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
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 to assess the long-term safety of LUTATHERA for the labeled indication (SmPC/USPI).
Nov 28, 2018
Jun 30, 2028
18 Years and older (Adult, Older Adult)
Labeled dosing regimen: 7.4 gigaBecquerel (GBq) (200 milliCurie [mCi]) every 8 weeks for a total of 4 doses.
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).
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.