Ignite Creation Date:
2024-05-05 @ 9:07 PM
Last Modification Date:
2024-10-26 @ 9:59 AM
Study NCT ID:
NCT00813943
Status:
COMPLETED
Last Update Posted:
2017-01-30
First Post:
2008-12-22
Brief Title:
Cilengitide Temozolomide and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma and Unmethylated Gene Promoter Status
Sponsor:
EMD Serono
Organization:
EMD Serono
Study Overview
Official Title:
Cilengitide in Subjects With Newly Diagnosed Glioblastoma and Unmethylated MGMT Gene Promoter - a Multicenter Open-label Phase II Study Investigating Two Cilengitide Regimens in Combination With Standard Treatment Temozolomide With Concomitant Radiation Therapy Followed by Temozolomide Maintenance Therapy The CORE Study
Status:
COMPLETED
Status Verified Date:
2017-01
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:
CORE
Brief Summary:
CORE is a Phase 2 clinical trial in newly diagnosed glioblastoma in subjects with an unmethylated O6-methylguanine-deoxyribonucleic acid methyltransferase MGMT gene promoter in the tumor tissue
The MGMT gene promoter is a section of deoxyribonucleic acid DNA that acts as a controlling element in the expression of MGMT Methylation of the MGMT gene promoter has been found to appear to be a predictive marker for benefit from temozolomide TMZ treatment
In a safety run-in period in dedicated study centers the safety and tolerability of Cilengitide given as an intense treatment in combination with the first part of standard therapy will be assessed Thereafter the trial will investigate the overall survival and progression-free survival in subjects receiving two different regimens of Cilengitide in combination with standard treatment versus standard treatment alone
The MGMT gene promoter is a section of deoxyribonucleic acid DNA that acts as a controlling element in the expression of MGMT Methylation of the MGMT gene promoter has been found to appear to be a predictive marker for benefit from temozolomide TMZ treatment
In a safety run-in period in dedicated study centers the safety and tolerability of Cilengitide given as an intense treatment in combination with the first part of standard therapy will be assessed Thereafter the trial will investigate the overall survival and progression-free survival in subjects receiving two different regimens of Cilengitide in combination with standard treatment versus standard treatment alone
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None