A Study to Evaluate the Safety, Tolerability of INCB160058 in Participants With Myeloproliferative Neoplasms
This research study is investigating a new medicine, INCB160058, for individuals diagnosed with specific blood disorders known as Myeloproliferative Neoplasms (MPN). These conditions, such as Myelofibrosis (MF), Polycythemia Vera (PV), and Essential Thrombocythemia (ET), affect how your body makes blood cells. The main goals of this study are to carefully check the safety of INCB160058, understand how well people tolerate the treatment, and learn about how the medicine works in the body. This is an early-stage study (Phase 1), meaning it's one of the first times this medicine is being tested in people. Participants may receive INCB160058 alone or alongside their usual treatments. The findings from this study will help doctors decide if this new medicine could be a promising treatment option in the future.
At a glance
What is this study about?
This study is exploring a new medicine called INCB160058. It's designed for people who have certain types of blood conditions known as Myeloproliferative Neoplasms (MPN). These conditions, like Myelofibrosis (MF), Polycythemia Vera (PV), and Essential Thrombocythemia (ET), cause your body to make too many or not enough certain blood cells, which can lead to various health problems. Our main aim with this study is to carefully check if INCB160058 is safe to use and how well people tolerate it, meaning if it causes uncomfortable side effects and how manageable those might be. We're also interested in understanding how the medicine behaves in the body once it's taken.
This is an early-stage study, known as 'Phase 1'. This means it's one of the first times this particular medicine is being tested in a small group of people. The information we gather will be very important for deciding whether to continue researching INCB160058 as a potential new treatment. Some people in the study might receive only INCB160058, while others might get it along with their usual treatment for their condition.
Ultimately, by conducting this research, we hope to gain a better understanding of INCB160058. If it proves to be safe and well-tolerated, it could potentially offer a new treatment option for people living with Myeloproliferative Neoplasms in the future. We want to find better ways to help manage these conditions and improve people's health and well-being.
Key takeaways
- This study is testing a new medicine (INCB160058) for specific blood disorders (MPN).
- Its main goal is to check safety and how well people tolerate the medicine.
- It's an early-stage ('Phase 1') study to gather initial information.
- Participation might involve hospital visits, blood tests, and bone marrow samples.
- You can withdraw from the study at any time without affecting your care.
Who may be eligible?
To join this study, you must be 18 years old or over. If you have Myelofibrosis (MF), you should generally have a certain level of disease severity and have already been treated with another type of medicine called a JAK inhibitor, but it didn't work well enough, or you couldn't tolerate it. If you have Polycythemia Vera (PV) or Essential Thrombocythemia (ET), you should have been diagnosed with these conditions and have already tried at least one standard treatment that didn't fully control your condition or caused problems. You also need to be expected to live more than six months and be willing to have bone marrow tests if needed.
There are also reasons why you might not be able to join. For example, if you have other types of cancer that need treatment, or if you've had serious bleeding or blood clots recently. If your blood, liver, or kidney test results are very abnormal, or if you've had a stem cell transplant in the past or plan to have one, you wouldn't be able to participate. Having certain serious infections like active hepatitis B or C, or HIV, would also mean you couldn't take part. We also can't include people who have received recent treatment for their MPN condition within a certain timeframe before the study starts. The study team will check all your health details carefully to see if this study is right for you.
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 Myelofibrosis, Polycythemia Vera, or Essential Thrombocythemia?
- Have your previous MPN treatments not worked well enough or caused problems?
- Are you willing to have bone marrow tests if required?
- Do you have a general good health otherwise, and no other active serious illnesses?
- Have you not had a serious bleeding or clotting issue in the last 3 months?
What does participation involve?
If you decide to take part in this study, you would begin by having several medical checks to make sure the study is suitable for you. This would involve physical exams, blood tests, and possibly bone marrow biopsies (where a small sample of your bone marrow is taken for examination). You'd then receive the study medicine, INCB160058, potentially alongside your current standard treatment. You would have regular appointments at the clinic for further blood tests, health checks, and to discuss any side effects you might be experiencing. These visits are important for monitoring your progress and ensuring your safety. The total length of your participation would be discussed with you by the study team, but typically, these early-stage studies last several months, with continued follow-up after stopping the medicine.
Potential risks and benefits
Locations (30)
- The University of Alabama At BirminghamVerified postcodeBirmingham, United States· Recruiting
- Stanford UniversityVerified postcodePalo Alto, United States· Recruiting
- Moffitt Cancer CenterVerified postcodeTampa, United States· Recruiting
- Northwestern UniversityVerified postcodeChicago, United States· Recruiting
- The University of Kansas Cancer Center Kucc University of Kansas Clinical Research CenterVerified postcodeFairway, United States· Recruiting
- University of MichiganVerified postcodeAnn Arbor, United States· Recruiting
- Cornell Medical CenterVerified postcodeNew York, United States· Recruiting
- Icahn School of Medicine At Mount SinaiVerified postcodeNew York, United States· Recruiting
- Sloan Kettering Institute For Cancer ResearchVerified postcodeNew York, United States· Recruiting
- Oregon Health & Science UniversityVerified postcodePortland, United States· Recruiting
- University of Pennsylvania Health SystemVerified postcodePhiladelphia, United States· Recruiting
- Vanderbilt-Ingram Cancer CenterVerified postcodeNashville, United States· Recruiting
Common questions
What kind of blood conditions is this study for?
This study is for people with specific blood disorders called Myeloproliferative Neoplasms, including Myelofibrosis (MF), Polycythemia Vera (PV), and Essential Thrombocythemia (ET).
What is INCB160058?
INCB160058 is a new medicine being studied to see how safe it is and how it affects people with Myeloproliferative Neoplasms.
Is this medicine available to everyone?
No, INCB160058 is an investigational medicine, meaning it's still being tested in clinical trials and is not yet available for general use.
What does 'Phase 1' mean for a study?
Phase 1 means this is an early-stage study, usually among the first times a new medicine is tested in people, primarily to check its safety and how it's tolerated.
Can I stop participating in the study if I change my mind?
Yes, you can choose to leave the study at any time, for any reason, and it will not affect your ongoing medical care.
How to find out more
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Always speak to your GP or specialist before deciding to take part in a study.
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