Open-label Rollover Study to Evaluate Long-Term Safety in Subjects with Metastatic Solid Tumors that are Benefiting from Continuation of Therapy with Sacituzumab Govitecan
This research study is for people who have advanced solid tumours (cancers that start as a lump) that have spread to other parts of their body. They are already taking a treatment called Trodelvy and it's working for them. The main purpose of this study is to closely watch the long-term safety of Trodelvy. Researchers want to understand if there are any side effects or changes in blood tests that happen when the treatment is continued for a longer time. This is an 'open-label' study, meaning both you and your doctor will know you're receiving Trodelvy. It's a phase 4 study, which means the treatment is already approved but doctors are gathering more information about its long-term use.
At a glance
What is this study about?
This study is for adults who have solid tumours that have spread (this means the cancer has moved from where it started to other parts of the body). Importantly, participants in this study are already using a treatment called Sacituzumab Govitecan, also known as Trodelvy, and it's showing positive results for them. The main goal of continuing this study is to gather more information about the safety of Trodelvy when it's used for a longer period of time.
Think of it like this: a new medication often starts with studies to see if it works and what the main side effects are. Once it's approved and helping patients, doctors want to understand what happens when people take it for many months or even years. This study is designed to do just that – to keep a close eye on anyone receiving Trodelvy for an extended time.
The researchers will be carefully looking for any new side effects, how often they occur, and if there are any changes in blood or urine tests that might suggest a problem. By gathering this detailed information, doctors can have a clearer picture of the long-term safety profile of Trodelvy, helping them to best care for patients like you in the future.
Key takeaways
- This study focuses on the long-term safety of Trodelvy for advanced solid cancers.
- It's for patients who are already receiving and benefiting from Trodelvy treatment.
- Participants will have ongoing monitoring of their health and side effects.
- The study aims to gather more information about how Trodelvy works over an extended time.
- You must be 18 or older to take part, with no upper age limit.
- Your doctor knows you are getting Trodelvy in this study.
Who may be eligible?
To be considered for this study, you must be at least 18 years old. The study is open to both men and women. There's no upper age limit, meaning older adults can also take part.
A key requirement is that you must have a solid tumour that has spread to other parts of your body, and you must currently be receiving Trodelvy (Sacituzumab Govitecan) as part of your treatment. It's also important that your current treatment with Trodelvy is beneficial for you, meaning it's helping to manage your cancer.
Your cancer doctor will be able to tell you if your specific situation matches all the requirements for joining this study. They will review your medical history and current health to determine if it's a suitable option for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Do you have a solid tumour that has spread to other parts of your body?
- Are you currently receiving and benefiting from treatment with Trodelvy?
- Are you able to attend regular appointments for check-ups and tests?
- Are you willing to have your health closely monitored for an extended period?
What does participation involve?
If you decide to take part in this study, you will continue to receive your Trodelvy treatment as prescribed by your doctor. The study primarily involves regular check-ups and tests that you would likely be having anyway while on this medication. These visits will include physical examinations, blood tests, and possibly other assessments to monitor your health and the effects of the treatment.
The research team will carefully record any side effects you experience, no matter how minor. This information is vital for understanding the long-term safety of Trodelvy. You will likely continue in the study for as long as your doctor believes Trodelvy is benefiting you, and you tolerate the treatment well. The total duration of your participation will depend on your individual response and health.
Potential risks and benefits
Locations (3)
- —UnverifiedSpain
- —UnverifiedBelgium
- —UnverifiedFrance
Common questions
What kind of cancer is this study for?
This study is for adults with solid tumours that have spread to other parts of the body.
What is Trodelvy?
Trodelvy (Sacituzumab Govitecan) is a medicine used to treat certain advanced cancers.
Will I know if I'm getting the drug in the study?
Yes, this is an 'open-label' study, which means both you and your doctor will know you are receiving Trodelvy.
What's the main goal of this study?
The main goal is to carefully track the long-term safety and any side effects of Trodelvy in people who are already benefiting from it.
Can I stop being in the study if I want to?
Yes, you can leave the study at any time without it affecting your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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