RecruitingPHASE1INTERVENTIONAL

Pharmacokinetics and Safety Study of Pelabresib in Patients With Advanced Malignancies and Hepatic Impairment

This study is for people with advanced cancers and liver problems. We are testing a new drug called pelabresib to understand how it behaves in the body, particularly in those with different levels of liver health compared to those with healthy livers. This will help us learn if the drug is processed differently and ensure it's safe and effective for everyone. Participants may be able to continue receiving the drug if it is helping them. The aim is to gather important information so future patients can benefit from this treatment option.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Novartis Pharmaceuticals

Enrolment target

Start

24 Apr 2026

Estimated completion

02 Aug 2028

Advanced Malignancies and Hepatic Impairment

What is this study about?

This study is looking into a new medication called pelabresib. It's designed for people who have advanced cancers, meaning cancers that have spread or are difficult to treat, and also have issues with their liver function. Our main goal is to understand how pelabresib acts in the body, especially how it's handled by people whose livers aren't working as well as they should be, compared to those with healthy livers. This is really important because our liver plays a big role in breaking down medicines, and we need to make sure the drug is safe and works properly for everyone.

We're testing pelabresib in two main stages. In the first stage, we'll carefully observe how the drug moves through the bodies of people with different levels of liver health. This will help us see if liver problems change how much of the drug stays in the body and for how long. The second stage gives participants the chance to continue taking pelabresib if their doctors believe it's helping them. This extended treatment option aims to provide ongoing benefit if the drug is proving useful.

By taking part, you would be helping medical researchers learn more about pelabresib. This information is key to making sure that in the future, doctors can give the right dose of pelabresib to patients, taking into account their liver health, to make the treatment as safe and effective as possible. Your participation could help many others facing similar health challenges.

Key takeaways

Tests a new cancer drug, pelabresib, in people with advanced cancers.
Specifically looking at how liver health affects the drug's action.
Potential for continued treatment if the drug benefits you.
Close monitoring of your health throughout the study.
Participation helps future patients with similar conditions.

Who may be eligible?

To join this study, you generally need to be between 18 and 75 years old and have an advanced cancer for which standard treatments are no longer working. Your cancer must be confirmed by a doctor.

We'll also need to check your blood and kidney function to make sure they are healthy enough for you to take part. For people with liver problems, there are specific levels of liver function we're looking for, which your doctor will be able to explain. If you have a matching participant with normal liver function, that also helps for one of the study groups.

There are some reasons why you might not be able to join. For example, if you're allergic to the study drug or similar medicines, are pregnant or breastfeeding, or if your doctor thinks another health condition makes the study unsafe for you. We also need you to have recovered well from any recent major surgery, chemotherapy, or radiotherapy, and expect to live for at least three more months.

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 between 18 and 75 years old?
Do you have an advanced cancer for which standard treatments aren't available?
Do you have generally good kidney function and blood test results?
Are you not pregnant or breastfeeding, if you are a woman?
Do you expect to live for at least 3 more months?

Answer every question to see your result.

What does participation involve?

If you decide to join, it starts with an initial check-up to see if you're suitable for the study. Once accepted, you'll begin taking the pelabresib medication. We'll be doing regular assessments, including blood tests, to see how the drug is working in your body and to monitor your liver function and overall health. You won't have breaks from treatment to 'wash out' the drug; we'll be checking how it works while you're regularly taking it.

The study has two main parts. In the first part, we'll focus on understanding how pelabresib is processed in your body, depending on your liver health. After this, if your doctor believes the treatment is helping you, you might be able to continue taking pelabresib in the second part of the study. This can last until the study ends, if the drug stops helping, or if you need to stop for other reasons.

After you stop taking the study drug, your doctor will see you for 'end of treatment' and 'safety follow-up' visits. These visits typically happen within seven days of your last dose and then again about 30 days later to check on your health and any side effects. If you have a blood cancer, there will be extra follow-up visits every three months after you finish treatment.

Potential risks and benefits

Participating in this study might offer you the chance to receive a new drug, pelabresib, that could potentially help with your advanced cancer. It's important to remember that this is a research study, and we don't yet know if the drug will benefit you significantly. There are always potential risks with any new medication, including side effects, which you will be fully informed about. Your health will be closely monitored throughout the study. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

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

Novartis Investigative Site
Verified postcode
Candiolo, Italy· Recruiting
Novartis Investigative Site
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is pelabresib?

Pelabresib is a new drug being tested for people with advanced cancers and liver problems.

Why is liver function important for this study?

Your liver helps process medicines, so we want to see if liver problems change how pelabresib works in your body.

Will I keep taking the drug if it helps me?

Yes, if your doctor believes pelabresib is helping you after the first part of the study, you may be able to continue taking it.

How long will the study last for me?

This varies; after the main assessment, you might continue treatment if it helps, with follow-up visits after stopping the drug.

Can I stop being part of the study at any time?

Yes, you can choose to leave the study at any point without it affecting your medical care.

How to find out more

Novartis Pharmaceuticals

novartis.email@novartis.com +41613241111 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.