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Clinical Trials in the USA / NCT03049189
Active, not recruiting Phase 3

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

NCT03049189 · tracked via the Priya Life Science USA tracker
Sponsor
ITM Solucin GmbH
Phase
Phase 3
Started
2017-02-02
Last updated
2026-08-07

Condition(s) studied

Neuroendocrine Tumors

Investigational drug(s) / intervention(s)

177Lu-edotreotide PRRTEverolimusAmino-Acid Solution

177Lu-edotreotide PRRT: PRRT using 177Lu-edotreotide will be performed 3-monthly. A maximum of four cycles will be administered.

Everolimus: Everolimus will be administered as a standard dosis of 10 mg daily which may be reduced where required for acceptable tolerability.

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

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.).

Primary outcome measure(s)

Trial sites (52)

FacilityCityRegionStatus
Banner Health d.b.a. Banner MD Anderson Cancer Center Gilbert Arizona
Stanford University Stanford California
Moffitt Cancer Center & Research Institute Tampa Florida
Northwestern Memorial Hospital Chicago Illinois
University of Michigan Comprehensive Cancer Center Ann Arbor Michigan
Excel Diagnostics & Nuclear Oncology Center Houston Texas
Royal North Shore Hospital Saint Leonards New South Wales
Olivia Newton-John Cancer & Wellness Centre, Austin Hospital Heidelberg Victoria
Peter MacCallum Cancer Centre Melbourne Victoria
Fiona Stanley Hospital Murdoch Western Australia
Allgemeines Krankenhaus Wien Vienna Austria
Institut Jules Bordet Brussels Belgium
Universitaire Ziekenhuizen Leuven Leuven Belgium
University Hospital Olomouc Olomouc Czechia
University Hospital Motol Prague Czechia
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 France
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 Würzburg Germany
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) Srl Meldola Italy
Fondazione IRCCS Istituto Nazionale dei Tumori Milan Italy
European Institute of Oncology (EIO) Milan Italy
Academic Medical Center, University of Amsterdam Amsterdam Netherlands
MSC Memorial Cancer Centre Gliwice Poland
"Gammed" Izabela Chuchrowksa Warsaw Poland
University Cape Town (UCT), Groote Schuur Hospital Cape Town South Africa
University of Pretoria & Steve Biko Academic Hospital Pretoria South Africa

+ 12 more sites — see the full list on the official registry below.

More ITM Solucin GmbH trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03049189 on ClinicalTrials.gov ↗ ← All trials in the USA