Efficacy and Safety Study in Pancreatic or Midgut Neuroendocrine Tumours Having Progressed Radiologically While Previously Treated With Lanreotide Autogel® 120 mg
NCT ID: NCT02651987
Last Updated: 2022-10-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
99 participants
INTERVENTIONAL
2015-12-15
2019-10-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Lanreotide Autogel®
One subcutaneous (SC) injection of lanreotide Autogel® 120mg every 14 days until disease progression or death or unacceptable toxicity or tolerability.
Lanreotide autogel 120 mg
Interventions
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Lanreotide autogel 120 mg
Eligibility Criteria
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Inclusion Criteria
* Positive somatostatin receptors type 2
* Progression as assessed by an independent central reviewer according to RECIST v1.0 while receiving first line treatment with lanreotide Autogel® at a standard dose of 120 mg every 28 days for at least 24 weeks
Exclusion Criteria
* Any NET other than pancreatic and midgut
* Previous treatment with any antitumour agent for NET other than lanreotide Autogel® 120 mg every 28 days. Exception made of prior treatment with Octreotide at standard dose stopped for other reason than disease progression.
* Symptomatic gallbladder lithiasis at screening echography or history of cholelithiasis with no cholecystectomy since then.
18 Years
ALL
No
Sponsors
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Ipsen
INDUSTRY
Responsible Party
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Principal Investigators
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Ipsen Medical Director
Role: STUDY_DIRECTOR
Ipsen
Locations
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Erasme Hospital
Brussels, , Belgium
Cliniques Unversitaires Saint Luc
Brussels, , Belgium
Antwerp University Hospital
Edegem, , Belgium
UZ Leuven
Leuven, , Belgium
Aarhus University Hospital
Aarhus, , Denmark
Rigshospitalet
Copenhagen, , Denmark
Hôpital Beaujon
Clichy, , France
Hôpital Edouard Herriot
Lyon, , France
Institut Paoli Calmette
Marseille, , France
Institut Gustave Roussy
Villejuif, , France
Charité - CVK
Berlin, , Germany
Universitätsklinikum Erlangen
Erlangen, , Germany
Nationales Centrum für Tumorerkrankungen (NCT)
Heidelberg, , Germany
St Vincent's University Hospital
Dublin, , Ireland
IRCCS Azienda Ospedaliera Universitaria
San Martino, Genova, Italy
Azienda Ospedaliera - Universitaria Careggi
Florence, , Italy
Fondacione IRCCS Istituto Nazionale Dei Tumori
Milan, , Italy
Università degli Studi "Federico II" di Napoli
Napoli, , Italy
Azienda Ospedaliera sant'Andrea
Roma, , Italy
AVL/NKI Medisch Oncologie
Amsterdam, , Netherlands
Academic Medical Center
Amsterdam, , Netherlands
Erasmus MC
Rotterdam, , Netherlands
Samodzielny Publiczny Szpital Kliniczny nr 5
Katowice, , Poland
Katedra i Klinika Endokrynologii
Poznan, , Poland
Centrum Diagnostyczno-Lecznicze "GAMMED"
Warsaw, , Poland
Hospital Universitario Vall D'hebron
Barcelona, , Spain
Hospital Universitario Ramón Y Cajal
Madrid, , Spain
Hospital Universitario 12 De Octubre
Madrid, , Spain
Hospital Universitario Central de Asturias
Oviedo, , Spain
Queen Elizabeth Medical Center
Birmingham, , United Kingdom
Royal Free Hospital
London, , United Kingdom
The Christie Hospital NHS Foundation Trust
Manchester, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2014-005607-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
8-79-52030-326
Identifier Type: -
Identifier Source: org_study_id
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