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Type(s) of Cancer
CNS
Study Phase
Phase 2B
Study Completion Date
2009
NCT00813943Uploaded 12-15-2020
Available for Download
PDS UID: Glioma_EMDSero_2009_440
N/A
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 SummaryN/A
ConditionsN/A
Intervention TypeDrug, Radiation
Drug(s)N/A
Total EnrolledN/A
RandomizationN/A
Blinding MethodN/A
Arms InterventionN/A
Secondary IDN/A
PubMed (PMID)N/A
Collaborator(s)N/A
Region(s)N/A
Age RangeN/A
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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