Efficacy of Everolimus Alone or in Combination With Pasireotide LAR in Advanced PNET

What Was Tested

This registered phase 2 trial tested Pasireotide.

This study will estimate the treatment effect of everolimus in combination with pasireotide LAR relative to everolimus alone on progression-free survival (PFS) in patients with advanced progressive PNET.

A planned primary analysis was completed with data cut of 02-Apr-2014.

The study did not meet its primary objective, which was based on progression-free survival (PFS) as per local radiology assessment and was prematurely terminated with the last patient last visit on 19-Feb-2015.

It had two arms (groups): Paseriotide LAR + Everolimus (experimental) and Everolimus (experimental).

The registry classes the interventions as drug.

Who Took Part

160 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: Advanced histologically confirmed well differentiated pancreatic neuroendocrine tumor. Progressive disease within the last 12 months. Measurable disease per RECIST Version 1.0 determined by multiphase MRI or triphasic CT.

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: patients currently requiring somatostatin analog treatment; prior therapy with mtor inhibitors or pasireotide; patients with more than 2 prior systemic treatment regimens.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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

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

Being open-label, the Pasireotide study did not mask who received what.

It started in 2011-06 with completion listed for 2015-02.

It ran at 47 sites in Belgium (5), France (5), United States (4), Hungary (3), Italy (3) and Spain (3).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Progression-free Survival (PFS) Per Local Radiological Review (time frame: Once 80 PFS events had occurred aproximately after 24 months).

It also tracked 11 secondary outcomes, for example Safety and Tolerability Profile of Everolimus Alone or in Combination With Pasireotide LAR, Objective Response Rate (ORR) as Per Radiology Review, Duration of Response (DoR), Overall Survival (OS) Using Kaplan Meier Method, PFS and the Predictive Probability of Success in Phase III and Disease Control Rate (DCR) as Per Radiology Review.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Pasireotide in 160 people.

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

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