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NCT03691064 Clinical Trial

Post-Authorization Long-Term Safety Study of LUTATHERA

Neuroendocrine Tumors Clinical Trial

— SALUS  

Official title:
International, Non-interventional, Post-Authorization Long-Term Safety Study of Lutathera, in Patients With Unresectable or Metastatic, Well-Differentiated, Somatostatin Receptor Positive, Gastroenteropancreatic Neuroendocrine Tumours

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03691064
Other study ID # A-LUT-T-E02-402
Secondary ID CAAA601A12402EUP
Status Active, not recruiting
Phase
First received
Last updated
Start date November 28, 2018
Est. completion date June 30, 2028

Study information
Verified date March 2023
Source Advanced Accelerator Applications
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Study to assess the long-term safety of LUTATHERA for the labeled indication (SmPC/USPI).

Description:

To assess the incidence and nature of potential long-term safety outcomes in patients with unresectable or metastatic, well-differentiated, somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours. Retrospective and prospective data will be used.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 1014
Est. completion date June 30, 2028
Est. primary completion date June 30, 2028
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - adult patients (fulfilling the definition of "age of majority" per local regulations), - with unresectable or metastatic, well-differentiated, somatostatin receptor positive GEP-NETs - and who were treated with Lutathera (regardless of the quantity and number of doses administered and whatever the reasons for ending). Exclusion Criteria: - Hypersensitivity to Lutathera (active substance or any of the excipients), - presence of established or suspected pregnancy or pregnancy not excluded, - presence of kidney failure with creatinine clearance < 30 mL/min.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• LUTATHERA
Labeled dosing regimen: 7.4 gigaBecquerel (GBq) (200 milliCurie [mCi]) every 8 weeks for a total of 4 doses.

Locations
Country Name City State
France Novartis Investigative site Clichy
France Novartis Investigative site Lyon
France Novartis Investigative site Villejuif
Portugal Novartis Investigative site Coimbra
Spain Novartis Investigative site Majadahonda Madrid
Spain Novartis Investigative site Santiago de Compostela La Corunya
United Kingdom Novartis Investigative site Birmingham
United Kingdom Novartis Investigative site Cambridge
United Kingdom Novartis Investigative site Glasgow
United Kingdom Novartis Investigative site Liverpool
United Kingdom Novartis Investigative site London
United Kingdom Novartis Investigative site London
United Kingdom Novartis Investigative site London
United Kingdom Novartis Investigative site London
United Kingdom Novartis Investigative site Manchester
United Kingdom Novartis Investigative site Scheffield
United States Banner MD Anderson Cancer Center Phoenix Arizona
United States Oregon Health & Sciences University Hospital Portland Oregon
United States The Ohio State University Wexner Medical Center Portland Ohio
United States Virginia Mason in Seattle Seattle Washington

Sponsors (1)
Lead Sponsor Collaborator
Advanced Accelerator Applications

Countries where clinical trial is conducted

United States,  France,  Portugal,  Spain,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary secondary cancers: incidence of secondary cancers incidence of secondary cancers up to 7 years follow-up
Secondary safety profile: incidence of adverse events incidence of adverse events up to 7 years follow-up
Secondary mortality mortality (all cause) up to 7 years follow-up
Secondary LUTATHERA dose per administration average dose per administration completion of treatment phase (approximately 2 years total)
Secondary LUTATHERA total dose average total dose administered completion of treatment phase (approximately 2 years total)
Secondary LUTATHERA number of administrations average number of LUTATHERA doses completion of treatment phase (approximately 2 years total)
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