biologic therapy
Cannot have received: immunotherapy
Ongoing radiation therapy, chemotherapy, hormonal therapy directed at a tumor, immunotherapy, or biologic therapy
Cannot have received: hormonal therapy
Ongoing radiation therapy, chemotherapy, hormonal therapy directed at a tumor, immunotherapy, or biologic therapy
Cannot have received: radiation therapy
Ongoing radiation therapy, chemotherapy, hormonal therapy directed at a tumor, immunotherapy, or biologic therapy
Cannot have received: investigational agent
Use of an investigational agent within the past 30 days
Lab requirements
Blood counts
Absolute neutrophil count ≥1200/µL, hemoglobin ≥9g/dL, and platelets ≥100,000/µL (without transfusions)
Kidney function
Creatinine clearance or radioisotope GFR ≥60ml/min/1.73 m2 or a normal serum creatinine based on age
Liver function
Bilirubin within 1.5 x the upper limit of normal for age, with the exception of those with Gilbert syndrome, and AST/ALT within ≤ 3 x upper limit of normal.
Cardiac function
Normal ejection fraction (ECHO or cardiac MRI) ≥ 53% (or the institutional normal; if a range is given then the upper value of the range will be used). EKG with QTC or QTcF ≤450 msec.
Hematologic Function: Absolute neutrophil count ≥1200/µL, hemoglobin ≥9g/dL, and platelets ≥100,000/µL (without transfusions). Hepatic Function: Bilirubin within 1.5 x the upper limit of normal for age, with the exception of those with Gilbert syndrome, and AST/ALT within ≤ 3 x upper limit of normal. Renal Function: Creatinine clearance or radioisotope GFR ≥60ml/min/1.73 m2 or a normal serum creatinine based on age. Cardiac Function: Normal ejection fraction (ECHO or cardiac MRI) ≥ 53% (or the institutional normal; if a range is given then the upper value of the range will be used). EKG with QTC or QTcF ≤450 msec.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Childrens of Alabama · Birmingham, Alabama
- Children's Hospital of Los Angeles · Los Angeles, California
- Children's National Hospital · Washington D.C., District of Columbia
- Lurie Children's Hospital of Chicago · Chicago, Illinois
- University of Chicago · Chicago, Illinois
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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