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

NCT04923126 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2026-02-04

No results posted yet for this study

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).

Conditions

  • Low-Grade Glioma
  • Recurrent Low-Grade Glioma
  • Progressive Low-Grade Glioma

Interventions

DRUG

Mirdametinib

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

Sponsors & Collaborators

Principal Investigators

  • Giles W. Robinson, MD · St. Jude Children's Research Hospital

  • Anna Vinitsky, MD, MS · St. Jude Children's Research Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
2 Years
Max Age
24 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-21
Primary Completion
2031-06-30
Completion
2031-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04923126 on ClinicalTrials.gov