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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00602745
Other study ID # EFC10203
Secondary ID S-1 - FI
Status Terminated
Phase Phase 3
First received January 16, 2008
Last updated December 16, 2010
Start date February 2008
Est. completion date March 2010

Study information

Verified date December 2010
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationCanada: Health CanadaIsrael: Ministry of Health
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 61
Est. completion date March 2010
Est. primary completion date March 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

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


Intervention

Drug:
S-1
oral administration
5-Fluorouracil
intravenous bolus

Locations

Country Name City State
Austria Sanofi-Aventis Administrative Office Vienna
Brazil Sanofi-Aventis Administrative Office Sao Paulo
Canada Sanofi-Aventis Administrative Office Laval
Costa Rica Sanofi-Aventis Administrative Office San José
Denmark Sanofi-Aventis Administrative Office Horsholm
France Sanofi-Aventis Administrative Office Paris
Greece Sanofi-Aventis Administrative Office Athens
Guatemala Sanofi-Aventis Administrative Office Mixco
Hungary Sanofi-Aventis Administrative Office Budapest
Israel Sanofi-Aventis Administrative Office Netanya
Panama Sanofi-Aventis Administrative Office Ocean Business Plaza
Peru Sanofi-Aventis Administrative Office Lima
Romania Sanofi-Aventis Administrative Office Bucuresti
South Africa Sanofi-Aventis Administrative Office Midrand
Sweden Sanofi-Aventis Administrative Office Bromma
Tunisia Sanofi-Aventis Administrative Office Megrine
United States Sanofi-Aventis Administrative Office Bridgewater New Jersey

Sponsors (2)

Lead Sponsor Collaborator
Sanofi Taiho Pharmaceutical Co., Ltd.

Countries where clinical trial is conducted

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

Outcome

Type Measure Description Time frame Safety issue
Primary Overall Survival study period No
Secondary Progression Free Survival every 6 weeks No
Secondary Overall Response Rate according to RECIST criteria every 6 weeks No
Secondary Clinical Benefit assessed by Time to Symptoms Worsening (TTSW) every 6 weeks No
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