In short
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.
Key points
- Clinical trials of Satoreotide Tetraxetan in the provided data focus on people with somatostatin receptor positive neuroendocrine tumours. The main study is a Phase 3 follow-up trial in participants who had already been treated in an Ipsen-sponsored study. It looks at long-term safety rather than symptom relief or tumour response. The key outcome is whether participants develop second primary cancers, including blood cancers and cancers in other organs. The trial is completed and enrolled 3 participants.
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.
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.
The study brief said the goal was to assess the incidence of second primary haematological and non-haematological malignancies.
Who was studied
The study population included participants who had previously been treated with 177Lu-IPN01072 in an Ipsen-sponsored clinical study.
The condition studied was somatostatin receptor positive neuroendocrine tumours, also called NETs.
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.
What the study measured
The main outcome was the presence of participants with second primary haematological and non-haematological malignancies.
A second primary malignancy is a new, separate cancer that appears after a person has already had another cancer.
Haematological cancers are cancers of the blood, bone marrow, or lymph system, while non-haematological cancers are cancers that start in other organs.
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.
The study was in Phase 3, a later trial phase that is often used to confirm safety findings in a larger research setting.
Although the enrollment was small, the phase still shows that the study was part of a later-stage clinical evaluation.
Trial status and size
The study status was Completed, which means the planned study activities and data collection were finished.
The enrollment was 3 participants, so this was a very small study population.
Because of the small number of participants, the study is best understood as a focused safety follow-up rather than a large efficacy trial.
Patient-friendly terms
- Surveillance study: a follow-up study that watches for health problems over time.
- Incidence: how often a new problem happens in a group of people.
- Multicentre: a study done at more than one medical site or hospital.
- Clinical study: a research study in people that helps doctors learn more about a treatment or its safety.