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

January 25, 2024 updated by: Camurus AB

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

332

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
      • Adelaide, Australia
        • The Queen Elizabeth Hospital (TQEH)
      • Alexandria, Australia
        • GenesisCare - North Shore
      • Blacktown, Australia
        • Blacktown Hospital
      • Melbourne, Australia
        • Peter MacCallum Cancer Centre
      • Murdoch, Australia
        • Fiona Stanley Hospital
  • Belgium
      • Brussels, Belgium
        • Hopital Erasme
      • Brussels, Belgium
        • Cliniques universitaires Saint-Luc
      • Edegem, Belgium
        • Antwerp University Hospital
      • Gent, Belgium
        • Algemeen ziekenhuis Maria Middelares
      • Leuven, Belgium
        • Universitair Ziekenhuis Leuven
      • Sint-Niklaas, Belgium
        • AZ Nikolaas
  • Canada
      • London, Canada
        • London Health Sciences Centre
      • Montréal, Canada
        • Jewish General Hospital
      • Montréal, Canada
        • Centre Hospitalier de l'Universite de Montreal - Notre-Dame Hospital
      • Ottawa, Canada
        • The Ottawa Hospital - General Campus
      • St. Catharines, Canada
        • Niagara Health System - St. Catharines General Site
      • Toronto, Canada
        • Sunnybrook Health Sciences Centre
      • Toronto, Canada
        • Princess Margaret Cancer Centre
      • Vancouver, Canada
        • BC Cancer Agency Vancouver Centre
  • France
      • Bordeaux, France
        • CHU Hopitaux de Bordeaux - Hôpital Haut-Lévêque
      • Chambray-lès-Tours, France
        • CHRU de Tours - Hopital Trousseau
      • Dijon, France
        • Centre Hospitalier Universitaire Dijon Bourgogne - L'Hopital General
      • Lille, France
        • Groupe Hospitalier de l'Institut Catholique de Lille - Hopital Saint Vincent de Paul
      • Lyon, France
        • CHU de Lyon - Groupement Hospitalier Edouard Herriot
      • Nantes, France
        • CHU de Nantes - Hôtel-Dieu
      • Rennes, France
        • Centre Eugène Marquis
      • Strasbourg, France
        • Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre
  • Germany
      • Berlin, Germany
        • Charite - UB - CVK - Medizinische Klinik
      • Erlangen, Germany
        • Universitaetsklinikum Erlangen - Hautklinik
      • Essen, Germany
        • Universitatsklinikum Essen
      • Hamburg, Germany
        • Universitätsklinikum Hamburg-Eppendorf (UKE)
      • Hamburg, Germany
        • Asklepios Klinik St. Georg
      • Heidelberg, Germany
        • Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg
      • Mannheim, Germany
        • Medizinischen Fakultät Mannheim der Universität Heidelberg
      • Ulm, Germany
        • Universitatsklinikum Ulm
  • Hungary
      • Budapest, Hungary
        • SE ÁOK I. sz. Belgyógyászati Klinika
      • Győr, Hungary
        • Petz Aladar Megyei Oktato Korhaz
      • Kecskemét, Hungary
        • Bacs-kiskun Megyei Korhaz
      • Szeged, Hungary
        • Szegedi Tudományegyetem; I.Belgyógyászati Klinika
  • Israel
      • Haifa, Israel
        • Rambam Medical Center
      • Jerusalem, Israel
        • Hadassah Medical Center (HMC) - Hadassah University Hospital (HUH) - Ein Kerem
      • Ramat Gan, Israel
        • The Chaim Sheba Medical Center
      • Tel Aviv, Israel
        • Tel Aviv Sourasky Medical Center
  • Italy
      • Aviano, Italy
        • Centro di Riferimento Oncologico (CRO)
      • Bari, Italy
        • Universita degli Studi di Bari - Aldo Moro
      • Bologna, Italy
        • Azienda Ospedaliero - Universitaria di Bologna Policlinico S. Orsola - Malpighi
      • Brescia, Italy
        • ASST degli Spedali Civili di Brescia
      • Firenze, Italy
        • Universita degli Studi di Firenze - Azienda Ospedaliero - Universitaria Careggi - SC di Oncologia Medical
      • Genova, Italy
        • Universita Degli Studi di Genova - Center of Excellence for Biomedical Research (CEBR)
      • Meldola, Italy
        • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST IRCCS
      • Milan, Italy
        • Istituto Clinico Humanitas
      • Modena, Italy
        • Azienda Ospedaliero - Universitaria di Modena Policlinico
      • Napoli, Italy
        • IRCCS - Istituto Nazionale dei Tumori di Napoli Fondazione G. Pascale - Oncologia Addominale
      • Padova, Italy
        • Istituto Oncologico Veneto - IRCCS
      • Roma, Italy
        • Azienda Ospedaliera Sant'Andrea
      • Verona, Italy
        • Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento
  • Netherlands
      • Amsterdam, Netherlands
        • Nederlands Kanker Instituut - Antoni van Leeuwenhoek Ziekenhuis
      • Arnhem, Netherlands
        • Rijnstate Ziekenhuis - Arnhem
      • Maastricht, Netherlands
        • Maastricht UMC+
      • Rotterdam, Netherlands
        • Erasmus MC
  • Romania
      • Bucharest, Romania
        • Institutul Clinic Fundeni
      • Cluj-Napoca, Romania
        • Medisprof srl
      • Cluj-Napoca, Romania
        • Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj Napoca
      • Suceava, Romania
        • Sigmedical Services S.R.L.
  • Spain
      • A Coruña, Spain
        • Complexo Hospitalario Universitario A Coruña
      • Barcelona, Spain
