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

Primary Purpose

Pancreatic Neoplasm, Neoplasm Metastasis

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
S-1
5-Fluorouracil
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Neoplasm focused on measuring pancreatic cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
  • Eastern Cooperative Oncology Group (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 fluoropyrimidines
  • 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.

Sites / Locations

  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

5-Fluorouracil

S-1

Arm Description

Outcomes

Primary Outcome Measures

Overall Survival

Secondary Outcome Measures

Progression Free Survival
Overall Response Rate according to RECIST criteria
Clinical Benefit assessed by Time to Symptoms Worsening (TTSW)

Full Information

First Posted
January 16, 2008
Last Updated
April 27, 2016
Sponsor
Sanofi
Collaborators
Taiho Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00602745
Brief Title
S-1 Versus 5-FU Bolus in Metastatic Pancreatic Cancer Patients Previously Treated With Gemcitabine-Based Regimen
Acronym
S-1 Pancreas
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Terminated
Why Stopped
Following the termination of development and commercialization agreement for S-1 with Taiho Pharmaceutical
Study Start Date
February 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
Collaborators
Taiho Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Neoplasm, Neoplasm Metastasis
Keywords
pancreatic cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
5-Fluorouracil
Arm Type
Active Comparator
Arm Title
S-1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
S-1
Intervention Description
oral administration
Intervention Type
Drug
Intervention Name(s)
5-Fluorouracil
Intervention Description
intravenous bolus
Primary Outcome Measure Information:
Title
Overall Survival
Time Frame
study period
Secondary Outcome Measure Information:
Title
Progression Free Survival
Time Frame
every 6 weeks
Title
Overall Response Rate according to RECIST criteria
Time Frame
every 6 weeks
Title
Clinical Benefit assessed by Time to Symptoms Worsening (TTSW)
Time Frame
every 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 Eastern Cooperative Oncology Group (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 fluoropyrimidines 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Bridgewater
State/Province
New Jersey
ZIP/Postal Code
08807
Country
United States
Facility Name
Sanofi-Aventis Administrative Office
City
Vienna
Country
Austria
Facility Name
Sanofi-Aventis Administrative Office
City
Sao Paulo
Country
Brazil
Facility Name
Sanofi-Aventis Administrative Office
City
Laval
Country
Canada
Facility Name
Sanofi-Aventis Administrative Office
City
San José
Country
Costa Rica
Facility Name
Sanofi-Aventis Administrative Office
City
Horsholm
Country
Denmark
Facility Name
Sanofi-Aventis Administrative Office
City
Paris
Country
France
Facility Name
Sanofi-Aventis Administrative Office
City
Athens
Country
Greece
Facility Name
Sanofi-Aventis Administrative Office
City
Mixco
Country
Guatemala
Facility Name
Sanofi-Aventis Administrative Office
City
Budapest
Country
Hungary
Facility Name
Sanofi-Aventis Administrative Office
City
Netanya
Country
Israel
Facility Name
Sanofi-Aventis Administrative Office
City
Ocean Business Plaza
Country
Panama
Facility Name
Sanofi-Aventis Administrative Office
City
Lima
Country
Peru
Facility Name
Sanofi-Aventis Administrative Office
City
Bucuresti
Country
Romania
Facility Name
Sanofi-Aventis Administrative Office
City
Midrand
Country
South Africa
Facility Name
Sanofi-Aventis Administrative Office
City
Bromma
Country
Sweden
Facility Name
Sanofi-Aventis Administrative Office
City
Megrine
Country
Tunisia

12. IPD Sharing Statement

Learn more about this trial

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

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