A Study of Mirdametinib in People With Central Nervous System Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Cohorts A and B
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 authorized representative may consent on behalf of a subject who is otherwise unable to provide informed consent, if acceptable to and approved by the institutional review board.
Absolute neutrophil count (ANC) >1,500/mm3
Disqualifiers
Is pregnant or nursing
Is participating in another interventional study at the same time; participation in non-therapeutic registries is allowed
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
Trial design
Design model
Parallel
Treatments tested in this trial
Mirdametinib
DrugMirdametinib is a highly selective and potent, non-ATP-competitive oral inhibitor of MEK1 and MEK2 kinases
Treatment groups
26 Participants
are divided into 3 treatment groupsGroup A: Cohort A: MirdametinibExperimental treatment 1 intervention
Group B: Cohort B: Perioperative mirdametinibExperimental treatment 1 intervention
Group C: Cohort B: No perioperative mirdametinibNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Best overall neurologic response rate
To determine the best overall neurologic response rate
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Memorial Sloan Kettering Cancer Center
Lead sponsor
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Collaborator
Source ClinicalTrials.gov