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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT07521657
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Neurofibromatosis 1 (NF1)

Eligibility Criteria

Sex
ALL
Age
12 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • mirdametinib with radiation — COMBINATION_PRODUCT
    Participants in Cohorts 1 and 2 will receive mirdametinib in combination with radiation therapy followed by mirdametinib alone.
  • mirdametinib — DRUG
    Participants in Cohort 3 will receive mirdametinib alone.

Study Details

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).

Key Dates

Start date
Aug 1, 2026
Status verified
Jan 2026
Primary completion
Aug 1, 2030
Completion
Aug 1, 2031

Study Design

Enrollment
55 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: Recurrent, sporadic glioblastoma (not NF1)
    Participants with recurrent sporadic glioblastoma (GBM) harboring NF1 alterations will receive mirdametinib and radiation.
  • Experimental: Cohort 2: New diagnosed glioblastoma with no prior therapy (NF1 participants only)
    NF1 participants with new glioblastoma (GBM) will receive mirdametinib and radiation.
  • Experimental: Cohort 3: HGAP or HGG not meeting criteria for Cohort 2 (NF1 participants only)
    NF1 participants with High-Grade Astrocytoma with Piloid Features (HGAP) or other NF1-associated HGG not meeting criteria for Cohort 2 will receive mirdametinib alone.

Primary Outcome Measure

Cohort 1 [ Time Frame: From treatment to 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Childrens of AlabamaBirminghamAlabama34294
NFCTC Operations Center
[email protected]
205-638-6259
Girish Dhall, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

By research site
Childrens of Alabama· Birmingham, AL

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