Study Stopped
Low enrollment
Lanreotide 120mg Effectiveness in Subjects With Pancreatic Neuroendocrine Tumours (PanNET) in Routine Clinical Practice.
PanNET
Lanreotide 120 mg Effectiveness in Subjects With Locally Advanced or Metastatic Pancreatic Neuroendocrine Tumours (PanNET) in Routine Clinical Practice
2 other identifiers
observational
54
2 countries
46
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2019
46 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 10, 2019
CompletedFirst Posted
Study publicly available on registry
May 13, 2019
CompletedStudy Start
First participant enrolled
July 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2021
CompletedJune 14, 2021
June 1, 2021
1.8 years
May 10, 2019
June 9, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-free survival (PFS) rate at 24 months
To estimate the progression-free survival (PFS) rate in subjects diagnosed with PanNET, according to investigator assessment.
24 months
Secondary Outcomes (10)
Progression-free survival (PFS) rate at 12 months
12 months
Medical tumour-related intervention
Baseline
Time from diagnosis to first therapeutic intervention
Baseline
Quality of Life (QoL)
From baseline up to 24 months
Median time to lanreotide discontinuation
Up to 24 months
- +5 more secondary outcomes
Eligibility Criteria
Hospital patients
You may qualify if:
- 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 with Eastern Cooperative Oncology Group (ECOG) ≤2
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (46)
IPO Coimbra
Coimbra, 300-075, Portugal
IPO Lisboa
Lisbon, 1099-023, Portugal
Hospital São João
Porto, 4200-319, Portugal
Hospital General de Alicante
Alicante, 03010, Spain
Hospital Torrecardenas
Almería, 04009, Spain
Hospital Universitario de Badajoz
Badajoz, 06010, Spain
ICO Badalona
Badalona, 08916, Spain
Hospital de Cruces
Barakaldo, 48903, Spain
Hospital Universitario Vall Hebrón
Barcelona, 08035, Spain
Hospital Santa Creu I Sant Pau
Barcelona, Spain
Hospital Basurto
Bilbao, 48013, Spain
Hospital Universitario de Burgos
Burgos, 09006, Spain
Hospital Universitario Puerto Real
Cadiz, 11510, Spain
Hospital San Pedro de Alcántara
Cáceres, 10003, Spain
Hospital General Ciudad Real
Ciudad Real, 13005, Spain
Hospital Universitario Reina Sofia
Córdoba, 14004, Spain
Hospital Donostia
Donostia / San Sebastian, 20014, Spain
Hospital Virgen de las Nieves
Granada, 18014, Spain
Hospital Juan Ramón Jimenez
Huelva, 21005, Spain
Hospital Can Misses
Ibiza Town, 07800, Spain
Hospital de Jerez
Jerez de la Frontera, 11407, Spain
ICO Bellvitge
L'Hospitalet de Llobregat, 08908, Spain
Hospital U. de Gran Canaria Negrín
Las Palmas de Gran Canaria, 35010, Spain
Hospital Virgen de La Victoria
Málaga, 29010, Spain
Hospital Clínico U. Virgen de la Arrixaca
Murcia, 30120, Spain
Hospital Morales Meseguer
Murcia, Spain
Hospital Santa María Nai
Ourense, 32005, Spain
Hospital Universitario Central de Asturias
Oviedo, 33011, Spain
Hospital Son Espases
Palma de Mallorca, 07120, Spain
Hospital de Navarra
Pamplona, 31008, Spain
Hospital Sant Joan de Reus
Reus, 43204, Spain
Corporació Sanitària Parc Taulí
Sabadell, Spain
Hospital Clínico de Salamanca
Salamanca, 37007, Spain
Hospital U. Nuestra Señora de Candelaria
Santa Cruz de Tenerife, 38010, Spain
Hospital Marqués de Valdecillas
Santander, 39008, Spain
Hospital Conxo
Santiago de Compostela, 15706, Spain
Hospital General de Segovia
Segovia, 40002, Spain
Hospital Virgen Macarena
Seville, 41009, Spain
Hs. Virgen del Rocio
Seville, 41013, Spain
Hospital Mutua Terrassa
Terrassa, 08221, Spain
Hospital Virgen de la Salud Toledo
Toledo, 45004, Spain
Hospital General de Valencia
Valencia, 46014, Spain
Hospital Universitario y Politécnico La Fe
Valencia, 46014, Spain
Hospital Álvaro Cunqueiro
Vigo, 36312, Spain
Hospital Lozano Blesa
Zaragoza, 50009, Spain
Hospital Miguel Servet
Zaragoza, 50009, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ipsen Medical Director
Ipsen
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 10, 2019
First Posted
May 13, 2019
Study Start
July 3, 2019
Primary Completion
April 30, 2021
Study Completion
April 30, 2021
Last Updated
June 14, 2021
Record last verified: 2021-06