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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Pancreatic Neoplasm, Neoplasm Metastasis

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Trial Information

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


Inclusion Criteria:



- Cytologically or histologically confirmed evidence of adenocarcinoma of the exocrine
pancreas

- Metastatic disease previously treated with a gemcitabine-based regimen

Exclusion Criteria:

- Locally advanced disease

- More than one prior chemotherapy-line for advanced pancreatic disease

- Prior treatment with fluoropyrimidines for advanced pancreatic cancer

- ECOG performance status >or= 2

- Poor kidney, liver or bone marrow functions

- Any serious active disease or co-morbid condition, which in the opinion of the
principle investigator, will interfere with the safety or with compliance with the
study

- Unable to swallow capsules

- Hypersensitivity history to any of the constituents of the study medications or
fluoropyrimides

- Concurrent participation in another clinical trial or treatment with any other
anticancer therapy

The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Time Frame:

study period

Safety Issue:

No

Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

United States: Food and Drug Administration

Study ID:

EFC10203

NCT ID:

NCT00602745

Start Date:

February 2008

Completion Date:

March 2010

Related Keywords:

  • Pancreatic Neoplasm
  • Neoplasm Metastasis
  • pancreatic cancer
  • Neoplasms
  • Neoplasm Metastasis
  • Pancreatic Neoplasms

Name

Location

Sanofi-Aventis Administrative OfficeBridgewater, New Jersey  08807