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

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.

Study Overview

• Status: Completed
• Conditions: Neuroendocrine Tumors
• Intervention / Treatment: Other: Data collection

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Melbourne, Australia, 3002
    • Peter MacCallum Cancer Center
  • Perth, Australia, 6009
    • Ramsay Hollywood Private Hospital
• Austria
  • Vienna, Austria, 1090
    • Medical University of Vienna
• Denmark
  • Aarhus, Denmark, 8200
    • Aarhus University Hospital
• France
  • Nantes, France, 44093 Cedex 1
    • Hôtel Dieu de Nantes
• Switzerland
  • Basel, Switzerland, 4031
    • University Hospital Basel
• United Kingdom
  • London, United Kingdom, NW3 2QG
    • Royal Free Hospital London

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).
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).
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).
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).

Collaborators and Investigators

• Sponsor: Ariceum Therapeutics GmbH
• Investigators: Study Director: Ariceum Chief Medical Officer, Ariceum

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2021
• Primary Completion (Actual): April 29, 2025
• Study Completion (Actual): April 29, 2025

Study Registration Dates

• First Submitted: August 6, 2021
• First Submitted That Met QC Criteria: August 17, 2021
• First Posted (Actual): August 24, 2021

Study Record Updates

• Last Update Posted (Estimated): September 4, 2025
• Last Update Submitted That Met QC Criteria: August 28, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Data Collection
• Other Study ID Numbers: D-FR-01072-004; 2024-515071-35-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.

Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.

• IPD Sharing Time Frame: Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
• IPD Sharing Access Criteria: Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No