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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
20
Participants will have surveillance visits every 3 months up to 5 years after their first dose of 177Lu-IPN01072 in Study OPS-C-001.
Peter Maccallum Cancer Center
Melbourne, Australia
Ramsay Hollywood Private Hospital
Perth, Australia
Medical University of Vienna
Vienna, Austria
Aarhus University Hospital
Aarhus, Denmark
Proportion of participants with second primary haematological and non-haematological malignancies.
Time frame: During the whole study period (approximately 5 years).
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: During the whole study period (approximately 5 years).
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Hôtel Dieu de Nantes
Nantes, France
University Hospital Basel
Basel, Switzerland
Royal Free Hospital London
London, United Kingdom