A Long-term Safety Surveillance Study in Participants Previously Treated With 177Lu-IPN01072

Neuroendocrine Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05017662
• Other study ID #: D-FR-01072-004
• Secondary ID: 2020-003640-88
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 14, 2021
• Est. completion date: April 1, 2025

Study information

• Verified date: May 2024
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: April 1, 2025
• Est. primary completion date: March 3, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neuroendocrine Tumors

Intervention

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.

Locations

Country	Name	City	State
Australia	Peter Maccallum Cancer Center	Melbourne
Australia	Ramsay Hollywood Private Hospital	Perth
Austria	Medical University of Vienna	Vienna
Denmark	Aarhus University Hospital	Aarhus
France	Hôtel Dieu de Nantes	Nantes
Switzerland	University Hospital Basel	Basel
United Kingdom	Royal Free Hospital London	London

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Countries where clinical trial is conducted

Australia,  Austria,  Denmark,  France,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants with second primary haematological and non-haematological malignancies.		During the whole study period (approximately 5 years).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).