Clinical trialPhase 3Terminated
S-1 Versus 5-FU Bolus in Metastatic Pancreatic Cancer Patients Previously Treated With Gemcitabine-Based Regimen
A Multicenter, Open-Label, Randomized Study Comparing Efficacy and Safety of S-1 as Single Agent Versus 5-FU Bolus for the Treatment of Patients With Metastatic Pancreatic Cancer Previously Treated With a Gemcitabine-Based Regimen
- Outcome
- Stopped earlyFollowing the termination of development and commercialization agreement for S-1 with Taiho Pharmaceutical (Business decision)
- Phase
- Phase 3
- Status
- Terminated
- Study type
- Interventional
- Start
- February 2008
- Ended
- March 2010
- Enrollment
- 61 participants
- Sites
- 17
- Primary outcomes
- Overall Survival
- Sponsor type
- Industry
- Results posted
- No
- Last update
- 26 May 2016
These fields come from the trial’s registry entry. A summary of its population, design, endpoints and results, each tied to a quote, has not been written for this trial yet.
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Brief summary public domain (ClinicalTrials.gov)
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.