Phase 4
N=42
Post-Authorization Safety Study (PASS) of LysaKare® in Adult Gastroenteropancreatic Neuroendocrine Tumor (GEP-NET) Patients
Gastroenteropancreatic Neuroendocrine Tumors
Bottom Line
View on ClinicalTrials.gov: NCT04524442 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Mean Change From Baseline in Serum Potassium Levels Over 24 Hours — 4.3; 0.25; 0.60; 0.49 mmol/L
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- arginine/lysine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Advanced Accelerator Applications
- Primary completion
- Nov 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Serum Potassium Levels Over 24 Hours |
4.3; 0.25; 0.60; 0.49; 0.38; 0.24 | — |
| SECONDARY Percentage of Participants With Treatment Adverse Events (AEs) & Serious Adverse Events (SAEs) |
11; 6; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Notable Changes in Vital Signs |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Notable Changes in Electrocardiogram (ECG) |
7; 0; 7; 0; 0; 9 | — |
| SECONDARY Number of Participants With Notable Changes in Hematology Parameters |
— | — |
| SECONDARY Number of Participants With Notable Changes in Chemistry Parameters |
4; 3; 4 | — |
| SECONDARY Number of Participants With Notable Changes in Electrolyte Parameters |
7; 12 | — |
| SECONDARY Mean Change From Baseline in Blood Gas Parameter, pH, Over 24 Hours |
7.35; -0.03; -0.06; -0.05; -0.05; -0.03 | — |
| SECONDARY Mean Change From Baseline in Blood Gas Parameter, Lactic Acid, Over 24 Hours |
1.40; -0.07; -0.23; -0.26; -0.19; -0.21 | — |
| SECONDARY Mean Change From Baseline in Blood Gas Parameter, Partial Pressure Carbon Dioxide, Over 24 Hours |
50.53; -1.08; -2.44; -4.90; -4.87; -5.71 | — |
Summary
The purpose of the study was to evaluate the effect of arginine/lysine solution administration on serum potassium levels. A systematic assessment of serum potassium levels was performed during infusion and up to 24 hours post start of infusion compared to baseline.
Eligibility Criteria
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):
- Pre-existing hyperkalemia (> 5.5 mmol/L at screening) if not adequately corrected before starting the arginine/lysine solution infusion.
Data sourced from ClinicalTrials.gov (NCT04524442). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.