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Type(s) of Cancer
Pancreas
Study Phase
Phase 3
Study Completion Date
July 2009
NCT00417209Uploaded 10-31-2014
Available for Download
PDS UID: Pancrea_Sanofi_2006_109
A Randomized, Open Label Multi-Center Study Of Single Agent Larotaxel (XRP9881) Compared To Continuous Administration of 5-FU For The Treatment Of Patients With Advanced Pancreatic Cancer Previously Treated With A Gemcitabine-Containing Regimen
Provider Information
Provider Data DescriptionPrimary end-point: - Overall survival will be assessed from the date of randomization to death. Main Secondary End-points: - Progression free survival will be evaluated from date of randomization to tumor progression or death. - Objective responses (CR and PR) as assessed by investigators according to RECIST criteria - Safety profile of the study treatment in terms of AEs/ SAEs and laboratory parameters. - Clinical Benefit will be based on the measurement of tumor related symptoms including a composite score of pain severity assessed by Visual Analog Scale (VAS), analgesic consumption as morphine equivalents, ECOG PS and weight loss of greater than or equal to 5% from baseline. The Clinical Benefit will be assessed by time to symptom worsening (TTSW).
SponsorSanofi US Services Inc.
Data ProviderSanofi
Partial set or SubsetOriginal Data
Patients in dataset453
# of Patients Control231
# of Patients ExperimentalN/A
DOIhttps://doi.org/10.34949/p40d-k690
CDISC StandardADS
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryThe purpose of this study is to compare the efficacy and the safety Larotaxel administered as single agent every 3 weeks to continuous administration of 5-FU every 3 weeks, in patients with advanced pancreatic cancer (non operable in a curative intent, locally recurrent or metastatic) previously treated with gemcitabine based therapy.
ConditionsPancreatic Neoplasms
Intervention TypeDrug: Larotaxel (XRP9881)
Drug: 5-Fluorouracil
Drug: Capecitabine
Drug(s)Drug: Larotaxel (XRP9881)
Drug: 5-Fluorouracil
Drug: Capecitabine
Total Enrolled408
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionLarotaxel (XRP9881) - Experimental
5-Fluorouracil or capecitabine - Active Comparator
Secondary IDEUDRACT: 2006-003086-14
PubMed (PMID)N/A
Collaborator(s)N/A
Region(s)United States
Belgium
Brazil
Canada
Chile
Colombia
Czech Republic
Finland
Germany
Hungary
India
Italy
Mexico
Norway
Peru
Poland
Russian Federation
Slovakia
Spain
Turkey
United Kingdom
Age Range18 Years and older (Adult, Older Adult)
Files:
PROTOCOLsanofi_XRP9881_efc6596_protocol_Redacted.pdf
CRFsanofi_XRP9881_EFC6596_Sample_CRF_redacted.pdf
DATA DICTIONARYRead me first-info data definition files XRP9881 EFC6596.docx
DATA (COMPARATOR ARM)SAS datasets.zip
Otherdata definition files.zip
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