A Study to Evaluate INCA035784 in Participants With Myeloproliferative Neoplasms
This research study is about a new drug called INCA035784, designed for people who have certain types of blood cancers known as myeloproliferative neoplasms (MPNs). These conditions affect how your blood cells are made in your bone marrow. This is a very early-stage study, which means it's one of the first times this drug is being tested in people. The main purpose of the study is to find out if INCA035784 is safe to use and to see what side effects people might experience. Researchers will also be looking at how well people's bodies handle the treatment. This information is crucial for deciding if the drug can be studied further in the future to see if it helps treat MPNs.
At a glance
What is this study about?
This research study is focusing on a new potential treatment, INCA035784, for blood cancers called myeloproliferative neoplasms, or MPNs. MPNs are a group of conditions where the bone marrow, the spongy tissue inside your bones, makes too many blood cells. This can lead to various symptoms and complications depending on the specific type of MPN.
The main aim of this study is to carefully check if INCA035784 is safe for people to take and to understand any side effects it might cause. This is a 'Phase 1' study, which means it's an early step in testing a new medication. Doctors need to understand how the drug behaves in the human body, what dose is best, and how well people tolerate it before they can move on to larger studies to see how effective it is at treating the disease.
By taking part, individuals could help doctors learn more about this new treatment. This knowledge is important for potentially developing new ways to help people living with MPNs in the future. It's important to remember that in early studies like this, the focus is on safety, and it's not known if the treatment will improve your condition.
Key takeaways
- This study is for a new drug called INCA035784 for specific blood cancers (MPNs).
- Its main goal is to check how safe the drug is and if people can tolerate it.
- It's a very early-stage study (Phase 1), so benefits are not guaranteed.
- Participation involves taking the study drug and regular health checks.
- You must meet specific health criteria to be eligible.
- You can stop participating at any time.
Who may be eligible?
To join this study, you must be 18 years or older. You'll need to have a specific type of MPN confirmed by certain medical guidelines, and importantly, have a particular gene change called a CALR exon-9 mutation. Also, your current MPN treatment should either no longer be working well enough, or you might have had difficulty taking other MPN medicines.
There are also some health checks to make sure taking part is safe for you. Your blood counts, like platelets and white blood cells, need to be at a certain level, and your liver and kidney functions will be checked to make sure they are working well enough. You also shouldn't have had a stem cell transplant recently or be planning one soon.
Some things would mean you can't join the study. For example, if you've had major bleeding or blood clots recently, or have certain ongoing infections like hepatitis or HIV that are active. If you've had certain other cancers recently, or if you are pregnant, planning to become pregnant, or aren't willing to use effective birth control, you also wouldn't be able to take part.
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.
- I am 18 years old or older.
- I have been diagnosed with a specific type of MPN, with a CALR exon-9 gene change.
- My current MPN treatment isn't working well enough, or I couldn't take other options.
- I have not had a stem cell transplant recently or planned one soon.
- I am not pregnant or breastfeeding, and I am willing to use effective birth control if needed.
- I haven't had recent major bleeding or blood clots, or certain active infections/other cancers.
What does participation involve?
If you decide to join this study, you will be given the experimental medicine, INCA035784. The study involves regular visits to the clinic where doctors and nurses will monitor your health very closely. They will carry out various checks, such as blood tests, to see how your body is reacting to the treatment and to look for any side effects. You will be closely followed for a period of time both during and after you take the medication. The total length of your participation will depend on the study's design and how you respond to the treatment, or until you and your doctor decide it's no longer right for you.
Potential risks and benefits
Locations (26)
- Mayo Clinic HospitalVerified postcodePhoenix, United States· Not yet recruiting
- Stanford UniversityVerified postcodePalo Alto, United States· Recruiting
- Colorado Blood Cancer InstituteVerified postcodeDenver, United States· Recruiting
- Mayo Clinic-FloridaVerified postcodeJacksonville, United States· Not yet recruiting
- University of Chicago Medical CenterVerified postcodeChicago, United States· Not yet recruiting
- Johns Hopkins UniversityVerified postcodeBaltimore, United States· Not yet recruiting
- Icahn School of Medicine At Mount SinaiVerified postcodeNew York, United States· Recruiting
- University of North Carolina At Chapel HillVerified postcodeChapel Hill, United States· Recruiting
- South Austin Medical CenterVerified postcodeAustin, United States· Recruiting
- University of Texas Southwestern Medical Center Harold C Simmons Comprehensive Cancer Center BloodVerified postcodeDallas, United States· Not yet recruiting
- Huntsman Cancer Institute At University of UtahVerified postcodeSalt Lake City, United States· Recruiting
- Medical College of WisconsinVerified postcodeMilwaukee, United States· Recruiting
Common questions
What is a 'Myeloproliferative Neoplasm' (MPN)?
MPN is a group of blood cancers where your bone marrow makes too many blood cells. This study is for specific types of MPNs.
What does 'Phase 1 study' mean?
A Phase 1 study is an early stage of testing a new drug in people. The main purpose is to check if the drug is safe and to find the right dose, rather than to see if it cures the disease.
What is INCA035784?
INCA035784 is the name of the new medicine being tested in this study. It's an experimental drug, not yet approved for general use.
Will I get better if I join this study?
It's important to understand that in early studies like this, we don't know yet if the treatment will make you better. The main goal is to learn about the drug's safety and side effects.
Can I stop participating in the study if I want to?
Yes, absolutely. You can choose to leave the study at any time, for any reason, and it won't affect your future 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.
Interested in taking part?
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