A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients with GEP-NET
- Conditions
- Gastro-enteropancreatic Neuroendocrine Tumor
- Interventions
- Registration Number
- NCT05050942
- Lead Sponsor
- Camurus AB
- 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
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 332
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Octreotide LAR or lanreotide ATG Octreotide LAR - Octreotide LAR or lanreotide ATG Lanreotide ATG - CAM2029 CAM2029 -
- Primary Outcome Measures
Name Time Method Progression-free survival (PFS) as assessed by a Blinded Independent Review Committee (BIRC) From date of randomization until disease progression or death due to any cause, whichever comes first, assessed up to 48 months 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)
- Secondary Outcome Measures
Name Time Method Incidence of treatment-emergent adverse events From screening to the safety follow-up, assessed up to 6 years Overall response rate From date of randomization until disease progression, assessed up to 48 months The proportion of patients with best overall response of complete response (CR) or partial response (PR), as per BIRC according to RECIST 1.1
Disease control rate From date of randomization until disease progression, assessed up to 48 months The proportion of patients with a best overall response of CR, PR or stable disease (SD), as per BIRC according to RECIST 1.1
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 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)
Time to tumor response From date of randomization until disease progression, assessed up to 48 months The time from the date of randomization to the first documented response of CR or PR, as per BIRC according to RECIST 1.1
Duration of response From date of randomization until disease progression or death due to underlying cancer, whichever comes first, assessed up to 48 months 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
Overall survival Up to 2 years following the primary efficacy analysis The time from the date of randomization to the date of death due to any cause
Trial Locations
- Locations (98)
UCLA Ahmanson Biological Imaging Center
🇺🇸Santa Monica, California, United States
Texas Oncology - Dallas
🇺🇸Dallas, Texas, United States
White Plains Hospital - Center for Cancer Care
🇺🇸White Plains, New York, United States
Centre Hospitalier de l'Universite de Montreal - Notre-Dame Hospital
🇨🇦Montréal, Canada
Nederlands Kanker Instituut - Antoni van Leeuwenhoek Ziekenhuis
🇳🇱Amsterdam, Netherlands
Rijnstate Ziekenhuis - Arnhem
🇳🇱Arnhem, Netherlands
Medisprof SRL
🇷🇴Cluj-Napoca, Romania
The University of Texas - MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Texas Oncology - San Antonio Northeast
🇺🇸San Antonio, Texas, United States
Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST IRCCS
🇮🇹Meldola, Italy
The Chaim Sheba Medical Center
🇮🇱Ramat Gan, Israel
Mayo Clinic Cancer Center (MCCC) - Phoenix
🇺🇸Phoenix, Arizona, United States
Anderson Family Cancer Institute
🇺🇸Jupiter, Florida, United States
Mayo Clinic Hospital - Florida
🇺🇸Jacksonville, 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
Texas Oncology - Denton North
🇺🇸Denton, Texas, United States
Texas Oncology - McAllen
🇺🇸McAllen, Texas, United States
GenesisCare - North Shore
🇦🇺Alexandria, Australia
The Queen Elizabeth Hospital (TQEH)
🇦🇺Adelaide, Australia
Blacktown Hospital
🇦🇺Blacktown, Australia
Fiona Stanley Hospital
🇦🇺Murdoch, Australia
Peter MacCallum Cancer Centre
🇦🇺Melbourne, Australia
Cliniques Universitaires Saint-Luc
🇧🇪Brussels, Belgium
Antwerp University Hospital
