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Clinical Trials/NCT03691064
NCT03691064Active, not recruitingNot Applicable

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

Advanced Accelerator Applications5 sites in 2 countries1,014 target enrollmentStarted: November 28, 2018Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
1,014
Locations
5
Primary Endpoint
secondary cancers: incidence of secondary cancers
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Other

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

LUTATHERA

Treated per labeled LUTATHERA dosing regimen.

Intervention: LUTATHERA (Drug)

Outcomes

Primary Outcomes

secondary cancers: incidence of secondary cancers

Time Frame: up to 7 years follow-up

incidence of secondary cancers

Secondary Outcomes

  • safety profile: incidence of adverse events(up to 7 years follow-up)
  • mortality(up to 7 years follow-up)
  • LUTATHERA number of administrations(completion of treatment phase (approximately 2 years total))
  • LUTATHERA dose per administration(completion of treatment phase (approximately 2 years total))
  • LUTATHERA total dose(completion of treatment phase (approximately 2 years total))

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (5)

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