A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With GEP-NET
NCT ID: NCT05050942
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
332 participants
INTERVENTIONAL
2021-10-22
2028-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CAM2029
CAM2029
CAM2029 (octreotide subcutaneous depot) 20 mg will be administered every 2 weeks as a subcutaneous injection
Octreotide LAR or lanreotide ATG
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed, advanced (unresectable and/or metastatic), and well-differentiated NET of GEP or presumed GEP origin
* At least 1 measurable, somatostatin receptor-positive lesion according to RECIST 1.1 determined by multiphasic CT or MRI (performed within 28 days before randomization)
* ECOG performance status of 0 to 2
Exclusion Criteria
* Known central nervous system metastases
* Consecutive treatment with long-acting SSAs for more than 6 months before randomization
* Carcinoid symptoms that are refractory to treatment (according to the Investigator's judgement) with conventional doses of octreotide LAR or lanreotide ATG and/or to treatment with daily doses of ≤600 µg of octreotide IR
* Previous treatment with more than 1 cycle of targeted therapies such as mTOR inhibitors or vascular endothelial growth factor inhibitors, or more than 1 cycle of chemotherapy or interferon for GEP-NET
* Treatment of GEP-NET with trans-arterial chemoembolization or trans-arterial embolization within 12 months before screening
* Previously received radioligand therapy (PRRT) at any time
18 Years
ALL
No
Sponsors
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Camurus AB
INDUSTRY
Responsible Party
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Principal Investigators
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Simron Singh, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
Locations
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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
Napoli, , Italy
Istituto Oncologico Veneto - IRCCS
Padua, , 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
Countries
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References
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Singh S, Ferone D, Capdevila J, Chan JA, de Herder WW, Halperin D, Mailman J, Hellstrom L, Liedman H, Svedberg A, Tiberg F. Methodology of the SORENTO clinical trial: a prospective, randomised, active-controlled phase 3 trial assessing the efficacy and safety of high exposure octreotide subcutaneous depot (CAM2029) in patients with GEP-NET. Trials. 2024 Jan 16;25(1):58. doi: 10.1186/s13063-023-07834-8.
Other Identifiers
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2023-508723-12-00
Identifier Type: CTIS
Identifier Source: secondary_id
2021-000849-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
HS-19-657
Identifier Type: -
Identifier Source: org_study_id