Clinical trial · Interventional
A Long-term Safety Surveillance Study in Participants Previously Treated With 177Lu-IPN01072
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
NCT05017662CI-TRIAL-00094556completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroendocrine Tumors | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Data collection | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Data collection
- interventionNames
- Other: Data collection
Primary outcomes (1)
- measure
- Proportion of participants with second primary haematological and non-haematological malignancies.
- timeFrame
- During the whole study period (approximately 5 years).
Secondary outcomes (4)
- measure
- Proportion of treatment-related adverse events of any grade.
- timeFrame
- During the whole study period (approximately 5 years).
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.