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NCT04923126 · ClinicalTrials.gov registry record · Phase 1
SJ901: Evaluation of Mirdametinib in Children, Adolescents, and Young Adults With Low-Grade Glioma
A Phase 1 study of Low Grade Glioma and Recurrent Low Grade Glioma, sponsored by St. Jude Children's Research Hospital.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 132
- Enrollment target
- 1
- Study location
NCT04923126: Recruiting Phase 1 study of Low Grade Glioma and Recurrent Low Grade Glioma, sponsored by St. Jude Children's Research Hospital.
NCT04923126 is a Phase 1 study of Low Grade Glioma and Recurrent Low Grade Glioma that is actively recruiting participants, run by St. Jude Children's Research Hospital. The registered enrollment target is 132 participants, above the 108-participant average among 23 other Low Grade Glioma trials with a reported enrollment target (22% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04923126, a Phase 1 study of Low Grade Glioma and Recurrent Low Grade Glioma, is actively recruiting participants, sponsored by St. Jude Children's Research Hospital.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 132 participants
- Enrollment target
- 1
- Study location
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).
Primary Outcome
The maximum tolerated dose (MTD) is empirically defined as the highest dose level at which six patients have been treated with at most one patient experiencing a dose-limiting toxicity (DLT) and the next higher dose level determined to be too toxic. The MTD estimate will not be available if the lowest dose level studied is too toxic or the highest dose level studied is considered safe. In the latter case, the highest studied safe dose may be considered as the recommended phase 2 dose (RP2D). The
Conditions Studied
Interventions
- DRUG Mirdametinib
Study Locations (1)
Tennessee
- St. Jude Children's Research Hospital - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2021-06-21 |
| Est. Completion | 2031-06 |
| Phase | Phase 1 |
What NCT04923126 shows while recruiting
NCT04923126 is an interventional study that assigns participants to a tested intervention. The registered 132 participants enrollment target is mid-sized for trials with a published cap, above the 108-participant average among 23 other Low Grade Glioma trials with a reported enrollment target (22% higher).
The record links to 3 conditions, with Low Grade Glioma appearing as the primary indexed condition, and to 1 intervention - of which Mirdametinib is the first listed.
NCT04923126 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT04923126 about?
NCT04923126 is a clinical study titled "SJ901: Evaluation of Mirdametinib in Children, Adolescents, and Young Adults With Low-Grade Glioma". 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).
What is the current status of trial NCT04923126?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 132 participants. The study started on 2021-06-21. Estimated completion is 2031-06.
What conditions does trial NCT04923126 study?
This clinical trial studies the following conditions: Low Grade Glioma, Recurrent Low Grade Glioma, Progressive Low-Grade Glioma.
What interventions are being tested in trial NCT04923126?
The interventions under investigation include: Mirdametinib (DRUG).
Who is sponsoring clinical trial NCT04923126?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04923126 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Low Grade Glioma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04923126's enrollment target sits among peer trials
132 7th of 23 higher than 17 of 23 other Low Grade Glioma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Low Grade Glioma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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