Phase II Study of SOM230 in Patients With Recurrent or Progressive Meningioma

What Was Tested

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

This is a single-arm, phase II trial of SOM230 in patients with documented recurrent or progressive intracranial meningioma who have failed conventional therapy and are not candidates for complete surgical resection of their tumors and/or radiation at the time of study entry.

At the time of the final analysis, all patients who are receiving treatment with SOM230 will complete the core phase of the study and will continue on the extension phase.

During this time, additional data on response duration, PFS, and safety will be collected.

It had 1 arm (groups): All participants (experimental).

The registry classes the interventions as drug.

More on the Plan

SOM230 (pasireotide) is a novel somatostatin analogue with affinity for multiple somatostatin receptors.

Compared to octreotide (Sandostatin®), SOM230 binds to a wider spectrum of somatostatin receptors, including subtypes 1, 2, 3, and 5, and possesses as a higher binding affinity for subtypes 1, 3, and 5).

In recently completed studies with SOM230 in patients with Cushing's disease and acromegaly, clinical responses have been documented in patients who were refractory to Sandostatin.

The researchers therefore, propose a formal phase II trial of SOM230 (pasireotide) in patients with recurrent or progressive meningiomas who have already undergone or are not candidates for additional surgery or radiation.

Who Took Part

2 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: Male or female patients aged 18 years or greater. Karnofsky Performance Status ≥ 60 (Requires occasional assistance, but is able to care for most of his/her personal needs.). Serum chemistries are as follows: bilirubin ≤ 1.5 X ULN, ALT or AST ≤ 2.5 X ULN, BUN ≤ 1.5X ULN, creatinine ≤ 1.5 X ULN. Signed informed consent.

The full record lists 6 inclusion and 22 exclusion criteria; among the exclusions: patients receiving any cytotoxic chemotherapy, radiation or immunotherapy within 4 weeks prior to study enrollment; patients who have undergone major surgery within 4 weeks(other than diagnostic surgery) or have not fully recovered, prior to study enrollment; patients with malabsorption syndrome, short bowel syndrome, or chologenic diarrhea not controlled by specific therapeutic means.

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 2008-11 with completion listed for 2013-03.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Objective Response Rate (ORR) of SOM230 Monotherapy in Meningioma (time frame: November 2011).

It also tracked 5 secondary outcomes, for example To Determine the Duration of Response to SOM230, To Establish the 6-month Progression-free Survival Rate, To Establish the Median PFS and Overall Survival (OS) and To Characterize the Safety and Tolerability of SOM230.

What This Means in Plain Language

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

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

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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