Post-Authorization Long-Term Safety Study of LUTATHERA

Launched by ADVANCED ACCELERATOR APPLICATIONS · Sep 25, 2018

Keywords

ClinConnect Summary

This clinical trial is focused on studying the long-term safety of a treatment called LUTATHERA for patients with a specific type of cancer known as neuroendocrine tumors. These tumors can be challenging to treat, especially when they cannot be removed through surgery. The trial is currently active, meaning researchers are still collecting information, but they are not enrolling new participants at this time.

To be eligible for the trial, participants must be adults who have been diagnosed with a type of neuroendocrine tumor that is advanced or cannot be surgically removed, and they should have previously received LUTATHERA treatment. However, individuals who are allergic to LUTATHERA, pregnant, or have severe kidney problems are not eligible to participate. If someone joins the study, they can expect to be monitored over time to ensure that LUTATHERA remains safe for long-term use. This research is important as it helps improve understanding of how well LUTATHERA works and its potential side effects in patients who have already received it.

Gender

ALL

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.