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ACTIVE NOT RECRUITING
NCT05050942
PHASE3

A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With GEP-NET

Sponsor: Camurus AB

View on ClinicalTrials.gov

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

DRUG

CAM2029

CAM2029 (octreotide subcutaneous depot) 20 mg will be administered every 2 weeks as a subcutaneous injection

DRUG

Octreotide LAR

Octreotide LAR 30 mg will be administered every 4 weeks as an intramuscular injection

DRUG

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