A Post Marketing Surveillance on Lutathera® in Patients With Somatostatin Receptor Positive Gastroenteropancreatic Neuroendocrine Tumor in Korea
1 other identifier
observational
89
1 country
6
Brief Summary
This is a prospective, open-label, multi-center, non-comparative, non-interventional observational study to assess safety and effectiveness of Lutathera in patients with somatostatin receptor-positive GEP-NET in the real-world setting in Korea.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2022
Typical duration for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2021
CompletedFirst Posted
Study publicly available on registry
June 30, 2021
CompletedStudy Start
First participant enrolled
May 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 8, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 8, 2024
CompletedAugust 9, 2024
August 1, 2024
2.2 years
June 23, 2021
August 8, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of Adverse Events
Incidence of Adverse Events (AEs), Serious AE and unexpected AEs.
Up to 36 weeks
Incidence of Adverse Drug Reactions
Incidence of Adverse Drug Reactions (ADRs), Serious ADRs and unexpected ADRs.
Up to 36 weeks
Secondary Outcomes (1)
Effectiveness in terms of Overall Response Rate (ORR)
Up to 32 weeks (4 cycles of 8 weeks)
Study Arms (1)
Lutathera
Patients administered Lutathera by prescription
Interventions
Prospective observational study. There is no treatment allocation. Patients administered Lutathera by prescription that have started before inclusion of the patient into the study will be enrolled.
Eligibility Criteria
Patients with somatostatin receptor-positive GEP-NET in the real-world setting in Korea.
You may qualify if:
- Patients who start Lutathera treatment per clinical judgment, according to the locally approved labeling.
- \- somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults.
- Patients who are willing to provide written informed consent.
You may not qualify if:
- \. Patients with contraindication according to prescribing information for Lutathera in Korea.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Novartis Investigative Site
Seongnam-si, Gyeonggi-do, 13620, South Korea
Novartis Investigative Site
Seoul, 03722, South Korea
Novartis Investigative Site
Seoul, 06351, South Korea
Novartis Investigative Site
Seoul, 110-799, South Korea
Novartis Investigative Site
Seoul, 137-040, South Korea
Novartis Investigative Site
Seoul, 138-736, South Korea
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2021
First Posted
June 30, 2021
Study Start
May 10, 2022
Primary Completion
July 8, 2024
Study Completion
July 8, 2024
Last Updated
August 9, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share