Post-Authorization Safety Study (PASS) of LysaKare® in adult GEP-NET patients.
- 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: SOCClassification code 10038359Term: Renal and urinary disordersSystem Organ Class: 10038359 - Renal and urinary disordersMedDRA version: 20.1Level: PTClassification code 10029140Term: Nephritis radiationSystem Organ Class: 10022117 - Injury, poisoning and procedural complicationsTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2019-004073-76-IT
- Lead Sponsor
- Advanced Accelerator Applications SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 40
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
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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the effect of LysaKare® administration on serum potassium concentrations in GEP-NET patients eligible for Lutathera® treatment;Secondary Objective: To confirm the safety profile of LysaKare® infusion in GEP-NET patients eligible for Lutathera® treatment, without co-administration of Lutathera®;Primary end point(s): Change in serum potassium levels at specified time points after LysaKare® IV administration compared to baseline.;Timepoint(s) of evaluation of this end point: 2 h, 4 h, 6 h, 8 h, 12 h, 24 h
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Incidence of LysaKare® related adverse events<br>- Changes in vital signs and ECG parameters<br>- Change in laboratory parameters;Timepoint(s) of evaluation of this end point: 2 h, 4 h, 6 h, 8 h, 12 h, 24 h, 48 h