Futibatinib in Patients Previously Enrolled in an Antecedent Futibatinib as Monotherapy or Combination Therapy.
This study is an option for people with advanced cancer who are already receiving treatment with a drug called futibatinib, either on its own or with other medicines, as part of a previous Taiho Pharmaceuticals study. It's designed to allow these patients to continue receiving futibatinib if their doctors believe it's helping them and causing no major problems. Essentially, it allows patients who are benefiting from futibatinib to keep taking it without a break between studies. This type of study is called a 'rollover' study because it rolls patients over from one study to another, providing continuous care. Researchers want to make sure patients who are doing well on futibatinib can keep getting it for as long as it's beneficial.
At a glance
What is this study about?
Imagine you're taking a medicine for your cancer as part of a research study, and it seems to be working well for you. This particular study is like a bridge to let you continue taking that medicine, called futibatinib, if you were already taking it in an earlier study sponsored by Taiho Pharmaceuticals. It's specifically for people whose cancer is advanced or has spread.
The main idea behind this study is to make sure that if futibatinib is helping you and you're not having serious side effects, you can keep receiving it. Often, when a study ends, patients might have to stop taking the experimental medicine. But a 'rollover' study like this one prevents that, allowing you to continue your treatment journey without interruption as long as your doctor believes it's beneficial and safe for you.
This study isn't looking for new patients to try futibatinib for the first time. Instead, it's focused on providing ongoing care and gathering more information on the long-term effects of futibatinib in people who have already shown a positive response to it. This helps doctors and researchers understand even more about how the drug works over time.
Key takeaways
- This study is for patients already taking futibatinib in another study.
- It allows continued access to futibatinib if it's helping and safe.
- Participation ensures uninterrupted treatment for eligible patients.
- Medical professionals will closely monitor your health and response.
- You can stop participating at any time if you wish.
Who may be eligible?
To join this study, you must currently be taking the drug futibatinib, either by itself or with other medicines, as part of an earlier study sponsored by Taiho. Importantly, your doctor must believe that the treatment is helping you and that you're not experiencing any unacceptable side effects. If you had to stop treatment in the previous study for any reason, you wouldn't be able to join this one.
You must be able to give your clear agreement in writing to join the study. If you could become pregnant, you'll need a negative pregnancy test shortly before starting. Also, both men and women who could have children must agree to use effective birth control throughout the study and for some time afterwards.
Finally, you need to be able to take medicines by mouth, as a feeding tube isn't allowed for this study.
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 currently receiving futibatinib in a previous Taiho study?
- Does your doctor believe futibatinib is helping you and is safe for you?
- Are you able to take medicines by mouth?
- Are you willing to use effective birth control if you could have children?
- Have you *not* had to stop your treatment in the previous study for any reason?
What does participation involve?
If you join this study, you will continue to receive the drug futibatinib by mouth. The study involves regular visits to your clinic or hospital to check your health, see how you're responding to the treatment, and monitor for any side effects. These visits will include checks like blood tests and physical examinations. You'll continue to take your medication as prescribed by the study team.
The amount of time you spend in the study will depend on how you respond to futibatinib and whether your doctor believes it's still beneficial and safe for you to continue. There isn't a fixed end date for all participants; you will continue as long as you are benefiting and not experiencing serious issues. The study team will explain the schedule of visits and what each visit will involve in detail.
Potential risks and benefits
Locations (9)
- University of California, San Francisco (UCSF)Verified postcodeSan Francisco, United States
- Institut Paoli-CalmettesVerified postcodeMarseille, France
- Institut De Cancerologie StrasbourgVerified postcodeStrasbourg, France
- Severance HospitalVerified postcodeSeoul, South Korea
- Hospital Universitari, Vall d'HebronVerified postcodeBarcelona, Spain
- Centro Integral OncologicoVerified postcodeMadrid, Spain
- Royal Marsden NHS Foundation TrustVerified postcodeLondon, United Kingdom
- Sarah Cannon Research Institute UKVerified postcodeLondon, United Kingdom
- University College London Hospitals NHS Foundation TrustVerified postcodeLondon, United Kingdom
Common questions
What is futibatinib?
Futibatinib is a type of medicine used in cancer treatment. You would have already received it in a previous research study.
Why is this study happening?
This study allows patients who are already benefiting from futibatinib in an earlier study to continue their treatment without interruption.
Do I have to take futibatinib if I join?
Yes, this study is about continuing treatment with futibatinib, so you would continue to take it as part of the study.
Can I join if I've never taken futibatinib before?
No, this study is only for patients who are already receiving futibatinib in a specific previous research study.
What if I decide I don't want to be in the study anymore?
You are free to leave the study at any time, for any reason, and it won't affect your regular medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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