Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A clinical trial to learn how an investigational drug (vimseltinib) is absorbed, distributed, broken down, and removed from the body when given to people with liver problems

This research study is investigating a new medication called vimseltinib. It's designed to understand how this drug acts in the body of people who also have liver problems. Researchers want to know how the body takes in the medicine (absorbed), where it goes (distributed), how it's broken down (metabolised), and how it leaves the body (excreted). This is important because liver problems can affect how medicines work, and understanding this helps ensure the drug is given safely and effectively. The study is open to adults aged 18 and over, of any gender, who have been diagnosed with certain types of tumours, specifically Tenosynovial Giant Cell Tumour (TGCT) or Malignant Solid Tumours (MST). This is an early-stage study, focusing on the basic effects of the drug in humans.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Deciphera Pharmaceuticals Inc.

Enrolment target

Start

15 Sep 2023

Tenosynovial Giant Cell Tumor (TGCT)Malignant Solid Tumors (MST)

What is this study about?

This study is designed to help us understand a new medicine called vimseltinib. Think of your body as a processing plant for medicines. When you take a drug, your body absorbs it, sends it to where it needs to go, breaks it down, and then gets rid of what’s left. This whole process is often called 'pharmacokinetics'. This study aims to carefully watch this process in people who have existing liver problems.

Why is this important? The liver plays a big role in breaking down many medicines. If someone’s liver isn't working as well as it should, it might not process the medicine in the usual way. This could mean the medicine stays in the body for longer, or that more of it reaches places it shouldn’t, potentially leading to different effects or side effects.

By understanding exactly how vimseltinib is handled by the body when someone has liver problems, doctors and researchers can figure out the best and safest dose to give. This helps ensure that if this medicine is approved in the future, it can be used effectively and safely for a wider range of patients, including those who also have liver conditions.

Key takeaways

This study is about understanding how a new medicine, vimseltinib, works in the body.
It focuses on people who also have liver problems, as the liver processes medicines.
The goal is to find out how the drug is absorbed, distributed, broken down, and removed.
This information helps doctors give the drug safely and correctly in the future.
It's an early-stage study (Phase I) in adults with specific types of tumours.
Participation involves regular visits and monitoring by a medical team.

Who may be eligible?

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

You would also need to have a specific health condition. This includes either Tenosynovial Giant Cell Tumour (TGCT) or certain types of Malignant Solid Tumours (MST). The study is particularly looking at people who also have some form of liver problem. Your doctors would check your medical records and perform tests to see if your specific condition and liver health meet the study’s requirements.

There will be other detailed medical checks to make sure the study is a good fit for you and safe for your current health. These will include reviews of your medical history, current medications, and other health conditions you might have. Not everyone with these conditions will be able to join, as there are strict health and safety criteria to protect participants.

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 Tenosynovial Giant Cell Tumour (TGCT) or a Malignant Solid Tumour (MST)?
Have you been told you have some form of liver problem?
Are you able to attend regular clinic appointments for monitoring?
Are you willing for doctors to review your full medical history?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a screening visit to check if you meet all the requirements. This would involve medical checks, blood tests, and a review of your health history. If you are eligible, you would receive the study medication, vimseltinib, as directed by the study doctors.

Your participation would involve regular visits to the clinic or hospital. These visits are important for the study team to monitor your health, check for any changes, and see how your body is responding to the medicine. They will take blood samples to measure how the drug is moving through your body, and you might have other tests or assessments.

Throughout the study, you’ll be closely monitored for any side effects or changes in your health. The total duration of your involvement in the study, including follow-up visits after you stop taking the medicine, will be explained in detail by the study team. You would be given a schedule outlining all your appointments and what to expect at each one.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as contributing to medical knowledge that could help others in the future, and receiving close medical attention from a study team. For you personally, there's a chance you might benefit from the investigational drug, though this is not guaranteed as it's still being studied. However, like all medicines, vimseltinib may have side effects, and some of these could be serious or unexpected. The study team will explain all known or potential risks to you before you decide to participate. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
Hungary

Common questions

What is vimseltinib?

Vimseltinib is an investigational drug, meaning it's a new medicine being studied and is not yet approved for general use. This study is helping us learn more about it.

Why is this study specifically looking at people with liver problems?

The liver helps break down many medicines. This study wants to understand how vimseltinib is processed in people whose livers might not be working perfectly, to ensure it can be given safely to them.

Is this a new treatment for my condition?

This is an early-stage study (Phase I). It's primarily focused on how the body handles the drug, rather than directly testing it as a new treatment for your condition right now. However, the information gathered is vital for its future development.

Will I know if I'm getting the actual drug or a placebo?

This study is focused on how the drug works in the body and involves giving the active drug to participants to measure its effects. The study team will explain exactly what you would receive.

How long will I need to be in the study?

The total length of time you'd be involved, including regular visits and follow-up, will be clearly explained by the study team before you join. It will depend on the study design.