Efficacy and Safety of Pasireotide Long Acting Release vs. Octreotide Long Acting Release in Patients With Metastatic Carcinoid Disease

What Was Tested

This registered phase 3 trial tested Octreotide and Pasireotide.

It had two arms (groups): Pasireotide LAR (active comparator) and Octreotide LAR (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 186 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: Male or female patients aged 18 or greater. Patients with carcinoid tumors and symptoms (diarrhea and flushing) that are not adequately controlled by somatostatin analogues. Female patients of child bearing potential must have a negative pregnancy test at baseline. Patients for whom written informed consent to participate in the study has been obtained.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: patients receiving radiolabeled somatostatin analogue therapy within the 3 months or any cytotoxic chemotherapy or interferon therapy within the 4 weeks prior to randomization; patients with symptomatic cholelithiasis; patient with malabsorption syndrome, short bowel or cholegenic diarrhea not controlled by specific therapeutic means.

How the Study Was Run

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

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

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

Neither the participants nor the staff measuring them knew who was on Octreotide, so expectations could not easily colour the readings.

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

It started in 2008-04 with completion listed for 2012-04.

It ran at 62 sites in United States (10), Italy (8), France (7), Germany (6), Sweden (6) and United Kingdom (6).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 9 secondary outcomes, for example Pasireotide LAR vs. Octreotide LAR on Time to Symptom Response, Objective Tumor Response Rate Assessed by Investigator, Pasireotide LAR vs. Octreotide LAR on Disease Control Rate Based on RECIST Criteria, Pasireotide LAR vs. Octreotide LAR on Quality of Life Assessed by FACIT-D Questionnaire, Pasireotide LAR vs. Octreotide LAR on Time to Symptom Progression and Pasireotide LAR vs. Octreotide LAR on Duration of Symptom Response.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Octreotide and Pasireotide in 186 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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