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)
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