18 and older, any sex, with Gastroenteropancreatic Neuroendocrine Tumors. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Mean Change From Baseline in Serum Potassium Levels Over 24 HoursPrimary· Day 0/Infusion Day (Hour 0, Hour 2, Hour 4, Hour 6, Hour 8, Hour 12, Hour 24)
Serum potassium levels at each collection time point will be measured at local laboratories of study sites using validated methods. The potassium concentration results will be summarized descriptively and will include mean change, maximum change, time to the maximum change, and the overall dynamics of the potassium concentration curve during and after the arginine/lysine infusion.
Pre-dose (hour 0)
Group
Value
95% CI
GEP-NET
4.3
± 0.397
Change from Baseline (BL) to Hour 2
Group
Value
95% CI
GEP-NET
0.25
± 0.452
Change from Baseline (BL) to Hour 4
Group
Value
95% CI
GEP-NET
0.60
± 0.666
Change from Baseline (BL) to Hour 6
Group
Value
95% CI
GEP-NET
0.49
± 0.602
Change from Baseline (BL) to Hour 8
Group
Value
95% CI
GEP-NET
0.38
± 0.487
Change from Baseline (BL) to Hour 12
Group
Value
95% CI
GEP-NET
0.24
± 0.557
Change from Baseline (BL) to Hour 24
Group
Value
95% CI
GEP-NET
0.07
± 0.396
Percentage of Participants With Treatment Adverse Events (AEs) & Serious Adverse Events (SAEs)Secondary· Day 0/Infusion Day up to 48 hours post infusion
Safety measured by the percentage of participants with treatment emergent adverse events (starting from the signing of the ICF until the end of the follow-up call (48 hours after infusion).
Adverse Event (AEs)
Group
Value
95% CI
GEP-NET
11
Treatment-related AEs
Group
Value
95% CI
GEP-NET
6
Serious Adverse Events (SAEs)
Group
Value
95% CI
GEP-NET
0
Fatal SAEs
Group
Value
95% CI
GEP-NET
0
AEs leading to discontinuation
Group
Value
95% CI
GEP-NET
0
AEs leading to Interrruption
Group
Value
95% CI
GEP-NET
0
AEs requiring additional therapy
Group
Value
95% CI
GEP-NET
5
Treatment related AEs req. additional therapy
Group
Value
95% CI
GEP-NET
3
Number of Participants With Notable Changes in Vital SignsSecondary· Day 0/Infusion Day (0, 2, 4, 6, 8, 12 and 24 hours)
Safety measured by the notable post-baseline changes in vital signs: (systolic blood pressure, diastolic blood pressure, pulse rate \& weight) compared to baseline.
Systolic blood pressure (mmHg): ≥180 with increase from baseline of ≥20
Group
Value
95% CI
GEP-NET
0
Systolic blood pressure (mmHg): ≤ 90 with decrease from baseline of ≥20
Group
Value
95% CI
GEP-NET
0
Diastolic blood pressure (mmHg): ≥105 with increase from baseline of ≥15
Group
Value
95% CI
GEP-NET
0
Diastolic blood pressure (mmHg): ≤ 50 with decrease from baseline of ≥15
Group
Value
95% CI
GEP-NET
0
Pulse rate (bpm): ≥100 with increase from baseline of >25%
Group
Value
95% CI
GEP-NET
0
Pulse rate (bpm): ≤ 50 with decrease from baseline of > 25%
Group
Value
95% CI
GEP-NET
0
Weight (kg): increase ≥10% from Baseline
Group
Value
95% CI
GEP-NET
0
Weight (kg): decrease > 10% from Baseline
Group
Value
95% CI
GEP-NET
0
Number of Participants With Notable Changes in Electrocardiogram (ECG)Secondary· Day 0/Infusion Day (0, 4, 8 and 24 hours)
Safety measured by the notable post-baseline changes in ECG values compared to baseline PR, QRS, QT, QTcF, and RR intervals were obtained from 12-lead ECGs for each subject during the study
QTcF (ms): Increase >30 to ≤ 60 ms
Group
Value
95% CI
GEP-NET
7
QTcF (ms): Increase >60 ms
Group
Value
95% CI
GEP-NET
0
QTcF (ms): New >450 to ≤ 480 ms
Group
Value
95% CI
GEP-NET
7
QTcF (ms): New >480 to ≤ 500 ms
Group
Value
95% CI
GEP-NET
0
QTcF (ms); New >500 ms
Group
Value
95% CI
GEP-NET
0
QT (ms): Increase >30 to ≤ 60 ms
Group
Value
95% CI
GEP-NET
9
QT (ms): Increase >60 ms
Group
Value
95% CI
GEP-NET
2
QT (ms): New >450 to ≤ 480 ms
Group
Value
95% CI
GEP-NET
6
Number of Participants With Notable Changes in Hematology ParametersSecondary· Day 0/Infusion Day (0 and 24 hours)
Safety measured by the notable post-baseline changes in Hematology parameters compared to baseline as represented by Shift tables based on common toxicity criteria (CTC) grades. Each participant was counted only for the worst grade observed post-baseline. Notable change is the shift to higher grades from baseline.
