A Long-term Safety Surveillance Study in Participants Previously Treated With 177Lu-IPN01072
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Data collection
|
Other: Data 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.
|
Outcome Measures
Primary Outcome Measures
- Proportion of participants with second primary haematological and non-haematological malignancies. [During the whole study period (approximately 5 years).]
Secondary Outcome Measures
- 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).]
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Peter Maccallum Cancer Center | Melbourne | Australia | 3002 | |
| 2 | Ramsay Hollywood Private Hospital | Perth | Australia | 6009 | |
| 3 | Medical University of Vienna | Vienna | Austria | 1090 | |
| 4 | Aarhus University Hospital | Aarhus | Denmark | 8200 | |
| 5 | Hôtel Dieu de Nantes | Nantes | France | 44093 Cedex 1 | |
| 6 | University Hospital Basel | Basel | Switzerland | 4031 | |
| 7 | Royal Free Hospital London | London | United Kingdom | NW3 2QG |
Sponsors and Collaborators
- Ipsen
Investigators
- Study Director: Ipsen Medical Director, Ipsen
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- D-FR-01072-004
- 2020-003640-88