Post-Authorization Long-Term Safety Study of LUTATHERA
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
ClinicalTrials.gov Identifier: NCT03691064
Novartis Reference Number: A-LUT-T-E02-402
Last Update: Nov 10, 2022
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
Study to assess the long-term safety of LUTATHERA for the labeled indication (SmPC/USPI).
Interventions
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.
Study Locations
Contacts
Have a question?
Call 1-888-669-6682 or email [email protected]