Lanreotide Combined With Telotristat Ethyl or Placebo for the First-line Treatment in Patients With Advanced Well Differentiated Small Intestinal Neuroendocrine Tumours (siNET) With Highly-functioning Carcinoid Syndrome

What Was Tested

In this phase 3 trial, researchers set out to test Lanreotide.

Patients will enter into a screening/run-in period of 1 week to establish baseline characteristics and symptomatology.

It had two arms (groups): Experimental arm (experimental) and Control arm (placebo comparator).

The registry classes the interventions as drug.

Who 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: Histologically confirmed well-differentiated (grade 1 or grade 2) neuroendocrine tumour from small bowel primary (or unknown primary suspected to be of small bowel origin) as per WHO / ENETS classification. Advanced disease (locally advanced, metastatic or recurrent, according to TNM staging version 8 or ENETS latest classification), not amenable for curative surgery. Highly functioning carcinoid syndrome, defined as:. Age ≥18 years (no upper limit) and life expectancy \>3 months. Adequate haematological, hepatic and renal laboratory values:.

The full record lists 18 inclusion and 18 exclusion criteria; among the exclusions: major surgery defined as procedures requiring general anesthesia or major regional anesthesia within 8 weeks prior to registration; administration of any investigational therapeutic agent prior to registration (investigational imaging tracers are allowed); patients with end-stage renal disease requiring dialysis.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

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.

As a double-blind Lanreotide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2020-04 with completion listed for 2023-07.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Number of bowel movements (BMs) (time frame: 43 months after first patient in).

It also tracked 3 secondary outcomes, for example Urine/serum/plasma 5-HIAA and chromogranin-A, Number of daily cutaneous flushing episodes and Health Related Quality of Life (HRQoL).

What This Means in Plain Language

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

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

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