Pasireotide, Everolimus and Selective Internal Radioembolization Therapy for Unresectable Hepatic Metastases

What Was Tested

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

The purpose of this study is to see the safety and activity of using pasireotide, everolimus and radioembolization (Selective Internal Radioembolization Therapy-SIRT) in the treatment of neuroendocrine tumors (carcinoid) that has spread to the liver.

Both everolimus or radioembolization are considered "standard of care" regimens in patients with liver lesions from neuroendocrine tumors.

However, the use of the combination of everolimus and radioembolization has not been formally evaluated in the setting of a clinical trial.

It had 1 arm (groups): Sir-sphere radioembolization (experimental).

Everolimus, Pasireotide and Sir-sphere radioembolization.

The registry classes the interventions as drug and procedure.

More on the Plan

Liver metastasis remain a major challenge in the care of patients with Neuroendocrine Tumors (NET).

This study is evaluating the combination of systemic therapies plus radioembolization for the treatment of liver metastasis from NET.

The study allows pancreatic and intestinal NET that have spread to the liver.

Who Took Part

The registry lists 13 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 low to intermediate grade neuroendocrine tumors with unresectable liver metastasis. Prior treatment permitted include: surgery, prior systemic therapies (≤ 2 prior lines of chemotherapy), or radiation therapy. Patients must have measurable disease by RECIST 1.1 criteria. For the patients in the phase Ib study, neuroendocrine tumor must involve both liver lobes. Minimum of four weeks since any major surgery, completion of radiation, or completion of all prior systemic anticancer therapy (adequately recovered from the acute toxicities of any prior therapy).

The full record lists 20 inclusion and 36 exclusion criteria; among the exclusions: evidence of ascites, cirrhosis, portal hypertension or portal vein thrombosis; prior radiation to the upper abdomen; contraindications to angiography.

How the Study Was Run

It was run as a single-group and open-label study.

Everyone knew when Pasireotide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

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

It started in 2011-12 with completion listed for 2018-10.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Evaluate the number of patients who develop side effects from combination therapy (time frame: 1 month).

It also tracked 1 secondary outcome, for example Compare the size of the tumor before and three months after treatment using cross sectional imaging (CT ro MRI).

What This Means in Plain Language

Put simply, this is a phase 1 trial of Pasireotide in 13 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.