Study on the Long-Term Safety of Sacituzumab Govitecan for Patients with Metastatic Solid Tumors

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What is this study about?

This clinical trial is focused on studying the long-term safety of a treatment called sacituzumab govitecan for patients with metastatic solid tumors. Metastatic solid tumors are cancers that have spread from their original site to other parts of the body. The treatment being studied, sacituzumab govitecan, is administered as a solution through an intravenous infusion, which means it is given directly into the bloodstream through a vein.

The purpose of this study is to evaluate how safe sacituzumab govitecan is for patients who are already benefiting from this therapy. Participants in the study will continue to receive the treatment as they have been, and researchers will monitor them over time to see if they experience any side effects or changes in their health. The study will track the percentage of participants who experience any adverse events, serious adverse events, or laboratory abnormalities.

This study is open-label, meaning both the researchers and participants know what treatment is being given. It is a rollover study, which means it includes patients who were already receiving sacituzumab govitecan in a previous study and are continuing to benefit from it. The study aims to provide valuable information about the long-term safety of this treatment for individuals with metastatic solid tumors.

1 joining the study

Participation begins after meeting specific criteria, including being 18 years or older and currently receiving treatment with sacituzumab govitecan in a previous study.

Participants must continue to benefit from the therapy and meet health requirements, such as a creatinine clearance of at least 30 mL/min.

2 treatment administration

The medication used in this study is Trodelvy, which contains sacituzumab govitecan.

It is administered as a solution for infusion through an intravenous route.

3 monitoring and safety evaluation

The main objective is to evaluate the long-term safety of the treatment in participants with metastatic solid tumors.

Participants are monitored for any adverse events (AEs), serious adverse events (SAEs), and laboratory abnormalities.

4 study duration

The study is expected to continue until January 11, 2027.

Participants will remain in the study as long as they continue to benefit from the treatment and meet the study’s safety requirements.

Who Can Join the Study?

Participants must be 18 years or older and able to understand and sign a consent form.
Participants must currently be receiving treatment with a medication called sacituzumab govitecan as part of a previous study.
Participants must continue to benefit from the treatment with sacituzumab govitecan.
Participants must have a creatinine clearance of at least 30 mL/min. This is a measure of how well the kidneys are working.
Participants who can have children and are sexually active must agree to use specific methods of contraception as outlined in the study guidelines.

Who Cannot Join the Study?

Patients who are not benefiting from the continuation of therapy with the study drug.
Patients who have medical conditions other than metastatic solid tumors. Metastatic solid tumors are cancers that have spread from their original location to other parts of the body.
Patients who are not within the specified age range for the study.
Patients who belong to a vulnerable population, which means groups that may need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Oncopole Claudius Regaud	Toulouse	France
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Institut Jules Bordet	Anderlecht	Belgium
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur	Namur	Belgium
Cnartm Ltsw Bmiudp	Lyon	France
Hwchrsze Vuvw diwpkyts	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	16.11.2020
France	Not recruiting	16.11.2020
Spain	Not recruiting	16.11.2020

Trial locations

Investigated drugs:

Sacituzumab Govitecan

Sacituzumab Govitecan is a medication used in this clinical trial to treat patients with metastatic solid tumors. It is designed to help patients who are already benefiting from its use by continuing the therapy to evaluate its long-term safety. This medication works by targeting specific cancer cells and delivering a chemotherapy agent directly to them, which may help in reducing the size of the tumors or slowing their growth.

Metastatic Solid Tumors – Metastatic solid tumors are cancers that have spread from their original site to other parts of the body. These tumors can originate in various organs, such as the breast, lung, or colon, and then metastasize to distant organs like the liver, bones, or brain. The progression involves cancer cells breaking away from the primary tumor, traveling through the bloodstream or lymphatic system, and forming new tumors in other organs. This spread can lead to a range of symptoms depending on the organs affected. The growth and spread of these tumors can disrupt normal organ function and lead to various complications. The nature and impact of metastatic solid tumors can vary widely based on the type of primary cancer and the organs involved.

Trial ID:

2023-505336-34-00

Protocol code:

IMMU-132-14

NCT ID:

NCT04319198

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Long-Term Safety of Sacituzumab Govitecan for Patients with Metastatic Solid Tumors

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?