Activity and Safety of Everolimus+Octreotide LAR+Metformin in Advanced Pancreatic Well-differentiated NETs

What Was Tested

The trial (phase 2) is built around Octreotide.

Abnormal PI3K-Akt-mTOR (mammalian target of rapamycin) pathway signaling and autocrine activation of the mTOR pathway, mediated through insulin-like growth factor 1 (IGF1), has been implicated in the proliferation of pNET ( primitive neuroectodermal tumor) cells.

It had 1 arm (groups): everolimus+octreotide LAR+metformin (experimental).

Everolimus+octreotide LAR+metformin.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 26 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: Signature of written informed consent (approved by the Institutional Ethics Committee Independent ) obtained after a careful study of screening procedures. Age \>= 18 years old. Patients with histological evidence of pNET well-differentiated G1 -G2. Configurable tumor disease (according to RECIST (Response Evaluation Criteria In Solid Tumors) ) . Life expectancy greater than 6 months.

The full record lists 16 inclusion and 17 exclusion criteria; among the exclusions: patients with histological evidence of malignant insulinoma ( pnet ); surgeries performed within 28 days prior to the start of treatment; active or uncontrolled severe infections .

How the Study Was Run

Design: single-group and open-label.

Being open-label, the Octreotide 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 2014-06 with completion listed for 2021-06.

It ran at 1 site in Italy.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: to determine the progression free survival rate (PFS) at 12 months from the first drug administration in patients with advanced pancreatic neuroendocrine tumors (time frame: 1 year).

It also tracked 4 secondary outcomes, for example to determine the overall survival of the combination of Everolimus, Octreotide LAR and Metformin, to determine the response rate of the combination of Everolimus, Octreotide LAR and Metformin and to determine the biochemical response of the combination of Everolimus, Octreotide LAR and Metformin.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Octreotide in 26 people.

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

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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