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Regorafenib for Recurrent Meningioma (MIRAGE Trial)

ConditionMeningioma, Malignant
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorIstituto Oncologico Veneto IRCCS

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Prior antineoplastic therapy for meningioma

Subject incapacitated to understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted

Are taking strong cytochrome P (CYP) CYP3A4 inhibitors (eg, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telithromycin, voriconazole) or strong CYP3A4 inducers (eg, carbamazepine, phenobarbital, phenytoin, rifampin, St. John's Wort)

Are taking strong UGT1A9 inhibitors (e.g. mefenamic acid, diflunisal and niflumic acid)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Regorafenib 40 MG Oral Tablet

    Drug

    REGORAFENIB 40 mg tablets once daily (160 mg/die), 3 weeks on, 1 week off, until disease progression or unacceptable toxicity

  • Local Standard of Care

    Drug

    In this setting there are not drugs with indication. Every site will treat patients as per their experience.

Treatment groups

104 Participants
are divided into 2 treatment groups
Group A: Arm A (interventional arm)Experimental treatment 1 intervention
Group B: Arm B (control arm)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Progression free survival (PFS)

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.

Time frame
Up to 54 months

Secondary outcomes

1

Overall survival (OS)

The overall survival (OS) will be determined as the time from the date of enrolment to the date of death from any cause.

Time frame
Up to 42 months
2

Objective response rate (ORR)

The objective response rate (ORR) will be defined as the percentage of patients with complete response (CR) and partial response (PR) determined using modified Macdonald criteria.

Time frame
Up to 42 months
3

Patient Reported Outcomes (PROs)

Quality of life will be assessed by EORTC QLQ-C30 questionnaire.

Time frame
Up to 42 months
4

Patient Reported Outcomes (PROs)

Quality of life will be assessed by the QLQBN20 questionnaire.

Time frame
Up to 42 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Istituto Oncologico Veneto IRCCS

Lead sponsor

Bayer

Collaborator

Source ClinicalTrials.gov
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