Clinical trial NCT05050942: A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients with GEP-NET
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Gastro-enteropancreatic Neuroendocrine Tumor
Keywords: CAM2029
GEP-NET
Octreotide
SORENTO
Lead sponsor: Camurus AB
Sponsor class: INDUSTRY
First posted: 2021-09-21
Enrollment: 332
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Progression-free survival (PFS) as assessed by a Blinded Independent Review Committee (BIRC)
timeFrame: From date of randomization until disease progression or death due to any cause, whichever comes first, assessed up to 48 months
Secondary outcomes:
measure: Overall survival
timeFrame: Up to 2 years following the primary efficacy analysis
measure: PFS as assessed by local Investigators
timeFrame: From date of randomization until disease progression or death due to any cause, whichever comes first, assessed up to 48 months
measure: Overall response rate
timeFrame: From date of randomization until disease progression, assessed up to 48 months
measure: Disease control rate
timeFrame: From date of randomization until disease progression, assessed up to 48 months
measure: Time to tumor response
timeFrame: From date of randomization until disease progression, assessed up to 48 months
measure: Duration of response
timeFrame: From date of randomization until disease progression or death due to underlying cancer, whichever comes first, assessed up to 48 months
measure: Incidence of treatment-emergent adverse events
timeFrame: From screening to the safety follow-up, assessed up to 6 years
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Cancer Center (MCCC) - Phoenix
state: Arizona
city: Santa Monica
country: United States
facility: UCLA Ahmanson Biological Imaging Center
state: California
city: Denver
country: United States
facility: Rocky Mountain Cancer Centers - Denver - Midtown
state: Colorado
city: Jacksonville
country: United States
facility: Mayo Clinic Hospital - Florida
state: Florida
city: Jupiter
country: United States
facility: Anderson Family Cancer Institute
state: Florida
city: Lexington
country: United States
facility: University of Kentucky (UK) - Markey Cancer Center
state: Kentucky
city: Metairie
country: United States
facility: East Jefferson General Hospital
state: Louisiana
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Bronx
country: United States
facility: The Mount Sinai Hospital
state: New York
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: White Plains
country: United States
facility: White Plains Hospital - Center for Cancer Care
state: New York
city: Austin
country: United States
facility: Texas Oncology - Austin
state: Texas
city: Dallas
country: United States
facility: Texas Oncology - Dallas
state: Texas
city: Denton
country: United States
facility: Texas Oncology - Denton North
state: Texas
city: Houston
country: United States
facility: The University of Texas - MD Anderson Cancer Center
state: Texas
city: McAllen
country: United States
facility: Texas Oncology - McAllen
state: Texas
city: San Antonio
country: United States
facility: Texas Oncology - San Antonio Northeast
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
city: Adelaide
country: Australia
facility: The Queen Elizabeth Hospital (TQEH)
city: Alexandria
country: Australia
facility: GenesisCare - North Shore
city: Blacktown
country: Australia
facility: Blacktown Hospital
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Brussels
country: Belgium
facility: Hôpital Erasme
city: Edegem
country: Belgium
facility: Antwerp University Hospital
city: Gent
country: Belgium
facility: Algemeen Ziekenhuis Maria Middelares
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven
city: Sint-Niklaas
country: Belgium
facility: AZ Nikolaas
city: London
country: Canada
facility: London Health Sciences Centre
city: Montréal
country: Canada
facility: Centre Hospitalier de l'Universite de Montreal - Notre-Dame Hospital
city: Montréal
country: Canada
facility: Jewish General Hospital
city: Ottawa
country: Canada
facility: The Ottawa Hospital - General Campus
city: St. Catharines
country: Canada
facility: Niagara Health System - St. Catharines General Site
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
city: Vancouver
country: Canada
facility: BC Cancer Agency Vancouver Centre
city: Bordeaux
country: France
facility: CHU Hopitaux de Bordeaux - Hôpital Haut-Lévêque
city: Chambray-lès-Tours
country: France
facility: CHRU de Tours - Hopital Trousseau
