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: Apr 26, 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:
patients with unresectable or metastatic, well-differentiated, somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours treated with LUTATHERA
Exclusion Criteria:
hypersensitivity to LUTATHERA (active substance or any of the excipients)
pregnancy (established, suspected, or when not excluded)
kidney failure with creatinine clearance < 30 mL/min
Study Locations
Contacts
Have a question?
Call 1-888-669-6682 or email [email protected]