A Long-term Safety Surveillance Study in Participants Previously Treated With 177Lu-IPN01072

Study Overview
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Brief Summary
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The purpose of the protocol is to evaluate the long-term safety of medicine 177Lu-satoreotide tetraxetan (also known as 177Lu-IPN01072 or 177Lu-OPS201) for patients who have previously received 177Lu-satoreotide tetraxetan in the clinical study OPS-C-001 / D-FR-01072-001.

Detailed Description
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The study qualifies as interventional not because of the use of an investigational product, but because the imposed specific data collection includes assessments/blood collection and on-site visits not necessarily part of routine clinical practice.

Official Title
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A Multicentre Surveillance Study to Evaluate the Long-term Safety in Participants Who Have Been Previously Treated With 177Lu-IPN01072 in an Ipsen-sponsored Clinical Study

Conditions
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Neuroendocrine Tumors

Intervention / Treatment
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* Other: Data collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant is capable of giving signed informed consent Participant must have received at least one infusion of 177Lu-IPN01072 in Study OPS-C-001 Exclusion Criteria: - There are no exclusion criteria in this safety surveillance study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Data collection<br> | Other: Data collection<br>* Participants will have surveillance visits every 3 months up to 5 years after their first dose of 177Lu-IPN01072 in Study OPS-C-001.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants with second primary haematological and non-haematological malignancies. |  | During the whole study period (approximately 5 years). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of treatment-related adverse events of any grade. | Adverse events assessed according to the National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE Version 5.0), including any treatment-related serious adverse events, as assessed by the investigators. | During the whole study period (approximately 5 years). | 
| Changes over time in laboratory tests (haematology) | Laboratory parameters (Platelet count, Haemoglobin and White Blood Cells count with differential) will be graded according to the NCI-CTCAE Version 5.0. | During the whole study period (approximately 5 years). | 
| Changes over time in laboratory tests (biochemistry) | Laboratory parameters (Creatinine) will be graded according to the NCI-CTCAE Version 5.0. | During the whole study period (approximately 5 years). | 
| Overall survival defined as the time from the first dose of 177Lu-IPN01072 until death from any cause. |  | During the whole study period (approximately 5 years). |