Post-Authorization Safety Study (PASS) of LysaKare® in Adult Gastroenteropancreatic Neuroendocrine Tumor (GEP-NET) Patients
A Multicenter, Open-label Post Authorization Safety Study to Evaluate the Effect of LysaKare® Infusion on Serum Potassium Levels in GEP-NET Patients Eligible for Lutathera® Treatment
ClinicalTrials.gov Identifier: NCT04524442
Novartis Reference Number: CAAA001A12401
Last Update: May 11, 2022
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.
Study Description
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.
Interventions
Eligibility 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.
Study Locations
Contacts
Have a question?
Call 1-888-669-6682 or email [email protected]