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New treatment option for Central Nervous System Tumors
Official title A Study of Mirdametinib in People With Central Nervous System Tumors
ClinicalTrials.gov ID: NCT07539441
What this study is testing
What is Mirdametinib?
Mirdametinib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for central nervous system tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Cohorts A and B Demographic Characteristics a. Be \> 18 years of age General Criteria
- Have Karnofsky Performance Status (KPS) of ≥ 70% or ECOG Performance Status of ≤ 2
- Is able to understand and provide written informed consent for the trial prior to any study-specific procedures and is willing to comply with...
- Have adequate bone marrow function, as determined by:
- Absolute neutrophil count (ANC) \>1,500/mm3
You likely can't join if
- people who meet any of the following criteria will not be enrolled in the study: General criteria
- Is pregnant or nursing
- Is participating in another treatment study at the same time; participation in non-therapeutic registries is allowed Medical and Therapeutic criteria
- Receipt of tumor directed therapy (chemotherapy, targeted therapy, biologic, investigational) within 28 days or 5 half-lives (whichever is shorter)...
- Concomitant use of medications that strongly induce CYP3A
- History of allergic reaction to the study agent(s), compounds of similar chemical or biologic composition to the study agent (s) (or any of its...
See the full eligibility criteria
Who can join
- Cohorts A and B Demographic Characteristics a. Be \> 18 years of age General Criteria
- Have Karnofsky Performance Status (KPS) of ≥ 70% or ECOG Performance Status of ≤ 2
- Is able to understand and provide written informed consent for the trial prior to any study-specific procedures and is willing to comply with scheduled visits, treatment plans, procedures and laboratory tests. A legally...
- Have adequate bone marrow function, as determined by:
- Absolute neutrophil count (ANC) \>1,500/mm3
- Platelet count \>100,000 mm³
- Hemoglobin \>9.0 mg/dL
- Have adequate hepatic function, as determined by:
- Total bilirubin ≤1.5 x ULN if baseline was normal or ≤1.5 x baseline if baseline was abnormal. Patients with previously documented Gilbert's Syndrome may have total bilirubin ≤3 x ULN.
- AST and ALT ≤3.0 x ULN if baseline was normal or ≤3.0 x baseline if baseline was abnormal
- Have adequate renal function, as determined by: o Creatinine clearance (CrCL) of ≥50 mL/min by the Cockcroft-Gault formula CrCl (mL/min) = [140 - age (years)] x weight (kg) x 0.85 for female patients 72 creatinine (mg /...
- Adequate cardiac function defined as follows
- Left ventricular ejection fraction \>50% as assessed by multi-gated acquisition or ultrasound or echocardiography and
- Corrected QT interval (QTc) \<480 ms according to the Fridericia method (QTcF)
- Women of childbearing potential must have a negative serum pregnancy test before the start of therapy.
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible for...
- Patients previously treated with radiotherapy must have recovered from acute toxicities associated with such treatment. Toxicities of investigational therapies should have recovered to grade 1 or less before start of...
- Have documented MAPK pathway mutation, or mutation not identified by tumor sequencing.: Patients with completed but negative tumor sequencing, or patients without sequencing performed but without safe disease sites for...
- Have documentation of disease: Patients must have a histologically confirmed histiocytic neoplasm or a constellation of histologic, radiologic, clinical, and/or molecular findings consistent with histiocytic neoplasm...
- Have measurable neurohistiocytic disease: Patients must have measurable radiologic or functional neurologic disease as defined by any of the following below. The presence of systemic disease is allowed however there...
- Measurable disease according to modified PERCIST (mPERCIST) involving neurologic structures, i.e. meninges, brain or spinal cord parenchyma, or ocular structures (see sections below for these criteria) OR
- Measurable disease according to RECIST 1.1 involving neurologic structures OR
- Any of the below neurologic deficits referable to neurohistiocytosis amenable to longitudinal quantified assessment. The following are the allowable deficits, deemed referable to disease, with their corresponding...
- Dysarthria as defined Speech Intelligibility of B or worse as measured by the Frenchay Dysarthria Scale
- Ataxia as defined by a score of 3 or higher on the Scale for assessment and rating of ataxia (SARA)
- Diplopia as defined by Prism Diopter of 5 or higher
- Loss of visual acuity defined as best corrected visual acuity (BCVA) 20/40 (0.3 LogMAR) or worse in either eye
- Diminished visual field, defined as 20% or higher deficit in Humphrey Visual Field 24-2 pattern deviation. Additional cohort specific - Glioma Cohort B people must meet all of the following criteria to be enrolled in...
- Have: somatic NF1 mutation as per next-generation sequencing (such as MSK Impact) --or- germline NF1 as per NIH clinical criteria
- Have a histologically confirmed glioma (per the 2021 WHO Classification of Tumors of the central nervous system)
- Have measurable, MRI-evaluable, unequivocal contrast enhancing disease as determined by radiologist on T1 post-contrast weighted images. Per RANO criteria, measurable lesion is defined as at least 1 enhancing lesion...
- Have recurrent or progressive disease and received prior treatment with chemotherapy, radiation, or both
- Surgical resection is indicated for treatment, but surgery is not urgently indicated (e.g. for whom surgery within the next 4-6 weeks is appropriate)
- Have expected survival of \> 3 months
What rules you out
- people who meet any of the following criteria will not be enrolled in the study: General criteria
- Is pregnant or nursing
- Is participating in another treatment study at the same time; participation in non-therapeutic registries is allowed Medical and Therapeutic criteria
- Receipt of tumor directed therapy (chemotherapy, targeted therapy, biologic, investigational) within 28 days or 5 half-lives (whichever is shorter) before the first dose of mirdametinib.
- Concomitant use of medications that strongly induce CYP3A
- History of allergic reaction to the study agent(s), compounds of similar chemical or biologic composition to the study agent (s) (or any of its excipients).
- Evidence of serious active infections. Patients are allowed to enroll if they have been fever free for at least 48 hours
- Uncontrolled or severe intercurrent medical condition
- Have significant active cardiac disease within 6 months before the start of treatment, including New York Heart Association Class III or IV congestive heart failure, atrial fibrillation, myocardial infarction, unstable...
- Have significant active ophthalmologic disease within 6 months before the start of treatment, including central retinal vein occlusion
- Has a history of or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or...
- Cohort A only: Patients with documented driver mutations outside of the MAPK pathway are not eligible for this study. These are uncommon and include mutations in ALK, RET, CSF1R, NTRK, and other kinases20 . On Study...
- Cohorts A and B: Patients with cytopenias, renal impairment or hepatic impairment deemed the direct result of disease and therefore amenable to improvement with mirdametinib treatment may be enrolled at the discretion...
- Cohort A: There is no prior therapy requirement given the poor CNS how well it works of standard therapies, morbidity of neurohistiocytosis, and the available data about safety and how well it works in nine patients...
- The effects of mirdametinib on the developing human fetus are unknown. For this reason, female participants of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth...
The study team makes the final eligibility decision.
Where it's taking place
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Rockville Centre, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States; New York, New York, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.