Design schema for clinical trial.
tumor, midline glioma, abemaciclib, high-grade glioma, PD, high-grade, cortical high-grade glioma
TUMOR
This protocol is an open-label single-armed study of the investigational off-label use of abemaciclib in recurrent high-grade and diffuse midline glioma and on-label use of temozolomide in recurrent high-grade and diffuse midline glioma for maintenance therapy. This is a safety and feasibility study to evaluate tumor pharmacokinetics (PK) and pharmacodynamics (PD) of abemaciclib in recurrent high-grade glioma and DMG participants in need of surgical resection or biopsy respectively. As such, two cohorts will be evaluated, 2 participants with cortical high-grade glioma and 3 participants with DMG.