Satoreotide Tetraxetan

Clinical trials are investigating Satoreotide Tetraxetan in people with somatostatin receptor positive neuroendocrine tumours. The study data focus on long-term safety, especially whether second primary cancers appear after treatment. These trials are designed to assess outcomes in participants who were previously treated in an Ipsen-sponsored study.

Table of Contents

Trial overview

Satoreotide Tetraxetan was studied in a multicentre surveillance study that followed people over time after earlier treatment in an Ipsen-sponsored clinical study.[1]

The trial focused on long-term safety, meaning it looked for problems that may appear after a longer follow-up period rather than right away.[1]

The study brief said the goal was to assess the incidence of second primary haematological and non-haematological malignancies.[1]

Who was studied

The study population included participants who had previously been treated with 177Lu-IPN01072 in an Ipsen-sponsored clinical study.[1]

The condition studied was somatostatin receptor positive neuroendocrine tumours, also called NETs.[1]

This means the trial was not a general study for all cancer patients. It was focused on a very specific group of people with this tumour type.[1]

What the study measured

The main outcome was the presence of participants with second primary haematological and non-haematological malignancies.[1]

A second primary malignancy is a new, separate cancer that appears after a person has already had another cancer.[1]

Haematological cancers are cancers of the blood, bone marrow, or lymph system, while non-haematological cancers are cancers that start in other organs.[1]

Trial design and phase

This was an interventional study, which means it was part of a planned clinical research program rather than simple observation only.[1]

The study was in Phase 3, a later trial phase that is often used to confirm safety findings in a larger research setting.[1]

Although the enrollment was small, the phase still shows that the study was part of a later-stage clinical evaluation.[1]

Trial status and size

The study status was Completed, which means the planned study activities and data collection were finished.[1]

The enrollment was 3 participants, so this was a very small study population.[1]

Because of the small number of participants, the study is best understood as a focused safety follow-up rather than a large efficacy trial.[1]

Patient-friendly terms

  • Surveillance study: a follow-up study that watches for health problems over time.[1]

  • Incidence: how often a new problem happens in a group of people.[1]

  • Multicentre: a study done at more than one medical site or hospital.[1]

  • Clinical study: a research study in people that helps doctors learn more about a treatment or its safety.[1]

Trial ID Phase Condition studied Status Enrollment
NCT05017662 Phase 3 Somatostatin Receptor Positive Neuroendocrine Tumours (NETs) Completed 3

Ongoing Clinical Trials on Satoreotide Tetraxetan

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

    Not recruiting

    1 1 1
    Investigated diseases:
    France

Glossary

  • Clinical trial: A planned research study in people that tests a medical treatment or follows patients over time.
  • Phase 3: A later stage of testing that usually includes more participants and looks more closely at safety and how well the study treatment performs.
  • Interventional study: A study where participants receive a treatment or intervention, rather than only being observed.
  • Somatostatin receptor positive: A term used for tumours that have a specific receptor on their cells. This helps identify the type of tumour studied.
  • Neuroendocrine tumours: A group of tumours that start in special hormone-producing cells in the body.
  • NETs: Short form for neuroendocrine tumours.
  • Long-term safety: How safe a treatment is after a longer period of time, not just right after treatment.
  • Second primary malignancy: A new, separate cancer that appears after a person has already had another cancer.
  • Haematological malignancy: A cancer that starts in the blood, bone marrow, or lymph system.
  • Non-haematological malignancy: A cancer that does not start in the blood or bone marrow, such as a cancer in another organ.
  • Enrollment: The number of participants included in a study.
  • Completed: The study has finished collecting its planned data.

References