🇧🇪Edegem, Belgium
Algemeen Ziekenhuis Maria Middelares
🇧🇪Gent, Belgium
Hôpital Erasme
🇧🇪Brussels, Belgium
Universitair Ziekenhuis Leuven
🇧🇪Leuven, Belgium
AZ Nikolaas
🇧🇪Sint-Niklaas, Belgium
The Ottawa Hospital - General Campus
🇨🇦Ottawa, Canada
London Health Sciences Centre
🇨🇦London, Canada
Jewish General Hospital
🇨🇦Montréal, Canada
Niagara Health System - St. Catharines General Site
🇨🇦St. Catharines, Canada
BC Cancer Agency Vancouver Centre
🇨🇦Vancouver, Canada
Princess Margaret Cancer Centre
🇨🇦Toronto, Canada
Sunnybrook Health Sciences Centre
🇨🇦Toronto, 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
CHU de Lyon - Groupement Hospitalier Edouard Herriot
🇫🇷Lyon, France
Groupe Hospitalier de l'Institut Catholique de Lille - Hopital Saint Vincent de Paul
🇫🇷Lille, 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
Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg
🇩🇪Heidelberg, Germany
Asklepios Klinik St. Georg
🇩🇪Hamburg, Germany
Universitätsklinikum Essen
🇩🇪Essen, Germany
Universitätsklinikum Hamburg-Eppendorf (UKE)
🇩🇪Hamburg, Germany
Medizinischen Fakultät Mannheim der Universität Heidelberg
🇩🇪Mannheim, Germany
Bács-Kiskun Megyei Kórház
🇭🇺Kecskemét, Hungary
SE ÁOK I. sz. Belgyógyászati Klinika
🇭🇺Budapest, Hungary
Universitätsklinikum Ulm
🇩🇪Ulm, Germany
Petz Aladár Megyei Oktató Kórház
🇭🇺Győr, 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
Tel Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel
Centro di Riferimento Oncologico (CRO)
🇮🇹Aviano, Italy
Universita degli Studi di Firenze - Azienda Ospedaliero - Universitaria Careggi - SC di Oncologia Medical
🇮🇹Firenze, Italy
Universita degli Studi di Bari - Aldo Moro
🇮🇹Bari, Italy
Azienda Ospedaliero - Universitaria di Bologna Policlinico S. Orsola - Malpighi
🇮🇹Bologna, Italy
Universita Degli Studi di Genova - Center of Excellence for Biomedical Research (CEBR)
🇮🇹Genova, Italy
ASST degli Spedali Civili di Brescia
🇮🇹Brescia, Italy
Istituto Clinico Humanitas
🇮🇹Milan, Italy
IRCCS - Istituto Nazionale dei Tumori di Napoli Fondazione G. Pascale - Oncologia Addominale
🇮🇹Napoli, Italy
Azienda Ospedaliero - Universitaria di Modena Policlinico
🇮🇹Modena, Italy
Istituto Oncologico Veneto - IRCCS
🇮🇹Padova, Italy
Azienda Ospedaliera Sant'Andrea
🇮🇹Roma, Italy
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento
🇮🇹Verona, Italy
Maastricht UMC+
🇳🇱Maastricht, Netherlands
Institutul Oncologic "Prof. Dr. Ion Chiricuţă" Cluj Napoca
🇷🇴Cluj-Napoca, Romania
Erasmus MC
🇳🇱Rotterdam, Netherlands
Institutul Clinic Fundeni
🇷🇴Bucharest, Romania
Sigmedical Services S.R.L.
🇷🇴Suceava, Romania
Hospital Universitari Vall d'Hebron - Vall d'Hebron Institut d'Oncologia (VHIO)
🇪🇸Barcelona, Spain
Complexo Hospitalario Universitario A Coruña
🇪🇸A Coruña, Spain
Hospital Universitario La Paz (HULP)
🇪🇸Madrid, Spain
Hospital Universitari de Girona Doctor Josep Trueta
🇪🇸Girona, Spain
Institut Catala d'Oncologia Hospitalet
🇪🇸Barcelona, Spain
Hospital General Universitario de Elche
🇪🇸Elche, 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
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Facultad de Medicina - Hospital Universitario Fundacion Jimenez Diaz (UAM-FJD) (Clinica de la Concepcion)
🇪🇸Madrid, Spain
Hospital Universitario Fundación Alcorcón
🇪🇸Madrid, Spain
Hospital Universitario Ramón y Cajal
🇪🇸Madrid, Spain
MD Anderson Cancer Center - Madrid
🇪🇸Madrid, Spain
Rocky Mountain Cancer Centers - Denver - Midtown
🇺🇸Denver, Colorado, United States
Texas Oncology - Austin
🇺🇸Austin, Texas, United States
Mayo Clinic Rochester
🇺🇸Rochester, Minnesota, United States
The Mount Sinai Hospital
🇺🇸Bronx, New York, United States