Title
Efficacy and Safety of 177Lu-edotreotide PRRT in GEP-NET Patients
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)
Phase
Phase 3Lead Sponsor
ITM Solucin GmbHStudy Type
InterventionalStatus
Active, not recruitingIndication/Condition
Neuroendocrine TumorsIntervention/Treatment
everolimus amino acids lutetium dotatate lu-177 ...Study Participants
309The 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).
PRRT using 177Lu-edotreotide will be performed 3-monthly. A maximum of four cycles will be administered.
Everolimus will be adminstered as a standard dosis of 10 mg daily which may be reduced where required for acceptable tolerability.
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
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 (Afinitor ®) Doses: 10 mg/d Route of administration: Oral Duration of treatment: Continuous daily treatment until diagnosis of progression or End of Study (EOS)
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.).
