NCT03947762TerminatedNot Applicable
Lanreotide 120 mg Effectiveness in Subjects With Locally Advanced or Metastatic Pancreatic Neuroendocrine Tumours (PanNET) in Routine Clinical Practice
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Ipsen
- Enrollment
- 54
- Locations
- 46
- Primary Endpoint
- Progression-free survival (PFS) rate at 24 months
Study Overview
Brief Summary
The purpose of the protocol is to estimate the progression-free survival (PFS) rate in subjects diagnosed with PanNET, according to investigator assessment, at 24 months after treatment initiation with lanreotide 120 mg every 28 days.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subjects aged ≥ 18
- •Subjects diagnosed of functioning or non-functioning PanNET, G1/ G2 (Ki67≤10%) unresectable locally advanced tumour or metastatic disease, who have been treated with lanreotide 120mg every 28 days for at least 3 months and a maximum of 12 months
- •Subject not progressive at inclusion study visit according to investigator assessment, and using as a reference lanreotide initiation
- •Subject with Eastern Cooperative Oncology Group (ECOG) ≤2
Exclusion Criteria
- •Subject who is participating in an interventional study
- •Pregnant or breast-feeding women
- •Subject who has received any previous therapy for PanNET (such as octreotide LAR, Molecular Targeted Therapy (MTT), Peptide receptor radionuclide therapy (PRRT), chemotherapy, etc.) except short-acting octreotide subcutaneous (SC) used for symptomatic control of functioning tumours
Outcomes
Primary Outcomes
Progression-free survival (PFS) rate at 24 months
Time Frame: 24 months
To estimate the progression-free survival (PFS) rate in subjects diagnosed with PanNET, according to investigator assessment.
Secondary Outcomes
- Changes of urine 5-Hydroxyindoleacetic Acid (5-HIAA) levels(Every 6 months up to 24 months)
- Changes of Chromogranin A (CgA) levels(Every 6 months up to 24 months)
- Progression-free survival (PFS) rate at 12 months(12 months)
- Medical tumour-related intervention(Baseline)
- Changes of pro-Brain Natriuretic Peptide (proBNP) levels(Every 6 months up to 24 months)
- Time from diagnosis to first therapeutic intervention(Baseline)
- Median time to lanreotide discontinuation(Up to 24 months)
- Changes of Glycated hemoglobin (HbA1c) levels(Every 6 months up to 24 months)
- Quality of Life (QoL)(From baseline up to 24 months)
- Patient satisfaction(Baseline visit and 12 months)
Investigators
Study Sites (46)
Loading locations...
Similar Trials
Completed
Phase 2
Efficacy and Safety of Lanreotide 120 Milligram (mg) as a Palliative Treatment of Clinical Symptoms Associated With Malignant Intestinal Obstruction in Inoperable PatientsMalignant Intestinal ObstructionNCT01076803University Hospital, Ghent40
Completed
Phase 2
A Randomised Placebo-Controlled Phase II Study of Continuous Maintenance Treatment With BIBF 1120 Following Chemotherapy in Patients With Relapsed Ovarian CancerOvarian NeoplasmsNCT00710762Boehringer Ingelheim89
Withdrawn
Not Applicable
Study to Assess the Use of Lanreotide Autogel® 120 mg in Patients With Locally Advanced or Metastatic Gastroenteropancreatic Neuroendocrine Tumours (GEP-NETs) in Routine Clinical PracticeNeuroendocrine TumorsNCT03895463Ipsen
Completed
Not Applicable
Somatuline Predictive Factors in Acromegaly and NETNeuroendocrine TumoursAcromegalyNCT01840449Ipsen156
Active, not recruiting
Phase 3
Relacorilant in Combination With Nab-Paclitaxel in Advanced, Platinum-Resistant, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube CancerOvarian NeoplasmFallopian Tube NeoplasmsPeritoneal NeoplasmsNCT05257408Corcept Therapeutics381