Post-Authorization Safety Study (PASS) of LysaKare® in Adult Gastroenteropancreatic Neuroendocrine Tumor (GEP-NET) Patients

NCT04524442 | Completed Phase 4 Results

• 2 other identifiers: CAAA001A124012019-004073-76
• Study Type: interventional
• Target: 42
• Locations: 4 countries
• Sites: 7

Brief 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.

Conditions

Gastroenteropancreatic Neuroendocrine Tumors

Keywords

GEP-NET; Neuroendocrine tumors; NETs; carcinoid tumors; LysaKare; arginine/lysine; amino acid; Peptide Receptor Radionuclide Therapy; PRRT; Lutathera; Lutetium Lu 177 oxodotreotide; Lutetium Lu 177 dotatate

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in Serum Potassium Levels Over 24 Hours

  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.

  Day 0/Infusion Day (Hour 0, Hour 2, Hour 4, Hour 6, Hour 8, Hour 12, Hour 24)

Secondary Outcomes (9)

• Percentage of Participants With Treatment Adverse Events (AEs) & Serious Adverse Events (SAEs)

  Day 0/Infusion Day up to 48 hours post infusion

• Number of Participants With Notable Changes in Vital Signs

  Day 0/Infusion Day (0, 2, 4, 6, 8, 12 and 24 hours)

• Number of Participants With Notable Changes in Electrocardiogram (ECG)

  Day 0/Infusion Day (0, 4, 8 and 24 hours)

• Number of Participants With Notable Changes in Hematology Parameters

  Day 0/Infusion Day (0 and 24 hours)

• Number of Participants With Notable Changes in Chemistry Parameters

  Day 0/Infusion Day (0 and 24 hours)

Study Arms (1)

GEP-NET

EXPERIMENTAL

One dose of arginine/lysine solution administered intravenously over a 4-hour period

Drug: arginine/lysine

Interventions

arginine/lysine DRUG

1000 milliliters (mL) administered at a constant rate of 250 mL per hour

Also known as: LysaKare

GEP-NET

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• \- Pre-existing hyperkalemia (\> 5.5 mmol/L at screening) if not adequately corrected before starting the arginine/lysine solution infusion.

Sponsors & Collaborators

• Advanced Accelerator Applications: lead

Study Sites (7)

Istituto Europeo di Oncologia

Milan, MI, 20141, Italy

Location

Erasmus University Medical Center

Rotterdam, Gelderland, 3015, Netherlands

Location

Gammed-Centrum Diagnostyczno-Lecznicze

Warsaw, 02-351, Poland

Location

University Hospitals Birmingham NHS Foundation Trust

Birmingham, B15 2GW, United Kingdom

Location

University Hospitals Coventry & Warwickshire NHS Trust

Coventry, CV2 2DX, United Kingdom

Location

Royal Surrey Country Hospital

Guildford, GU2 7XX, United Kingdom

Location

Liverpool Royal Hospital

Liverpool, L7 8YA, United Kingdom

Location

MeSH Terms

Conditions

Gastro-enteropancreatic neuroendocrine tumor; Neuroendocrine Tumors; Carcinoid Tumor

Interventions

arginyllysine

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial

Results Point of Contact

• Title: Clinical Disclosure Office
• Organization: Novartis Pharmaceuticals

novartis.email@novartis.com

862-778-3000

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2020
• First Posted: August 24, 2020
• Study Start: January 25, 2021
• Primary Completion: November 18, 2023
• Study Completion: November 18, 2023
• Last Updated: January 24, 2025
• Results First Posted: January 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

IT (1); GB (4); PL (1); NL (1)