A study looking at a drug called INCB057643 for cancers affecting the bone marrow

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:

• myelofibrosis
• myelodysplastic/myeloproliferative overlap syndrome
• myelodysplastic syndrome
• essential thrombocythaemia

And all of the following apply.

• You had at least 1 course of treatment for your condition.
• Your cancer continued to grow, came back, you couldn’t continue with treatment due to bad side effects or there isn't any other available treatment that might help.
• 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.
• 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 tests and 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

Cancer related
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. You might be able to join part 1 of the study if you have had this type of drug. Your doctor will know more about 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
• have 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 cancer of the cervix and some others. Your doctor will know about this. 

Medical conditions
You cannot join this study if any of these apply. You:

• have problems with your digestive system such 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 heart problem .
• 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

Other
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