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Sponsors and Collaborators: |
Sanofi-Aventis Regeneron Pharmaceuticals |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00574275 |
The main objective of the study is evaluate the effectiveness of aflibercept administered once every 2 weeks in increasing the overall survival in patients with metastatic pancreatic cancer treated with gemcitabine.
Secondary objectives include response to treatment, progression free survival, safety, documentation of potential immunogenicity of aflibercept and the pharmacokinetics of aflibercept.
Condition | Intervention | Phase |
---|---|---|
Pancreatic Neoplasm |
Drug: placebo Drug: Aflibercept (AVE0005) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Multinational, Randomized, Double-Blind Study, Comparing the Efficacy of Aflibercept Once Every 2 Weeks Versus Placebo in Patients Treated With Gemcitabine for Metastatic Pancreatic Cancer |
Estimated Enrollment: | 630 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | November 2010 |
Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm A: Experimental |
Drug: Aflibercept (AVE0005)
Associated to gemcitabine
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Arm B: Placebo Comparator |
Drug: placebo
Associated to gemcitabine
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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.
Contact: Public Registry ICD | GV-Contact-us@sanofi-aventis.com |
Study Director: | ICD | Sanofi-Aventis |
Responsible Party: | sanofi-aventis ( ICD Study Director ) |
Study ID Numbers: | EFC10547, AVE0005, EudraCT 2007-003476-19 |
Study First Received: | December 14, 2007 |
Last Updated: | September 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00574275 |
Health Authority: | United States: Food and Drug Administration; Italy: Ministry of Health; Poland: Ministry of Health |
metastatic pancreatic cancer angiogenesis inhibitor gemcitabine |
Digestive System Diseases Digestive System Neoplasms Pancreatic Neoplasms 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 Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses |