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

What Was Tested

The trial (phase 3) is built around Lanreotide.

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.

It had two arms (groups): lanreotide (Autogel formulation) (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 264 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: Endocrine tumour in the intestine or pancreas and with locally advanced or metastatic disease. No hormone related symptoms. Well or moderately differentiated tumour confirmed by histology. Tumour lesions which are measurable by a CT or MRI scan.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: previously treated with a somatostatin analogue unless more than 6 months ago and given for no more than 15 days; treated within the last 6 months with interferon, chemoembolisation or chemotherapy or at any time with a radionuclide; pregnant or lactating.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

Random assignment meant chance, not the researchers, decided who got Lanreotide and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Lanreotide.

Those kept unaware of assignments: participant and investigator.

It started in 2006-06 with completion listed for 2013-04.

It ran at 71 sites in United Kingdom (12), France (9), United States (8), Germany (6), Italy (6) and Poland (6).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Progression-Free Survival (PFS).

It also tracked 5 secondary outcomes, for example Percentage of Patients Alive & Without Disease Progression, Change in the Global Health Status Quality of Life Assessment and Percentage of Patients Still Alive Based on Available Overall Survival Data.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Lanreotide in 264 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.