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Sponsors and Collaborators: |
Sanofi-Aventis Taiho Pharmaceutical Co., Ltd. |
---|---|
Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00602745 |
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.
Condition | Intervention | Phase |
---|---|---|
Pancreatic Neoplasm Neoplasm Metastasis |
Drug: S-1 Drug: 5-Fluorouracil |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 400 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Arm A: Active Comparator |
Drug: 5-Fluorouracil
intravenous bolus
|
Arm B: Experimental |
Drug: S-1
oral administration
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study Director: | ICD CSD | Sanofi-Aventis |
Responsible Party: | sanofi-aventis ( ICD study director ) |
Study ID Numbers: | EFC10203, S-1 - FI |
Study First Received: | January 16, 2008 |
Last Updated: | November 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00602745 |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada; Israel: Ministry of Health |
pancreatic cancer |
Digestive System Diseases Digestive System Neoplasms Fluorouracil Pancreatic Neoplasms Neoplasm Metastasis Endocrine System Diseases |
Pancreatic Diseases Gastrointestinal Neoplasms Endocrinopathy Gemcitabine Endocrine Gland Neoplasms |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Antiviral Agents |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplastic Processes Pathologic Processes Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses |