Post-Authorization Long-Term Safety Study of LUTATHERA

Active, not recruiting

• Conditions: Neuroendocrine Tumors
• Interventions: Drug: LUTATHERA

• Registration Number: NCT03691064
• Lead Sponsor: Advanced Accelerator Applications

Brief Summary

Study to assess the long-term safety of LUTATHERA for the labeled indication (SmPC/USPI).

Detailed Description

To assess the incidence and nature of potential long-term safety outcomes in patients with unresectable or metastatic, well-differentiated, somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours. Retrospective and prospective data will be used.

Study Timeline

• Study First Submitted: 2018-09-22
• Study First Submitted QC: 2018-09-25
• Study First Posted: 2018-10-01
• Study Start: 2018-11-28
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-30
• Primary Completion: 2028-06-30
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1014

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
LUTATHERA	LUTATHERA	Treated per labeled LUTATHERA dosing regimen.

Primary Outcome Measures

Name	Time	Method
secondary cancers: incidence of secondary cancers	up to 7 years follow-up	incidence of secondary cancers

Secondary Outcome Measures

Name	Time	Method
safety profile: incidence of adverse events	up to 7 years follow-up	incidence of adverse events
mortality	up to 7 years follow-up	mortality (all cause)
LUTATHERA number of administrations	completion of treatment phase (approximately 2 years total)	average number of LUTATHERA doses
LUTATHERA dose per administration	completion of treatment phase (approximately 2 years total)	average dose per administration
LUTATHERA total dose	completion of treatment phase (approximately 2 years total)	average total dose administered

Trial Locations

Locations (5)

Novartis Investigative site; 🇬🇧 Scheffield, United Kingdom

Banner MD Anderson Cancer Center; 🇺🇸 Phoenix, Arizona, United States

Virginia Mason in Seattle; 🇺🇸 Seattle, Washington, United States

Oregon Health & Sciences University Hospital; 🇺🇸 Portland, Oregon, United States

The Ohio State University Wexner Medical Center; 🇺🇸 Portland, Ohio, United States