A trial looking at using BN83495 to treat advanced womb (endometrial) cancer

Who can enter

You can enter this trial if you

• Have advanced womb cancer or womb cancer that has come back after treatment (recurred)
• Have womb cancer that has tested positive for hormone receptors
• Have at least 1 area of cancer that can be measured on a scan
• Have stopped having periods – are post menopausal
• Can look after yourself and are up and about for at least half the day – performance status 0, 1 or 2
• Have satisfactory blood test results
• Have recovered from any other treatment you had for your cancer before
• Are able to take tablets
• Are at least 18 years old

You cannot enter this trial if you

• Have womb cancer that has spread to your spinal cord or brain (central nervous system)
• Are able to have surgery or radiotherapy
• Have had hormone therapy or biological therapy to treat your womb cancer before
• Have had chemotherapy in the last 6 months
• Have had another cancer in the last 5 years– you may join if you had basal cell skin cancer that has been treated or carcinoma in situ of the cervix
• Have blood pressure that cannot be controlled with medication
• Have a blood clot in a vein or artery
• Have had any drug as part of a clinical trial in the past 4 weeks
• Have a heart problem that causes concern
• Are on medication that could affect you taking part in this trial
• Have a medical condition that could affect you taking part in this trial

Trial design

This is a phase 2 trial. It is an international trail that will recruit about 80 women from different countries around the world. It is a randomised trial. The women taking part are put into 1 of 2 groups by a computer. Neither you nor your doctor can choose which group you are in.

If you are in group 1 you will have BN83495.

If you are in group 2, you will have megestrol.

Both BN83495 and megestrol are tablets. You take a tablet every morning 30 minutes before eating breakfast.

You will have a diary to write down when you took your tablet. You bring this in when you see your doctor.

You can continue with treatment as long as your doctor thinks it is helping you.

You will be asked to fill in a questionnaire before starting treatment and during treatment. This will ask about any symptoms you have and how you feel. It is called a quality of life study.

If you take part in this trial, the researchers will ask your permission to take a small piece of tissue from when you had your surgery. They will also ask permission to take some extra blood samples.

Studying these samples may help researchers learn more about cancer of the womb and how BN83495 works in the body.

If you don’t wish to give permission for these samples, you don’t have to. You can still take part in the trial.

Hospital visits

You will see the doctor and have some tests before taking part in this trial. These tests include

• A physical examination
• Blood tests
• A urine test
• A CT scan or MRI scan
• A heart trace – ECG

You see the doctor 2, 4 and 8 weeks after starting treatment and then every 8 weeks. You will have the following tests

• A physical examination
• Blood tests
• A urine test
• A heart trace
• CT scan or MRI scan – every 8 weeks

You see the doctor 4 weeks after finishing treatment for a physical examination.

Side effects

The most common side effects of BN83495 are

• Dry skin
• Tiredness
• Feeling, or being, sick
• Hot flushes
• Headaches
• Blurred vision
• Loss of taste
• Bone and joint pain
• Protein in the urine
• Infection

The most common side effects of megestrol are

• Weight gain
• Inflammation of a vein related to a blood clot
• Feeling, or being, sick
• Swelling due to retention of fluid
• Shortness of breath
• Hair loss
• High blood pressure
• Rash
• Hot flushes
• Tiredness

You can find more information about megestrol on CancerHelp UK.