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Brief Title: A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With GEP-NET
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
Study ID: NCT05050942
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
The Mount Sinai Hospital, Bronx, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, 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, Gent, , 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, Montréal, , Canada
Jewish General Hospital, Montréal, , 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, Firenze, , 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, Napoli, , 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 General Universitario Morales Meseguer, Murcia, , Spain
Hospital Universitario Virgen de la Victoria, Málaga, , Spain
Hospital Universitario Central de Asturias, Oviedo, , Spain
Parc Taulí Sabadell Hospital Universitari, Sabadell, , Spain
Hospital Universitario Marques de Valdecilla (HUMV), Santander, , Spain
Name: Simron Singh, MD, MPH
Affiliation: Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
Role: PRINCIPAL_INVESTIGATOR