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Type(s) of Cancer
Pancreas
Study Phase
Phase 3
Study Completion Date
November 2012
NCT01124786Uploaded 05-17-2017
Available for Download
PDS UID: Pancrea_ClovisO_2010_186
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 DescriptionSee outcome measures
SponsorClovis Oncology
Data ProviderClovis
Partial set or SubsetN/A
Patients in dataset232
# of Patients Control118
# of Patients Experimental114
DOIhttps://doi.org/10.34949/q15p-en76
CDISC StandardADS
Study ArmsBoth comparator and experimental arm data
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:
PROTOCOLProtocol_CO-101-001_Amend2 20110314 final.pdf
CRFCVSDVPAN-ADVPAN aCRF 13-Sep-2010_2.pdf
DATA DICTIONARYdefine.pdf
DATA (ACTIVE ARM)SAP CO-101-001 Amendment 1 03May2012.docx
DATA (ACTIVE ARM)DataSphere.zip
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