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

Phase 3

Active, not recruiting

• Conditions: Neuroendocrine Tumors
• Interventions: Drug: 177Lu-edotreotide PRRT; Drug: Everolimus; Other: Amino-Acid Solution

• Registration Number: NCT03049189
• Lead Sponsor: ITM Solucin GmbH

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-13
• Study Start: 2017-02-02
• Study First Submitted QC: 2017-02-07
• Study First Posted: 2017-02-09
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-29
• Last Update Posted: 2023-11-30
• Primary Completion: 2024-12
• Study Completion: 2029-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 309

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.).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
177Lu-edotreotide PRRT	177Lu-edotreotide PRRT	177Lu-edotreotide (177Lu-DOTATOC) A maximum of four cycles of 7.5 ± 0.7 GBq (gigabequerel) 177Lu-edotreotide, each. Route of administration: Slow intravenous infusion/injection (i.v.) Duration of treatment: 4 cycles, 90 days apart (total duration: 270 days/9 months)
177Lu-edotreotide PRRT	Amino-Acid Solution	177Lu-edotreotide (177Lu-DOTATOC) A maximum of four cycles of 7.5 ± 0.7 GBq (gigabequerel) 177Lu-edotreotide, each. Route of administration: Slow intravenous infusion/injection (i.v.) Duration of treatment: 4 cycles, 90 days apart (total duration: 270 days/9 months)
Everolimus	Everolimus	Everolimus (Afinitor ®) Doses: 10 mg/d Route of administration: Oral Duration of treatment: Continuous daily treatment until diagnosis of progression or End of Study (EOS)

Primary Outcome Measures

Name	Time	Method
progression-free survival (PFS)	12 weeks +/- 14 days, up to 30 months	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

Secondary Outcome Measures

Name	Time	Method
overall survival (OS)	every 3 months for a period of at least 30 months	OS as secondary outcome measure will be assessed per patient from date of randomization until the date of death, whichever came first

Trial Locations

Locations (52)

Allgemeines Krankenhaus Wien; 🇦🇹 Wien, Austria

"Gammed" Izabela Chuchrowksa; 🇵🇱 Warsaw, Poland

Inselspital, Universitätsspital Bern; 🇨🇭 Bern, Switzerland

Universitätsspital Basel; 🇨🇭 Basel, Switzerland

UniversitätsSpital Zürich; 🇨🇭 Zürich, Switzerland

Banner Health d.b.a. Banner MD Anderson Cancer Center; 🇺🇸 Gilbert, Arizona, United States

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States

Universitätsklinikum Bonn; 🇩🇪 Bonn, Germany

Institut Jules Bordet; 🇧🇪 Brussels, Belgium

University Hospital Motol; 🇨🇿 Prague, Czechia

MSC Memorial Cancer Centre; 🇵🇱 Gliwice, Poland

Vall d'Hebron University Hospital; 🇪🇸 Barcelona, Spain

ICO Hospitalet, Granvia de l'Hospitalet; 🇪🇸 Barcelona, Spain

CHU de Nantes - Hôtel Dieu; 🇫🇷 Nantes, France

Academic Medical Center, University of Amsterdam; 🇳🇱 Amsterdam, Netherlands

University and Polytechnic Hospital La Fe; 🇪🇸 Valencia, Spain

The Christie NHS Foundation Trust; 🇬🇧 Manchester, United Kingdom

Universitätsklinikum Essen; 🇩🇪 Essen, Germany

MD Anderson Cancer Center Madrid; 🇪🇸 Madrid, Spain

Fondazione IRCCS Istituto Nazionale dei Tumori; 🇮🇹 Milano, Italy

Klinikum rechts der Isar Technische Universität München; 🇩🇪 Munich, Germany

University of Pretoria & Steve Biko Academic Hospital; 🇿🇦 Pretoria, South Africa

University Cape Town (UCT), Groote Schuur Hospital; 🇿🇦 Cape Town, South Africa

Central University Hospital de Asturias (HUCA); 🇪🇸 Oviedo, Spain

Royal Free NHS Foundation Trust; 🇬🇧 London, United Kingdom

Institut de Recherche en Cancérologie de Montpellier (IRCM); 🇫🇷 Montpellier, France

Hospices civils de Lyon; 🇫🇷 Bron, France

Centre Jean Perrin; 🇫🇷 Clermont-Ferrand, France

Stanford University; 🇺🇸 Stanford, California, United States

Olivia Newton-John Cancer & Wellness Centre, Austin Hospital; 🇦🇺 Heidelberg, Victoria, Australia

Peter MacCallum Cancer Centre; 🇦🇺 Melbourne, Victoria, Australia

University of Michigan Comprehensive Cancer Center; 🇺🇸 Ann Arbor, Michigan, United States

Excel Diagnostics & Nuclear Oncology Center; 🇺🇸 Houston, Texas, United States

Universitaire Ziekenhuizen Leuven; 🇧🇪 Leuven, Belgium

Fiona Stanley Hospital; 🇦🇺 Murdoch, Western Australia, Australia

HP Hôpital Beaujon; 🇫🇷 Clichy, France

University Hospital Olomouc; 🇨🇿 Olomouc, Czechia

IUCT-Oncopole; 🇫🇷 Toulouse, France

Zentralklinik Bad Berka GmbH; 🇩🇪 Bad Berka, Germany

Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany

Universitätsklinikum Erlangen; 🇩🇪 Erlangen, 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

University Hospital 12 de Octubre; 🇪🇸 Madrid, Spain

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) Srl; 🇮🇹 Meldola, Italy

Universitätsklinikum Würzburg; 🇩🇪 Wurzburg, Germany

European Institute of Oncology (EIO); 🇮🇹 Milano, Italy

Kings College Hospital; 🇬🇧 London, United Kingdom

Moffitt Cancer Center & Research Institute; 🇺🇸 Tampa, Florida, United States

Royal North Shore Hospital; 🇦🇺 Saint Leonards, New South Wales, Australia

Universitätsklinikum Ulm; 🇩🇪 Ulm, Germany