At a glance
ClinicalIndex Comparison Record- ✓Histological diagnosis of meningioma according to WHO 2021 classification
- ✓Radiologically documented progression with >25% growth (bidirectional) in last 12 months or new lesions
- ✓Ineligible for further surgery and/or radiotherapy
- ✓At least 1 measurable lesion (minimum 10 x 10mm) on baseline MRI
- ✕Prior antineoplastic therapy for meningioma
- ✕Disease outside the brain (spinal cord, bone, or distant organ metastasis)
- ✕Candidate for urgent palliative intervention (e.g., impending herniation)
- ✕History of allergy or hypersensitivity to study treatments or excipients
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Regorafenib for Recurrent Meningioma. A Multicenter, Randomized Phase II Study (MIRAGE Trial)
In Brief
A Phase 2 clinical trial evaluating Regorafenib 40 MG Oral Tablet and Local Standard of Care for Meningioma, Malignant. Currently recruiting, targeting 104 participants across 17 sites.
Detailed Summary
The focus of this study will be to investigate whether Regorafenib demonstrates antitumor activity against recurrent meningiomas. Small trials and case series suggest clinical relevant activity of several VEGF inhibitors such as sunitinib, bevacizumab and valatinib reporting a 6m-PFS rate of 42-64%. Indeed, VEGF and VEGF receptors (VEGFR) are regularly overexpressed in meningiomas and can correlate with outcome. Regorafenib inhibits angiogenic receptor tyrosine kinases (RTKs) and is highly selective for VEGFR1/2/3; moreover Regorafenib inhibits PDGFRB, FGFR1 and oncogenic intracellular signalling cascades involving c-RAF/RAF1 and BRAF highly expressed in meningiomas. Noteworthy, Regorafenib showed antitumor activity in vitro and in vivo in a recent study; indeed, Regorafenib showed significant inhibition of meningioma cell motility and invasion and in vivo, mice with orthotopic meningioma xenografts showed a reduced volume of signal enhancement in MRI following Regorafenib therapy; this translated in a significantly increased overall survival time (p\<0.05) for Regorafenib treated mice. Moreover, Regorafenib showed good efficacy in different cancer types, such as colorectal cancer, GIST, hepatocellular carcinoma and glioblastoma (REGOMA trial) , maintainingmaintaining a good quality of life.
Study Details
Timeline
Interventions
REGORAFENIB 40 mg tablets once daily (160 mg/die), 3 weeks on, 1 week off, until disease progression or unacceptable toxicity
In this setting there are not drugs with indication. Every site will treat patients as per their experience.