Study of Lanreotide in Patients With Metastatic Gastrointestinal Neuroendocrine Tumors Who Are Undergoing Liver-directed Radioembolization With Yttrium-90 Microspheres

What Was Tested

The trial (phase 2) is built around Lanreotide.

Neuroendocrine tumors (NETs) and cancers that originate from the gastrointestinal tract can be resistant to standard chemotherapy and often metastasize to the liver.

The purpose of this study is to determine if treatment for patients with NETs can be optimized by combining these therapies.

The registry classes the interventions as device and drug.

More on the Plan

This is an open-label, prospective, multi-center Phase II study for patients with metastatic well-to-moderately differentiated neuroendocrine tumors, including typical carcinoid and pancreatic neuroendocrine tumors, who are candidates for liver-directed radioembolization.

Patients who are currently receiving or have previously received lanreotide are eligible, and treatment with lanreotide can continue monthly until disease progression or unacceptable toxicity.

Up to 25 patients are planned for enrollment to be conducted at approximately 5 investigational sites in the U.S.

Who Took Part

6 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: Metastatic well-to-moderately differentiated (or low-grade) neuroendocrine carcinoma, including typical carcinoid or pancreatic islet cell carcinoma. Patients who are currently receiving or have previously received lanreotide or another somatostatin analogue are eligible. Previous treatment with lanreotide or another somatostatin analogue is not required for study entry. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1. Adequate hematologic, hepatic and renal function. Life expectancy ≥ 3 months.

The full record lists 9 inclusion and 22 exclusion criteria; among the exclusions: anti-cancer therapy with the exception of lanreotide or another somatostatin analogue within 21 days or 5 half-lives (whichever is shorter) of starting study treatment; major surgical procedures ≤28 days of beginning study drug, or minor surgical procedures ≤7 days. no waiting required following port-a-cath placement; pregnant or lactating.

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 2017-07-28 with completion listed for 2022-05-27.

It ran at 3 sites in United States (3).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability.

It also tracked 4 secondary outcomes, for example Overall Response Rate, Disease Control Rate, Progression Free Survival and Overall Survival.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Lanreotide in 6 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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