Phase II Study of Everolimus Combined With Octreotide LAR to Treat Advanced GI NET

What Was Tested

The trial (phase 2) is built around Octreotide.

Both types of inhibition would completely cancel this signal transduction pathway, which is so important in neuroendocrine tumours.

Furthermore, the biological study proposed in this protocol will allow for better establishing the relationship between the activation of the IGFR-PI3K-mTOR signal transduction pathway (i.e., the mTOR pathway stimulated by IGFR) and treatment response; this information is relevant since the IGFR-PI3K-mTOR activation status could be a response prediction factor.

It had 1 arm (groups): Everolimus + Octreotide LAR treatment (experimental).

The registry classes the interventions as drug.

More on the Plan

Everolimus has been developed following two administration regimens: weekly and daily.

These factors can be better outlined in a phase II study, where patients who have received fewer previous treatments can respond better, and where the profile of responders and non-responders can be identified more easily.

Who Took Part

The registry lists 43 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 non-operable or metastatic non-functioning, well differentiated advanced GI NET, confirmed by cytology or histology. In case of liver metastasis, neuroendocrine tumours of unknown origin are accepted. Confirmation of diagnosis of neuroendocrine carcinoma of low to intermediate histology grade. Adequate bone marrow. liver and renal function.

The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: previous treatment with mtor inhibitors (sirolimus, temsirolimus, everolimus, deforolimus); patients with any serious disease and/or an uncontrolled clinical condition; patients on chronic treatment with corticosteroids or any other immunosuppressive agent.

How the Study Was Run

The set-up was 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 2011-06-08 with completion listed for 2014-09-01.

It ran at 1 site in Spain.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Percentage of patients with progression-free survival (PFS) (time frame: After 12 month of study treatment).

It also tracked 5 secondary outcomes, for example Number of patients positive for insulin like growth factor 1 receptor (IGF1R) and ribosomal kinase S6 (S6K) phosphorylation, Rate of patients with objective responses, Median and average of time for Overall survival and Percentage of patients with Adverse Events.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Octreotide in 43 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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