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

June 9, 2021 updated by: Ipsen

Lanreotide 120 mg Effectiveness in Subjects With Locally Advanced or Metastatic Pancreatic Neuroendocrine Tumours (PanNET) in Routine Clinical Practice

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Coimbra, Portugal, 300-075
        • Ipo Coimbra
      • Lisboa, Portugal, 1099-023
        • Ipo Lisboa
      • Porto, Portugal, 4200-319
        • Hospital Sao Joao
  • Spain
      • Alicante, Spain, 03010
        • Hospital General de Alicante
      • Almería, Spain, 04009
        • Hospital Torrecardenas
      • Badajoz, Spain, 06010
        • Hospital Universitario de Badajoz
      • Badalona, Spain, 08916
        • Ico Badalona
      • Baracaldo, Spain, 48903
        • Hospital de Cruces
      • Barcelona, Spain
        • Hospital Santa Creu i Sant Pau
      • Barcelona, Spain, 08035
        • Hospital Universitario Vall Hebrón
      • Bilbao, Spain, 48013
        • Hospital Basurto
      • Burgos, Spain, 09006
        • Hospital Universitario de Burgos
      • Cadiz, Spain, 11510
        • Hospital Universitario Puerto Real
      • Ciudad Real, Spain, 13005
        • Hospital General Ciudad Real
      • Cáceres, Spain, 10003
        • Hospital San Pedro de Alcantara
      • Córdoba, Spain, 14004
        • Hospital Universitario Reina Sofia
      • Donostia, Spain, 20014
        • Hospital Donostia
      • Granada, Spain, 18014
        • Hospital Virgen de las Nieves
      • Hospitalet de Llobregat, Spain, 08908
        • ICO Bellvitge
      • Huelva, Spain, 21005
        • Hospital Juan Ramón Jimenez
      • Ibiza, Spain, 07800
        • Hospital Can Misses
      • Jerez De La Frontera, Spain, 11407
        • Hospital de Jerez
      • Las Palmas De Gran Canaria, Spain, 35010
        • Hospital U. de Gran Canaria Negrín
      • Murcia, Spain
        • Hospital Morales Meseguer
      • Murcia, Spain, 30120
        • Hospital Clínico U. Virgen de la Arrixaca
      • Málaga, Spain, 29010
        • Hospital Virgen de la Victoria
      • Ourense, Spain, 32005
        • Hospital Santa María Nai
      • Oviedo, Spain, 33011
        • Hospital Universitario Central de Asturias
      • Palma De Mallorca, Spain, 07120
        • Hospital Son Espases
      • Pamplona, Spain, 31008
        • Hospital De Navarra
      • Reus, Spain, 43204
        • Hospital Sant Joan de Reus
      • Sabadell, Spain
        • Corporacio Sanitaria Parc Tauli
      • Salamanca, Spain, 37007
        • Hospital Clínico de Salamanca
      • Santa Cruz De Tenerife, Spain, 38010
        • Hospital U. Nuestra Señora de Candelaria
      • Santander, Spain, 39008
        • Hospital Marqués de Valdecillas
      • Santiago De Compostela, Spain, 15706
        • Hospital Conxo
      • Segovia, Spain, 40002
        • Hospital General de Segovia
      • Sevilla, Spain, 41009
        • Hospital Virgen Macarena
      • Sevilla, Spain, 41013
        • Hs. Virgen del Rocio
      • Terrassa, Spain, 08221
        • Hospital Mutua Terrassa
      • Toledo, Spain, 45004
        • Hospital Virgen de la Salud Toledo
      • Valencia, Spain, 46014
        • Hospital General de Valencia
      • Valencia, Spain, 46014
        • Hospital Universitario y Politécnico La Fe
      • Vigo, Spain, 36312
        • Hospital Álvaro Cunqueiro
      • Zaragoza, Spain, 50009
        • Hospital Miguel Servet
      • Zaragoza, Spain, 50009
        • Hospital Lozano Blesa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hospital patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS) rate at 12 months
Time Frame: 12 months
PFS rate at 12 months after lanreotide treatment initiation according to investigator assessment
12 months
Medical tumour-related intervention
Time Frame: Baseline
Description of the disease history management of subjects with PanNET will be collected by the investigator and recorded in an electronic CRF (eCRF) designed for the study
Baseline
Time from diagnosis to first therapeutic intervention
Time Frame: Baseline
Description of the disease history management of subjects with PanNET
Baseline
Quality of Life (QoL)
Time Frame: From baseline up to 24 months
To describe the change in Quality of Life (QoL) as assessed by European Organisation for Research and Treatment of Cancer (EORTC) QoL questionnaire for gastrointestinal neuroendocrine tumours (QLQ-GINET21) questionnaires.Where the patient assess experienced symptoms or problems using the scale from 1 to 4. Where 1 represents "not at all" and 4 "very much".
From baseline up to 24 months
Median time to lanreotide discontinuation
Time Frame: Up to 24 months
Up to 24 months
Changes of Chromogranin A (CgA) levels
Time Frame: Every 6 months up to 24 months
Changes in CgA levels between last CgA value prior to lanreotide start (if available) and values at each study visit
Every 6 months up to 24 months
Changes of Glycated hemoglobin (HbA1c) levels
Time Frame: Every 6 months up to 24 months
Changes in HbA1c levels between last HbA1c value prior to lanreotide start (if available) and values at each study visit
Every 6 months up to 24 months
Changes of urine 5-Hydroxyindoleacetic Acid (5-HIAA) levels
Time Frame: Every 6 months up to 24 months
Changes in 5-HIAA levels between last 5-HIAA value prior to lanreotide start (if available) and values at each study visit
Every 6 months up to 24 months
Changes of pro-Brain Natriuretic Peptide (proBNP) levels
Time Frame: Every 6 months up to 24 months
Changes in proBNP levels between last proBNP value prior to lanreotide start (if available) and values at each study visit
Every 6 months up to 24 months
Patient satisfaction
Time Frame: Baseline visit and 12 months
To evaluate patient' satisfaction (TSQM-9 questionnaire) at inclusion visit. Treatment Satisfaction Questionnaire for Medication (TSQM) is an instrument to assess patients' satisfaction with medication, providing scores on four scales - side effects, effectiveness, convenience and global satisfaction. The effectiveness scored as: 1 (extremely dissatisfied) to 7 (extremely satisfied). For the convenience scored as 1(extremely difficult) to 7 (extremely easy).
Baseline visit and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ipsen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 3, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 10, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 13, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 14, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A-ES-52030-383
  • IPS-LAN-2018-01 (OTHER: Spanish Drug Agency AEMPS)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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