Post-Authorization Safety Study (PASS) of LysaKare® in Adult Gastroenteropancreatic Neuroendocrine Tumor (GEP-NET) Patients

• Status: Recruiting
• Trial end date: 2022-03-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to evaluate the effect of arginine/lysine solution administration on serum potassium levels. A systematic assessment of serum potassium levels will be performed during infusion and up to 24 hours post start of infusion compared to baseline.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Advanced Accelerator Applications

Criteria

Inclusion Criteria:

• Patients with somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs), who are eligible for the treatment with Lutathera as per Lutathera label indication.

• Patients who have provided a signed informed consent form to participate in the study, obtained prior to the start of any protocol related procedures.

Exclusion Criteria:

• Pre-existing hyperkalemia (>6.0 mmol/L at screening) if not adequately corrected before starting the arginine/lysine solution infusion (applicable to all countries except Poland).

• Instances when Lutathera is not recommended per the Lutathera Summary of Product Characteristics (SmPC).

• Pregnancy or lactation, positive pregnancy test at screening or pre-dose based on the contraindication for Lutathera.

• Any significant medical or social condition which may interfere with the subject's ability to comply with the study visit schedule or the study assessments.

• Patients who have received any investigational agent within the last 30 days.

• Patients that have received a dose of Lutathera prior to the screening visit or are scheduled for Peptide Receptor Repeat (PRRT) treatment within 7 days of the study infusion of arginine/lysine solution.

• Other protocol-defined exclusion criteria may apply.

Exclusion Criteria (Poland Only):

• Pre-existing hyperkalemia (> 5.5 mmol/L at screening) if not adequately corrected before starting the arginine/lysine solution infusion.