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
Qualifiers
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
Treatments tested in this trial
- Mirdametinib
Treatment groups
26 Participants
are divided into 3 treatment groupsSponsors and collaborators
Memorial Sloan Kettering Cancer Center
Lead sponsor
SpringWorks Therapeutics, Inc.
Collaborator
Source ClinicalTrials.gov