Pharmacokinetics, Efficacy and Safety of an Octreotide Implant in Patients With Carcinoid Syndrome

What Was Tested

In this phase 1, phase 2 trial, researchers set out to test Octreotide.

It had two arms (groups): 1 implant (experimental) and 2 implants (experimental).

The registry classes the interventions as drug.

More on the Plan

This study will evaluate a longer acting octreotide formulation.

Who Took Part

Enrollment: 10 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Histologically confirmed tumor. Documented evidence of carcinoid syndrome. Life expectancy of at least 6 months. Previous positive octreotide scan. Performance status of 0-2 on the ECOG performance scale.

The full record lists 6 inclusion and 2 exclusion criteria; among the exclusions: poorly differentiated or high grade neuroendocrine tumor.

How the Study Was Run

Design: non-randomized, parallel-group and open-label.

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

Nothing was hidden in this open-label Octreotide study: the participants and staff both knew the treatment.

It started in 2009-07 with completion listed for 2011-11.

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

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Assess the effects of 1 or 2 implants on carcinoid syndrome symptoms of flushing and diarrhea (time frame: 9 months).

It also tracked 1 secondary outcome, for example safety and tolerability of the implants.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, non-randomized trial of Octreotide in 10 people.

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

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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