
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This is a trial to learn more about a drug called INC424 for myelofibrosis.
Myelofibrosis (pronounced my-eh-lo-fy-bro-sis) is a rare blood disorder that causes scarring of the . A small number of people with myelofibrosis go on to develop acute myeloid leukaemia.
Myelofibrosis can develop without having had any other condition. This is called primary myelofibrosis (PMF) or chronic idiopathic myelofibrosis. It can also develop in people who have polycythaemia vera or thrombocythaemia. This is called secondary myelofibrosis. This trial is for people with either primary or secondary myelofibrosis.
We know from earlier trials that a type of biological therapy called INC424 can help people with myelofibrosis. But researchers want to learn more about how well it works and how it affects peoples’ .
The aims of the trial are to
You may be able to enter this trial if you
You cannot enter this trial if you
This phase 2 trial will recruit about 33 people in the UK. Everybody taking part will have INC424 tablets.
The researchers are looking at 2 different doses of INC424. The dose you have will depend on your platelet count. During the trial, the doctors may increase or reduce your dose, depending on how well the treatment is working and whether you have side effects.
You take INC424 tablets every day. The trial team will explain more about how and when to take your tablets. As long as you don’t have bad side effects, you can carry on taking them for as long as they help you, or until the last person joining the study has had nearly a year of treatment, whichever comes first.
The trial team will ask you to fill out a questionnaire before you start treatment and then at each hospital visit during your treatment. The questionnaires will ask about any side effects you have had and about how you have been feeling. This is called a quality of life study.
You will see the trial team and have some tests before you start treatment. The tests include
You go to hospital
Each visit lasts 2 or 3 hours and you must not eat or drink anything (apart from water) for 8 hours beforehand. You have blood tests each time.
After you finish treatment, you go back and see the trial team 4 weeks later.
As INC424 is quite a new drug, there may be side effects we don’t know about yet. The known side effects include
There are some risks associated with stopping INC424 suddenly. These include feeling anxious, difficulty sleeping and weakness. Also, symptoms of myelofibrosis may come back.
If you need to stop taking INC424, the dose will be reduced gradually if possible. The doctors may give you steroids to reduce the withdrawal effects.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Adam Mead
Experimental Cancer Medicine Centre (ECMC)
Novartis
Freephone 0808 800 4040
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”