A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With GEP-NET
SORENTO
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
3 other identifiers
interventional
332
12 countries
86
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2021
Longer than P75 for phase_3
86 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 9, 2021
CompletedFirst Posted
Study publicly available on registry
September 21, 2021
CompletedStudy Start
First participant enrolled
October 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2028
July 28, 2026
July 1, 2026
5 years
September 9, 2021
July 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free survival (PFS) as assessed by a Blinded Independent Review Committee (BIRC)
PFS is defined as time from the date of randomization to the date of the first documented disease progression as per RECIST 1.1 or death due to any cause (whichever occurs first)
From date of randomization until disease progression or death due to any cause, whichever comes first, assessed up to 48 months
Secondary Outcomes (7)
Overall survival
Up to 2 years following the primary efficacy analysis
PFS as assessed by local Investigators
From date of randomization until disease progression or death due to any cause, whichever comes first, assessed up to 48 months
Overall response rate
From date of randomization until disease progression, assessed up to 48 months
Disease control rate
From date of randomization until disease progression, assessed up to 48 months
Time to tumor response
From date of randomization until disease progression, assessed up to 48 months
- +2 more secondary outcomes
Study Arms (2)
CAM2029
EXPERIMENTALOctreotide LAR or lanreotide ATG
ACTIVE COMPARATORInterventions
CAM2029 (octreotide subcutaneous depot) 20 mg will be administered every 2 weeks as a subcutaneous injection
Octreotide LAR 30 mg will be administered every 4 weeks as an intramuscular injection
Lanreotide ATG 120 mg will be administered every 4 weeks as a deep subcutaneous injection
Eligibility Criteria
You may qualify if:
- Male or female patient ≥18 years old
- 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
You may not qualify if:
- Documented evidence of disease progression while on treatment (including SSAs) for locally advanced unresectable or metastatic disease
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Camurus ABlead
Study Sites (86)
Mayo Clinic Cancer Center (MCCC) - Phoenix
Phoenix, Arizona, 85054, United States
UCLA Ahmanson Biological Imaging Center
Santa Monica, California, 90404, United States
Rocky Mountain Cancer Centers - Denver - Midtown
Denver, Colorado, 80218, United States
Mayo Clinic Hospital - Florida
Jacksonville, Florida, 32224, United States
University of Kentucky (UK) - Markey Cancer Center
Lexington, Kentucky, 40536, United States
East Jefferson General Hospital
Metairie, Louisiana, 70065, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
Texas Oncology - Austin
Austin, Texas, 78705, United States
Texas Oncology - Dallas
Dallas, Texas, 75246, United States
The University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030, United States
Texas Oncology - McAllen
McAllen, Texas, 78503, United States
Texas Oncology - San Antonio Northeast
San Antonio, Texas, 78240, United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
GenesisCare - North Shore
Alexandria, 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
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
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
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
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
Related Publications (1)
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.
PMID: 38229199DERIVED
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Simron Singh, MD, MPH
Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2021
First Posted
September 21, 2021
Study Start
October 22, 2021
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
November 1, 2028
Last Updated
July 28, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share