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

Launched by ITM SOLUCIN GMBH · Feb 7, 2017

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Peptide Receptor Radionuclide Therapy (PRRT) using a substance called 177Lu-Edotreotide. The goal is to see how effective and safe this treatment is compared to another medication called Everolimus in patients who have certain types of neuroendocrine tumors (NETs) that cannot be surgically removed and are growing. These tumors can come from the gastrointestinal tract or the pancreas and must have specific characteristics to qualify for the study.

To be eligible for this trial, participants must have a confirmed diagnosis of a well-differentiated neuroendocrine tumor and show measurable signs of disease progression based on imaging tests like a CT or MRI scan. Eligible participants should also have tumors that are positive for somatostatin receptors, which means they can respond to the treatment being studied. Throughout the trial, participants will receive either the new treatment or the standard medication and will be monitored for their health and response to treatment. It’s important to know that individuals with certain health conditions or who are pregnant cannot participate.

Gender

ALL

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.).