INCB 54828-801: An Open-Label, Multicenter, Rollover Study to Provide Continued Treatment for Participants With Advanced Malignancies Previously Enrolled in Studies of Pemigatinib
This study is designed for adults with advanced cancers who are currently benefiting from treatment with a medicine called pemigatinib in another clinical trial. If you are in this situation and cannot access pemigatinib after your current trial ends, this 'rollover' study offers a way to continue your treatment. It helps ensure that you can keep receiving a medicine that is working for you. Doctors will continue to monitor your health, looking especially at any side effects that might happen. This helps them understand the long-term safety and how well pemigatinib works over time. It’s important for gathering more information about this treatment to potentially help other patients in the future.
At a glance
What is this study about?
This study, called INCB 54828-801, is set up for patients who are already receiving a cancer medicine called pemigatinib through another research study. Sometimes, when a study ends, patients who are benefiting from a treatment might not be able to get that medicine anymore, especially if it's not yet widely available. This 'rollover' study aims to solve that problem by allowing you to continue receiving pemigatinib if your current study ends and the medicine is still working well for you.
The main goal is to let you keep getting a treatment that is helping you, even if you can't access it outside of a research setting. It also gives doctors more time to understand how pemigatinib works over a longer period. They will carefully watch for any side effects and see how your body responds to the treatment over time. This information is really important because it helps medical experts learn more about the medicine's overall safety and effectiveness.
By taking part, you're not just continuing your own treatment; you're also contributing valuable information that could help many other patients in the future who are battling similar cancers. It's a way for researchers to gather even more details that are needed before a new medicine can be made available to everyone. This particular study is in an earlier stage, called Phase II, which means researchers are still learning about the best ways to use the medicine and understanding its effects.
Key takeaways
- This study helps you keep getting pemigatinib if it's working for your cancer.
- It's for adults (18+) already in a pemigatinib trial.
- Doctors will carefully watch for any side effects.
- Your participation helps gather more information about the medicine.
- You can stop participating at any time.
Who may be eligible?
This study is for adults, both men and women, who are at least 18 years old.
The most important requirement is that you must already be taking the cancer medicine called pemigatinib as part of another clinical trial. You also need to be benefiting from this treatment, meaning it is helping with your cancer.
Crucially, you must not be able to get pemigatinib through other means, such as your doctor prescribing it or another way outside of a new study. This study is specifically for those who need a way to continue their ongoing, successful treatment.
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?
- Are you currently taking pemigatinib in another clinical study?
- Is pemigatinib currently helping with your cancer?
- Can you not get pemigatinib outside of a clinical study?
What does participation involve?
If you join this study, you will continue to take pemigatinib, likely in tablet form (Pemazyre), at one of the available strengths (4.5 mg, 9 mg, or 13.5 mg), as determined by your study doctor. The main thing doctors will be doing is carefully observing your health. They will hold regular check-ups to note down any side effects you might experience. These visits will allow them to check how your body is reacting to the medicine and ensure you are doing okay.
The total duration of your participation will depend on how you respond to the treatment and whether it continues to benefit you. There isn't a fixed end date mentioned, as the goal is to provide continued treatment. You'll have regular appointments where blood tests and other assessments will be done to monitor your condition and the effects of the medicine. The focus is on your continued well-being while on pemigatinib.
Potential risks and benefits
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Common questions
What is pemigatinib?
Pemigatinib is a medicine used to treat certain types of advanced cancer.
Why is this study needed?
It allows patients who are successfully taking pemigatinib in another study to continue receiving it if they can't get it elsewhere after their initial study ends.
Who can join this study?
Adults (18 years or older) who are already benefiting from pemigatinib treatment in another clinical trial and can't access it outside of a study.
What will doctors be looking for?
They will mainly be monitoring any side effects you might have and how well the treatment continues to work over time.
Will I have to pay for the medicine?
No, if you are part of a clinical trial, the study usually provides the medication free of charge.
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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