A Post Marketing Surveillance on Lutathera® in Patients With Somatostatin Receptor Positive Gastroenteropancreatic Neuroendocrine Tumor in Korea
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|ClinicalTrials.gov Identifier: NCT04946305|
Recruitment Status : Not yet recruiting
First Posted : June 30, 2021
Last Update Posted : July 28, 2021
|Condition or disease||Intervention/treatment|
|Somatostatin Receptor-positive GEP-NET||Other: Lutathera|
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official 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|
|Estimated Study Start Date :||December 31, 2021|
|Estimated Primary Completion Date :||June 30, 2023|
|Estimated Study Completion Date :||June 30, 2023|
Patients administered Lutathera by prescription
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.
- Incidence of Adverse Events [ Time Frame: Up to 36 weeks ]Incidence of Adverse Events (AEs), Serious AE and unexpected AEs.
- Incidence of Adverse Drug Reactions [ Time Frame: Up to 36 weeks ]Incidence of Adverse Drug Reactions (ADRs), Serious ADRs and unexpected ADRs.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04946305
|Contact: Novartis Pharmaceuticalsfirstname.lastname@example.org|
|Contact: Novartis Pharmaceuticals|
|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|