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Type(s) of Cancer
Pancreas
Study Phase
Phase 2B
Study Completion Date
2013-12-31
NCT01016483Uploaded 12-16-2020
Available for Download
PDS UID: Pancrea_EMDSero_2009_442
Phase II Randomized Trial of MEK Inhibitor MSC1936369B or Placebo Combined With Gemcitabine in Metastatic Pancreas Cancer Subjects
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 SummaryThe research trial is testing the experimental treatment MSC1936369B in combination with Gemcitabine, in subjects with metastatic pancreatic adenocarcinoma. The study will be run in two parts: Safety Run-In: Will determine the Maximum Tolerated Dose (MTD) and the recommended Phase II dose of MSC1936369B, when combined with gemcitabine, in subjects with metastatic pancreatic adenocarcinoma. Phase II: Will assess the anti-tumor activity of MSC1936369B combined with gemcitabine compared to gemcitabine alone as first line treatment in subjects with metastatic pancreatic adenocarcinoma.
ConditionsPancreatic Adenocarcinoma
Intervention TypeDrug: Pimasertib
Drug: Gemcitabine
Drug: Placebo
Drug(s)Drug: Pimasertib
Drug: Gemcitabine
Drug: Placebo
Total Enrolled141
RandomizationRandomized
Blinding MethodQuadruple
Arms InterventionSafety Run-in Part: Regimen 1 - Experimental
Safety Run-in Part: Regimen 2 - Experimental
Phase II: Arm 1 (Gemcitabine + Placebo) - Active Comparator
Phase II: Arm 2 (Gemcitabine + Pimasertib) - Experimental
Secondary ID2009-011992-61
PubMed (PMID)29756206
Collaborator(s)Merck KGaA, Darmstadt, Germany
Region(s)United States
Germany
Age Range18 Years and older (ADULT, OLDER_ADULT)
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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