Study of Pasireotide Long Acting Release (LAR) in Patients With Metastatic Neuroendocrine Tumors (NETs)

What Was Tested

This registered phase 2 trial tested Pasireotide.

It had 1 arm (groups): Pasireotide LAR Treatment (experimental).

The registry classes the interventions as drug.

More on the Plan

This is a multi-institutional, prospective phase II open-label trial.

Pasireotide will be administered as an intramuscular injection at the beginning of every cycle which is defined as 28 days (+/- 3 days).

Study treatment should begin within 14 days following enrollment into the study and continue until disease progression, unacceptable toxicity, or withdrawal of consent.

Who Took Part

29 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: Locally unresectable or metastatic carcinoid or pancreatic neuroendocrine tumors. Tumors must be considered well or moderately differentiated (or low to intermediate grade). Patients with poorly differentiated neuroendocrine carcinomas or small cell carcinomas are excluded from the study. Minimum of four weeks since any major surgery. Measureable disease by Response Evaluation Criteria in Solid Tumors (RECIST). Life expectancy 12 weeks or more.

The full record lists 13 inclusion and 16 exclusion criteria; among the exclusions: uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases; patients with symptomatic cholelithiasis; patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:.

How the Study Was Run

Design: single-group and open-label.

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 2011-02-01 with completion listed for 2021-10-06.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Progression-free Survival (PFS) at One Year (time frame: 12 months).

It also tracked 2 secondary outcomes, for example Overall Radiographic Response Rate (ORR) and Adverse Events Possibly Related to Study Treatment.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Pasireotide in 29 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.