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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-515071-35-00 | EU Trial (CTIS) Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Data collection | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Data collection | Other | Participants will have surveillance visits every 3 months up to 5 years after their first dose of 177Lu-IPN01072 in Study OPS-C-001. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with second primary haematological and non-haematological malignancies. | During the whole study period (approximately 5 years). |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
- There are no exclusion criteria in this safety surveillance study.
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| Name | Affiliation | Role |
|---|---|---|
| Ariceum Chief Medical Officer | Ariceum | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peter Maccallum Cancer Center | Melbourne | 3002 | Australia | |||
| Ramsay Hollywood Private Hospital |
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| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| ID | Term |
|---|---|
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
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| 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). |
| Perth |
| 6009 |
| Australia |
| Medical University of Vienna | Vienna | 1090 | Austria |
| Aarhus University Hospital | Aarhus | 8200 | Denmark |
| Hôtel Dieu de Nantes | Nantes | 44093 Cedex 1 | France |
| University Hospital Basel | Basel | 4031 | Switzerland |
| Royal Free Hospital London | London | NW3 2QG | United Kingdom |
| D009380 | Neoplasms, Nerve Tissue |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |