Lanreotide 120mg Effectiveness in Subjects With Pancreatic Neuroendocrine Tumours (PanNET) in Routine Clinical Practice.

NCT ID: NCT03947762

Last Updated: 2021-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

54 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-03

Study Completion Date

2021-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pancreatic Neuroendocrine Tumor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ipsen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ipsen Medical Director

Role: STUDY_DIRECTOR

Ipsen

Locations

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IPO Coimbra

Coimbra, , Portugal

Site Status

IPO Lisboa

Lisbon, , Portugal

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Hospital São João

Porto, , Portugal

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Hospital General de Alicante

Alicante, , Spain

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Hospital Torrecardenas

Almería, , Spain

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Hospital Universitario de Badajoz

Badajoz, , Spain

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ICO Badalona

Badalona, , Spain

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Hospital de Cruces

Barakaldo, , Spain

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Hospital Universitario Vall Hebrón

Barcelona, , Spain

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Hospital Santa Creu I Sant Pau

Barcelona, , Spain

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Hospital Basurto

Bilbao, , Spain

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Hospital Universitario de Burgos

Burgos, , Spain

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Hospital Universitario Puerto Real

Cadiz, , Spain

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Hospital San Pedro de Alcántara

Cáceres, , Spain

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Hospital General Ciudad Real

Ciudad Real, , Spain

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Hospital Universitario Reina Sofia

Córdoba, , Spain

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Hospital Donostia

Donostia / San Sebastian, , Spain

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Hospital Virgen de las Nieves

Granada, , Spain

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Hospital Juan Ramón Jimenez

Huelva, , Spain

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Hospital Can Misses

Ibiza Town, , Spain

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Hospital de Jerez

Jerez de la Frontera, , Spain

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ICO Bellvitge

L'Hospitalet de Llobregat, , Spain

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Hospital U. de Gran Canaria Negrín

Las Palmas de Gran Canaria, , Spain

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Hospital Virgen de La Victoria

Málaga, , Spain

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Hospital Clínico U. Virgen de la Arrixaca

Murcia, , Spain

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Hospital Morales Meseguer

Murcia, , Spain

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Hospital Santa María Nai

Ourense, , Spain

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Hospital Universitario Central de Asturias

Oviedo, , Spain

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Hospital Son Espases

Palma de Mallorca, , Spain

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Hospital de Navarra

Pamplona, , Spain

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Hospital Sant Joan de Reus

Reus, , Spain

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Corporació Sanitària Parc Taulí

Sabadell, , Spain

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Hospital Clínico de Salamanca

Salamanca, , Spain

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Hospital U. Nuestra Señora de Candelaria

Santa Cruz de Tenerife, , Spain

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Hospital Marqués de Valdecillas

Santander, , Spain

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Hospital Conxo

Santiago de Compostela, , Spain

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Hospital General de Segovia

Segovia, , Spain

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Hospital Virgen Macarena

Seville, , Spain

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Hs. Virgen del Rocio

Seville, , Spain

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Hospital Mutua Terrassa

Terrassa, , Spain

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Hospital Virgen de la Salud Toledo

Toledo, , Spain

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Hospital General de Valencia

Valencia, , Spain

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Hospital Universitario y Politécnico La Fe

Valencia, , Spain

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Hospital Álvaro Cunqueiro

Vigo, , Spain

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Hospital Lozano Blesa

Zaragoza, , Spain

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Hospital Miguel Servet

Zaragoza, , Spain

Site Status

Countries

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Portugal Spain

Other Identifiers

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IPS-LAN-2018-01

Identifier Type: OTHER

Identifier Source: secondary_id

A-ES-52030-383

Identifier Type: -

Identifier Source: org_study_id

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