Study on Long-term Safety of Satoreotide Tetraxetan Lutetium-177 for Patients with Somatostatin Receptor Positive Neuroendocrine Tumors

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What is this study about?

This clinical trial is focused on studying the long-term safety of a treatment for a type of cancer known as neuroendocrine tumors (NETs) that have a specific feature called somatostatin receptor positive. The treatment being studied is a medication called 177Lu-IPN01072, which was used in a previous clinical study. This medication is given as a solution through a vein, a method known as intravenous administration. The main goal of this study is to observe if there are any new cases of other types of cancers, both blood-related and non-blood-related, in participants who have previously received this treatment.

Participants in this study will be monitored over time to check for any new health issues, particularly focusing on the development of other cancers. The study will also look at any side effects related to the treatment, as well as changes in blood and chemistry tests. Additionally, the study will track the overall survival of participants, which means observing the time from when they first received the treatment until any cause of death.

This study is part of a larger effort to ensure the safety of treatments for neuroendocrine tumors and to better understand the long-term effects of using 177Lu-IPN01072. By gathering this information, researchers hope to improve future treatment options and provide better care for patients with this type of cancer.

1 joining the study

Participation begins after signing an informed consent form. This document outlines the study’s requirements and restrictions.

Eligibility requires previous treatment with at least one infusion of 177Lu-IPN01072 in a prior study.

2 treatment monitoring

The study involves monitoring for long-term safety after previous treatment with 177Lu-IPN01072, a solution for infusion administered intravenously.

The main objective is to assess the occurrence of new primary cancers, both blood-related and non-blood-related.

3 safety assessments

Regular assessments will be conducted to monitor for any treatment-related side effects, using criteria from the National Cancer Institute.

Laboratory tests, including blood and biochemistry tests, will be performed to track changes over time.

4 study duration

The study is expected to continue until March 2025.

Overall survival will be measured from the first dose of 177Lu-IPN01072 until any cause of death.

Who Can Join the Study?

The participant must be able to give signed informed consent. This means they understand the study and agree to follow the rules and restrictions.
The participant must have received at least one treatment with a medicine called 177Lu-IPN01072 in a previous study named OPS-C-001.
The participant must have a type of tumor called Somatostatin Receptor Positive Neuroendocrine Tumors (NETs). These are specific types of growths in the body.
Both males and females can participate in the study.
The study is open to adults, which means participants must be within certain age ranges.

Who Cannot Join the Study?

Patients who do not have Somatostatin Receptor Positive Neuroendocrine Tumours (NETs) cannot participate. These are specific types of tumors that have certain receptors on their surface.
Patients who are not within the specified age range cannot participate. The age range is typically defined by the study.
Patients who are part of a vulnerable population cannot participate. This usually means people who might be at higher risk of harm or exploitation.
Patients who have other types of cancer, known as second primary malignancies, cannot participate. This means having another separate cancer diagnosis besides the one being studied.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Nantes	Nantes	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	01.02.2022

Trial locations

Investigated drugs:

177Lu-IPN01072 is a medication used in this clinical trial. It is a type of targeted therapy that involves a radioactive substance, lutetium-177, which is linked to a molecule designed to target specific cancer cells. The purpose of this therapy is to deliver radiation directly to the cancer cells, minimizing damage to surrounding healthy tissue. This study is focused on evaluating the long-term safety of this treatment in participants who have previously received it in another clinical study.

Investigated diseases:

Neuroendocrine tumour

Somatostatin Receptor Positive Neuroendocrine Tumors (NETs) – These are a group of rare tumors that originate from neuroendocrine cells, which are found throughout the body. These tumors are characterized by their ability to express somatostatin receptors, which can be targeted for diagnostic and therapeutic purposes. NETs can occur in various organs, including the pancreas, gastrointestinal tract, and lungs. They often grow slowly and may not cause symptoms until they become large or spread to other parts of the body. The progression of these tumors can vary significantly, with some remaining stable for years while others may grow more rapidly. Understanding the behavior of these tumors is crucial for managing their impact on the body.

Trial ID:

2024-515071-35-00

Protocol code:

D-FR-01072-004

NCT ID:

NCT05017662

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Long-term Safety of Satoreotide Tetraxetan Lutetium-177 for Patients with Somatostatin Receptor Positive Neuroendocrine Tumors

What is this study about?

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