A Study of Sunitinib Versus Placebo in Combination With Lanreotide in Patients With Progressive Advanced/Metastatic Midgut Carcinoid Tumors

What Was Tested

The trial (phase 2) is built around Lanreotide.

Sunitinib may provide an opportunity for a novel therapeutic strategy for the treatment of subjects with neuroendocrine tumors.

It had two arms (groups): Sunitinib (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Available treatment options for unresectable disease include the use of somatostatin analogs, which may relieve symptoms related to hormonal hypersecretion.

Receptor tyrosine kinases (RTKs) are implicated in deregulated/ autocrine proliferation and survival of solid and hematologic cancer cells.

Sunitinib malate is an orally administered small molecule that inhibits the tyrosine kinase enzymatic activities of the receptors for VEGF and PDGF, and also blocks signalling through the KIT, FLT3 and RET pathways.

Therefore, sunitinib malate may provide an opportunity for a novel therapeutic strategy for the treatment of subjects with NET.

Who Took Part

The registry lists 44 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: Patients with midgut well-differentiated Grade 1-2 endocrine tumor. Local, locally advanced or metastatic disease documented as progressive by RECIST v1.1. on CT-scan or MRI at baseline and within 12 months prior to baseline. Disease that is not amenable to surgery with curative intent. Presence of at least one measurable target lesion for further evaluation according to RECIST v1.1. Adequate organ function.

The full record lists 14 inclusion and 22 exclusion criteria; among the exclusions: patients with undifferentiated, poorly differentiated gastrointestinal neuroendocrine tumors, pancreatic neuroendocrine tumors, bronchial carcinoid tumors; patients with carcinoid tumors with the presence of an obstructive intestinal tumor; patients with uncontrolled cardiac complication as part of their carcinoid syndrome.

How the Study Was Run

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

The participants were allocated by chance, so the Lanreotide group and the comparison group should start out alike.

The Lanreotide group and the comparison group ran side by side rather than switching.

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

Those kept unaware of assignments: participant and investigator.

It started in 2013-01-07 with completion listed for 2017-12.

It ran at 20 sites in France (14) and Belgium (6).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Progression free survival (PFS).

It also tracked 7 secondary outcomes, for example Overall survival (OS), Objective response (OR), Duration of response (DR), Time to tumor response (TTR), Biological responses and Safety.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Lanreotide in 44 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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