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Type(s) of Cancer
CNS
Study Phase
Phase 2B
Study Completion Date
2013-02
NCT00813943Uploaded 12-15-2020
Available for Download
PDS UID: Glioma_EMDSero_2009_440
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]
Provider Information
Provider Data DescriptionTo determine the safety and tolerability of a 5-day administration schedule of 2000 mg cilengitide given in combination with radiation therapy (RTX) and temozolomide (TMZ) standard treatment in the safety run-in part of the trial: To investigate the overall survival (OS) in subjects receiving 2 different regimens of 2000 mg cilengitide in combination with RTX and TMZ standard treatment in the randomized part of the trial.
SponsorEMD Serono
Data ProviderEMD Serono
Partial set or SubsetOriginal Data
Patients in dataset265
# of Patients Control89
# of Patients ExperimentalN/A
DOIhttps://doi.org/10.34949/067t-vx73
CDISC StandardSDTM
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryCORE 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.
ConditionsGlioblastoma
Intervention TypeDrug: Cilengitide (2-times weekly)
Drug: cilengitide (5-times weekly)
Drug: Temozolomide
Radiation: Radiotherapy
Drug(s)Drug: Cilengitide (2-times weekly)
Drug: Temozolomide
Drug: cilengitide (5-times weekly)
Total Enrolled265
RandomizationRandomized
Blinding MethodNone
Arms InterventionCilengitide (2-times weekly) + Temozolomide + Radiotherapy - Experimental
Cilengitide (5-times weekly) + Temozolomide + Radiotherapy - Experimental
Temozolomide + Radiotherapy - Active Comparator
Secondary IDN/A
PubMed (PMID)N/A
Collaborator(s)Merck KGaA, Darmstadt, Germany
Region(s)United States
Germany
Age Range18 Years and older (ADULT, OLDER_ADULT)
Files:
PROTOCOLctp-emd-121974-core-v3.0-signed_Redacted.pdf
CRFCentric_eCRF_ANNOTATED_Version 4_18AUG2011.pdf
DATA DICTIONARYdatadict.xpt
DATA SUMMARYDescriptive_Stats_EMD_121974_012.xlsx
DATA SUMMARYProc Contents Data Dictionary EMD_121974_012.pdf
DATA (COMPARATOR ARM)DATA.zip
DATA (COMPARATOR ARM)DATA_XPT.zip
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