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Efficacy of Mirdametinib Alone or Combination With Radiotherapy for Germline and Sporadic NF1-Altered High-Grade Glioma

Study acronym: NF118
StatusNot Yet Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later Aug 1, 2030 → Jan 1, 2031
See other at-risk trials from University of Alabama at Birmingham

Record History

  1. Start date: Aug 1, 2026 to Jan 1, 2027 Primary completion pushed from Aug 1, 2030 to Jan 1, 2031 · Completion pushed from Aug 1, 2031 to Jan 1, 2032 · Eligibility criteria expanded, about 62 words · 1 more Show 4 more changesShow less
    • Primary completion pushed from Aug 1, 2030 to Jan 1, 2031
    • Completion pushed from Aug 1, 2031 to Jan 1, 2032
    • Eligibility criteria expanded, about 62 words
    • Collaborators: details revised at 1 of 2 entries
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a phase 2, open label, parallel multi-arm study of mirdametinib in combination with radiation in participants with recurrent sporadic glioblastoma (GBM) harboring NF1 alterations (Cohort 1); participants with NF1 with a newly diagnosed GBM (Cohort 2); mirdametinib alone in other NF1-associated High-Grade Gliomas (Cohort 3).
Trial Details
NCT Number NCT07521657
Lead Sponsor University of Alabama at Birmingham
Collaborators: Children's Hospital of Philadelphia, Congressionally Directed Medical Research Programs
Conditions Neurofibromatosis 1 (NF1)
Enrollment 55 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov