Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06275919
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-02-07
Brief Title:
Regorafenib for Recurrent Grade 2 and 3 Meningioma MIRAGE Trial
Sponsor:
Istituto Oncologico Veneto IRCCS
Organization:
Istituto Oncologico Veneto IRCCS
Study Overview
Official Title:
Regorafenib for Recurrent Grade 2 and 3 Meningioma a Multicenter Randomized Phase II Study MIRAGE Trial
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MIRAGE
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 VEGFR123 moreover Regorafenib inhibits PDGFRB FGFR1 and oncogenic intracellular signalling cascades involving c-RAFRAF1 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 p005 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
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 VEGFR123 moreover Regorafenib inhibits PDGFRB FGFR1 and oncogenic intracellular signalling cascades involving c-RAFRAF1 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 p005 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None