Somatostatin Receptor-positive GEP-NETNCT04946305
A Post Marketing Surveillance on Lutathera® in Patients With Somatostatin Receptor Positive Gastroenteropancreatic Neuroendocrine Tumor in Korea
An observational study of Somatostatin Receptor-positive GEP-NET, run by Novartis Pharmaceuticals at 6 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Somatostatin Receptor-positive GEP-NET
- What is being tested?
- Lutathera
- How many people
- 89 participants
- Where
- 6 sitesSouth Korea
- Study dates
- 10 May 2022to 8 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with somatostatin receptor-positive GEP-NET in the real-world setting in Korea.
Who may be able to join
- 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.
Who cannot join
- 1. Patients with contraindication according to prescribing information for Lutathera in Korea.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
South Korea6 sites
Novartis Investigative Site
Seongnam-si, Gyeonggi-do, 13620
Novartis Investigative Site
Seoul, 03722
Novartis Investigative Site
Seoul, 06351
Novartis Investigative Site
Seoul, 110-799
Novartis Investigative Site
Seoul, 137-040
Novartis Investigative Site
Seoul, 138-736
About this study
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
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.
- Conditions
- Somatostatin Receptor-positive GEP-NET
- Being tested
- Lutathera
- Keywords
- somatostatin receptor-positive GEP-NET, Lutathera, Observational, prospective
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LutatheraOther
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 group | Role | What they receive |
|---|---|---|
| Lutathera | Patients administered Lutathera by prescription Receives: Other: Lutathera |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events
Incidence of Adverse Events (AEs), Serious AE and unexpected AEs.
Measured: Up to 36 weeks
Incidence of Adverse Drug Reactions
Incidence of Adverse Drug Reactions (ADRs), Serious ADRs and unexpected ADRs.
Measured: Up to 36 weeks
Secondary outcomes (1)
Effectiveness in terms of Overall Response Rate (ORR)
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
Measured: Up to 32 weeks (4 cycles of 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2021
- Study start10 May 2022
- Primary completion8 Jul 2024
- Study completion8 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Somatostatin Receptor-positive GEP-NETStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04946305
- Sponsor's protocol ID
- CAAA601A12403
- Status last verified
- Aug 2024
- First submitted
- 23 Jun 2021
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04946305
- Acronym / sponsor ID
- CAAA601A12403
- Conditions
- Somatostatin Receptor-positive GEP-NET
- Keywords
- somatostatin receptor-positive GEP-NET, Lutathera, Observational, prospective
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 10 May 2022 (actual)
- Primary completion
- 8 Jul 2024 (actual)
- Study completion
- 8 Jul 2024 (actual)
- First posted
- 30 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lutathera | – | Other: LutatheraPatients administered Lutathera by prescription |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with somatostatin receptor-positive GEP-NET in the real-world setting in Korea.
Key inclusion criteria (3 listed)
- Patients who start Lutathera treatment per clinical judgment, according to the locally approved labeling.
- Patients who are willing to provide written informed consent.
Key exclusion criteria (1 listed)
- 1. Patients with contraindication according to prescribing information for Lutathera in Korea.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LutatheraProspective 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. | Other | Lutathera |
Primary outcome
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.
1 secondary outcome
Effectiveness in terms of Overall Response Rate (ORR)
Time frame: Up to 32 weeks (4 cycles of 8 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Somatostatin Receptor-positive GEP-NET
RecruitingPhase 1
Phase I Trial to Determine the Dose and Evaluate the PK and Safety of Lutetium Lu 177 Edotreotide Therapy in Pediatric Participants With SSTR-positive Tumors
Somatostatin Receptor Positive, NETs
Active, not recruitingPhase 3
Efficacy and Safety of 177Lu-edotreotide PRRT in GEP-NET Patients
Neuroendocrine Tumors
RecruitingPhase 1/2
Somatostatin-Receptors (SSTR)-Agonist [212Pb]VMT-alpha-NET in Metastatic or Inoperable SSTR+ Gastrointestinal Neuroendocrine Tumor and Pheochromocytoma/Paraganglioma Previously Treated With Systemic Targeted Radioligand Therapy
Somatostatin Receptor Positive, Gastrointestinal Neuroendocrine Tumors
RecruitingPhase 1/2
Targeted Alpha-Particle Therapy for Advanced Somatostatin Receptor Type 2 (SSTR2) Positive Tumors
Neuroendocrine Tumors Unresectable, Neuroendocrine Tumor Metastatic
RecruitingPhase 3
Study to Evaluate the Efficacy and Safety of [177Lu]Lu-DOTA-TATE in Patients With Grade 1 and Grade 2 Advanced GEP-NET
Somatostatin Receptor Positive (SSTR+), Gastroenteropancreatic Neuroendocrine Tumor (GEP-NET)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Somatostatin Receptor-positive GEP-NET, run by Novartis Pharmaceuticals at 6 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (time frame: Up to 36 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.