drugset / Trial / NCT00689221

Cilengitide, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma and Methylated Gene Promoter Status

NCT00689221

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2008-09
Primary completion
2012-11
Completion
2013-08

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject cilengitide Peptide 2000 mg Intravenous
Background Temozolomide Small molecule 75 mg/m2 Intravenous
Background Temozolomide Small molecule 150 mg/m2 Intravenous
Background Temozolomide Small molecule 200 mg/m2 Intravenous

Indications