Phase II Trial of SOM230 in Patients With Unresectable Hepatocellular Carcinoma

What Was Tested

This registered phase 2 trial tested Pasireotide.

The hypothesis of this clinical trial is that hepatocellular carcinomas contain somatostatin receptors which make them sensitive to the inhibitory effects of a new somatostatin analog, SOM230.

This analog has greater and broader binding affinity to somatostatin receptors compared to the current drug in use, sandostatin LAR.

It had 1 arm (groups): SOM230 (experimental).

The registry classes the interventions as biological.

More on the Plan

Patients will receive SOM230C (IM) as an outpatient and will be observed for at least 30 minutes for any immediate adverse reactions.

Toxicity checks will be done every 2 weeks and laboratory tests every 4 weeks during study therapy).

Toxicities will be graded using the Common Terminology Criteria for Adverse Events, version 4.02.

Therapy will continue for maximum of two years if the patient shows no evidence of disease progression or intolerable toxicity.

Who Took Part

The registry lists 20 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: Diagnosis of unresectable HCC by either:. Elevated serum Alpha-fetoprotein (AFP) \>400 ng/ml and findings on magnetic resonance imaging (MRI) or CT scans characteristic of a primary liver tumor. Findings on MRI or CT scans characteristic of a primary liver tumor in patients with cirrhosis. Tumors at least 1 cm or greater. Age ≥ 18 years.

The full record lists 19 inclusion and 29 exclusion criteria; among the exclusions: prior octreotide therapy or any somatostatin analog; chronic treatment with systemic steroids or another immunosuppressive agent; uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases.

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 2012-07 with completion listed for 2016-08.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Disease Control Rate (DCR) (time frame: At least 2 cycles, about 8 weeks).

It also tracked 5 secondary outcomes, for example Rate of Progression-Free Survival (PFS):, Rate of Overall Survival (OS), Overall Response Rate (ORR), Duration of Overall Response and Toxicity Profile of Protocol Therapy.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Pasireotide in 20 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.