RecruitingPhase 1Phase 2NCT04923126

SJ901: Evaluation of Mirdametinib in Children, Adolescents, and Young Adults With Low-Grade Glioma

SJ901: Phase 1/2 Evaluation of Single Agent Mirdametinib (PD-0325901), a Brain-Penetrant MEK1/2 Inhibitor, for the Treatment of Children, Adolescents, and Young Adults With Low-Grade Glioma


Sponsor

St. Jude Children's Research Hospital

Enrollment

132 participants

Start Date

Jun 21, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This is an open-label, multi-center, Phase 1/2 study of the brain-penetrant MEK inhibitor, mirdametinib (PD-0325901), in patients with pediatric low-grade glioma (pLGG).


Eligibility

Min Age: 2 YearsMax Age: 24 Years

Plain Language Summary

Simplified for easier understanding

This study is testing mirdametinib, a drug that blocks a specific cell-signaling pathway (MEK), in children, teenagers, and young adults with low-grade glioma — a type of slow-growing brain or spinal cord tumor that is hard to treat with standard therapies. **You may be eligible if:** - You are at least 2 and under 25 years old (Phase 1) or broader age range (Phase 2) - You have a confirmed or suspected low-grade glioma (including certain mixed brain tumors) - Adequate tumor tissue is available for testing - You (and your guardian) are willing and able to give informed consent **You may NOT be eligible if:** - You have known retinal eye problems that could worsen with treatment (such as conditions affecting the macula or retinal vein) - You have a digestive condition that would prevent proper absorption of the drug (such as gastric bypass surgery) - You have known significant liver disease or bile duct problems (except for a harmless condition called Gilbert's syndrome) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMirdametinib

By mouth, nasogastric (NG) tube or gastrostomy tube (G-tube) BID, days 1-28


Locations(1)

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

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NCT04923126


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