
"I am glad that taking part in a trial might help others on their own cancer journey.”
This study is looking at a new drug called INCB057643 to treat cancers that affect how well the bone marrow works.
It is open to people who have:
INCB057643 is a called a cancer growth inhibitor. It works by blocking a protein called BET. Blocking BET could stop the cancer cells growing.
To find out if INCB057643 can help fight these cancers researchers need to do a large . Before doing this they need to find out what is the best dose for people to take. The best dose is one that helps the most and has the fewest side effects.
There are 2 parts to this study. In the 2nd part some people with myelofibrosis take INCB057643 with ruxolitinib.
The aims of this study are to find:
The following bullet points are a summary of the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.
Who can take part
You may be able to join this study if you have one of the following:
And all of the following apply.
Who can’t take part
Cancer related
You cannot join this study if any of these apply. You:
Medical conditions
You cannot join this study if any of these apply. You:
Other
You cannot join this study if any of these apply. You are:
This is a phase 1 study. The team need about 39 people to take part. There are 2 parts to the study.
In part 1 the team want to find the best dose of INCB057643. This is one that helps the most and has the fewest side effects.
The first people in this part take a small dose of INCB057643. If that goes well then the next people take a higher dose. And so on until the team find the best dose of INCB057643.
For people with myelofibrosis 8 days after starting treatment you go in to the clinic. You take your tablets when you are in the clinic. You must not eat or drink (fast) before you come in to the clinic. This is for a blood test that the team take before you have your tablets.
Part 2 is for people with myelofibrosis only. There are 2 groups. Your doctor will tell you which group you are in.
People in group A have INCB057643 by itself.
People in group B have INCB056743 with ruxolitinib. You continue taking ruxolitinib as you did before taking part in the study.
For people in group B 8 days after starting treatment you go in to the clinic. You take your INCB056743 tablets and ruxolitinib when you are in the clinic. You must not eat or drink (fast) before you come in to the clinic. This is for a blood test that the team take before you have your tablets.
INCB056743 is a tablet. You take it in the morning. You can take it with or without food. Your doctor will tell you how many to take.
You continue treatment for as long as it is helping. And the side effects aren’t too bad.
Quality of life
This is only for people who have myelofibrosis. You fill in a few questionnaires a number of times during the study. The questions ask about:
These are quality of life questionnaires.
Samples for research
You give and blood samples. The team use these to find out:
You see the doctor to have tests before taking part. These tests include:
You see the doctor regularly while having treatment for blood tests and to see how you are.
You have a bone marrow test every 24 weeks and a scan every 12 weeks.
You see the doctor at the end of treatment and then about a month after.
The study team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.
INCB057643 is a new drug and there might be side effects we don’t know about yet. The most common side effects we do know are:
We have information on ruxolitinib and its side effects.
Your doctor will talk to you about the possible side effects of the treatments before you agree to take part.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Emma Searle
Incyte Corporation
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
"I am glad that taking part in a trial might help others on their own cancer journey.”