A Study to Evaluate CC-486 in Participants With Moderate or Severe Hepatic Impairment Compared With Normal Hepatic Function in Cancer Participants
This research study is investigating a new medicine called CC-486. It's designed for people with certain blood cancers, specifically myeloid malignancies. The main goal is to understand how this medicine is processed by the body when someone also has liver problems, whether moderate or severe. We'll compare this to how it works in people with normal, healthy livers. This is a very early stage (Phase I) study, focusing on how the drug moves through and is used by the body. By doing this research, doctors can learn how to give CC-486 safely and effectively to patients who might also have liver conditions, making sure they get the right dose and care.
At a glance
What is this study about?
Imagine you need a specific medicine, but your liver, which helps process drugs, isn't working perfectly. How does that change how your body handles the medicine? This study, called a 'Human Pharmacology' or Phase I study, is designed to answer exactly that question for a medicine named CC-486.
CC-486 is being developed for people who have a type of blood cancer called myeloid malignancies. The liver plays a really important role in breaking down medicines and clearing them from your body. If your liver isn't working as well, a medicine might stay in your system longer, or reach higher levels than intended, which could lead to different effects or side effects.
So, this study will carefully look at how the body manages CC-486 in two groups of people with cancer: those with normal, healthy livers, and those with livers that are not working as well (moderate or severe 'hepatic impairment'). By comparing these groups, researchers hope to get a clear picture of how liver health affects the medicine. This information is crucial for doctors to decide the best and safest way to give CC-486 to patients, especially those who also have liver conditions.
Key takeaways
- This study looks at how a new cancer medicine (CC-486) works in people with liver issues.
- It's for adults with myeloid malignancies, with or without liver problems.
- The goal is to help doctors give the right dose safely to all patients.
- It's an early-stage study focusing on how the body handles the medicine.
- Participation involves clinic visits, medicine, and health checks.
Who may be eligible?
To join this study, you need to be an adult, aged 18 or older. The study is open to both men and women.
You must have been diagnosed with a type of blood cancer called a myeloid malignancy. Importantly, your liver health is a key factor. The study is specifically looking at two groups of people: those with normal liver function, and those who have either moderate or severe liver problems.
Since this is a very early stage study, there will likely be many other specific health checks and tests to make sure it's safe for you to take part and that the study can collect the information it needs accurately. The best way to know for sure if you might be suitable is to talk to your doctor.
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 a diagnosis of a myeloid malignancy (a type of blood cancer)?
- Have you been told you have normal liver function OR moderate or severe liver impairment?
- Are you able to attend regular clinic appointments and follow study instructions?
What does participation involve?
Taking part in this study would involve several visits to a clinic or hospital over a period of time. You would receive the study medicine, CC-486, likely in a carefully controlled way. During these visits, the study team would perform various assessments. These typically include blood tests to check how your body is handling the medicine and to monitor your liver health, along with other general health checks.
You might also have physical examinations and be asked about any side effects you experience. The number of visits, how often you take the medicine, and how long the study lasts for each person will be explained in detail by the study team. There would also be follow-up appointments after you stop taking the medicine to ensure your safety and well-being. Exactly how long the entire process would take will be fully explained before you decide to join.
Potential risks and benefits
Locations (2)
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Common questions
What is a myeloid malignancy?
It's a type of cancer that starts in the bone marrow, affecting how certain blood cells are made.
What does 'hepatic impairment' mean?
It means your liver isn't working as well as it should. It can be mild, moderate, or severe.
Why is liver function important for this study?
Your liver helps process medicines. This study wants to see if CC-486 works differently in people with liver problems.
Is CC-486 an approved medicine?
No, it's an investigational medicine, meaning it's still being studied and is not yet available outside of clinical trials.
What is a 'Phase I' study?
It's an early stage of research to understand how a new medicine moves through the body and if it's safe.
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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