P:II Above-Label Octreotide-LAR With Insufficiently Controlled Carcinoid Syndrome

What Was Tested

In this phase 2 trial, researchers set out to test Octreotide.

It had 1 arm (groups): Octreotide Long-acting Release (LAR) (experimental).

The registry classes the interventions as drug.

More on the Plan

The study population will consist of patients with advanced (metastatic or unresectable) neuroendocrine tumors with suboptimally controlled carcinoid syndrome.

While the majority of patients will have primary tumors of the ileocecum (midgut), any serotonin-producing neuroendocrine tumors will be eligible (including pancreatic, lung and unknown primary).

Who Took Part

The registry lists 2 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 neuroendocrine tumors that are considered well or moderately differentiated (or low to intermediate grade). Patients with poorly differentiated neuroendocrine carcinomas or small cell carcinomas are excluded from the study. Elevated urine 5-hydroxyindoleacetic acid (5-HIAA). More than 2 bowel-movements per day OR more than 4 flushing episodes per week on average. Age ≥ 18 years. Eastern Cooperative Oncology Group (ECOG) performance status ≤2.

The full record lists 10 inclusion and 17 exclusion criteria; among the exclusions: known hypersensitivity to somatostatin analogues; patients with liver cirrhosis; patients receiving hemodialysis or peritoneal dialysis.

How the Study Was Run

It was run as a single-group and open-label study.

Everyone knew when Octreotide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

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

It started in 2013-12 with completion listed for 2014-08.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 1 secondary outcome, for example Rate of Progression Free Survival (PFS) at 6 Months.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Octreotide in 2 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 Octreotide compound page, all human trials.