A phase II, randomized, open-label study to assess the efficacy, safety, and pharmacokinetics (PK) of maintenance cabozantinib (XL184) plus best supportive care (BSC) versus BSC in children, adolescents and young adults (AYA) with unresectable residual osteosarcoma either at diagnosis or at first relapse after standard treatment.
This study is for children, teenagers, and young adults with osteosarcoma, a type of bone cancer that has either come back or can't be removed with surgery. It's a Phase II study, which means it builds on earlier research to look more closely at how well the new medicine, cabozantinib (also known as CABOMETYX), works and if it's safe. Participants will be split into groups by chance: one group will receive cabozantinib tablets along with standard supportive care, and the other will receive only supportive care. The main goal is to see if cabozantinib helps stop the cancer from growing for longer. Researchers will also look at how many people respond to the treatment and how safe it is.
At a glance
What is this study about?
This study is looking into a type of bone cancer called osteosarcoma, specifically in children, teenagers, and young adults. This cancer can sometimes be hard to treat, especially if it returns after standard treatments or if surgery isn't an option to remove the tumour completely. Researchers want to find better ways to help young people in this situation. They are testing a medicine called cabozantinib, which comes as a tablet.
The study is designed to answer important questions: Does cabozantinib, when given along with the best supportive care (which helps manage symptoms and improve quality of life), prevent the cancer from growing or spreading for longer than just having supportive care alone? It also aims to understand how safe cabozantinib is and how the body handles the medicine. By carefully comparing the two groups, the researchers hope to learn if cabozantinib could become a helpful new treatment option for young people with osteosarcoma.
This is a 'Phase II' study, which means it builds on initial research that showed some promise. The information gathered from this study will help decide if cabozantinib should be tested in an even larger study (Phase III) before it can potentially be made widely available. Every step in these studies helps scientists understand new medicines better and brings hope for improved treatments.
Key takeaways
- This study is for young people with osteosarcoma that is hard to treat.
- It tests a new medicine called cabozantinib alongside standard supportive care.
- The main goal is to see if cabozantinib helps stop the cancer from growing for longer.
- Participants will be randomly assigned to receive cabozantinib plus supportive care, or supportive care alone.
- You will have regular medical checks and scans throughout the study.
- You can stop participating in the study at any time.
Who may be eligible?
This study is looking for children, teenagers, and young adults with osteosarcoma. For you to be considered, your osteosarcoma must either have been diagnosed as a tumour that can't be completely removed by surgery, or it must be a return of the cancer after you've already had standard treatments.
There may be other specific health requirements or conditions that would mean you can or cannot join the study. These could include other medical conditions, medicines you might be taking, or certain results from blood tests.
The study is open to both male and female participants.
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 a child, teenager, or young adult?
- Do you have osteosarcoma?
- Has your osteosarcoma been diagnosed as 'unresectable residual' (can't be fully removed or has returned)?
- Have you already had standard treatments for your osteosarcoma (if it's a first relapse)?
- Are you able to take medicines in tablet form?
- Do you meet other specific medical and blood test requirements?
What does participation involve?
If you join this study, you'll first be randomly assigned to one of two groups, like flipping a coin. One group will receive the study medicine, cabozantinib, as tablets, in addition to supportive care. The other group will receive the best supportive care only. You won't know which group you are in if it's a 'blinded' study, but this particular study is 'open-label', meaning both you and your doctor will know if you are taking cabozantinib.
Throughout the study, you'll have regular visits to the clinic for medical checks, blood tests, and scans (like X-rays or MRI scans). These checks are important for monitoring your health, whether the cancer is growing, and how your body is responding to any treatment. The study aims to follow participants for about 34 months, or until the cancer grows or you need to stop for other reasons.
Potential risks and benefits
Locations (11)
- —UnverifiedPoland
- —UnverifiedFrance
- —UnverifiedNetherlands
- —UnverifiedSweden
- —UnverifiedItaly
- —UnverifiedSpain
- —UnverifiedDenmark
- —UnverifiedIreland
- —UnverifiedBelgium
- —UnverifiedGermany
- —UnverifiedAustria
Common questions
What is osteosarcoma?
Osteosarcoma is a type of cancer that starts in the bones. It mostly affects children, teenagers, and young adults.
What does 'unresectable residual' mean?
It means the cancer can't be completely removed by surgery, or some cancer cells might have been left behind after surgery.
What is 'best supportive care'?
This is the usual care given to help manage symptoms and improve your comfort and well-being, without specifically targeting the cancer itself.
What is cabozantinib?
Cabozantinib (also known as CABOMETYX) is a medicine that comes as a tablet. It's designed to target certain pathways that help cancer cells grow.
How long will the study last for each person?
The study aims to follow each person for about 34 months, or until the cancer progresses or they decide to leave the study.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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