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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 )

Tracking Information
First Submitted Date June 23, 2021
First Posted Date June 30, 2021
Last Update Posted Date July 28, 2021
Estimated Study Start Date December 31, 2021
Estimated Primary Completion Date June 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 23, 2021)
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 23, 2021)
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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Post Marketing Surveillance on Lutathera® in Patients With Somatostatin Receptor Positive Gastroenteropancreatic Neuroendocrine Tumor in Korea
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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with somatostatin receptor-positive GEP-NET in the real-world setting in Korea.
Condition Somatostatin Receptor-positive GEP-NET
Intervention 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.
Study Groups/Cohorts Lutathera
Patients administered Lutathera by prescription
Intervention: Other: Lutathera
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: June 23, 2021)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 30, 2023
Estimated Primary Completion Date June 30, 2023   (Final data collection date for primary outcome measure)
Eligibility 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.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Novartis Pharmaceuticals +41613241111 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT04946305
Other Study ID Numbers CAAA601A12403
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor Novartis Pharmaceuticals
Collaborators Not Provided
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date July 2021