Everolimus and Pasireotide (SOM230) in Patients With Advanced or Metastatic Hepatocellular Carcinoma

What Was Tested

The trial (phase 2) is built around Pasireotide.

The purpose of this study is to estimate the time to disease progression when everolimus and pasireotide are given together in patients with advanced or metastatic HCC who have not had any prior systemic therapy.

It had 1 arm (groups): Everolimus + pasireotide (experimental).

The registry classes the interventions as drug.

More on the Plan

This open label, single-arm Phase II study will assess time to progression (TTP) and safety of everolimus and pasireotide in patients with advanced or metastatic hepatocellular carcinoma (HCC) and limited prior systemic therapy.

At least 30 patients will be enrolled into this Phase II study.

Additionally, given the potential importance of the RAS/RAF/MEK/ERK and RAS/pAKT pathways, the researchers propose to correlate outcomes with baseline pAKT, p-S6, somatostatin receptor tumor expression, and serum VEGF expression.

Who Took Part

24 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: Each subject must meet all of the following inclusion criteria to participate in this study:. Maximum Childs-Pugh score 6 (see Appendix A) with no active encephalopathy. Prior systemic therapy limited to sorafenib that was discontinued due to intolerance. Patients must undergo at least a 4-week washout prior to enrollment. Eastern Cooperative Oncology Group (ECOG) PS of 0-2. Life expectancy of \>12 weeks.

The full record lists 23 inclusion and 34 exclusion criteria; among the exclusions: patients meeting any of the following exclusion criteria at baseline will be excluded from study participation:; patients who have received prior treatment with an mtor inhibitor (e.g., sirolimus, temsirolimus, everolimus) or somatostatin analog (e.g. octeotride); patients with a known hypersensitivity to everolimus or other rapamycins (e.g., sirolimus, temsirolimus) or to its excipients.

How the Study Was Run

Design: single-group and open-label.

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

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

It started in 2011-12 with completion listed for 2015-03.

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

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Time to Progression (TTP) (time frame: 3.5 years).

It also tracked 3 secondary outcomes, for example Number of Individuals Experiencing Toxicity, Overall Survival (OS) and Objective Response Rate (ORR).

What This Means in Plain Language

Put simply, this is a phase 2 trial of Pasireotide in 24 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.