Group
Value
95% CI
GEP-NET
0
Number of Participants With Notable Changes in Chemistry ParametersSecondary· Day 0/Infusion Day (0 and 24 hours)
Safety measured by the notable post-baseline changes in Chemistry parameters compared to baseline. Each participant was counted only for the worst grade observed post-baseline. Notable change is the shift to higher grades from baseline.
Key shifts were in the following parameters: creatinine, lactate dehydrogenase and creatinine clearance.
Creatinine (increase)
Group
Value
95% CI
GEP-NET
4
Lactate dehydrogenase (increase)
Group
Value
95% CI
GEP-NET
3
Creatinine clearance (decrease)
Group
Value
95% CI
GEP-NET
4
Number of Participants With Notable Changes in Electrolyte ParametersSecondary· Day 0/Infusion Day (0, 2, 4, 6, 8, 12 and 24 hours)
Safety measured by the notable post-baseline changes in Electrolyte parameters compared to baseline. Each participant was counted only for the worst grade observed post-baseline. Notable change is the shift to higher grades from baseline.
For Potassium (increase)
Group
Value
95% CI
GEP-NET
7
For sodium (decrease)
Group
Value
95% CI
GEP-NET
12
Mean Change From Baseline in Blood Gas Parameter, pH, Over 24 HoursSecondary· Day 0/Infusion Day (0, 2, 4, 6, 8, 12 and 24 hours)
Safety measured by the mean changes in blood gas compared to baseline. Blood gas parameter: pH.
Day 0/Infusion Day (Pre-dose) (hour 0)
Group
Value
95% CI
GEP-NET
7.35
± 0.046
Change from Baseline (BL) to Hour 2
Group
Value
95% CI
GEP-NET
-0.03
± 0.046
Change from Baseline (BL) to Hour 4
Group
Value
95% CI
GEP-NET
-0.06
± 0.055
Change from Baseline (BL) to Hour 6
Group
Value
95% CI
GEP-NET
-0.05
± 0.051
Change from Baseline (BL) to Hour 8
Group
Value
95% CI
GEP-NET
-0.05
± 0.056
Change from Baseline (BL) to Hour 12
Group
Value
95% CI
GEP-NET
-0.03
± 0.054
Change from Baseline (BL) to Hour 24
Group
Value
95% CI
GEP-NET
-0.04
± 0.051
Mean Change From Baseline in Blood Gas Parameter, Lactic Acid, Over 24 HoursSecondary· Day 0/Infusion Day (0, 2, 4, 6, 8, 12 and 24 hours)
Safety measured by the mean changes in blood gas compared to baseline. Blood gas parameter: Lactic Acid
Day 0/Infusion Day (Pre-dose) (hour 0)
Group
Value
95% CI
GEP-NET
1.40
± 0.604
Change from Baseline (BL) to Hour 2
Group
Value
95% CI
GEP-NET
-0.07
± 0.671
Change from Baseline (BL) to Hour 4
Group
Value
95% CI
GEP-NET
-0.23
± 0.523
Change from Baseline (BL) to Hour 6
Group
Value
95% CI
GEP-NET
-0.26
± 0.546
Change from Baseline (BL) to Hour 8
Group
Value
95% CI
GEP-NET
-0.19
± 0.465
Change from Baseline (BL) to Hour 12
Group
Value
95% CI
GEP-NET
-0.21
± 0.657
Change from Baseline (BL) to Hour 24
Group
Value
95% CI
GEP-NET
-0.16
± 0.650
Mean Change From Baseline in Blood Gas Parameter, Partial Pressure Carbon Dioxide, Over 24 HoursSecondary· Day 0/Infusion Day (0, 2, 4, 6, 8, 12 and 24 hours)
Safety measured by the mean changes in blood gas compared to baseline. Blood gas parameter: Partial Pressure Carbon Dioxide.
Day 0/Infusion Day (Pre-dose) (hour 0)
Group
Value
95% CI
GEP-NET
50.53
± 8.712
Change from Baseline (BL) to Hour 2
Group
Value
95% CI
GEP-NET
-1.08
± 6.670
Change from Baseline (BL) to Hour 4
Group
Value
95% CI
GEP-NET
-2.44
± 8.717
Change from Baseline (BL) to Hour 6
Group
Value
95% CI
GEP-NET
-4.90
± 8.507
Change from Baseline (BL) to Hour 8
Group
Value
95% CI
GEP-NET
-4.87
± 8.399
Change from Baseline (BL) to Hour 12
Group
Value
95% CI
GEP-NET
-5.71
± 8.002
Change from Baseline (BL) to Hour 24
Group
Value
95% CI
GEP-NET
-2.54
± 8.242
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse Events (AEs) were collected from the administration of the study treatment up to 48 hours in addition to the infusion time, an average of 52 hours total..
Reporting threshold: 2%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Advanced Accelerator Applications
Last refreshed: 24 January 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04524442.