city: Dijon
country: France
facility: Centre Hospitalier Universitaire Dijon Bourgogne - L'Hopital General
city: Lille
country: France
facility: Groupe Hospitalier de l'Institut Catholique de Lille - Hopital Saint Vincent de Paul
city: Lyon
country: France
facility: CHU de Lyon - Groupement Hospitalier Edouard Herriot
city: Nantes
country: France
facility: CHU de Nantes - Hôtel-Dieu
city: Rennes
country: France
facility: Centre Eugène Marquis
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre
city: Berlin
country: Germany
facility: Charite - UB - CVK - Medizinische Klinik
city: Erlangen
country: Germany
facility: Universitaetsklinikum Erlangen - Hautklinik
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Hamburg
country: Germany
facility: Asklepios Klinik St. Georg
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf (UKE)
city: Heidelberg
country: Germany
facility: Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg
city: Mannheim
country: Germany
facility: Medizinischen Fakultät Mannheim der Universität Heidelberg
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
city: Budapest
country: Hungary
facility: SE ÁOK I. sz. Belgyógyászati Klinika
city: Győr
country: Hungary
facility: Petz Aladár Megyei Oktató Kórház
city: Kecskemét
country: Hungary
facility: Bács-Kiskun Megyei Kórház
city: Szeged
country: Hungary
facility: Szegedi Tudományegyetem; I.Belgyógyászati Klinika
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Medical Center (HMC) - Hadassah University Hospital (HUH) - Ein Kerem
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico (CRO)
city: Bari
country: Italy
facility: Universita degli Studi di Bari - Aldo Moro
city: Bologna
country: Italy
facility: Azienda Ospedaliero - Universitaria di Bologna Policlinico S. Orsola - Malpighi
city: Brescia
country: Italy
facility: ASST degli Spedali Civili di Brescia
city: Firenze
country: Italy
facility: Universita degli Studi di Firenze - Azienda Ospedaliero - Universitaria Careggi - SC di Oncologia Medical
city: Genova
country: Italy
facility: Universita Degli Studi di Genova - Center of Excellence for Biomedical Research (CEBR)
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST IRCCS
city: Milan
country: Italy
facility: Istituto Clinico Humanitas
city: Modena
country: Italy
facility: Azienda Ospedaliero - Universitaria di Modena Policlinico
city: Napoli
country: Italy
facility: IRCCS - Istituto Nazionale dei Tumori di Napoli Fondazione G. Pascale - Oncologia Addominale
city: Padova
country: Italy
facility: Istituto Oncologico Veneto - IRCCS
city: Roma
country: Italy
facility: Azienda Ospedaliera Sant'Andrea
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento
city: Amsterdam
country: Netherlands
facility: Nederlands Kanker Instituut - Antoni van Leeuwenhoek Ziekenhuis
city: Arnhem
country: Netherlands
facility: Rijnstate Ziekenhuis - Arnhem
city: Maastricht
country: Netherlands
facility: Maastricht UMC+
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Bucharest
country: Romania
facility: Institutul Clinic Fundeni
city: Cluj-Napoca
country: Romania
facility: Institutul Oncologic "Prof. Dr. Ion Chiricuţă" Cluj Napoca
city: Cluj-Napoca
country: Romania
facility: Medisprof SRL
city: Suceava
country: Romania
facility: Sigmedical Services S.R.L.
city: A Coruña
country: Spain
facility: Complexo Hospitalario Universitario A Coruña
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron - Vall d'Hebron Institut d'Oncologia (VHIO)
city: Barcelona
country: Spain
facility: Institut Catala d'Oncologia Hospitalet
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
city: Girona
country: Spain
facility: Hospital Universitari de Girona Doctor Josep Trueta
city: Madrid
country: Spain
facility: Facultad de Medicina - Hospital Universitario Fundacion Jimenez Diaz (UAM-FJD) (Clinica de la Concepcion)
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Alcorcón
city: Madrid
country: Spain
facility: Hospital Universitario La Paz (HULP)
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: MD Anderson Cancer Center - Madrid
city: Murcia
country: Spain
facility: Hospital General Universitario Morales Meseguer
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: Sabadell
country: Spain
facility: Parc Taulí Sabadell Hospital Universitari
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla (HUMV)
Study officials:
affiliation: Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
name: Simron Singh, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: