Post-Authorization Long-Term Safety Study of LUTATHERA (NCT03691064) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Post-Authorization Long-Term Safety Study of LUTATHERA
United States, France1,014 participantsStarted 2018-11-28
Plain-language summary
Study to assess the long-term safety of LUTATHERA for the labeled indication (SmPC/USPI).
Who can participate
Age range18 Years
SexALL
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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.