Efficacy and Safety of 177Lu-edotreotide PRRT in GEP-NET Patients

Neuroendocrine Tumors Clinical Trial

— COMPETE  

Official title:

A Prospective, Randomised, Controlled, Open-label, Multicentre Phase III Study to Evaluate Efficacy and Safety of Peptide Receptor Radionuclide Therapy (PRRT) With 177Lu-Edotreotide Compared to Targeted Molecular Therapy With Everolimus in Patients With Inoperable, Progressive, Somatostatin Receptor-positive (SSTR+), Neuroendocrine Tumours of Gastroenteric or Pancreatic Origin (GEP-NET)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03049189
• Other study ID #: ITM-LET-01
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: February 2, 2017
• Est. completion date: December 2029

Study information

• Verified date: November 2023
• Source: ITM Solucin GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to evaluate efficacy and safety of Peptide Receptor Radionuclide Therapy (PRRT) with 177Lu-Edotreotide compared to targeted molecular therapy with Everolimus in patients with inoperable, progressive, somatostatin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin (GEP-NET).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 309
• Est. completion date: December 2029
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically confirmed diagnosis of well-differentiated neuro-endocrine tumour of non-functional gastroenteric origin (GE-NET) or both functional or non-functional pancreatic origin (P-NET)
• Measurable disease per RECIST 1.1
• Somatostatin receptor positive (SSTR+) disease
• Progressive disease based on RECIST 1.1. criteria as evidenced by two morphological imaging examinations made with the same imaging method (either CT or MRI)

Exclusion Criteria:

• Known hypersensitivity to edotreotide or everolimus
• Known hypersensitivity to DOTA, lutetium-177, or any excipient of edotreotide or everolimus or any other Rapamycin derivative
• Prior exposure to any peptide receptor radionuclide therapy (PRRT)
• Prior therapy with mTor inhibitors
• Prior EFR (external field radiation) to GEP-NET lesions within 90 days before randomisation or radioembolisation therapy
• Therapy with an investigational compound and/or medical device within 30 days prior to randomisation
• Indication for surgical lesion removal with curative potential
• Planned alternative therapy (for the period of study participation)
• Serious non-malignant disease
• Clinically relevant renal, hepatic, cardiovascular, or haematological organ dysfunction, potentially interfering with the safety of the study treatments
• Pregnant or breast-feeding women
• Subjects not able to declare meaningful informed consent on their own (e.g. with legal guardian for mental disorders) or any other vulnerable population to that sense (e.g. persons institutionalised, incarcerated etc.).

Related Conditions & MeSH terms

• Neuroendocrine Tumors

Intervention

Drug:
• 177Lu-edotreotide PRRT
PRRT using 177Lu-edotreotide will be performed 3-monthly. A maximum of four cycles will be administered.
• Everolimus
Everolimus will be adminstered as a standard dosis of 10 mg daily which may be reduced where required for acceptable tolerability.

Other:
• Amino-Acid Solution
The Amino-Acid Solution (AAS) to be used in this study will contain a mixture of 25 g lysine and 25 g arginine diluted in 2000 mL of electrolyte solution, infused over 4 - 6 h, starting 30 - 60 min before PRRT

Locations

Country	Name	City	State
Australia	Olivia Newton-John Cancer & Wellness Centre, Austin Hospital	Heidelberg	Victoria
Australia	Peter MacCallum Cancer Centre	Melbourne	Victoria
Australia	Fiona Stanley Hospital	Murdoch	Western Australia
Australia	Royal North Shore Hospital	Saint Leonards	New South Wales
Austria	Allgemeines Krankenhaus Wien	Wien
Belgium	Institut Jules Bordet	Brussels
Belgium	Universitaire Ziekenhuizen Leuven	Leuven
Czechia	University Hospital Olomouc	Olomouc
Czechia	University Hospital Motol	Prague
France	Hospices civils de Lyon	Bron
France	Centre Jean Perrin	Clermont-Ferrand
France	HP Hôpital Beaujon	Clichy
France	Institut de Recherche en Cancérologie de Montpellier (IRCM)	Montpellier
France	CHU de Nantes - Hôtel Dieu	Nantes
France	IUCT-Oncopole	Toulouse
Germany	Zentralklinik Bad Berka GmbH	Bad Berka
Germany	Charité - Universitätsmedizin Berlin	Berlin
Germany	Universitätsklinikum Bonn	Bonn
Germany	Universitätsklinikum Erlangen	Erlangen
Germany	Universitätsklinikum Essen	Essen
Germany	University Medical Center, Abteilung für Nuklearmedizin	Hamburg
Germany	Universitätsklinikum Magdeburg A.ö.R., Otto-von-Guericke Universität	Magdeburg
Germany	Philipps Universität Marburg	Marburg
Germany	Klinikum rechts der Isar Technische Universität München	Munich
Germany	Universitätsklinikum Ulm	Ulm
Germany	Universitätsklinikum Würzburg	Wurzburg
Italy	Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) Srl	Meldola
Italy	European Institute of Oncology (EIO)	Milano
Italy	Fondazione IRCCS Istituto Nazionale dei Tumori	Milano
Netherlands	Academic Medical Center, University of Amsterdam	Amsterdam
Poland	MSC Memorial Cancer Centre	Gliwice
Poland	"Gammed" Izabela Chuchrowksa	Warsaw
South Africa	University Cape Town (UCT), Groote Schuur Hospital	Cape Town
South Africa	University of Pretoria & Steve Biko Academic Hospital	Pretoria
Spain	ICO Hospitalet, Granvia de l'Hospitalet	Barcelona
Spain	Vall d'Hebron University Hospital	Barcelona
Spain	MD Anderson Cancer Center Madrid	Madrid
Spain	University Hospital 12 de Octubre	Madrid
Spain	Central University Hospital de Asturias (HUCA)	Oviedo
Spain	University and Polytechnic Hospital La Fe	Valencia
Switzerland	Universitätsspital Basel	Basel
Switzerland	Inselspital, Universitätsspital Bern	Bern
Switzerland	UniversitätsSpital Zürich	Zürich
United Kingdom	Kings College Hospital	London
United Kingdom	Royal Free NHS Foundation Trust	London
United Kingdom	The Christie NHS Foundation Trust	Manchester
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	Banner Health d.b.a. Banner MD Anderson Cancer Center	Gilbert	Arizona
United States	Excel Diagnostics & Nuclear Oncology Center	Houston	Texas
United States	Stanford University	Stanford	California
United States	Moffitt Cancer Center & Research Institute	Tampa	Florida

Sponsors (3)

Lead Sponsor	Collaborator
ITM Solucin GmbH	ABX CRO, PSI CRO

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Czechia,  France,  Germany,  Italy,  Netherlands,  Poland,  South Africa,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression-free survival (PFS)	PFS will be assessed individually per patient from date of randomization until the date of first documented progression, assessed up to 30 months, primary outcome will be measured by CT/MRI every 12 weeks +/- 14 days	12 weeks +/- 14 days, up to 30 months
Secondary	overall survival (OS)	OS as secondary outcome measure will be assessed per patient from date of randomization until the date of death, whichever came first	every 3 months for a period of at least 30 months