Clinical trial NCT03049189: Efficacy and Safety of 177Lu-edotreotide PRRT in GEP-NET Patients
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Neuroendocrine Tumors
Keywords: non-functional and functional P-NET
non-functional GE-NET
Lead sponsor: ITM Solucin GmbH
Sponsor class: INDUSTRY
Collaborators: name: ABX CRO
name: PSI CRO
First posted: 2017-02-09
Enrollment: 309
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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 outcomes:
measure: progression-free survival (PFS)
timeFrame: 12 weeks +/- 14 days, up to 30 months
Secondary outcomes:
measure: objective response rates (ORR)
timeFrame: 12 weeks +/- 14 days, up to 30 months
measure: overall survival (OS)
timeFrame: 12 weeks +/- 14 days, up to 90 months
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Banner Health d.b.a. Banner MD Anderson Cancer Center
state: Arizona
city: Stanford
country: United States
facility: Stanford University
state: California
city: Tampa
country: United States
facility: Moffitt Cancer Center & Research Institute
state: Florida
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
city: Houston
country: United States
facility: Excel Diagnostics & Nuclear Oncology Center
state: Texas
city: Saint Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Heidelberg
country: Australia
facility: Olivia Newton-John Cancer & Wellness Centre, Austin Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
city: Wien
country: Austria
facility: Allgemeines Krankenhaus Wien
city: Brussels
country: Belgium
facility: Institut Jules Bordet
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen Leuven
city: Olomouc
country: Czechia
facility: University Hospital Olomouc
city: Prague
country: Czechia
facility: University Hospital Motol
city: Bron
country: France
facility: Hospices civils de Lyon
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
city: Clichy
country: France
facility: HP Hôpital Beaujon
city: Montpellier
country: France
facility: Institut de Recherche en Cancérologie de Montpellier (IRCM)
city: Nantes
country: France
facility: CHU de Nantes - Hôtel Dieu
city: Toulouse
country: France
facility: IUCT-Oncopole
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka GmbH
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Hamburg
country: Germany
facility: University Medical Center, Abteilung für Nuklearmedizin
city: Magdeburg
country: Germany
facility: Universitätsklinikum Magdeburg A.ö.R., Otto-von-Guericke Universität
city: Marburg
country: Germany
facility: Philipps Universität Marburg
city: Munich
country: Germany
facility: Klinikum rechts der Isar Technische Universität München
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
city: Wurzburg
country: Germany
facility: Universitätsklinikum Würzburg
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) Srl
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
city: Milano
country: Italy
facility: European Institute of Oncology (EIO)
city: Amsterdam
country: Netherlands
facility: Academic Medical Center, University of Amsterdam
city: Gliwice
country: Poland
facility: MSC Memorial Cancer Centre
city: Warsaw
country: Poland
facility: "Gammed" Izabela Chuchrowksa
city: Cape Town
country: South Africa
facility: University Cape Town (UCT), Groote Schuur Hospital
city: Pretoria
country: South Africa
facility: University of Pretoria & Steve Biko Academic Hospital
city: Barcelona
country: Spain
facility: Vall d'Hebron University Hospital
city: Barcelona
country: Spain
facility: ICO Hospitalet, Granvia de l'Hospitalet
city: Madrid
country: Spain
facility: MD Anderson Cancer Center Madrid
city: Madrid
country: Spain
facility: University Hospital 12 de Octubre
city: Oviedo
country: Spain
facility: Central University Hospital de Asturias (HUCA)
city: Valencia
country: Spain
facility: University and Polytechnic Hospital La Fe
city: Basel
country: Switzerland
facility: Universitätsspital Basel
city: Bern
country: Switzerland
facility: Inselspital, Universitätsspital Bern
city: Zürich
country: Switzerland
facility: UniversitätsSpital Zürich
city: London
country: United Kingdom
facility: Royal Free NHS Foundation Trust
city: London
country: United Kingdom
facility: Kings College Hospital
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
Study officials:
References: