NCT05017662

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

Longer than P75 for not_applicable

Geographic Reach
5 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 24, 2021

Completed
21 days until next milestone

Study Start

First participant enrolled

September 14, 2021

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2025

Completed
Last Updated

September 4, 2025

Status Verified

January 1, 2025

Enrollment Period

3.6 years

First QC Date

August 6, 2021

Last Update Submit

August 28, 2025

Conditions

Neuroendocrine Tumors

Outcome Measures

Primary Outcomes (1)

  • Proportion of participants with second primary haematological and non-haematological malignancies.

    During the whole study period (approximately 5 years).

Secondary Outcomes (4)

  • Proportion of treatment-related adverse events of any grade.

    During the whole study period (approximately 5 years).

  • Changes over time in laboratory tests (haematology)

    During the whole study period (approximately 5 years).

  • Changes over time in laboratory tests (biochemistry)

    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).

Study Arms (1)

Data collection

OTHER
Other: Data collection

Interventions

Data collectionOTHER

Participants will have surveillance visits every 3 months up to 5 years after their first dose of 177Lu-IPN01072 in Study OPS-C-001.

Data collection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participant is capable of giving signed informed consent
  • Participant must have received at least one infusion of 177Lu-IPN01072 in Study OPS-C-001

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Peter Maccallum Cancer Center

Melbourne, 3002, Australia

Location

Ramsay Hollywood Private Hospital

Perth, 6009, Australia

Location

Medical University of Vienna

Vienna, 1090, Austria

Location

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Hôtel Dieu de Nantes

Nantes, 44093 Cedex 1, France

Location

University Hospital Basel

Basel, 4031, Switzerland

Location

Royal Free Hospital London

London, NW3 2QG, United Kingdom

Location

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Neuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Ariceum Chief Medical Officer

    Ariceum

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2021

First Posted

August 24, 2021

Study Start

September 14, 2021

Primary Completion

April 29, 2025

Study Completion

April 29, 2025

Last Updated

September 4, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

Locations

DK(1)FR(1)CH(1)AU(2)GB(1)