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The MetNET-2 Trial
Plain-language guide to NCT02823691: early phase 1 interventional trial of Lanreotide, 20 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02823691
- Phase
- early phase 1
- Status
- status unknown
- Start
- 2016-04
- Completion (planned or actual)
- 2021-12
- Participants
- 20 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Neuroendocrine Tumors
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this early phase 1 trial, researchers set out to test Lanreotide.
The patient population will include patients with a histologically documented diagnosis of Well differentiated NET, G1-G2 according to the last WHO Classification criteria for GI and lung NET carcinoids.
It had 1 arm (groups): Lanreotide and Metformin (experimental).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 20 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: Adult patients (male or female, age \> 18 years). Patients with a histologically documented diagnosis of advanced well differentiated (G1 and G2) GI or lung carcinoids, defined according to the last WHO Classification criteria for NET. Tumor tissue available for analysis. Measurable disease and disease progression in the 6 months before study inclusion (according to RECIST vs 1.1), documented and appropriate imaging. Patient who has received prior treatment with surgery or chemotherapy or somatostatin analogues or m-TOR inhibitors or other systemic antineoplastic/target therapies.
The full record lists 22 inclusion and 18 exclusion criteria; among the exclusions: surgery performed within 28 days prior to the beginning of study treatment; brain metastasis or spinal cord compression; type-1 diabetes.
How the Study Was Run
Design: single-group and open-label.
Everyone knew when Lanreotide 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 2016-04 with completion listed for 2021-12.
It ran at 1 site in Italy.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: incidence of SAEs and AEs (time frame: 1 year).
What This Means in Plain Language
Put simply, this is a early phase 1 trial of Lanreotide in 20 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 Lanreotide compound page, all human trials.
Our Notes on the Compound
Lanreotide: A long-acting 8-amino-acid somatostatin analog (Somatuline Depot) in the same class as octreotide.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.