        • Hospital Universitari Vall d'Hebron - Vall d'Hebron Institut d'Oncologia (VHIO)
      • Barcelona, Spain
        • Institut Catala d'Oncologia Hospitalet
      • Elche, Spain
        • Hospital General Universitario de Elche
      • Girona, Spain
        • Hospital Universitari de Girona Doctor Josep Trueta
      • Madrid, Spain
        • Hospital Universitario Ramon Y Cajal
      • Madrid, Spain
        • Hospital Universitario Fundación Alcorcón
      • Madrid, Spain
        • MD Anderson Cancer Center - Madrid
      • Madrid, Spain
        • Hospital Universitario La Paz (HULP)
      • Madrid, Spain
        • Facultad de Medicina - Hospital Universitario Fundacion Jimenez Diaz (UAM-FJD) (Clinica de la Concepcion)
      • Murcia, Spain
        • Hospital General Universitario Morales Meseguer
      • Málaga, Spain
        • Hospital Universitario Virgen de la Victoria
      • Oviedo, Spain
        • Hospital Universitario Central de Asturias
      • Sabadell, Spain
        • Parc Taulí Sabadell Hospital Universitari
      • Santander, Spain
        • Hospital Universitario Marqués de Valdecilla (HUMV)
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic Cancer Center (MCCC) - Phoenix
    • California
      • Santa Monica, California, United States, 90404
        • UCLA Ahmanson Biological Imaging Center
    • Colorado
      • Denver, Colorado, United States, 80218
        • Rocky Mountain Cancer Centers - Denver - Midtown
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic Hospital - Florida
      • Jupiter, Florida, United States, 33469
        • Anderson Family Cancer Institute
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky (UK) - Markey Cancer Center
    • Louisiana
      • Metairie, Louisiana, United States, 70065
        • East Jefferson General Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana-Farber Cancer Institute
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Rochester
    • New York
      • Bronx, New York, United States, 10461
        • The Mount Sinai Hospital
      • New York, New York, United States, 10065
        • Memorial Sloan-Kettering Cancer Center
      • White Plains, New York, United States, 10601
        • White Plains Hospital - Center for Cancer Care
    • Texas
      • Austin, Texas, United States, 78705
        • Texas Oncology - Austin
      • Dallas, Texas, United States, 75246
        • Texas Oncology - Dallas
      • Denton, Texas, United States, 76201
        • Texas Oncology - Denton North
      • Houston, Texas, United States, 77030
        • The University of Texas - MD Anderson Cancer Center
      • McAllen, Texas, United States, 78503
        • Texas Oncology - McAllen
      • San Antonio, Texas, United States, 78240
        • Texas Oncology - San Antonio Northeast
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CAM2029
Drug: CAM2029
CAM2029 (octreotide subcutaneous depot) 20 mg will be administered every 2 weeks as a subcutaneous injection
Active Comparator: Octreotide LAR or lanreotide ATG
Drug: Octreotide LAR
Octreotide LAR 30 mg will be administered every 4 weeks as an intramuscular injection
Drug: Lanreotide ATG
Lanreotide ATG 120 mg will be administered every 4 weeks as a deep subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS) as assessed by a Blinded Independent Review Committee (BIRC)
Time Frame: 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)
From date of randomization until disease progression or death due to any cause, whichever comes first, assessed up to 48 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 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
Up to 2 years following the primary efficacy analysis
PFS as assessed by local Investigators
Time Frame: 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)
From date of randomization until disease progression or death due to any cause, whichever comes first, assessed up to 48 months
Overall response rate
Time Frame: 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
From date of randomization until disease progression, assessed up to 48 months
Disease control rate
Time Frame: 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
From date of randomization until disease progression, assessed up to 48 months
Time to tumor response
Time Frame: 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
From date of randomization until disease progression, assessed up to 48 months
Duration of response
Time Frame: 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
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
Time Frame: From screening to the safety follow-up, assessed up to 6 years
From screening to the safety follow-up, assessed up to 6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Camurus AB

Investigators

  • Principal Investigator: Simron Singh, MD, MPH, Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 22, 2021

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

September 9, 2021

First Submitted That Met QC Criteria

September 17, 2021

First Posted (Actual)

September 21, 2021

Study Record Updates

Last Update Posted (Estimated)

January 26, 2024

Last Update Submitted That Met QC Criteria

January 25, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS-19-657
  • 2021-000849-40 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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