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Type(s) of Cancer
Glioma

Study Phase

Phase 2B

Study Completion Date
February 2013

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 SubsetN/A

Patients in dataset265

# of Patients Control89

# of Patients Experimental89

DOIN/A

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 (Open Label)

Arms InterventionCilengitide (2-times weekly) + Temozolomide + Radiotherapy - Experimental
Cilengitide (5-times weekly) + Temozolomide + Radiotherapy - Experimental
Temozolomide + Radiotherapy - Active Comparator

Secondary IDNA

PubMed (PMID)NA

Collaborator(s)Merck KGaA, Darmstadt, Germany

Region(s)United States
Germany

Age RangeMinimum Age: 18 Years
Maximum Age: NA

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)ae.xpt

DATA (COMPARATOR ARM)dv.xpt

DATA (COMPARATOR ARM)dm.xpt

DATA (COMPARATOR ARM)ie.xpt

DATA (COMPARATOR ARM)ds.xpt

DATA (COMPARATOR ARM)mh.xpt

DATA (COMPARATOR ARM)co.xpt

DATA (COMPARATOR ARM)se.xpt

DATA (COMPARATOR ARM)cm.xpt

DATA (COMPARATOR ARM)ex.xpt

DATA (COMPARATOR ARM)suppdm.xpt

DATA (COMPARATOR ARM)suppae.xpt

DATA (COMPARATOR ARM)suppeg.xpt

DATA (COMPARATOR ARM)suppds.xpt

DATA (COMPARATOR ARM)suppcm.xpt

DATA (COMPARATOR ARM)suppmh.xpt

DATA (COMPARATOR ARM)supplb.xpt

DATA (COMPARATOR ARM)suppsv.xpt

DATA (COMPARATOR ARM)suppxh.xpt

DATA (COMPARATOR ARM)suppxx.xpt

DATA (COMPARATOR ARM)suppxn.xpt

DATA (COMPARATOR ARM)suppyf.xpt

DATA (COMPARATOR ARM)suppyh.xpt

DATA (COMPARATOR ARM)suppyp.xpt

DATA (COMPARATOR ARM)qs.xpt

DATA (COMPARATOR ARM)suppzm.xpt

DATA (COMPARATOR ARM)suppex.xpt

DATA (COMPARATOR ARM)ta.xpt

DATA (COMPARATOR ARM)te.xpt

DATA (COMPARATOR ARM)ti.xpt

DATA (COMPARATOR ARM)ts.xpt

DATA (COMPARATOR ARM)tv.xpt

DATA (COMPARATOR ARM)eg.xpt

DATA (COMPARATOR ARM)xh.xpt

DATA (COMPARATOR ARM)sv.xpt

DATA (COMPARATOR ARM)suppyr.xpt

DATA (COMPARATOR ARM)xp.xpt

DATA (COMPARATOR ARM)suppya.xpt

DATA (COMPARATOR ARM)yf.xpt

DATA (COMPARATOR ARM)yh.xpt

DATA (COMPARATOR ARM)yp.xpt

DATA (COMPARATOR ARM)xx.xpt

DATA (COMPARATOR ARM)zm.xpt

DATA (COMPARATOR ARM)xn.xpt

DATA (COMPARATOR ARM)ya.xpt

DATA (COMPARATOR ARM)yr.xpt

DATA (COMPARATOR ARM)vs.xpt

DATA (COMPARATOR ARM)lb.xpt

DATA (COMPARATOR ARM)DATA.zip

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