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

NCT03049189

Active Not RecruitingPhase 3

Sponsor: ITM Solucin GmbH

Conditions: Neuroendocrine Tumors

Interventions: 177Lu-edotreotide PRRT, Everolimus, Amino-Acid Solution

Countries: United States, Australia, Austria, Belgium, Czechia, France, Germany, Italy

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.).
Locations (52)
  • Gilbert, Arizona, United States
  • Stanford, California, United States
  • Tampa, Florida, United States
  • Chicago, Illinois, United States
  • Ann Arbor, Michigan, United States
  • Houston, Texas, United States
  • Saint Leonards, New South Wales, Australia
  • Heidelberg, Victoria, Australia
  • Melbourne, Victoria, Australia
  • Murdoch, Western Australia, Australia
  • Vienna, Austria
  • Brussels, Belgium
  • Leuven, Belgium
  • Olomouc, Czechia
  • Prague, Czechia
  • Bron, France
  • Clermont-Ferrand, France
  • Clichy, France
  • Montpellier, France
  • Nantes, France
  • Toulouse, France
  • Bad Berka, Germany
  • Berlin, Germany
  • Bonn, Germany
  • Erlangen, Germany
  • Essen, Germany
  • Hamburg, Germany
  • Magdeburg, Germany
  • Marburg, Germany
  • Munich, Germany
  • + 22 more on CT.gov