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Spots Global Cancer Trial Database for Regorafenib for Recurrent Grade 2 and 3 Meningioma (MIRAGE Trial)

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Trial Identification

Brief Title: Regorafenib for Recurrent Grade 2 and 3 Meningioma (MIRAGE Trial)

Official Title: Regorafenib for Recurrent Grade 2 and 3 Meningioma. A Multicenter, Randomized Phase II Study (MIRAGE Trial)

Study ID: NCT06275919

Study Description

Brief Summary: The focus of this study will be to investigate whether Regorafenib demonstrates antitumor activity against recurrent grade II or III 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.

Detailed Description:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

IRST Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori", Meldola, Forlì-Cesena, Italy

Humanitas Cancer Center, Rozzano, Milano, Italy

Ospedale San Paolo, Bari, , Italy

Ospedale Bellaria - AUSL Bologna, Bologna, , Italy

Azienda Ospedaliero Universitaria Careggi, Firenze, , Italy

Policlinico San Martino, Genova, , Italy

Spedali Riuniti, Livorno, , Italy

Azienda Ospedaliero Universitaria G. Martino, Messina, , Italy

Fondazione IRCCS Istituto Neurologico Carlo Besta, Milano, , Italy

IRCCS Ospedale San Raffaele, Milano, , Italy

Ospedale del Mare, Napoli, , Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, , Italy

IRCCS Istituto Tumori Regina Elena, Roma, , Italy

Policlinico Umberto I - Università Sapienza Roma, Roma, , Italy

A.O.U. Città della Salute e della Scienza di Torino, Torino, , Italy

Contact Details

Name: Giuseppe Lombardi, MD

Affiliation: Istituto Oncologico Veneto IOV IRCCS

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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