A Study of Mirdametinib in People With Central Nervous System Tumors

Conditions

• Central Nervous System Tumors
• Glioma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Mirdametinib — DRUG
  Mirdametinib is a highly selective and potent, non-ATP-competitive oral inhibitor of MEK1 and MEK2 kinases

Study Details

The purpose of this study to find out whether mirdametinib is a safe and effective treatment for Central Nervous System/CNS tumors (glioma and neurohistiocytosis).

Key Dates

Start date

Apr 10, 2026

Status verified

May 2026

Primary completion

Oct 10, 2029

Completion

Oct 10, 2029

Study Design

Enrollment

26 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort A: Mirdametinib
  11 participants with refractory neurohistiocytosis will be treated with mirdametinib in continuous treatment cycles
• Experimental: Cohort B: Perioperative mirdametinib
  15 participants with recurrent NF1-mutant glioma will be randomized in a 2:1 ratio to receive either perioperative mirdametinib (for 5 days) or no drug before standard of care surgery. All 15 participants will be treated with mirdametinib twice daily after surgery, continuously until clinical or radiographic progression of disease
• No Intervention: Cohort B: No perioperative mirdametinib
  15 participants with recurrent NF1-mutant glioma will be randomized in a 2:1 ratio to receive either perioperative mirdametinib (for 5 days) or no drug before standard of care surgery. All 15 participants will be treated with mirdametinib twice daily after surgery, continuously until clinical or radiographic progression of disease

Primary Outcome Measure

Best overall neurologic response rate [ Time Frame: 1 year ]

Central Contacts

• Anna Piotrowski, MD
  212-610-0483
  [email protected]
• Eli Diamond, MD
  212-610-0243
  [email protected]

Locations (7)

Find similar trials in Basking Ridge, NJ

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