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NCT Number: NCT05017662

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

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.

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Key information

Conditions

Neuroendocrine Tumors Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peter Maccallum Cancer Center, Melbourne, Australia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Data Collection

Other

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

Primary outcomes

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

    Time frame: During the whole study period (approximately 5 years).

Secondary outcomes

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

    Time frame: 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.

  2. Changes over time in laboratory tests (haematology)

    Time frame: 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.

  3. Changes over time in laboratory tests (biochemistry)

    Time frame: During the whole study period (approximately 5 years).

    Laboratory parameters (Creatinine) will be graded according to the NCI-CTCAE Version 5.0.

  4. Overall survival defined as the time from the first dose of 177Lu-IPN01072 until death from any cause.

    Time frame: During the whole study period (approximately 5 years).

Sponsors and collaborators

Lead sponsor

Ariceum Therapeutics GmbH

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Aug 24, 2021
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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