A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With GEP-NET

Gastro-enteropancreatic Neuroendocrine Tumor Clinical Trial

— SORENTO  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05050942
• Other study ID #: HS-19-657
• Secondary ID: 2021-000849-40
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: October 22, 2021
• Est. completion date: December 2026

Study information

• Verified date: January 2024
• Source: Camurus AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 332
• Est. completion date: December 2026
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastro-enteropancreatic Neuroendocrine Tumor
• Neuroendocrine Tumors

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Australia	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
Belgium	Cliniques Universitaires Saint-Luc	Brussels
Belgium	Hôpital Erasme	Brussels
Belgium	Antwerp University Hospital	Edegem
Belgium	Algemeen Ziekenhuis Maria Middelares	Gent
Belgium	Universitair Ziekenhuis Leuven	Leuven
Belgium	AZ Nikolaas	Sint-Niklaas
Canada	London Health Sciences Centre	London
Canada	Centre Hospitalier de l'Universite de Montreal - Notre-Dame Hospital	Montréal
Canada	Jewish General Hospital	Montréal
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
France	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
Germany	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
Hungary	SE ÁOK I. sz. Belgyógyászati Klinika	Budapest
Hungary	Petz Aladár Megyei Oktató Kórház	Gyor
Hungary	Bács-Kiskun Megyei Kórház	Kecskemét
Hungary	Szegedi Tudományegyetem; I.Belgyógyászati Klinika	Szeged
Israel	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
Italy	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	Firenze
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	Padova
Italy	Azienda Ospedaliera Sant'Andrea	Roma
Italy	Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento	Verona
Netherlands	Nederlands Kanker Instituut - Antoni van Leeuwenhoek Ziekenhuis	Amsterdam
Netherlands	Rijnstate Ziekenhuis - Arnhem	Arnhem
Netherlands	Maastricht UMC+	Maastricht
Netherlands	Erasmus MC	Rotterdam
Romania	Institutul Clinic Fundeni	Bucharest
Romania	Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj Napoca	Cluj-Napoca
Romania	Medisprof SRL	Cluj-Napoca
Romania	Sigmedical Services S.R.L.	Suceava
Spain	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
United States	Texas Oncology - Austin	Austin	Texas
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	The Mount Sinai Hospital	Bronx	New York
United States	Texas Oncology - Dallas	Dallas	Texas
United States	Texas Oncology - Denton North	Denton	Texas
United States	Rocky Mountain Cancer Centers - Denver - Midtown	Denver	Colorado
United States	The University of Texas - MD Anderson Cancer Center	Houston	Texas
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	Texas Oncology - McAllen	McAllen	Texas
United States	East Jefferson General Hospital	Metairie	Louisiana
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	Mayo Clinic Cancer Center (MCCC) - Phoenix	Phoenix	Arizona
United States	Mayo Clinic Rochester	Rochester	Minnesota
United States	Huntsman Cancer Institute	Salt Lake City	Utah
United States	Texas Oncology - San Antonio Northeast	San Antonio	Texas
United States	UCLA Ahmanson Biological Imaging Center	Santa Monica	California
United States	White Plains Hospital - Center for Cancer Care	White Plains	New York

Sponsors (1)

Lead Sponsor	Collaborator
Camurus AB

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  France,  Germany,  Hungary,  Israel,  Italy,  Netherlands,  Romania,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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)	From date of randomization until disease progression or death due to any cause, whichever comes first, assessed up to 48 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Incidence of treatment-emergent adverse events		From screening to the safety follow-up, assessed up to 6 years