NCT00602745|TerminatedPhase 3DMC

Study Stopped

Following the termination of development and commercialization agreement for S-1 with Taiho Pharmaceutical

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

S-1 Pancreas

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

Sanofi ClinicalTrials.gov

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2 other identifiers

EFC10203S-1 - FI

Study Type

interventional

Target

Locations

17 countries

Sites

Timeline

RegisteredJan 2008

StartedFeb 2008

CompletionMar 2010

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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_3

Timeline

Completed

Started Feb 2008

Geographic Reach

17 countries

17 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.1 years study duration

First Submitted

Initial submission to the registry

January 16, 2008

Completed

12 days until next milestone

First Posted

Study publicly available on registry

January 28, 2008

Completed

4 days until next milestone

Study Start

First participant enrolled

February 1, 2008

Completed

2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed

Last Updated

May 26, 2016

Status Verified

April 1, 2016

Enrollment Period

2.1 years

First QC Date

January 16, 2008

Last Update Submit

April 27, 2016

Conditions

Pancreatic Neoplasm Neoplasm Metastasis

Keywords

pancreatic cancer

Outcome Measures

Primary Outcomes (1)

Overall Survival
study period

Secondary Outcomes (3)

Progression Free Survival
every 6 weeks
Overall Response Rate according to RECIST criteria
every 6 weeks
Clinical Benefit assessed by Time to Symptoms Worsening (TTSW)
every 6 weeks

Study Arms (2)

5-Fluorouracil

ACTIVE COMPARATOR

Drug: 5-Fluorouracil

S-1

EXPERIMENTAL

Drug: S-1

Interventions

S-1DRUG

oral administration

S-1

5-FluorouracilDRUG

intravenous bolus

5-Fluorouracil

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Cytologically or histologically confirmed evidence of adenocarcinoma of the exocrine pancreas
Metastatic disease previously treated with a gemcitabine-based regimen

You may not qualify if:

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.

Contact the study team to confirm eligibility.