Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2023-508723-12-00 | EU Trial (CTIS) Number | ||
| 2021-000849-40 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAM2029 | Experimental |
| |
| Octreotide LAR or lanreotide ATG | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAM2029 | Drug | CAM2029 (octreotide subcutaneous depot) 20 mg will be administered every 2 weeks as a subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | The time from the date of randomization to the date of death due to any cause | Up to 2 years following the primary efficacy analysis |
| PFS as assessed by local Investigators | 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Simron Singh, MD, MPH | Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Cancer Center (MCCC) - Phoenix | Phoenix | Arizona | 85054 | United States | ||
| UCLA Ahmanson Biological Imaging Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38229199 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Octreotide LAR | Drug | Octreotide LAR 30 mg will be administered every 4 weeks as an intramuscular injection |
|
| Lanreotide ATG | Drug | Lanreotide ATG 120 mg will be administered every 4 weeks as a deep subcutaneous injection |
|
| From date of randomization until disease progression or death due to any cause, whichever comes first, assessed up to 48 months |
| Overall response rate | The proportion of patients with best overall response of complete response (CR) or partial response (PR), as per BIRC according to RECIST 1.1 | From date of randomization until disease progression, assessed up to 48 months |
| Disease control rate | The proportion of patients with a best overall response of CR, PR or stable disease (SD), as per BIRC according to RECIST 1.1 | From date of randomization until disease progression, assessed up to 48 months |
| Time to tumor response | The time from the date of randomization to the first documented response of CR or PR, as per BIRC according to RECIST 1.1 | From date of randomization until disease progression, assessed up to 48 months |
| Duration of response | The time from the date of the first documented response of CR or PR to the date of the first documented progression or death due to underlying cancer, as per BIRC according to RECIST 1.1 | From date of randomization until disease progression or death due to underlying cancer, whichever comes first, assessed up to 48 months |
| Incidence of treatment-emergent adverse events | From screening to the safety follow-up, assessed up to 6 years |
| 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 |
| ID | Term |
|---|---|
| C535650 | Gastro-enteropancreatic neuroendocrine tumor |
Not provided
Not provided
Not provided