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Sponsored by: |
Ipsen |
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Information provided by: | Ipsen |
ClinicalTrials.gov Identifier: | NCT00353496 |
The study will compare the difference between lanreotide Autogel and placebo on progression free survival in patients who have an endocrine tumour in the pancreas or intestines.
Condition | Intervention | Phase |
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Endocrine Tumors |
Drug: lanreotide (Autogel formulation) Other: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Phase III, Randomised, Double-Blind, Stratified Comparative, Placebo Controlled, Parallel Group, Multi-Centre Study to Assess the Effect of Deep Subcutaneous Injections of Lanreotide Autogel 120mg Administered Every 28 Days on Tumour Progression Free Survival in Patients With Non-Functioning Entero-Pancreatic Endocrine Tumour |
Estimated Enrollment: | 200 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | June 2011 |
Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: lanreotide (Autogel formulation)
120mg administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.
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2: Placebo Comparator |
Other: Placebo
Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.
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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:
Contact: Ipsen Recruitment Enquiries | clinical.trials@ipsen.com |
Study Director: | Catherine Lesage, MD | Ipsen |
Responsible Party: | Ipsen ( Catherine Lesage ) |
Study ID Numbers: | 2-55-52030-726 |
Study First Received: | July 17, 2006 |
Last Updated: | December 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00353496 |
Health Authority: | United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency; France: Ministry of Health; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment; Belgium: Directorate general for the protection of Public health: Medicines; Spain: Spanish Agency of Medicines; Germany: Federal Institute for Drugs and Medical Devices; Poland: Ministry of Health; Greece: Ministry of Health and Welfare; Czech Republic: State Institute for Drug Control; Denmark: Danish Medicines Agency; Sweden: Medical Products Agency; Italy: Ministry of Health; Austria: Ministry of Health |
Non functioning entero-pancreatic tumours |
Digestive System Neoplasms Pancreatic Neoplasms Disease Progression Angiopeptin Endocrine System Diseases Adenoma, Islet Cell Lanreotide |
Digestive System Diseases Gastrointestinal Neoplasms Pancreatic Diseases Endocrinopathy Adenoma Endocrine Gland Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Histologic Type Neoplasms by Site Antineoplastic Agents |
Therapeutic Uses Cardiovascular Agents Pharmacologic Actions |