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SJ901: Study of Mirdametinib as a Treatment for Children, Adolescents and Young Adults with Low-Grade Glioma

About this study

Pediatric low-grade glioma tumors are the most common central nervous system tumor in children. Treatments typically include surgery, observation, chemotherapy (anti-cancer medicine) or radiation. If the tumor is in an area where it is safe to remove, the neurosurgeon will attempt to remove as much as possible.

SJ901 is a study of an experimental drug called mirdametinib. It is experimental because it has not been approved by the U.S. Food and Drug Administration. Mirdametinib belongs to a class of drugs called MEK inhibitors. It has been used in children and adults, but there is a lot we do not know about it yet. We are using mirdametinib because it is in a drug class that seems to be effective in treating low-grade glioma. It is also available in a liquid form, which allows patients who cannot swallow to take the drug.

This study will be done in two parts, or phases. Phase 1 will determine the highest dose of mirdametinib that can be taken safely. During this phase, we will also look to see how well the drug is working in young patients. Phase 2 will see how well tumors respond to the drug.

You may or may not benefit from taking part in this study. However, information learned from this study may help future patients with low-grade glioma tumors.

Eligibility overview

  • At least 2 years old and younger than 25 years old
  • Diagnosis of progressive or relapsed low-grade glioma

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.


Full title:

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

Study goal:

The main goal of this study is to test the experimental drug mirdametinib in hopes of finding a treatment that may be effective against low-grade glioma brain tumors in children, adolescents and young adults.


Low-grade glioma


At least 2 years old and younger than 25 years old.

SJ901 Overview: Insights from the Principal Investigator

Giles Robinson, MD, discusses the rationale for using the MEK inhibitor mirdametinib to target brain tumors in children, adolescents and young adults with low-grade gliomas. 

A Study of MEK Inhibitor Mirdametinib for Low-Grade Glioma  

Eligibility for SJ901

For physicians and researchers

Patients accepted to St. Jude must be referred by a physician or other qualified medical professional. Learn how St. Jude can partner with you to care for your patient.


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