NCT00353496

Study of Lanreotide Autogel in Non-functioning Entero-pancreatic Endocrine Tumours

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 264 (actual)
• Sponsor: Ipsen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Endocrine Tumors

Interventions

Type	Name	Description
DRUG	lanreotide (Autogel formulation)	120mg administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
DRUG	Placebo	Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.

Timeline

• Start date: 2006-06-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2006-07-18
• Last updated: 2025-03-05
• Results posted: 2015-02-18

Locations

71 sites across 15 countries: United States, Austria, Belgium, Czechia, Denmark, France, Germany, India, Italy, Netherlands, Poland, Slovakia, Spain, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study