Actively Recruiting
A Study of Mirdametinib in People With Central Nervous System Tumors
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-05-13
26
Participants Needed
7
Research Sites
182 weeks
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
S
SpringWorks Therapeutics, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Study of Mirdametinib in People With Central Nervous System Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be older than 18 years of age
- Have Karnofsky Performance Status of 70% or higher, or ECOG Performance Status of 2 or less
- Able to understand and provide written informed consent or have a legal representative do so
- Adequate bone marrow function with ANC >1500/mm3, platelet count >100,000/mm3, and hemoglobin >9.0 mg/dL
- Adequate liver function with total bilirubin ≤1.5 times upper limit of normal (ULN) or baseline, AST and ALT ≤3 times ULN or baseline
- Adequate kidney function with creatinine clearance ≥50 mL/min
- Adequate heart function with left ventricular ejection fraction >50% and QTc interval <480 ms
- Women of childbearing potential must have negative pregnancy test before therapy
- Patients with prior or concurrent malignancy not interfering with safety or efficacy assessment
- Recovery from acute toxicities of prior radiotherapy to grade 1 or less
- For Neurohistiocytosis cohort: documented or suspected MAPK pathway mutation, confirmed or consistent histiocytic neoplasm, and measurable neurohistiocytic disease
- For Glioma cohort: somatic or germline NF1 mutation, histologically confirmed glioma, measurable enhancing disease on MRI, recurrent or progressive disease with prior treatment, surgery indicated but not urgent, expected survival over 3 months
You will not qualify if you...
- Pregnant or nursing
- Participating in another interventional study concurrently
- Received tumor-directed therapy within 28 days or 5 half-lives before starting mirdametinib
- Using medications that strongly induce CYP3A
- History of allergic reaction to mirdametinib or similar compounds
- Serious active infections (unless fever-free for at least 48 hours)
- Uncontrolled or severe medical conditions
- Significant active cardiac disease within 6 months before treatment
- Significant active eye disease within 6 months before treatment
- Conditions or therapies that could interfere with study results or participation
- For Neurohistiocytosis cohort only: documented driver mutations outside the MAPK pathway
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (Limited protocol activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Rockville Centre, New York, United States, 11570
Actively Recruiting
Research Team
A
Anna Piotrowski, MD
CONTACT
E
Eli Diamond, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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