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 - LysAA

Advanced Accelerator Applications SA0 个研究点目标入组 40 人开始时间: 2020年10月21日最近更新: 2020年12月7日

试验速览

暂无简介。

•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®.

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