A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With GEP-NET

What Was Tested

The trial (phase 3) is built around Octreotide and Lanreotide.

Patients who experience progressive disease in the randomized part of the study may proceed to an open-label extension part with intensified treatment with CAM2029.

It had two arms (groups): CAM2029 (experimental) and Octreotide LAR or lanreotide ATG (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 332 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 patient ≥18 years old. Histologically confirmed, advanced (unresectable and/or metastatic), and well-differentiated NET of GEP or presumed GEP origin. At least 1 measurable, somatostatin receptor-positive lesion according to RECIST 1.1 determined by multiphasic CT or MRI (performed within 28 days before randomization). ECOG performance status of 0 to 2.

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: documented evidence of disease progression while on treatment (including ssas) for locally advanced unresectable or metastatic disease; known central nervous system metastases; consecutive treatment with long-acting ssas for more than 6 months before randomization.

How the Study Was Run

Design: randomized, parallel-group and open-label.

The participants were allocated by chance, so the Octreotide group and the comparison group should start out alike.

The Octreotide group and the comparison group ran side by side rather than switching.

Being open-label, the Octreotide study did not mask who received what.

It started in 2021-10-22 with completion listed for 2026-11.

It ran at 86 sites in United States (15), Spain (15), Italy (11), Canada (8), France (8) and Germany (7).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Progression-free survival (PFS) as assessed by a Blinded Independent Review Committee (BIRC).

It also tracked 7 secondary outcomes, for example Overall survival, PFS as assessed by local Investigators, Overall response rate, Disease control rate, Time to tumor response and Duration of response.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Octreotide and Lanreotide in 332 people.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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