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A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With GEP-NET
Sponsor: Camurus AB
Summary
The purpose of this study is to compare the effectiveness and safety of CAM2029 to octreotide LAR or lanreotide ATG in patients with advanced, well-differentiated GEP-NET. Patients who experience progressive disease in the randomized part of the study may proceed to an open-label extension part with intensified treatment with CAM2029.
Official title: A Randomized, Multi-center, Open-label, Active-controlled Phase 3 Trial to Assess the Efficacy and Safety of Octreotide Subcutaneous Depot (CAM2029) Versus Octreotide LAR or Lanreotide ATG in Patients With GEP-NET
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
332
Start Date
2021-10-22
Completion Date
2028-07
Last Updated
2025-11-06
Healthy Volunteers
No
Interventions
CAM2029
CAM2029 (octreotide subcutaneous depot) 20 mg will be administered every 2 weeks as a subcutaneous injection
Octreotide LAR
Octreotide LAR 30 mg will be administered every 4 weeks as an intramuscular injection
Lanreotide ATG
Lanreotide ATG 120 mg will be administered every 4 weeks as a deep subcutaneous injection
Locations (98)
Mayo Clinic Cancer Center (MCCC) - Phoenix
Phoenix, Arizona, United States
UCLA Ahmanson Biological Imaging Center
Santa Monica, California, United States
Rocky Mountain Cancer Centers - Denver - Midtown
Denver, Colorado, United States
Mayo Clinic Hospital - Florida
Jacksonville, Florida, United States
Anderson Family Cancer Institute
Jupiter, Florida, United States
University of Kentucky (UK) - Markey Cancer Center
Lexington, Kentucky, United States
East Jefferson General Hospital
Metairie, Louisiana, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
The Mount Sinai Hospital
The Bronx, New York, United States
White Plains Hospital - Center for Cancer Care
White Plains, New York, United States
Texas Oncology - Austin
Austin, Texas, United States
Texas Oncology - Dallas
Dallas, Texas, United States
Texas Oncology - Denton North
Denton, Texas, United States
The University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Texas Oncology - McAllen
McAllen, Texas, United States
Texas Oncology - San Antonio Northeast
San Antonio, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
The Queen Elizabeth Hospital (TQEH)
Adelaide, Australia
GenesisCare - North Shore
Alexandria, Australia
Blacktown Hospital
Blacktown, Australia
Peter MacCallum Cancer Centre
Melbourne, Australia
Fiona Stanley Hospital
Murdoch, Australia
Cliniques Universitaires Saint-Luc
Brussels, Belgium
Hôpital Erasme
Brussels, Belgium
Antwerp University Hospital
Edegem, Belgium
Algemeen Ziekenhuis Maria Middelares
Ghent, Belgium
Universitair Ziekenhuis Leuven
Leuven, Belgium
AZ Nikolaas
Sint-Niklaas, Belgium
London Health Sciences Centre
London, Canada
Centre Hospitalier de l'Universite de Montreal - Notre-Dame Hospital
Montreal, Canada
Jewish General Hospital
Montreal, Canada
The Ottawa Hospital - General Campus
Ottawa, Canada
Niagara Health System - St. Catharines General Site
St. Catharines, Canada
Princess Margaret Cancer Centre
Toronto, Canada
Sunnybrook Health Sciences Centre
Toronto, Canada
BC Cancer Agency Vancouver Centre
Vancouver, Canada
CHU Hopitaux de Bordeaux - Hôpital Haut-Lévêque
Bordeaux, France
CHRU de Tours - Hopital Trousseau
Chambray-lès-Tours, France
Centre Hospitalier Universitaire Dijon Bourgogne - L'Hopital General
Dijon, France
