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Type(s) of Cancer
CNS
Study Phase
Phase 3
Study Completion Date
November 2012
NCT00689221Uploaded 12-15-2020
Available for Download
PDS UID: Glioma_EMDSero_2008_441
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)
Provider Information
Provider Data DescriptionThe primary objective of this study is to assess whether overall survival time in subjects receiving 2000 mg cilengitide in combination with standard treatment (TMZ with concomitant RTX, followed by TMZ maintenance therapy: TMZ/RTX?TMZ) is statistically significantly prolonged compared to subjects receiving standard treatment only (TMZ/RTX?TMZ). Only subjects with newly diagnosed GBM and tumors with methylated MGMT gene promoter will be randomized. Secondary objective is to investigate the Progression Free Survival (PFS). PFS will be assessed by the IRC according to the Macdonald criteria in an independent and blinded manner (details specified in the IRC charter). This will provide an objective, unbiased review of the eligible subject population based on the baseline assessment of the disease and the benefit of the respective study treatment.
SponsorEMD Serono
Data ProviderEMD Serono
Partial set or SubsetOriginal Data
Patients in dataset545
# of Patients Control273
# of Patients ExperimentalN/A
DOIhttps://doi.org/10.34949/wqh9-tx27
CDISC StandardSDTM
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryCENTRIC 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.
ConditionsGlioblastoma
Intervention TypeDrug: Cilengitide
Drug: Temozolomide
Radiation: Radiotherapy
Drug(s)Drug: Cilengitide
Drug: Temozolomide
Total Enrolled545
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionCilengitide + Temozolomide + Radiotherapy - Experimental
Temozolomide + Radiotherapy - Active Comparator
Secondary IDEORTC 26071-22072
PubMed (PMID)25163906
Collaborator(s)European Organisation for Research and Treatment of Cancer - EORTC
Merck KGaA, Darmstadt, Germany
Region(s)United States
Germany
Age Range18 Years and older (Adult, Older Adult)
Files:
PROTOCOLCTP_EMD121974-011_final_redacted.pdf
CRFblankcrf.pdf
DATA DICTIONARYdatadict.xpt
DATA SUMMARYDescriptive_Stats_EMD121974_011.xlsx
DATA SUMMARYProc Contents Data Dictionary EMD121974_011.pdf
DATA (COMPARATOR ARM)DATA_XPT.zip
DATA (COMPARATOR ARM)DATA_SAS.zip
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