S-1 Versus 5-FU Bolus in Metastatic Pancreatic Cancer Patients Previously Treated With Gemcitabine-Based Regimen
NCT ID: NCT00602745
Last Updated: 2016-05-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
61 participants
INTERVENTIONAL
2008-02-29
2010-03-31
Brief Summary
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The secondary objectives are to compare: progression free survival, overall response rate, clinical benefit and improvement in tumor related symptoms and also to assess overall safety and pharmacokinetics of S-1.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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5-Fluorouracil
5-Fluorouracil
intravenous bolus
S-1
S-1
oral administration
Interventions
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S-1
oral administration
5-Fluorouracil
intravenous bolus
Eligibility Criteria
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Inclusion Criteria
* Metastatic disease previously treated with a gemcitabine-based regimen
Exclusion Criteria
* More than one prior chemotherapy-line for advanced pancreatic disease
* Prior treatment with fluoropyrimidines for advanced pancreatic cancer
* Eastern Cooperative Oncology Group (ECOG) performance status \>or= 2
* Poor kidney, liver or bone marrow functions
* Any serious active disease or co-morbid condition, which in the opinion of the principle investigator, will interfere with the safety or with compliance with the study
* Unable to swallow capsules
* Hypersensitivity history to any of the constituents of the study medications or fluoropyrimidines
* Concurrent participation in another clinical trial or treatment with any other anticancer therapy
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
18 Years
ALL
No
Sponsors
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Taiho Pharmaceutical Co., Ltd.
INDUSTRY
Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States
Sanofi-Aventis Administrative Office
Vienna, , Austria
Sanofi-Aventis Administrative Office
São Paulo, , Brazil
Sanofi-Aventis Administrative Office
Laval, , Canada
Sanofi-Aventis Administrative Office
San José, , Costa Rica
Sanofi-Aventis Administrative Office
Hørsholm, , Denmark
Sanofi-Aventis Administrative Office
Paris, , France
Sanofi-Aventis Administrative Office
Athens, , Greece
Sanofi-Aventis Administrative Office
Mixco, , Guatemala
Sanofi-Aventis Administrative Office
Budapest, , Hungary
Sanofi-Aventis Administrative Office
Netanya, , Israel
Sanofi-Aventis Administrative Office
Ocean Business Plaza, , Panama
Sanofi-Aventis Administrative Office
Lima, , Peru
Sanofi-Aventis Administrative Office
Bucharest, , Romania
Sanofi-Aventis Administrative Office
Midrand, , South Africa
Sanofi-Aventis Administrative Office
Bromma, , Sweden
Sanofi-Aventis Administrative Office
Mégrine, , Tunisia
Countries
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Other Identifiers
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S-1 - FI
Identifier Type: -
Identifier Source: secondary_id
EFC10203
Identifier Type: -
Identifier Source: org_study_id
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