"I am glad that taking part in a trial might help others on their own cancer journey.”
A study looking at a drug called INCB057643 for cancers affecting the bone marrow
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:
More about this trial
INCB057643 is a
To find out if INCB057643 can help fight these cancers researchers need to do a large
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:
- what is the best dose of INCB057643
- out more about the side effects taken by itself and with ruxolitinib
- out how acceptable it is to take by itself and with ruxolitinib
Who can enter
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:
- myelodysplastic/myeloproliferative overlap syndrome
And all of the following apply.
- You had at least 1
course of treatmentfor your condition.
- Your cancer continued to grow, came back or you couldn’t continue with treatment due to bad side effects.
- If you have myelofibrosis you had a drug that stops the JAK2 gene such as ruxolitinib. Or you have taken ruxolitinib for at least the past 8 weeks and the dose has been the same.
- There is no further treatment available for you.
- You are up and about for at least half the day but might not be able to work (performance status 0, 1 or 2).
- You are willing to have a
bone marrow testsand there is a previous sample of tissue ( biopsy) that the study team can access.
- You have satisfactory blood test results.
- You are willing to use reliable contraception during treatment and for a period of time after if there is any chance you or your partner could become pregnant.
- You are at least 18 years old.
Who can’t take part
You cannot join this study if any of these apply. You:
- are able to have treatment with the aim to cure such as a
stem cell transplant
- are having a targeted drug that stops the BET gene. Your doctor will know if you are taking this.
- had another cancer treatment within a certain time period before starting the study treatment. Your doctor will know how long this is for the different treatments.
- are having another cancer treatment. This is apart from a small dose of steroids.
- had a stem cell transplant from a donor (allogeneic) within 6 months of taking part
- had a stem cell transplant of your own cells (autologous) within 3 months of taking part
graft versus host disease(GvHD)
- are taking medication that damps down your
immune system. This after a stem cell transplant and within 2 weeks of starting study treatment.
- have ongoing side effects from previous treatment. This is unless they are mild, stable and not expected to get any better.
- have another cancer that is getting worse or needs treatment. This is apart from certain ones such as
non melanoma skin cancer, in situ cancerof the cervix and some others. Your doctor will know about this.
You cannot join this study if any of these apply. You:
- have problems with your
digestive systemsuch as bleeding, an ulcer, diarrhoea or inflammation of the bowel. Your doctor will know more about this.
- have had a heart attack, chest pain (angina) or another
- have an infection that needs treatment
- have HIV, hepatitis B or hepatitis C
- are taking certain medications such as ones that thin your blood or affect the CYP enzymes. Your doctor will know which medications these are.
- have not recovered from any major surgery you might have had
- have a disorder that can cause bleeding problems. Or you are at a high risk of bleeding.
- have any other medical condition or mental health problem that your doctor thinks will affect you taking part
You cannot join this study if any of these apply. You are:
- allergic or very sensitive to INCB057643 or any of its ingredients
- pregnant or breastfeeding
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:
- your general health
- what you are able to do
- side effects and symptoms
These are quality of life questionnaires.
Samples for research
- what happens to INCB056743 in the body
- how it affects the body
- about the genes that might control or affect the development of cancer
You see the doctor to have tests before taking part. These tests include:
- blood tests
- urine test
- heart scan (
- heart trace (
- bone marrow test
- CT scan or MRI scan
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:
- feeling or being sick
- tiredness (fatigue)
- loss of appetite and changes to taste
- a drop in blood cells causing shortness of breath and an increased risk of bruising and bleeding
- diarrhoea or constipation
- a high level of sugar in the blood
- difficulty breathing
- not enough fluid in the body (dehydration)
- high temperature (fever)
- acute kidney injury
- dry mouth
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.
How to join a clinical trial
Dr Emma Searle