Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Study of Oral Tazemetostat in Subjects With Moderate and Severe Liver Impairment With Advanced solid tumors or hematological malignancies

This research study is testing a new medicine called tazemetostat. It's for adults who have advanced solid tumours (like breast or lung cancer) or blood cancers (like lymphoma or leukaemia). We are particularly interested in how this medicine works in people with liver problems, as well as those with healthy livers. This early-stage study, called a Phase 1 study, aims to understand how the body handles the medicine and what dose is safe. It will help us learn if tazemetostat behaves differently in people whose livers aren't working normally compared to those with healthy livers. This information is important for making sure future treatments are safe and effective for all patients.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Epizyme Inc.

Enrolment target

Start

17 Oct 2024

Advanced solid tumors or hematological malignancies and normal hepatic function or moderate or severe hepatic impairment.

What is this study about?

This research is looking at a new medicine called tazemetostat. This medicine is designed to treat certain advanced cancers, which means cancers that have spread or are difficult to treat. These cancers can be solid tumours, which are lumps that grow in organs like the breast, lung, or bowel, or blood cancers, which affect the blood, bone marrow, or lymph nodes.

The main goal of this study is to see how the medicine works in people who have liver problems compared to those with healthy livers. Your liver is a very important organ that helps process medicines in your body. If your liver isn't working properly, it might change how a medicine affects you. We want to understand if tazemetostat behaves differently in people with mild or severe liver issues, and if the dose needs to be adjusted for them. This is vital to make sure the medicine is safe and works as it should for everyone.

This is a "Phase 1" study, which means it's an early stage of research. These types of studies are usually smaller and focus on finding out if a new medicine is safe and what the right dose might be, rather than how well it treats the cancer. The information we gather will help doctors decide if and how this medicine can be used safely in more people with cancer in the future, especially if they also have liver conditions.

Key takeaways

This study is testing a new cancer medicine called tazemetostat.
It's for adults with advanced solid tumours or blood cancers.
Researchers want to see how the medicine works in people with and without liver problems.
It's an early-stage study focused on safety and how the body processes the medicine.
You can discuss participation with your doctor and can leave the study at any time.

Who may be eligible?

To take part in this study, you need to be an adult, 18 years old or older. The study is open to both men and women.

Participants must have either an advanced solid tumour or a blood cancer like lymphoma or leukaemia. You might also be able to join if you have a healthy liver, or if you have moderate or severe liver problems.

The research team will carry out some checks to make sure this study is right for you and that you meet all the necessary requirements. This helps ensure your safety and that the study can gather accurate information.

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 an advanced solid tumour or a blood cancer?
Do you have a healthy liver, or moderate or severe liver problems?
Are you able to attend study appointments as required?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be given the study medicine, tazemetostat, to take by mouth. The exact details of how often you'll take it will be explained by the study team. You will need to attend several appointments at the clinic. During these visits, doctors and nurses will monitor your health closely, take blood samples, and perform other tests to see how your body is reacting to the medicine and if there are any side effects. They will also check how your liver is functioning. The total length of time you will be involved in the study will depend on your individual response and what the study team advises, but there will be regular follow-up to ensure your well-being.

Potential risks and benefits

Taking part in any clinical study carries potential benefits and risks. You might not directly benefit from this study, but the information gathered could help future patients with similar conditions. There's a chance you could experience side effects from the study medicine, tazemetostat, or from any tests involved. The study team will explain all known potential risks before you decide to join. Remember, taking part is completely voluntary, and you can withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Belgium
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Unverified
Poland
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Unverified
Slovakia
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Unverified
France

Common questions

What is tazemetostat?

It's a new medicine being studied to treat certain advanced cancers. This study will help us understand how it works.

Why are you looking at people with liver problems?

Your liver helps process medicines. We need to see if tazemetostat acts differently in people with liver problems to make sure it's safe and effective for them.

What kind of cancers is this study for?

It's for adults with advanced solid tumours (like breast or lung cancer) or blood cancers (like lymphoma or leukaemia).

Will I get better if I join this study?

This early-stage study mainly focuses on the safety of the medicine and how the body handles it. While some patients may benefit, it's not the main goal to find out how well it treats cancer at this stage.

Can I leave the study if I change my mind?

Yes, you are free to leave the study at any time without giving a reason, and it won't affect your regular medical care.