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

NCT00602745 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2016-05-26

No results posted yet for this study

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.

Conditions

  • Pancreatic Neoplasm
  • Neoplasm Metastasis

Interventions

DRUG

S-1

oral administration

DRUG

5-Fluorouracil

intravenous bolus

Sponsors & Collaborators

  • Taiho Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Sanofi

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2010-03-31
Completion
2010-03-31

Countries

  • United States
  • Austria
  • Brazil
  • Canada
  • Costa Rica
  • Denmark
  • France
  • Greece
  • Guatemala
  • Hungary
  • Israel
  • Panama
  • Peru
  • Romania
  • South Africa
  • Sweden
  • Tunisia

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00602745 on ClinicalTrials.gov