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| Descriptive Information Fields | |||||
| Brief Title † | Larotaxel Compared To Continuous Administration of 5-FU in Advanced Pancreatic Cancer Patients Previously Treated With A Gemcitabine-Containing Regimen | ||||
| Official Title † | 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 | ||||
| Brief Summary | The 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. |
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| Detailed Description | |||||
| Study Phase | Phase III | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||
| Primary Outcome Measure † | overall survival (OS) defined as the time interval from the date of randomization to the date of death due to any cause [ Time Frame: study period ] [ Designated as safety issue: No ] | ||||
| Secondary Outcome Measure † | Progression free survival (PFS); Overall Response Rate (proportion of patients with confirmed RECIST-defined complete response (CR) or partial response (PR); clinical benefit based on the measurement of tumor related symptoms; [ Time Frame: study period ] [ Designated as safety issue: No ] | ||||
| Condition † | Pancreatic Neoplasms | ||||
| Intervention † | Drug: larotaxel (XRP9881) Drug: 5-Fluorouracil |
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| MEDLINE PMIDs | |||||
| Links | Related Info  |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 400 | ||||
| Start Date † | December 2006 | ||||
| Completion Date | March 2009 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† |
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| Location Countries † | United States, Belgium, Brazil, Canada, Chile, Colombia, Czech Republic, Germany, India, Italy, Mexico, Poland, Russian Federation, Slovakia, Spain, Turkey, United Kingdom | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00417209 | ||||
| Organization ID | EFC6596 | ||||
| Secondary IDs †† | XRP9881 | ||||
| Study Sponsor † | Sanofi-Aventis | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | Sanofi-Aventis | ||||
| Verification Date | August 2008 | ||||
| First Received Date † | December 28, 2006 | ||||
| Last Updated Date | August 29, 2008 | ||||
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