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Satoreotide Tetraxetan Lutetium-177

This article discusses a clinical trial investigating the long-term safety of Satoreotide Tetraxetan Lutetium-177 (177Lu-IPN01072) in patients with somatostatin receptor-positive neuroendocrine tumors (NETs). The study aims to evaluate the occurrence of secondary cancers and overall survival in patients who have previously received this treatment in an Ipsen-sponsored clinical study.

Table of Contents

What is SATOREOTIDE TETRAXETAN LUTETIUM-177?

SATOREOTIDE TETRAXETAN LUTETIUM-177 is an innovative medical treatment that is currently being studied for its potential in treating certain types of cancer. This compound is also known by several other names, including:

  • 177Lu-SSO110
  • Lutetium-177 DOTA Satoreotide
  • OPS201
  • Lu-177 OPS-201
These alternative names may be used interchangeably in medical literature or discussions with healthcare providers.[1]

What Medical Condition Does It Treat?

SATOREOTIDE TETRAXETAN LUTETIUM-177 is being investigated for the treatment of Somatostatin Receptor Positive Neuroendocrine Tumors (NETs). Neuroendocrine tumors are a type of cancer that begins in specialized cells called neuroendocrine cells. These cells have traits similar to both nerve cells and hormone-producing cells, and are found throughout the body.[1]

How Does It Work?

While the exact mechanism is not fully detailed in the provided information, we can infer some details based on the drug’s composition and target:

  1. Targeted Approach: The drug targets somatostatin receptors, which are often overexpressed in neuroendocrine tumors. This allows for a more focused treatment approach.
  2. Radioactive Component: The “Lutetium-177” in the drug’s name indicates that it contains a radioactive isotope. This suggests it may work through targeted radiation therapy, delivering radiation directly to cancer cells.
  3. Peptide Receptor Radionuclide Therapy (PRRT): Based on its composition, this drug likely falls under the category of PRRT, a type of treatment that combines a targeting molecule (peptide) with a radioactive material.
This approach allows the drug to specifically target and potentially destroy cancer cells while minimizing damage to healthy tissues.[1]

Current Clinical Study

A clinical study is currently underway to evaluate the long-term safety of SATOREOTIDE TETRAXETAN LUTETIUM-177. This study, identified as “2024-515071-35-00”, has the following key features:

  • Study Type: It is a multicentre surveillance study, meaning it’s being conducted at multiple medical centers to gather more comprehensive data.
  • Main Objective: To assess the incidence of second primary haematological and non-haematological malignancies in patients who have received this treatment.
  • Secondary Objectives:
    • To evaluate the long-term safety profile of the drug
    • To evaluate overall survival of patients who have received the treatment
  • Eligibility: Participants must have received at least one infusion of 177Lu-IPN01072 in a previous study (OPS-C-001) and be capable of giving informed consent.
This study aims to provide crucial information about the long-term effects and safety of this treatment.[1]

How Is It Administered?

SATOREOTIDE TETRAXETAN LUTETIUM-177 is administered as a solution for infusion. This means it is given intravenously (directly into a vein). The drug is measured in units called gigabecquerels (GBq), which is a measure of radioactivity.

  • The maximum daily dose is 7.4 GBq
  • The maximum total dose over the course of treatment is 3 GBq
  • The maximum treatment period is 36 months
It’s important to note that these are maximum amounts, and the actual dose given to a patient may be lower, depending on individual factors determined by the healthcare team.[1]

Safety Profile and Monitoring

The ongoing clinical study is focused on assessing the long-term safety of SATOREOTIDE TETRAXETAN LUTETIUM-177. Key aspects of safety monitoring include:

  • Second Primary Malignancies: The study is closely monitoring for the development of new cancers that might be related to the treatment.
  • Adverse Events: Researchers are tracking any side effects or complications that may be related to the treatment.
  • Laboratory Tests: Regular blood tests are being conducted to monitor changes in haematology (blood cells) and biochemistry (organ function).
  • Long-term Follow-up: Patients are being followed over an extended period to understand the long-term effects of the treatment.
This comprehensive monitoring helps ensure patient safety and provides valuable data on the long-term effects of the treatment.[1]

