Ignite Creation Date:
2024-05-06 @ 4:06 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04874506
Status:
UNKNOWN
Last Update Posted:
2021-05-05
First Post:
2021-05-03
Brief Title:
MBM-02 Tempol for the Treatment of Glioblastoma Multiforme GBM
Sponsor:
Matrix Biomed Inc
Organization:
Matrix Biomed Inc
Study Overview
Official Title:
An Open Label Study to Assess the Safety and Clinical Efficacy of MBM-02 to Increase Survival in Patients With Newly Diagnosed Glioblastoma Multiforme GBM
Status:
UNKNOWN
Status Verified Date:
2021-05
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
MBM-02 Tempol is an HIF-1 and HIF-2 inhibitor that is being tested as an addition to standard of care treatment that includes radiotherapy and TMZ MBM-02s ability to increase progression free survival and decrease side effects of TMZ and radiotherapy treatment will be assessed
Detailed Description:
MBM-02 is an HIF-1 and HIF-2 inhibitor that has shown in animal models to turn back on the apoptosis process cell death in cancer
Hypoxia is well documented in most solid tumors Vaupel et al 1991 Acute intermittent and cycling hypoxia are associated with inadequate blood flow whereas chronic hypoxia is the consequence of increased oxygen diffusion distance resulting from tumor expansion Dewhirst et al 2008 A study by Chen and colleagues 2015 showed that cycling hypoxia and chronic hypoxia are important tumor microenvironment phenomena that limit tumor response to chemotherapy in GBM
In hypoxic conditions observed in solid state tumors the hypoxia inducible factors HIF-1α and HIF-2α are upregulated and transcribe a panel of genes associated with cancer survival and progression such as vascular endothelial growth factor receptor VEGFR platelet derived growth factor PDGF and glucose transporter 1 GLUT1 These factors are essential for tumor survival thereby increasing tumor progression and decreasing apoptosis Without the functions of the HIF family of genes solid-state tumors could not progress and would not survive In both Chen et al 2015 and Sourbier et al 2012 researchers established that the active compound in MBM-02 is an inhibitor of both HIF-1α and HIF-2α
This is an open label multisite trial that will assess MBM-02s ability to increase progress free survival in patients receiving standard of care for glioblastoma
Hypoxia is well documented in most solid tumors Vaupel et al 1991 Acute intermittent and cycling hypoxia are associated with inadequate blood flow whereas chronic hypoxia is the consequence of increased oxygen diffusion distance resulting from tumor expansion Dewhirst et al 2008 A study by Chen and colleagues 2015 showed that cycling hypoxia and chronic hypoxia are important tumor microenvironment phenomena that limit tumor response to chemotherapy in GBM
In hypoxic conditions observed in solid state tumors the hypoxia inducible factors HIF-1α and HIF-2α are upregulated and transcribe a panel of genes associated with cancer survival and progression such as vascular endothelial growth factor receptor VEGFR platelet derived growth factor PDGF and glucose transporter 1 GLUT1 These factors are essential for tumor survival thereby increasing tumor progression and decreasing apoptosis Without the functions of the HIF family of genes solid-state tumors could not progress and would not survive In both Chen et al 2015 and Sourbier et al 2012 researchers established that the active compound in MBM-02 is an inhibitor of both HIF-1α and HIF-2α
This is an open label multisite trial that will assess MBM-02s ability to increase progress free survival in patients receiving standard of care for glioblastoma
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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