Completed
CLARINET FORTEEfficacy and Safety of Lanreotide Autogel® 120 mg Administered Every 14 Days in Well Differentiated, Metastatic or Locally Advanced, Unresectable Pancreatic or Midgut Neuroendocrine Tumours Having Progressed Radiologically While Previously Treated With Lanreotide Autogel® 120 mg Administered Every 28 Days
What is being tested
Lanreotide autogel 120 mg
Drug
Who is being recruted
Over 18 Years
+7 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 2
Interventional
Study Start: December 2015
Summary
Principal SponsorIpsen
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: December 15, 2015
Actual date on which the first participant was enrolled.This study aims to explore the efficacy and safety of lanreotide Autogel® 120 mg administered every 14 days in subjects with grade 1 or 2, metastatic or locally advanced, unresectable pancreatic or intestinal neuroendocrine tumours (NETs) once they have progressed on the standard dose of lanreotide Autogel® 120 mg every 28 days.
Official TitleEfficacy and Safety of Lanreotide Autogel® 120 mg Administered Every 14 Days in Well Differentiated, Metastatic or Locally Advanced, Unresectable Pancreatic or Midgut Neuroendocrine Tumours Having Progressed Radiologically While Previously Treated With Lanreotide Autogel® 120 mg Administered Every 28 Days
Principal SponsorIpsen
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
99 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
3 inclusion criteria required to participate
Histopathologically confirmed, grade 1 or 2, metastatic or locally advanced, unresectable pNET (pNET cohort) or midgut NET (midgut cohort) with or without hormone related syndromes, with a proliferation index (Ki67) ≤20%.
Positive somatostatin receptors type 2
Progression as assessed by an independent central reviewer according to RECIST v1.0 while receiving first line treatment with lanreotide Autogel® at a standard dose of 120 mg every 28 days for at least 24 weeks
4 exclusion criteria prevent from participating
Grade 3 or rapidly progressive (within 12 weeks) NET
Any NET other than pancreatic and midgut
Previous treatment with any antitumour agent for NET other than lanreotide Autogel® 120 mg every 28 days. Exception made of prior treatment with Octreotide at standard dose stopped for other reason than disease progression.
Symptomatic gallbladder lithiasis at screening echography or history of cholelithiasis with no cholecystectomy since then.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalOne subcutaneous (SC) injection of lanreotide Autogel® 120mg every 14 days until disease progression or death or unacceptable toxicity or tolerability.
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 32 locations
Suspended
Suspended
Erasme Hospital
Brussels, BelgiumSuspended
Cliniques Unversitaires Saint Luc
Brussels, BelgiumSuspended
Antwerp University Hospital
Edegem, BelgiumCompleted32 Study Centers