Neuroendocrine Tumors
Conditions
Brief summary
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
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.
Interventions
OTHERData collection
Participants will have surveillance visits every 3 months up to 5 years after their first dose of 177Lu-IPN01072 in Study OPS-C-001.
Sponsors
Ariceum Therapeutics GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants with second primary haematological and non-haematological malignancies. | During the whole study period (approximately 5 years). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of treatment-related adverse events of any grade. | During the whole study period (approximately 5 years). | 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. |
| Changes over time in laboratory tests (haematology) | During the whole study period (approximately 5 years). | Laboratory parameters (Platelet count, Haemoglobin and White Blood Cells count with differential) will be graded according to the NCI-CTCAE Version 5.0. |
| Changes over time in laboratory tests (biochemistry) | During the whole study period (approximately 5 years). | Laboratory parameters (Creatinine) will be graded according to the NCI-CTCAE Version 5.0. |
| 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). | — |
Countries
Australia, Austria, Denmark, France, Switzerland, United Kingdom
Outcome results
None listed