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Studies

Interventional Recruiting Phase 2

NCT06275919 on ClinicalTrials.gov

Regorafenib for Recurrent Meningioma (MIRAGE Trial)

Official title: Regorafenib for Recurrent Meningioma. A Multicenter, Randomized Phase II Study (MIRAGE Trial)

  • Sponsor: Istituto Oncologico Veneto
  • Collaborators: Bayer
  • Enrollment: 104 (Estimated)
  • Study start: 2024-09-23 (Actual)
  • Primary completion: 2028-12-01 (Estimated)
  • Study completion: 2029-03-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: None
  • PrimaryPurpose: Treatment

Brief 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.

Conditions

  • Meningioma, Malignant

Intervention / Treatment

  • Drug: Regorafenib 40 MG Oral Tablet
  • Drug: Local Standard of Care

Primary Outcome Measures

  • Progression free survival (PFS) (Up to 54 months)
    The progression free survival (PFS) will be determined as the time from the date of enrolment to the date of disease progression determined using RANO criteria or to the date of death, whichever occurs first.

Countries

Italy

Locations and Investigators

  • Ospedale San Raffaele S.r.l., Milan, Italy
    • Nicole, Liscia
  • IRCCS Ospedale Policlinico San Martino, Genoa, Italy
    • Elisa, Bennicelli
  • Istituto Oncologico Veneto, Padova, Italy
  • Humanitas Research Hospital, Rozzano, Italy
    • Matteo, Simonelli
  • Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino, Turin, Italy
    • Roberta, Rudà
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy
    • Silvia, Chiesa
  • Azienda Sanitaria Locale Della Provincia Di Bari, Bari, Italy
    • Valeria, Internò
  • Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l., Meldola, Italy
    • Lorena, Gurrieri
  • Careggi University Hospital, Florence, Italy
    • Isacco, Desideri
  • Azienda Ospedaliera Universitaria Gaetano Martino Messina, Messina, Italy
    • Mariacarmela, Santapia
  • Azienda Ospedaliero-Universitaria Policlinico Umberto I, Rome, Italy
  • IRCCS Foundation Istituto Neurologico Carlo Besta, Milan, Italy
    • Paola, Gaviani
  • Azienda Universitaria Ospedaliera Consorziale Policlinico Bari, Bari, Italy
    • Valeria, Internò
  • Azienda Sanitaria Locale Napoli 1 Centro, Naples, Italy
    • Pasqualina, Giordano
  • Azienda Unita Sanitaria Locale Di Bologna, Bologna, Italy
    • Enrico, Franceschi
  • Azienda Unita Sanitaria Locale Toscana Nord Ovest, Leghorn, Italy
    • Anna Luisa, Di Stefano
  • I.F.O. Istituti Fisioterapici Ospitalieri, Rome, Italy
    • Veronica, Villani

Study Officials