RecruitingPHASE1INTERVENTIONAL

A Study to Evaluate INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms

This study is investigating a new medication called INCA033989. It is being tested either on its own or in combination with an existing drug called ruxolitinib. The patients taking part have certain blood cancers known as myeloproliferative neoplasms. The main goals of this early-stage study are to understand how safe the new drug is, what side effects it might cause, and to find the highest dose that can be given without causing serious problems. This will help researchers decide on the best dose to use in future, larger studies. It's a way of carefully exploring a new treatment to see if it could help people with these conditions, while prioritising patient safety.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Incyte Corporation

Enrolment target

225

Start

25 Sep 2023

Estimated completion

29 Feb 2028

Myeloproliferative Neoplasms

What is this study about?

This research study is focused on a group of blood cancers called myeloproliferative neoplasms. These conditions cause the body to make too many blood cells. The study is particularly interested in different types of these conditions, such as Myelofibrosis (MF) and Essential Thrombocythemia (ET).

The main aim is to explore a new drug, INCA033989. Researchers want to see how safe this new drug is when given on its own, and also when it's combined with another medicine already used for these conditions, called ruxolitinib. This is an early-stage study, often called a 'Phase 1' study, which means it’s one of the first times the drug is being tested in people. The focus at this stage is always on understanding safety and figuring out the right dose.

By carefully watching patients for any side effects and how well they tolerate the treatment, the study aims to find the best dose to recommend for further investigation. This helps new treatments move forward safely and responsibly, so that eventually, they might be able to help more people struggling with these blood cancers.

Key takeaways

This study is for people with specific blood cancers called Myeloproliferative Neoplasms.
It's testing a new drug, INCA033989, sometimes with an existing drug, ruxolitinib.
The main goals are to check safety and find the right dose for the new drug.
Participation involves regular hospital visits, blood tests, and possibly bone marrow tests.
You can stop participating at any time without affecting your normal care.

Who may be eligible?

To join this study, you generally need to be at least 18 years old and have a life expectancy of more than six months. You would need to have certain types of myeloproliferative neoplasms, specifically Myelofibrosis (MF) or Essential Thrombocythemia (ET), and have a specific genetic change (CALR exon-9 mutation) confirmed by a local lab. You also need to be willing to have regular bone marrow tests throughout the study.

There are several reasons why someone might not be able to join. For example, if you have other types of blood cancer, or if you've had certain other cancers in the last two years that are still active. People with active infections like Hepatitis B/C or HIV, or those with significant heart problems, would also not be able to take part. If you've had a stem cell transplant or are planning to have one, or if you've had certain bleeding or clotting issues recently, you would also be excluded.

Also, if you've recently used certain medications or treatments for your condition, or if some of your blood test results are outside a healthy range, you might not be suitable for this study. The medical team will check all these details very carefully to make sure the study is safe 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?
Have you been diagnosed with Myelofibrosis (MF) or Essential Thrombocythemia (ET)?
Has a specific genetic change (CALR exon-9 mutation) been found in your blood tests?
Are you able to have regular bone marrow tests?
Have you had no major heart problems or active infections (like Hepatitis or HIV) recently?
Have you not had a recent stem cell transplant or certain major bleeding/clotting issues?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the study drug, INCA033989 (either alone or with ruxolitinib), as prescribed by the study doctors. The exact schedule of your visits and how long you take the medication would depend on the study plan, but it's common to have regular check-ups at the hospital or clinic.

These visits often include physical exams, blood tests, and sometimes other tests like bone marrow biopsies, to carefully monitor your health, how the drug is affecting you, and if your body is responding to the treatment. The study team will explain all the procedures and tests in detail. The total duration of your participation could vary, but the team will discuss this with you before you agree to join.

Potential risks and benefits

As with any medical research, there are potential benefits and risks to consider. A potential benefit of joining this study is that you would have access to a new treatment, INCA033989, which is not yet widely available. This new drug might help improve your condition, though this is not guaranteed, especially in an early-stage study. Potential risks include experiencing side effects from the study medication, which the doctors will monitor very closely. These side effects can range from mild to serious, and the research team will explain what is known about them. It's very important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (29)

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

Royal Brisbane and Women'S Hospital
Verified postcode
Herston, Australia· Recruiting
Royal Adelaide Hospital
Verified postcode
Adelaide, Australia· Recruiting
Peter Maccallum Cancer Centre
Verified postcode
Melbourne, Australia· Recruiting
The Alfred Hospital
Verified postcode
Melbourne, Australia· Recruiting
Princess Margaret Cancer Center
Verified postcode
Toronto, Canada· Recruiting
Hopital Maisonneuve-Rosemont, Montreal, Qc
Verified postcode
Montreal, Canada· Recruiting
Odense University Hospital
Verified postcode
Odense C, Denmark· Withdrawn
Sjaellands Universitetshospital
Verified postcode
Roskilde, Denmark· Recruiting
Vejle Hospital
Verified postcode
Vejle, Denmark· Recruiting
Institut Bergonie
Verified postcode
Bordeaux, France· Recruiting
Chu Nimes
Verified postcode
Nîmes, France· Recruiting
Hospital Saint Louis
Verified postcode
Paris, France· Recruiting

Common questions

What is a 'Myeloproliferative Neoplasm'?

It's a type of slow-growing blood cancer that causes your body to make too many blood cells, such as red blood cells, white blood cells, or platelets.

What does 'Phase 1' mean for a study?

Phase 1 is an early stage of clinical research where a new drug is tested in a small group of people for the first time. The main goals are to check its safety, find out what side effects it has, and determine a safe dose.

What is INCA033989?

INCA033989 is the name of the new experimental drug being investigated in this study. It is not currently approved for widespread use.

What is ruxolitinib?

Ruxolitinib is an existing medication that is already approved and used to treat certain myeloproliferative neoplasms.

Will I get the new drug or the existing drug?

You might get the new drug INCA033989 on its own, or in combination with ruxolitinib. The study team will explain which treatment arm you would be in.

How to find out more

Incyte Corporation Call Center (US)

medinfo@incyte.com 1.855.463.3463 Official trial record

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