A multi-center, open-label, drug-drug interaction study to evaluate the effect of pralsetinib (Gavreto) on the pharmacokinetics of CYP3A4, CYP2C8, and CYP2C9 substrates, and hormones estradiol/norethisterone acetate in patients with advanced or metastatic solid tumors.
This study is for people with advanced or metastatic solid tumours. It aims to understand how a cancer medicine called Gavreto (pralsetinib) interacts with other common medicines, including some hormones. When you take more than one medicine, they can sometimes affect how each other work in your body. This study wants to see if Gavreto changes how your body handles other drugs that are broken down by specific enzymes, or how it affects hormones like those found in some birth control. By understanding these interactions better, doctors can make sure that patients receive the safest and most effective treatment. It's an important step in making sure new cancer treatments work well with other medications patients might be taking.
At a glance
What is this study about?
This research study is looking at an important aspect of how a cancer medicine called Gavreto works inside the body. Gavreto is used to treat advanced or widespread (metastatic) solid tumours. When you take any medicine, your body processes it, and this can sometimes be affected by other medicines or even hormones in your system. This study is specifically designed to understand if Gavreto changes how your body handles other medicines, especially those that are processed by particular enzymes.
Think of these enzymes as tiny workers in your body that help break down or use medicines. If one medicine affects these workers, it could change how quickly or slowly your body uses another medicine. For example, it might mean another medicine becomes stronger or weaker than expected. The study is also looking at how Gavreto might affect levels of hormones like oestrogen and norethisterone acetate, which are key ingredients in some hormone therapies or contraceptives.
By carefully studying these interactions, researchers can learn more about how Gavreto behaves when a patient is also taking other medicines. This information is really important for doctors to ensure they provide the best and safest treatment plans. It helps them decide on the right doses and timings of medicines to make sure all treatments work as effectively as possible for people living with cancer.
Key takeaways
- Study examines how Gavreto (a cancer drug) interacts with other medicines and hormones.
- Aimed at people with advanced or spreading solid tumours.
- Helps understand how drugs are processed in the body.
- Information will lead to safer and more effective treatment plans.
- All adults (18+) with eligible cancer can be considered.
- Involves taking Gavreto and giving blood samples for testing.
Who may be eligible?
To take part in this study, you must be an adult with cancer. Specifically, you need to have solid tumours that are advanced (meaning they have grown significantly) or metastatic (meaning they have spread to other parts of the body).
There are no restrictions based on whether you are male or female; both men and women can participate. You also need to be at least 18 years old. There is no upper age limit, so older adults are welcome to join if they meet the other criteria.
The researchers will check other aspects of your health to make sure it's safe for you to take part. This will include things like your general health and any other medicines you're currently taking. These checks are standard for all clinical trials to protect your safety.
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 solid tumours that are advanced or have spread?
- Are you able to attend regular clinic visits for blood tests?
- Are you willing to take Gavreto capsules as part of the study?
What does participation involve?
If you decide to join this study, you will be given Gavreto capsules to take. The study will involve several visits to the clinic. During these visits, the research team will take blood samples to measure how Gavreto and other medicines are being processed by your body. They'll be looking at things like how much medicine is in your blood at different times and how long it stays there.
You might be asked to take specific 'probe' medicines, which are standard drugs used to see how your body's processing systems are working, before and during your Gavreto treatment. The total time you spend in the study will depend on the phase of the research and your own treatment plan, but the main part of the study focuses on understanding drug levels over short, specific periods. There will be initial assessment visits, dosing periods, and follow-up checks. All procedures will be explained in detail by the study team.
Potential risks and benefits
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Common questions
What is Gavreto?
Gavreto is a medicine used to treat certain types of advanced cancer. It comes in capsule form.
Why is this study looking at drug interactions?
Drugs can affect how each other work in your body. This study helps doctors understand if Gavreto changes how other medicines, including some hormones, are processed.
What does 'advanced or metastatic solid tumours' mean?
This means your cancer has either grown significantly or has spread from its original site to other parts of your body.
Will I have to stop other medicines if I join?
The study team will review all your current medications. It's possible some might need to be adjusted or temporarily paused, but this will be discussed with you carefully.
Is this study safe?
Researchers take great care to ensure participant safety. You will be monitored closely for any side effects or drug interactions, and all procedures will be explained to you.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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