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

  • STATUS
    Recruiting
  • End date
    Jun 23, 2029
  • participants needed
    300
  • sponsor
    ITM Solucin GmbH
Updated on 23 September 2021
measurable disease
everolimus
somatostatin
progressive disease
radionuclide therapy
edotreotide

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).

Details
Condition Neuroendocrine Tumor, Neuroectodermal Tumor, Neurectoderma, neuroendocrine tumors, neuroendocrine tumour
Treatment Everolimus, 177Lu-edotreotide PRRT, Amino-Acid Solution
Clinical Study IdentifierNCT03049189
SponsorITM Solucin GmbH
Last Modified on23 September 2021

Eligibility

Yes No Not Sure

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.)
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