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

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

ClinicalTrials.gov Identifier: NCT04524442

Novartis Reference Number: CAAA001A12401

Last Update: May 11, 2022

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

The purpose of the study is to evaluate the effect of arginine/lysine solution administration on serum potassium levels. A systematic assessment of serum potassium levels will be performed during infusion and up to 24 hours post start of infusion compared to baseline.

Condition 
Gastroenteropancreatic Neuroendocrine Tumors
Phase 
Phase 4
Overall status 
Recruiting
Start date 
Jan 27, 2021
Completion date 
Jun 30, 2022
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
arginine/lysine
1000 milliliters (mL) administered at a constant rate of 250 mL per hour

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 arginine/lysine solution infusion (applicable to all countries except Poland).
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.

Study Locations

Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
Recruiting
Meldola, 47014 - FC
Contact: Stefano Severi
Italy
Istituto Europero di Oncologia
Recruiting
Milan, 20141 - MI
Contact: Chiara Grana
Italy
Netherlands
Erasmus University Medical Center
Recruiting
Rotterdam, 3015 - GD
Contact: Hans Hofland
Netherlands
Poland
Gammed-Centrum Diagnostyczno-Lecznicze
Recruiting
Warsaw, 02-351
Contact: Jaroslaw B. Cwikla, Dr
Poland
United Kingdom
University Hospitals Birmingham NHS Foundation Trust
Recruiting
Birmingham, B15 2GW
Contact: Tahir Shah, Dr
United Kingdom
University Hospitals Coventry & Warwickshire NHS Trust
Recruiting
Coventry, CV2 2DX
Contact: Martin Weickert
United Kingdom
The Beatson West of Scotland Cancer
Recruiting
Glasgow, G12 0YN
Contact: Nicholas Reed
United Kingdom
Royal Surrey County Hospital
Recruiting
Guildford, GU2 7XX
Contact: Vineet Prakash, Dr
United Kingdom

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

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Call 1-888-669-6682 or email [email protected]