Clinical trial NCT03691064: Post-Authorization Long-Term Safety Study of LUTATHERA
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Neuroendocrine Tumors
Keywords: Gastroenteropancreatic neuroendocrine tumours
Lead sponsor: Advanced Accelerator Applications
Sponsor class: INDUSTRY
First posted: 2018-10-01
Enrollment: 1014
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients treated with LUTATHERA for the labeled indication using the approved dosing regimen.

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: secondary cancers: incidence of secondary cancers
timeFrame: up to 7 years follow-up
Secondary outcomes:
measure: safety profile: incidence of adverse events
timeFrame: up to 7 years follow-up
measure: mortality
timeFrame: up to 7 years follow-up
measure: LUTATHERA dose per administration
timeFrame: completion of treatment phase (approximately 2 years total)
measure: LUTATHERA total dose
timeFrame: completion of treatment phase (approximately 2 years total)
measure: LUTATHERA number of administrations
timeFrame: completion of treatment phase (approximately 2 years total)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner MD Anderson Cancer Center
state: Arizona
city: Portland
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Sciences University Hospital
state: Oregon
city: Seattle
country: United States
facility: Virginia Mason in Seattle
state: Washington
city: Clichy
country: France
facility: Novartis Investigative site
city: Lyon
country: France
facility: Novartis Investigative site
city: Villejuif
country: France
facility: Novartis Investigative site
city: Coimbra
country: Portugal
facility: Novartis Investigative site
city: Santiago de Compostela
country: Spain
facility: Novartis Investigative site
state: La Corunya
city: Majadahonda
country: Spain
facility: Novartis Investigative site
state: Madrid
city: Birmingham
country: United Kingdom
facility: Novartis Investigative site
city: Cambridge
country: United Kingdom
facility: Novartis Investigative site
city: Glasgow
country: United Kingdom
facility: Novartis Investigative site
city: Liverpool
country: United Kingdom
facility: Novartis Investigative site
city: London
country: United Kingdom
facility: Novartis Investigative site
city: London
country: United Kingdom
facility: Novartis Investigative site
city: London
country: United Kingdom
facility: Novartis Investigative site
city: London
country: United Kingdom
facility: Novartis Investigative site
city: Manchester
country: United Kingdom
facility: Novartis Investigative site
city: Scheffield
country: United Kingdom
facility: Novartis Investigative site
Study officials:
affiliation: Advanced Accelerator Applications
name: Study Director
role: STUDY_DIRECTOR
References: