Regorafenib for Recurrent Meningioma (MIRAGE Trial)

Inclusion Criteria: * Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted * Patients capable of taking oral medication * Subject is willing and able to adhere to the study visit schedule and other protocol requirements. * Histological diagnosis of meningioma according to the WHO 2021 classification * Radiologically documented progression of any existing tumor with an estimated planar growth \>25% (bidirectional) in the last 12 months or appearance of new lesions * Ineligible for further surgery and/or radiotherapy * at least 1 Measurable lesion (minimum 10 x 10mm) on baseline MRI * Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1 (or KPS ³70) * Male or female ≥ 18 years of age * Subjects must have life expectancy of at least 6 months * Paraffin-embedded tumor tissue available (mandatory) * Dosage of dexamethasone or equivalent steroid within 7 days prior the randomization ≤4mg/die * Stable or decreasing dosage of steroids for 7 days prior to the randomization. * Adequate cardiac function and adequate liver, renal and hematological function * Subject must have the following laboratory values at screening within 14 days before starting Regorafenib: * Absolute neutrophil count (ANC) ≥ 1.5 x 109/L without growth factor support for 7 days (14 days if subject received pegfilgrastim). * Hemoglobin (Hgb) ≥10 g/dL * Platelet count (plt) ≥100x 109/L * Serum potassium concentration within normal …