Safety and Tolerability of Pasireotide LAR in Combination With Everolimus in Advanced Metastatic NETs

What Was Tested

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

The purpose of this study is to assess the safety and tolerability of pasireotide LAR in combination with everolimus in advanced metastatic gastroenteropancreatic or pulmonary neuroendocrine Tumors (NET).

It had six arms (groups): Functional tumors, pre-treated (experimental), Functional tumors, treatment naïve (experimental), Nonfunctional tumors, pretreated 1 (experimental), Nonfunctional tumors, pretreated 2 (experimental) and Nonfunctional tumors, treatment-naïve 1 (experimental).

The registry classes the interventions as drug.

Who Took Part

36 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: Confirmed diagnosis of grade 1/2 advanced pulmonary or gastroenteropancreatic neuroendocrine tumor. Progressive disease within last 12 months (only patients with nonfunctional tumors). Documented liver metastasis. Measurable disease per RECIST determined by multiphase MRI or triphasic CT.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: previous treatment with radiolabeled somatostatin analogs within 12 months prior to reporting baseline symptoms; previous treatment with mtor inhibitors or pasireotide; patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study.

How the Study Was Run

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

Because people in this Pasireotide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

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

It started in 2010-11 with completion listed for 2014-03.

It ran at 4 sites in Germany (4).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Evaluate safety and tolerability profile of pasireotide LAR in combination with everolimus in patients with advanced metastatic NET (time frame: 3 months).

It also tracked 5 secondary outcomes, for example Evaluate safety and tolerability of pasireotide LAR and/or everolimus in patients with advanced metastatic NET, To assess potential drug-drug interactions between pasireotide and everolimus during combination therapy and To assess the biochemical response (chromograninA, CgA) to pasireotide LAR in combination with everolimus.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Pasireotide in 36 people.

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

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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