Study of Lanreotide Autogel [amount hidden] in Patients With Non-functioning Entero- Pancreatic Endocrine Tumour

What Was Tested

This registered phase 3 trial tested Lanreotide.

It had 1 arm (groups): Lanreotide (Autogel formulation) (experimental).

The registry classes the interventions as drug.

More on the Plan

While somatostatin analogue treatment is the primary medical therapy for patients with hormone related symptoms and is indicated for the treatment of hormone related symptoms in many international countries, there is no reference standard medical therapy for asymptomatic patients.

A 96-week study (Study 2-55-52030-726 (726), NCT00353496) was conducted to investigate the effect of lanreotide Autogel on progression free survival (PFS) in patients with well or moderately differentiated nonfunctioning enteropancreatic NET.

Who Took Part

89 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Had provided written informed consent prior to any study-related procedures. Had been enrolled and treated in Study 2-55-52030-726 and either:. Was stable at 96 weeks of treatment (whatever the treatment received during the 2 years of participation, i.e. no code break at Week 96); or,. Had a World Health Organisation (WHO) performance score lower than or equal to 2.

The full record lists 5 inclusion and 10 exclusion criteria; among the exclusions: had received any new treatment for the entero-pancreatic net since the end of participation in the study; had been treated with radionuclide at any time prior to study entry; were likely to require treatment during the study with drugs that were not permitted by the study protocol.

How the Study Was Run

Design: single-group and open-label.

Being open-label, the Lanreotide study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2009-02 with completion listed for 2015-12.

It ran at 25 sites in United Kingdom (6), France (4), Italy (4), United States (2), Belgium (2) and Czechia (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Adverse Events (time frame: Throughout the study until the completion/early discontinuation visit).

It also tracked 1 secondary outcome, for example Progression Free Survival (PFS): Kaplan-Meier Estimate.

What This Means in Plain Language

Put simply, this is a phase 3 trial of Lanreotide in 89 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Lanreotide compound page, all human trials.