Trials / Active Not Recruiting
Active Not RecruitingNCT03691064
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
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,014 (actual)
- Sponsor
- Advanced Accelerator Applications · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | LUTATHERA | Labeled dosing regimen: 7.4 gigaBecquerel (GBq) (200 milliCurie \[mCi\]) every 8 weeks for a total of 4 doses. |
Timeline
- Start date
- 2018-11-28
- Primary completion
- 2027-09-30
- Completion
- 2027-09-30
- First posted
- 2018-10-01
- Last updated
- 2025-12-23
Locations
20 sites across 5 countries: United States, France, Portugal, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03691064. Inclusion in this directory is not an endorsement.