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

Phase 4

Completed

• Conditions: Gastroenteropancreatic neuroendocrine tumors (GEP-NET); Carcinoid tumors; 10014713

• Registration Number: NL-OMON52585
• Lead Sponsor: Advanced Accelerator Applications International SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 8

Inclusion Criteria

1. Male or female patients with somatostatin receptor positive
gastroenteropancreatic neuroendocrine tumours (GEP-NETs), who are eligible for
the treatment with Lutathera® as per Lutathera® label indication.
2. Age *18 years.
3. 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

1. Pre-existing hyperkalemia (>6.0 mmol/L at screening) if not adequately
corrected before starting the LysaKare® infusion.
2. Instances when Lutathera® is not recommended per the Lutathera® SmPC:
a. Uncontrolled congestive heart failure (NYHA III, IV);
b. Kidney failure with creatinine clearance < 50 mL/min calculated by the
Cockroft Gault method;
c. Impaired haematological function with either Hb < 4.9 mmol/L (8 g/dL),
platelets < 75 G/L (75x103/mm3), or leucocytes < 2 G/L (2,000/mm3) (except
lymphopenia);
d. Liver impairment with either total bilirubinemia > 3 times the upper limit
of normal or albuminemia < 30 g/L and prothrombin ratio decreased < 70%.
3. Pregnancy or lactation, positive pregnancy test at screening or pre-dose
based on the contraindication for Lutathera®.
4. Hypersensitivity to the IMP active substances.
5. 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.
6. Patients who have received any investigational agent within the last 30 days.
7. 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 LysaKare®.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Change in serum potassium levels at specified time points after LysaKare® IV<br /><br>administration compared to baseline.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Incidence of LysaKare® related adverse events<br /><br>* Changes in vital signs and ECG parameters<br /><br>* Change in laboratory parameters </p><br>