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

Advanced Accelerator Applications

Status and phase

Completed

Phase 4

Conditions

Gastroenteropancreatic Neuroendocrine Tumors

Treatments

Drug: arginine/lysine

Study type

Interventional

Funder types

Industry

Identifiers

NCT04524442

2019-004073-76 (EudraCT Number)

CAAA001A12401

Details and patient eligibility

About

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.

Full description

The study schedule for each patient consists 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 screening, patient eligibility will be determined according to inclusion and exclusion criteria, with evaluation of patient's vital signs, ECG and laboratory parameters. The duration of screening can be as short as one day but should not exceed 7 days. Patients who show potassium level > 6.0 mmol/L (> 5.5 mmol/L for Poland only) at screening should have their potassium level corrected and can be re-screened afterwards.

Treatment Phase:

Eligible patients will be admitted to the in-clinic unit to be dosed with arginine/lysine solution for infusion of 1,000 mL, which is administered intravenously over a period of 4 hours. Before the infusion (at 0 h time point), a set of baseline tests will be performed. During and after the infusion, patient condition will be monitored for evaluation of any adverse events. Only patients with a potassium level of ≤ 6 mmol/L at screening (> 5.5 mmol/L for Poland only) will be allowed to be dosed. Potassium testing on the infusion day will be performed at 0h (before the infusion), and at 2h, 4h, 6h, 8h, 12h, and 24h after the start of infusion. Vital signs and ECGs will be taken as specified in the assessment schedule. All patients will be monitored closely for signs and symptoms of hyperkalemia, e.g. dyspnoea, weakness, numbness, chest pain and cardiac manifestations (conduction abnormalities and cardiac arrhythmias). Other common adverse reactions during arginine/lysine solution administration are nausea and vomiting. Before the start of arginine/lysine solution infusion, an intravenous bolus of an anti-emetic should be given. The choice of anti-emetic drugs is at the discretion of the physician.

Follow-up Phase:

All patients will be called for a safety follow-up in 48 hours after dosing. Patients should not be scheduled to receive repeat dosing with arginine/lysine solution as concomitant medication with Lutathera® within 7 days of the arginine/lysine solution infusion in the study.

Enrollment

42 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 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):