Groupe Hospitalier de l'Institut Catholique de Lille - Hopital Saint Vincent de Paul
Lille, France
CHU de Lyon - Groupement Hospitalier Edouard Herriot
Lyon, France
CHU de Nantes - Hôtel-Dieu
Nantes, France
Centre Eugène Marquis
Rennes, France
Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre
Strasbourg, France
Charite - UB - CVK - Medizinische Klinik
Berlin, Germany
Universitaetsklinikum Erlangen - Hautklinik
Erlangen, Germany
Universitätsklinikum Essen
Essen, Germany
Asklepios Klinik St. Georg
Hamburg, Germany
Universitätsklinikum Hamburg-Eppendorf (UKE)
Hamburg, Germany
Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg
Heidelberg, Germany
Medizinischen Fakultät Mannheim der Universität Heidelberg
Mannheim, Germany
Universitätsklinikum Ulm
Ulm, Germany
SE ÁOK I. sz. Belgyógyászati Klinika
Budapest, Hungary
Petz Aladár Megyei Oktató Kórház
Győr, Hungary
Bács-Kiskun Megyei Kórház
Kecskemét, Hungary
Szegedi Tudományegyetem; I.Belgyógyászati Klinika
Szeged, Hungary
Rambam Medical Center
Haifa, Israel
Hadassah Medical Center (HMC) - Hadassah University Hospital (HUH) - Ein Kerem
Jerusalem, Israel
The Chaim Sheba Medical Center
Ramat Gan, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Centro di Riferimento Oncologico (CRO)
Aviano, Italy
Universita degli Studi di Bari - Aldo Moro
Bari, Italy
Azienda Ospedaliero - Universitaria di Bologna Policlinico S. Orsola - Malpighi
Bologna, Italy
ASST degli Spedali Civili di Brescia
Brescia, Italy
Universita degli Studi di Firenze - Azienda Ospedaliero - Universitaria Careggi - SC di Oncologia Medical
Florence, Italy
Universita Degli Studi di Genova - Center of Excellence for Biomedical Research (CEBR)
Genova, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST IRCCS
Meldola, Italy
Istituto Clinico Humanitas
Milan, Italy
Azienda Ospedaliero - Universitaria di Modena Policlinico
Modena, Italy
IRCCS - Istituto Nazionale dei Tumori di Napoli Fondazione G. Pascale - Oncologia Addominale
Naples, Italy
Istituto Oncologico Veneto - IRCCS
Padova, Italy
Azienda Ospedaliera Sant'Andrea
Roma, Italy
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento
Verona, Italy
Nederlands Kanker Instituut - Antoni van Leeuwenhoek Ziekenhuis
Amsterdam, Netherlands
Rijnstate Ziekenhuis - Arnhem
Arnhem, Netherlands
Maastricht UMC+
Maastricht, Netherlands
Erasmus MC
Rotterdam, Netherlands
Institutul Clinic Fundeni
Bucharest, Romania
Institutul Oncologic "Prof. Dr. Ion Chiricuţă" Cluj Napoca
Cluj-Napoca, Romania
Medisprof SRL
Cluj-Napoca, Romania
Sigmedical Services S.R.L.
Suceava, Romania
Complexo Hospitalario Universitario A Coruña
A Coruña, Spain
Hospital Universitari Vall d'Hebron - Vall d'Hebron Institut d'Oncologia (VHIO)
Barcelona, Spain
Institut Catala d'Oncologia Hospitalet
Barcelona, Spain
Hospital General Universitario de Elche
Elche, Spain
Hospital Universitari de Girona Doctor Josep Trueta
Girona, Spain
Facultad de Medicina - Hospital Universitario Fundacion Jimenez Diaz (UAM-FJD) (Clinica de la Concepcion)
Madrid, Spain
Hospital Universitario Fundación Alcorcón
Madrid, Spain
Hospital Universitario La Paz (HULP)
Madrid, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain
MD Anderson Cancer Center - Madrid
Madrid, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Spain
Hospital General Universitario Morales Meseguer
Murcia, Spain
Hospital Universitario Central de Asturias
Oviedo, Spain
Parc Taulí Sabadell Hospital Universitari
Sabadell, Spain
Hospital Universitario Marques de Valdecilla (HUMV)
Santander, Spain