drugset / Trial / NCT00602745

S-1 Versus 5-FU Bolus in Metastatic Pancreatic Cancer Patients Previously Treated With Gemcitabine-Based Regimen

NCT00602745

Phase 3 Terminated 61 enrolled Sanofi Taiho Pharmaceutical Co., Ltd. · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

The primary objective of this study is to determine whether S-1 increases overall survival when compared to 5-Fluorouracil (5-FU) in patients with metastatic pancreatic cancer previously treated with a gemcitabine-based therapy. 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.

Timeline

Start
2008-02
Primary completion
2010-03
Completion
2010-03

Drugs

EvaluationDrugModalityDoseRoute
Subject S-1 Small molecule Oral
Comparator fluorouracil Small molecule Intravenous