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 (PAPRIKA)

NCT00417209 Phase 3 COMPLETED

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.

Details

Lead sponsor	Sanofi
Phase	Phase 3
Status	COMPLETED
Enrolment	408
Start date	2006-12
Completion	2009-11

Conditions

• Pancreatic Neoplasms

Interventions

• Larotaxel (XRP9881)
• 5-Fluorouracil
• Capecitabine

Primary outcomes

• overall survival (OS) defined as the time interval from the date of randomization to the date of death due to any cause — study period

Countries

United States, Belgium, Brazil, Canada, Chile, Colombia, Czechia, Finland, Germany, Hungary, India, Italy, Mexico, Norway, Peru, Poland, Russia, Slovakia, Spain, Turkey (Türkiye), United Kingdom