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Type(s) of Cancer
Pancreas
Study Phase
Phase 2B
Study Completion Date
2009
NCT01016483Uploaded 12-16-2020
Available for Download
PDS UID: Pancrea_EMDSero_2009_442
N/A
Provider Information
Provider Data DescriptionPrimary Objective: - To evaluate the anti-tumor activity of MSC1936369B combined with gemcitabine compared to gemcitabine alone as first line treatment in subjects with metastatic pancreatic adenocarcinoma. Secondary Objectives: - To determine the safety and tolerability of MSC1936369B combined to gemcitabine in subjects with metastatic pancreatic cancer. - To evaluate the anti-tumor activity in each treatment arm in terms of response rate, clinical benefit, overall survival and time to progression. - To assess the pharmacokinetics (PK) of MSC1936369B when given in combination, in subjects with metastatic pancreatic cancer. Tertiary Objectives: - To explore potential markers in plasma - To explore the expression of predictive and prognostic markers in tumor tissue. - To explore genes that may be involved in the absorption, distribution, metabolism and elimination (ADME) of MSC1936369B and gemcitabine in combination, to identify potential genetic variations that may be predictive of differences of PK profile (optional). - To explore potential genetic variations in blood and tumor tissue (e.g. K-RAS and other known genetic variations in candidate genes) that may be predictive of differences in response to MSC1936369B and gemcitabine in combination. - To assess the anti-tumor activity, safety and tolerability of MSC1936369B treatment in subjects with metastatic pancreatic adenocarcinoma who failed previous gemcitabine treatment.
SponsorEMD Serono
Data ProviderEMD Serono
Partial set or SubsetOriginal Data
Patients in dataset141
# of Patients Control44
# of Patients ExperimentalN/A
DOIhttps://doi.org/10.34949/kdzs-bz42
CDISC StandardSDTM
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryN/A
ConditionsN/A
Intervention TypeDrug
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:
PROTOCOLEMR200066-003 CTP V7.0 20Mar2013 fully signed_Redacted.pdf
CRFMEKi003_24May2013_Version_3.0_eCRF.pdf
DATA DICTIONARYdatadict.xpt
DATA SUMMARYDescriptive_Stats_EMR 200066-003.xlsx
DATA SUMMARYProc Contents Data Dictionary EMR 200066-003.pdf
DATA (COMPARATOR ARM)DATA.zip
DATA (COMPARATOR ARM)DATA_XPT.zip
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