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OpenTrials
Completed

NCT Number: NCT04946305

A Post Marketing Surveillance on Lutathera® in Patients With Somatostatin Receptor Positive Gastroenteropancreatic Neuroendocrine Tumor in Korea

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.

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Key information

Conditions

Somatostatin Receptor-positive GEP-NET

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site, Seongnam-si, Gyeonggi-do, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Patients with contraindication according to prescribing information for Lutathera in Korea.

Treatment and study plan

LUTATHERA

Other

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.

Primary outcomes

  1. Incidence of Adverse Events

    Time frame: Up to 36 weeks

    Incidence of Adverse Events (AEs), Serious AE and unexpected AEs.

  2. Incidence of Adverse Drug Reactions

    Time frame: Up to 36 weeks

    Incidence of Adverse Drug Reactions (ADRs), Serious ADRs and unexpected ADRs.

Secondary outcomes

  1. Effectiveness in terms of Overall Response Rate (ORR)

    Time frame: Up to 32 weeks (4 cycles of 8 weeks)

    ORR is defined as the proportion of treated patients who achieve a best overall response of partial response (PR) or complete response (CR) according to RECIST 1.1.

    Partial Response (PR): At least a 30% decrease from baseline, confirmed at 4 weeks.

    Complete Response (CR): Disappearance of all known disease, confirmed at 4 weeks, lymph nodes must be less than 10 mm short axis

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Post Marketing Surveillance on Lutathera® (Lutetium (177Lu) Oxodotreotide, 177Lu-DOTA0-Tyr3-Octreotate) in Patients With Somatostatin Receptor Positive Gastroenteropancreatic Neuroendocrine Tumor (GEP-NET) in Korea

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 30, 2021
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.