A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess Efficacy and Safety of REGN7508, a Monoclonal Antibody Against FXI, for Primary Prophylaxis of Cancer-Associated Thrombosis for Participants with Solid Tumors Undergoing Cancer Treatment (ROXI-CAT-I)
This study, called ROXI-CAT-I, is looking into a new medicine, REGN7508, which is a type of antibody, to help prevent blood clots in people with strong forms of cancer. We know that cancer patients, especially those having treatments like chemotherapy or radiotherapy, have a higher chance of developing problems like deep vein thrombosis (DVT) or pulmonary embolism (PE), which are types of blood clots that can be serious. This study is designed to compare REGN7508 against a dummy treatment (placebo) to see if it can successfully stop these clots from forming. Researchers want to find out how effective REGN7508 is at preventing these clots and if it causes any unwanted side effects when used in this way.
At a glance
What is this study about?
When people have cancer, especially during their treatment, they can be at a higher risk of developing blood clots. These clots can form in deep veins, often in the legs (this is called deep vein thrombosis, or DVT), or they can travel to the lungs, which is known as a pulmonary embolism (PE). These clots can be very serious and even life-threatening.
This study is testing a new medicine called REGN7508, which is a type of antibody. Antibodies are like natural defenders in our bodies. In this case, REGN7508 is designed to target a specific factor in the blood that helps it clot, with the goal of preventing these unwanted clots from forming in people with cancer who are currently having cancer treatments. The main goal is to see if REGN7508 can reduce the number of blood clots that occur and if it is safe for patients to use.
To understand if REGN7508 works, the study will compare it to a 'placebo.' A placebo looks just like the real medicine but contains no active drug. This helps doctors know for sure if any benefits or side effects are due to the medicine itself. Researchers will be carefully monitoring participants for any signs of blood clots, major bleeding, or other side effects to get a clear picture of how well and how safely REGN7508 performs.
Key takeaways
- This study tests a new medicine to prevent blood clots in cancer patients.
- It aims to reduce the risk of serious conditions like DVT and PE.
- Participants will receive either the new medicine or a dummy treatment.
- Safety and effectiveness will be carefully monitored throughout the study.
- The study is for adults with solid tumour cancers undergoing treatment.
Who may be eligible?
To join this study, you generally need to be an adult, aged 18 or over. The study is open to both men and women.
Specifically, the study is for people who have been diagnosed with solid tumour cancers (this means cancers that form a lump or growth, not blood cancers) and are currently receiving treatment for their cancer. This could include treatments like chemotherapy or radiotherapy.
There will also be other specific health requirements that your doctor will check against, such as your overall health, other medical conditions you might have, and medications you are currently taking. These checks are important to make sure the study is safe for you and that the results will be clear.
- Are you 18 years old or older?
- Do you have a solid tumour cancer (not a blood cancer)?
- Are you currently receiving treatment for your cancer?
- Are you interested in learning more about preventing blood clots?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you would be randomly assigned to either receive the new medicine, REGN7508, or a placebo (a dummy treatment). You, and your study doctor, would not know which one you are receiving – this is called a 'double-blind' study and helps ensure the results are unbiased. The medicine would likely be given as an injection.
Your participation would involve regular visits to the clinic for medical check-ups, blood tests, and scans to monitor your health and look for any signs of blood clots or bleeding. Researchers would also ask about any side effects you might be experiencing. The study would keep track of when any blood clots occur or if you have any serious bleeding episodes. The total duration of your participation, including how long you take the medicine and how long you are followed up afterwards, would be explained in detail by the study team.
Potential risks and benefits
Locations (8)
- —Belgium
- —Czechia
- —France
- —Romania
- —Germany
- —Poland
- —Bulgaria
- —Spain
Common questions
What is a 'blood clot' in this study?
In this study, a blood clot means an unwanted blockage in a blood vessel, like a DVT (deep vein clot, usually in the leg) or a PE (a clot that travels to the lungs). We are also looking at clots in arteries.
What does 'placebo-controlled' mean?
This means some people will get the new medicine, and others will get a 'dummy' treatment that looks the same but has no active drug. This helps us see if the new medicine really works.
Will I know if I'm getting the real medicine or the placebo?
No, neither you nor your study doctor will know. This is called 'double-blind' and helps make sure the study results are fair and accurate.
What are 'side effects'?
Side effects are any unwanted or unexpected reactions to a medicine. The study will carefully record and monitor any side effects people experience.
Can I leave the study if I change my mind?
Yes, you can leave the study at any point, for any reason, and it will not affect your usual 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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