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Type(s) of Cancer
Pancreas
Study Phase
Phase 2BPhase 3
Study Completion Date
November 2012
NCT01124786Uploaded 10-02-2020
Available for Download
PDS UID: Pancrea_Multipl_2020_430
A Phase II Randomized, Open-Label, Multicenter Study Comparing CO-1.01 With Gemcitabine as First-Line Therapy in Patients With Metastatic Pancreatic Adenocarcinoma
Provider Information
Provider Data DescriptionThis data enhancement project seeks to further advance the mission of the PDS platform by enabling new explorations into the potential influence of health care access, socioeconomic factors, and health behaviors on the patient-level efficacy and outcomes data contained in the PDS online service. This was achieved using a statistical linkage method in which patient-level records from PDS dataset, Pancrea_ClovisO_2010_186, were matched with pancreatic cancer survivors from the nationally representative Medical Expenditure Panel Survey (MEPS). Linkage criteria were based on age, sex, race, and a quality of life assessment called the EQ-5D index score. The use of the EQ-5D score as a linkage criterion reduces the multitude of many-to-many exact matches that would have occurred using only age, race, and sex. The addition of the MEPS data to the patient-level data within the PDS enclave will facilitate hypothesis-generating research efforts that explore the level of variation in patient outcomes potentially attributable to differentials in access to basic health care services and their utilization, to socioeconomic characteristics, and to health behaviors and preferences. It will support exploratory analyses designed to examine questions such as How are variations in cancer patients' access to health care and income impacting patient outcomes in specific phase III clinical trials? What variations in patient outcomes are associated with specific demographic, socioeconomic, and health-related factors? Are the demographic characteristics of those cancer patients enrolled in specific phase III clinical trials comparable to cancer patients with the same disease in the general population?
SponsorResearcher Curated
Data ProviderRTI International
Partial set or SubsetOriginal Data
Patients in dataset0
# of Patients Control0
# of Patients ExperimentalN/A
DOIhttps://doi.org/10.34949/yqx7-0m42
CDISC StandardN/A
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryThe purpose of this study is to determine whether CO-1.01 is safe and effective in the treatment of patients with metastatic pancreatic cancer and low hENT1 expression compared with gemcitabine.
ConditionsMetastatic Pancreatic Adenocarcinoma
Intervention TypeDrug: CO-1.01
Drug: Gemcitabine
Drug(s)Drug: CO-1.01
Drug: Gemcitabine
Total Enrolled367
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionCO-1.01 - Experimental
gemcitabine - Active Comparator
Secondary IDN/A
PubMed (PMID)N/A
Collaborator(s)N/A
Region(s)United States
Argentina
Australia
Belgium
Brazil
Canada
France
Germany
Italy
Netherlands
Norway
Russian Federation
Sweden
Ukraine
United Kingdom
Age Range18 Years and older (Adult, Older Adult)
Files:
PROTOCOLLinked Pancrea_ClovisO_2010_186 Documentation.docx
CRFDataset Contents and Variable Crosswalk.xlsx
DATA DICTIONARYCODEBOOK_linked_pancrea186.pdf
DATA SUMMARYDescriptive_Stats_Linked_Pancrea_ClovisO_2010_186.xlsx
DATA SUMMARYProc Contents Data Dictionary linked_pancrea186.pdf
DATA (COMPARATOR ARM)linked_pancrea186.sas7bdat
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