Post-Authorization Safety Study (PASS) of LysaKare® in adult GEP-NET patients.

Phase 1

• Conditions: ysaKare® is indicated for reduction of renal radiation exposure during peptide-receptor radionuclide therapy (PRRT) with lutetium (177 Lu) oxodotreotide in adults.; MedDRA version: 20.0Level: PTClassification code 10038428Term: Renal disorderSystem Organ Class: 10038359 - Renal and urinary disorders; MedDRA version: 20.1Level: PTClassification code 10029140Term: Nephritis radiationSystem Organ Class: 10022117 - Injury, poisoning and procedural complications; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2019-004073-76-PL
• Lead Sponsor: Advanced Accelerator Applications International SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-13
• Last Update Posted: 26 February 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

1. Pre-existing hyperkalemia (>5.5 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 clinical trial of medicinal product
• Study Design: Not specified