Ignite Creation Date:
2024-05-05 @ 7:31 PM
Last Modification Date:
2024-10-26 @ 9:50 AM
Study NCT ID:
NCT00689221
Status:
COMPLETED
Last Update Posted:
2014-11-04
First Post:
2008-05-29
Brief Title:
Cilengitide Temozolomide and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma and Methylated Gene Promoter Status
Sponsor:
EMD Serono
Organization:
EMD Serono
Study Overview
Official Title:
Cilengitide for Subjects With Newly Diagnosed Glioblastoma and Methylated MGMT Gene Promoter - A Multicenter Open-label Controlled Phase III Study Testing Cilengitide in Combination With Standard Treatment Temozolomide With Concomitant Radiation Therapy Followed by Temozolomide Maintenance Therapy Versus Standard Treatment Alone CENTRIC
Status:
COMPLETED
Status Verified Date:
2014-10
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:
CENTRIC
Brief Summary:
CENTRIC is a Phase 3 clinical trial assessing efficacy and safety of the investigational integrin inhibitor cilengitide in combination with standard treatment versus standard treatment alone in newly diagnosed glioblastoma subjects with a methylated 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 be a predictive marker for benefit from temozolomide TMZ treatment
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 be a predictive marker for benefit from temozolomide TMZ treatment
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EORTC 26071-22072 | None | None | None |
| 2007-004344-78 | EUDRACT_NUMBER | None | None |