RAD001 (Everolimus) and Pasireotide (SOM230) LAR in Patients With Advanced Uveal Melanoma

What Was Tested

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

The purpose of this study is to find out what effects, good and/or bad, the drugs everolimus and pasireotide have on the patient and on melanoma.

Pasireotide is also called SOM-230.

Pasireotide is an experimental drug and is not approved by the Food and Drug Administration.

It had 1 arm (groups): RAD001 and pasireotide LAR (experimental).

This study will be an open-label, single-arm, phase II study of RAD001 and pasireotide LAR.

The registry classes the interventions as drug.

Who Took Part

The registry lists 14 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: Patients must have histologically or cytologically confirmed metastatic uveal melanoma. Life expectancy of greater than 3 months. ECOG performance status 0 or 1. Patients must have normal organ and marrow function as defined below:. Leukocytes \> or = to 3,000/mcL.

The full record lists 19 inclusion and 22 exclusion criteria; among the exclusions: patients may not be receiving any other investigational agents; history of allergic reactions attributed to compounds of similar chemical or biologic composition to rad001 or som230; baseline qtc \> 450 ms.

How the Study Was Run

Design: single-group and open-label.

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

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

It started in 2010-11 with completion listed for 2016-06.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of Participants With Complete Response (CR) (time frame: at 16 weeks). Number of Participants With Partial Response (PR) (time frame: at 16 weeks). Number of Participants With Stable Disease (SD) (time frame: at 16 weeks).

It also tracked 3 secondary outcomes, for example Median Progression Free Survival(PFS), Safety and Toxicity in This Patient Population and Median Overall Survival (OS).

What This Means in Plain Language

Put simply, this is a phase 2 trial of Pasireotide in 14 people.

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

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

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