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

Not Applicable

Active, not recruiting

• Conditions: Neuroendocrine Tumors
• Interventions: Other: Data collection

• Registration Number: NCT05017662
• Lead Sponsor: Ipsen

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.

Study Timeline

• Study First Submitted: 2021-08-06
• Study First Submitted QC: 2021-08-17
• Study First Posted: 2021-08-24
• Study Start: 2021-09-14
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-31
• Last Update Posted: 2024-08-01
• Primary Completion: 2025-03-03
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

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

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Exclusion Criteria

• There are no exclusion criteria in this safety surveillance study.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Data collection	Data collection	-

Primary Outcome Measures

Name	Time	Method
Proportion of participants with second primary haematological and non-haematological malignancies.	During the whole study period (approximately 5 years).

Secondary Outcome Measures

Name	Time	Method
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 (biochemistry)	During the whole study period (approximately 5 years).	Laboratory parameters (Creatinine) will be graded according to the NCI-CTCAE Version 5.0.
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.
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).

Trial Locations

Locations (7)

Peter Maccallum Cancer Center; 🇦🇺 Melbourne, Australia

Medical University of Vienna; 🇦🇹 Vienna, Austria

Ramsay Hollywood Private Hospital; 🇦🇺 Perth, Australia

University Hospital Basel; 🇨🇭 Basel, Switzerland

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

Royal Free Hospital London; 🇬🇧 London, United Kingdom

Hôtel Dieu de Nantes; 🇫🇷 Nantes, France