Status:
COMPLETED
Post-Authorization Safety Study (PASS) of LysaKare® in Adult Gastroenteropancreatic Neuroendocrine Tumor (GEP-NET) Patients
Lead Sponsor:
Advanced Accelerator Applications
Conditions:
Gastroenteropancreatic Neuroendocrine Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of the study was to evaluate the effect of arginine/lysine solution administration on serum potassium levels. A systematic assessment of serum potassium levels was performed during infusio...
Detailed Description
The study schedule for each patient consisted of a screening period followed by an infusion day with an optional overnight in-clinic stay, and a follow up call 48h post infusion. Screening Phase: At...
Eligibility Criteria
Inclusion
- 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
- Pre-existing hyperkalemia (\>6.0 mmol/L at screening) if not adequately corrected before starting the LysaKare (arginine/lysine) infusion. For Poland only, pre-existing hyperkalemia (\> 5.5 mmol/L at screening) if not adequately corrected before starting the LysaKare (arginine/lysine) infusion.
- 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.
Key Trial Info
Start Date :
January 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 18 2023
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04524442
Start Date
January 25 2021
End Date
November 18 2023
Last Update
January 24 2025
Active Locations (7)
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1
Istituto Europeo di Oncologia
Milan, MI, Italy, 20141
2
Erasmus University Medical Center
Rotterdam, Gelderland, Netherlands, 3015
3
Gammed-Centrum Diagnostyczno-Lecznicze
Warsaw, Poland, 02-351
4
University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom, B15 2GW