Active not recruitingPHASE1, PHASE2INTERVENTIONAL

INCB000928 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Anemia Due to Myeloproliferative Disorders

This research study is testing a new medication called INCB000928. It's being studied both on its own and in combination with an existing drug called ruxolitinib. The focus is on people who have myelofibrosis, a type of blood disorder, and are also experiencing anaemia. This means they have a low number of red blood cells, which can make them feel tired and unwell, and often require blood transfusions. The main goals of this study are to: understand how safe the new drug is, find the right dose for patients, see how it moves through the body, and check if it helps improve anaemia. The study is divided into two parts: a 'dose-finding' stage to figure out the best amount of medication, and an 'expansion' stage where more people will receive that chosen dose.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

Incyte Corporation

Enrolment target

Start

19 Mar 2021

Estimated completion

26 Nov 2027

Anemia Post-essential Thrombocythemia Myelofibrosis Post-polycythemia Vera Myelofibrosis

What is this study about?

This study is about exploring a new treatment called INCB000928 for people living with myelofibrosis. Myelofibrosis is a condition where scar tissue builds up in the bone marrow, making it hard for the body to produce enough healthy blood cells. A common and challenging problem for people with myelofibrosis is anaemia, which means they don't have enough red blood cells. This can lead to symptoms like extreme tiredness, shortness of breath, and a need for regular blood transfusions.

The research is designed to see if INCB000928 can help improve anaemia in people with myelofibrosis. It will be given either on its own or alongside another medication, ruxolitinib, which is already used to treat myelofibrosis. The study is important because it aims to find new ways to manage anaemia caused by myelofibrosis, which can significantly affect a person's quality of life.

By taking part, individuals could contribute to understanding whether INCB000928 is a safe and effective treatment. This type of research is crucial for developing better options for patients in the future who struggle with the impacts of anaemia related to myelofibrosis.

Key takeaways

This study tests a new drug, INCB000928, for myelofibrosis patients with anaemia.
It aims to make anaemia better and reduce the need for blood transfusions.
The drug will be given alone or with an existing treatment, ruxolitinib.
Researchers will check for safety, the best dose, and how well it works.
This is an early-stage study (Phase 1/2) to gather initial information.
You can discuss with your doctor if this study might be suitable for you.

Who may be eligible?

To be considered for this study, you would need to have myelofibrosis and also be experiencing anaemia. This means your haemoglobin levels (a measure of red blood cells) must be low on several tests, or you're needing regular blood transfusions. You would also need to be able to carry out your daily activities without too much difficulty, and your doctors would expect you to live for more than six months.

There are a few different groups within the study. Some participants will have already been treated with a medication for myelofibrosis called a "JAK inhibitor" (like ruxolitinib) for at least 12 weeks. Another group will be taking a steady dose of ruxolitinib already. A third group will be new to JAK inhibitor treatments and would normally be starting ruxolitinib.

However, some things would mean you can't join the study. For example, if you've already had a stem cell transplant, or if you're being considered for one, you wouldn't be eligible. Also, you must agree to prevent pregnancy or fathering children during the study.

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.

Do I have myelofibrosis and also suffer from anaemia?
Have I had low red blood cell counts on several recent tests, or do I need regular blood transfusions?
Am I generally well enough to go about my daily activities?
Have I previously been treated with a JAK inhibitor (like ruxolitinib)? (There are different groups for different treatment histories).
Am I willing to use contraception to prevent pregnancy or fathering children during the study?
Have I *not* had a stem cell transplant or am I not planning to have one?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive the study medication, INCB000928, either by itself or along with ruxolitinib. The study doctors will carefully monitor your health and response to the treatment. This will involve regular visits to the clinic for check-ups, blood tests, and other assessments to see how you are doing and track any changes. The first part of the study will involve finding the right dose, then more people will take part in an expanded stage once the dose is set. The exact duration of your participation will be discussed with you by the study team, but it will involve ongoing follow-up to ensure your safety and monitor the drug's effects.

Potential risks and benefits

Participating in any clinical trial comes with potential benefits and risks. You might benefit from a new treatment that could improve your anaemia symptoms or overall condition before it's widely available. However, new treatments can also have side effects, and it's possible that INCB000928 may not work for you, or it could cause unexpected reactions. The study team will explain all known potential risks and side effects to you in detail. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (34)

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

City of Hope National Medical Center
Verified postcode
Duarte, United States
City of Hope Orange County
Verified postcode
Irvine, United States
Usc Norris Comprehensive Cancer Center
Verified postcode
Los Angeles, United States
Stanford Cancer Center
Verified postcode
Palo Alto, United States
Prebys Cancer Center
Verified postcode
San Diego, United States
Emory University - Winship Cancer Institute
Verified postcode
Atlanta, United States
Emory University-Winship Cancer Institute
Verified postcode
Atlanta, United States
Start Midwest
Verified postcode
Grand Rapids, United States
Washington University School of Medicine
Verified postcode
St Louis, United States
Weill Cornell Medical Centers
Verified postcode
New York, United States
Duke University Medical Center, Department of Hematologic Malignancies and Cellular Therapy
Verified postcode
Durham, United States
Vanderbilt University Medical Center
Verified postcode
Nashville, United States

Common questions

What is myelofibrosis?

Myelofibrosis is a condition where your bone marrow, which makes blood cells, becomes scarred. This can lead to your body not making enough healthy red blood cells, causing anaemia.

What is anaemia?

Anaemia means you have a lower than normal number of red blood cells. These cells carry oxygen around your body, so if you don't have enough, you might feel very tired, weak, and short of breath.

What does 'dose-finding' mean?

In the early stages of a study, 'dose-finding' means researchers are trying out different amounts of the drug to figure out which dose is safest and most effective for patients.

Will I get the new drug or the existing one?

You will receive the new drug, INCB000928, either on its own or in combination with ruxolitinib, depending on which group you fit into based on your medical history and the study design.

What is a 'JAK inhibitor'?

JAK inhibitors are a type of medication that target specific pathways in the body and are used to treat certain conditions, including myelofibrosis.