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Efficacy and Safety Study in Pancreatic or Midgut Neuroendocrine Tumours Having Progressed Radiologically While Previously Treated With Lanreotide Autogel® [amount hidden]
Plain-language guide to NCT02651987: phase 2 interventional trial of Lanreotide, 99 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02651987
- Phase
- phase 2
- Status
- completed
- Start
- 2015-12-15
- Completion (planned or actual)
- 2019-10-16
- Participants
- 99 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Pancreatic Tumours; Midgut Neuroendocrine Tumours
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
In this phase 2 trial, researchers set out to test Lanreotide.
It had 1 arm (groups): Lanreotide Autogel® (experimental).
The registry classes the interventions as drug.
Who Took Part
99 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: Positive somatostatin receptors type 2.
The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: grade 3 or rapidly progressive (within 12 weeks) net; any net other than pancreatic and midgut; symptomatic gallbladder lithiasis at screening echography or history of cholelithiasis with no cholecystectomy since then.
How the Study Was Run
Design: single-group and open-label.
Being open-label, the Lanreotide 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 2015-12-15 with completion listed for 2019-10-16.
It ran at 32 sites in Italy (5), Belgium (4), France (4), Spain (4), Germany (3) and Netherlands (3).
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Median Progression Free Survival (PFS) (time frame: From Day 1 up to Week 60 for the panNET cohort and Week 103 for the midgut NET cohort).
It also tracked 16 secondary outcomes, for example Median Time to Progression, Percentage of Subjects Alive and Progression Free, Overall Survival, Objective Response Rate (ORR), Disease Control Rate (DCR) and Best Overall Response Rate.
What This Means in Plain Language
Put simply, this is a phase 2 trial of Lanreotide in 99 people.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
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.