Potential Benefits

While the study is primarily focused on safety, it also aims to evaluate the overall survival of patients who have received SATOREOTIDE TETRAXETAN LUTETIUM-177. This suggests that the treatment may have the potential to extend life in patients with somatostatin receptor positive neuroendocrine tumors. It’s important to note that as this is an ongoing study, the full benefits and risks of the treatment are still being evaluated. Patients considering this treatment should discuss the potential benefits and risks thoroughly with their healthcare provider.[1]

Aspect Details
Study Type Long-term safety surveillance study
Drug Name Satoreotide Tetraxetan Lutetium-177 (177Lu-IPN01072)
Condition Studied Somatostatin Receptor Positive Neuroendocrine Tumors (NETs)
Main Objective Assess incidence of second primary malignancies
Secondary Objectives Evaluate long-term safety profile and overall survival
Inclusion Criteria Previous treatment with 177Lu-IPN01072 in Study OPS-C-001
Exclusion Criteria None specified
Primary Endpoint Presence of second primary malignancies
Secondary Endpoints Treatment-related adverse events, changes in laboratory tests, overall survival
Maximum Treatment Period 36 months
Maximum Dose 7.4 GBq per day, 3 GBq total
Administration Route Intravenous

FAQ

  • What is the main purpose of this clinical trial? The main purpose of this clinical trial is to assess the long-term safety of Satoreotide Tetraxetan Lutetium-177 in patients who have previously received this treatment. Specifically, it aims to evaluate the occurrence of second primary cancers, both blood-related and non-blood-related.
  • Who can participate in this study? Participants must have received at least one infusion of 177Lu-IPN01072 in a previous Ipsen-sponsored clinical study called OPS-C-001. They must also be capable of giving informed consent and complying with the study requirements.
  • What will be monitored during the study? The study will monitor the occurrence of second primary cancers, treatment-related side effects, changes in blood tests over time, and overall survival of the participants.
  • How long will participants be followed in this study? The study will follow participants for up to 36 months (3 years) to evaluate the long-term safety of the treatment.
  • What is Satoreotide Tetraxetan Lutetium-177 used for? Satoreotide Tetraxetan Lutetium-177 is used to treat patients with somatostatin receptor-positive neuroendocrine tumors (NETs). It is a radioactive drug that targets specific receptors on tumor cells.

Ongoing Clinical Trials on Satoreotide Tetraxetan Lutetium-177

  • 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:
    Investigated drugs:
    France

Glossary

  • Neuroendocrine Tumors (NETs): A type of cancer that begins in specialized cells called neuroendocrine cells. These cells have traits of both nerve cells and hormone-producing cells and are found throughout the body.
  • Somatostatin Receptor: A protein on the surface of some cells that can bind to somatostatin, a hormone that regulates various functions in the body. Some tumors, particularly NETs, have a high number of these receptors.
  • Lutetium-177: A radioactive isotope of lutetium used in targeted radiation therapy for certain types of cancer.
  • Second Primary Malignancy: A new, unrelated cancer that develops in a person who has previously had cancer. This is different from a recurrence or spread of the original cancer.
  • Overall Survival: The length of time from the start of treatment until death from any cause. It is often used to measure the effectiveness of cancer treatments.
  • Adverse Event: Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.
  • Serious Adverse Event: An adverse event that results in death, is life-threatening, requires hospitalization, causes a significant incapacity, or results in a congenital anomaly or birth defect.
  • Infusion: The process of delivering a fluid, such as a medication, directly into a vein over a period of time.
  • Becquerel (Bq): The international system unit of radioactivity. One becquerel is defined as the activity of a quantity of radioactive material in which one nucleus decays per second.
  • Gigabecquerel (GBq): A unit of radioactivity equal to one billion (109) becquerels.

References

  1. http://clinicaltrials.eu/trial/study-on-long-term-safety-of-satoreotide-tetraxetan-lutetium-177-for-patients-with-somatostatin-receptor-positive-neuroendocrine-tumors/