A Phase 3 interventional study of Larotaxel (XRP9881) and 5-Fluorouracil in Pancreatic Neoplasms, sponsored by Sanofi. Completed at 21 sites in 21 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-06-03.
Sponsored by Sanofi · Phase 3, Interventional, and Treatment
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.
3,311 studies on the registry are indexed under Pancreatic Neoplasms; 910 are open to participants now.
This study's enrollment of 408 is above the median of 46 across 2,480 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Sanofi is the lead sponsor of 1,548 studies on the registry; 88 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 122 (60%) have results posted.
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Exclusion Criteria:
Drug: Larotaxel (XRP9881)
Each Investigator must choose either IV 5-FU or oral capecitabine regimen before the first participant begins the study and has to consistently use the chosen regimen throughout the study for all participants treated at her/his site.
Drug: 5-Fluorouracil · Drug: Capecitabine
administered as a 1-hour IV infusion on Day 1 of every 3 weeks (q3w)
administered as IV infusion from Day 1 to Day 4
administered orally from Day 1 to Day 14 q3w
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
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
This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Larotaxel