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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
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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.

Condition or disease Intervention/treatment
Somatostatin Receptor-positive GEP-NET Other: Lutathera

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
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


Group/Cohort Intervention/treatment
Lutathera
Patients administered Lutathera by prescription
Other: Lutathera
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 Outcome Measures :
  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 Outcome Measures :
  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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with somatostatin receptor-positive GEP-NET in the real-world setting in Korea.
Criteria

Inclusion Criteria:

  1. Patients who start Lutathera treatment per clinical judgment, according to the locally approved labeling.

    - somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults.

  2. Patients who are willing to provide written informed consent.

Exclusion Criteria:

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


Information from the National Library of Medicine

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


Contacts
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Contact: Novartis Pharmaceuticals +41613241111 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals

Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04946305    
Other Study ID Numbers: CAAA601A12403
First Posted: June 30, 2021    Key Record Dates
Last Update Posted: July 28, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
somatostatin receptor-positive GEP-NET
Lutathera
Observational
prospective
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Lutetium Lu 177 dotatate
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action