A Phase I, Open-label, Parallel Group Study to Investigate Olaparib Safety and Tolerability, Efficacy and Pharmacokinetics in Paediatric Patients with Solid Tumours
This research study is about a medicine called olaparib, also known as Lynparza. It's for children and young people who have solid tumours, which are types of cancer that form solid lumps. The main goals are to check how safe the medicine is for these young patients and how well their bodies can tolerate it. We also want to understand how the medicine moves through and is processed by the body. This helps us find the best and safest dose for children. Because it's an early-stage study, we'll be watching very closely for any side effects and how patients are feeling. The information we gather will be really important for developing new treatments in the future.
At a glance
What is this study about?
This study is an important first step in understanding a medicine called olaparib (also known as Lynparza) when used for children and young people with solid tumours. Solid tumours are a type of cancer that forms a solid mass. The main aim of this early phase study is to carefully look at how safe this medicine is and how well young patients' bodies can cope with it. We also want to understand how the medicine behaves in the body – for example, how much is absorbed, how long it stays in the system, and how the body gets rid of it. This detailed information is crucial for figuring out the best and safest dose.
Imagine you're trying a new recipe; this study is like testing a small batch first to see if the ingredients work well together and how much of each ingredient is just right. For this medicine, we are particularly keen to identify the highest amount that can be given safely without causing too many side effects. This is called the 'recommended Phase 2 dose' (RP2D).
Even though this is an early study, the findings are incredibly important. By carefully collecting information on safety, side effects, and how the body processes the medicine, we can make informed decisions about whether to carry out larger studies in the future. The ultimate goal is to find effective and safe new treatments to help young patients living with solid tumours.
Key takeaways
- This study tests a medicine called olaparib (Lynparza) for childhood solid tumours.
- The main goals are to find out how safe the medicine is and what the best dose is for children.
- It's an early-stage study, so monitoring for safety and side effects is very important.
- All children and young people with solid tumours can be considered for enrolment.
- Taking part involves regular hospital visits for checks and tests.
- You can withdraw from the study at any time without affecting your child's care.
Who may be eligible?
This study is open to children and young people of all ages who have solid tumours. Both boys and girls can take part.
Before anyone can join, the study team will carefully check to make sure it's the right choice for them. They will look at your child's medical history and current health to ensure the study is safe and suitable.
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.
- Does my child have a solid tumour?
- Is my child any age (from very young to older teenagers)?
- Am I comfortable with my child having regular hospital visits for check-ups and blood tests?
- Do I understand that this is an early study focused on safety, not guaranteed treatment?
What does participation involve?
If your child takes part in this study, they will receive the study medicine, olaparib, in tablet form. You will need to bring your child to the hospital or clinic for regular visits. During these visits, the doctors and nurses will carry out various checks and tests. These might include blood tests to look at how their body is responding and managing the medicine, measurements of their vital signs (like temperature, pulse, and blood pressure), and questions about how they are feeling.
Initially, visits will be more frequent, especially when starting the medicine, so the team can carefully monitor your child. The study team will explain exactly how often these visits will be. There will also be a follow-up period after your child stops taking the study medicine, where the team will continue to check on their health. The total time your child will be involved in the study will depend on how well they are doing and if the medicine is helping, but the team will give you a clear idea of the expected duration.
Potential risks and benefits
Locations (5)
- —UnverifiedItaly
- —UnverifiedDenmark
- —UnverifiedHungary
- —UnverifiedFrance
- —UnverifiedSpain
Common questions
What is a 'solid tumour'?
A solid tumour is a type of cancer that forms a solid lump of cells in the body, rather than a liquid cancer like leukaemia.
What does a 'Phase I' study mean?
A Phase I study is the first step in testing a new medicine in people. It mainly focuses on finding a safe dose and understanding how the medicine affects the body.
What is olaparib?
Olaparib (also known as Lynparza) is a medicine that works by targeting specific ways cancer cells repair themselves, aiming to stop them from growing.
Will my child definitely get better if they join this study?
This early study primarily focuses on safety and finding the right dose. While some patients may benefit, we cannot promise that the medicine will cure or improve your child's condition.
What if we change our minds about participating?
You are free to withdraw your child from the study at any time, for any reason. This decision will not affect your child's ongoing medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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