Octreotide LAR in the Induction of Immunologic Response in NENs Patients

What Was Tested

This registered phase 2 trial tested Octreotide.

Evaluating the impact of OCTREOTIDE LAR on the immune response by studying Regulatory T-cell (T-Reg) and Myeloid-derived suppressor cells (MDSC) and the immunoregulatory cell population in peripheral blood of NET G1 / G2 patients treated with Octreotide LAR.

It had 1 arm (groups): OCTREOTIDE LONG-ACTING RELEASE (OCT LAR) (other).

OCT LAR is already registered By FDA for USA, by EMA for Europe and , also, by AIFA for Italy.

The registry classes the interventions as drug.

More on the Plan

MDSCs and T-Regs will be evaluated at baseline pre-treatment with octreotide, after 15 days, at three and at six months and before each octreotide LAR administration for 12 months.

MDSC cells will be detected by surface receptors LIN-, CD11b, CD14, CD15, CD33, CD124-IL4-Ra, CD184-CXCR4, CD279-PD1, HLA-DR and T-reg cells from CD3, CD4, CD8 receptors , CD25, CD39, CD45RA, CD45R0, CD62L, CD127, CD152-CTLA-4, CD184-CXCR4, CD278-ICOS, CD279-PD-1.

Briefly, CD4 + cells will be separated by negative selection, using the mixture of human CD4 antibodies.

Octreotide is currently a registered drug to the FDA, EMA and AIFA with the indication for the treatment of well and moderately differentiated NETs functioning and not working on the front line. .

Who Took Part

The registry lists 34 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: Signed informed consent prior to initiation of any study-specific procedures or treatment, as confirmation of the patients awareness and willingness to comply with the study requirements. Patients ≥18 years of age. ECOG performance status (PS) of 0-2. At least 28 days since prior the last radiation therapy or surgery. Estimated life expectancy of ≥12 weeks.

The full record lists 6 inclusion and 9 exclusion criteria; among the exclusions: patients \< 18 years of age; according to the current smpc of the prescribed drug agent; previuos treatment with octreotide.

How the Study Was Run

It was run as a single-group and open-label study.

Nothing was hidden in this open-label Octreotide study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2017-06-28 with completion listed for 2019-12-01.

It ran at 1 site in Italy.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Exploring the changes in immune-regulatory cells induced by OCT LAR (time frame: 6 months).

It also tracked 2 secondary outcomes, for example Outcome and safety assessment.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Octreotide in 34 people.

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

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.