A trial looking at AZD2281 for advanced solid tumours including breast or ovarian cancer in people with BRCA gene faults

Please note this trial is no longer recruiting patients.

This trial is looking at a new drug called AZD2281 for solid tumours that are no longer responding to other treatments. Most of the people in this trial will have either breast cancer or ovarian cancer and have a BRCA gene fault. A small number of people with other types of cancer who do not have a known BRCA gene fault will also be able to take part.

Every cell contains DNA. This is the genetic information which controls how cells behave. If DNA becomes damaged (as in cancer cells), a protein called PARP-1 helps to repair it. AZD2281, which is also known as olaparib, is a drug that stops PARP-1 from working. It is called a ‘PARP-1 inhibitor’. If PARP-1 doesn’t work, cancer cells can’t repair themselves and they die.

Up until now, researchers have used capsules of AZD2281 in clinical trials. But people had to take a lot of capsules each day to get the full dose. In this trial, the researchers are looking at a new tablet form of the drug. Some people will have the capsules, some people will have fewer, smaller tablets.

The aims of the trial are to

Compare the amount of AZD2281 that is absorbed into the bloodstream when you have it either as capsules or as tablets
See what effect AZD2281 has on advanced cancer
Learn more about the side effects

Recruitment

Start 20/07/2009

End 02/11/2009

Phase

Phase 1

Who can enter

You can enter this trial if you

Have a solid tumour that is advanced and is not responding to standard treatment, or for which there is no standard treatment available (a solid tumour is any cancer apart from leukaemia or lymphoma)
Are well enough to take part in the trial (performance status of 0, 1 or 2)
Have satisfactory blood test results
Are willing to use reliable contraception during the trial and for 3 months afterwards if there is any chance you or your partner could become pregnant

You cannot enter this trial if you

Have cancer that has spread to your brain and is causing symptoms
Have had chemotherapy or radiotherapy in the last 4 weeks - you can take part if you have had radiotherapy to relieve symptoms (palliative radiotherapy)
Have started taking drugs called bisphosphonates or steroids in the last 4 weeks, or have had your dose of either of these drugs increased in the last month
Have had major surgery in the last 4 weeks
Have already taken part in this trial
Have had any other experimental drug in the last 2 weeks
Have had a heart attack in the last 3 months
Have another serious medical condition that cannot be controlled with medication
Cannot take or absorb tablets for any reason
Are known to be sensitive to AZD2281 or any of its ingredients
Have fits (seizures) or take medication to prevent them
Are known to be HIV, hepatitis B or hepatitis C positive
Are pregnant or breastfeeding

Trial design

The trial will recruit 20 people who have breast or ovarian cancer with a BRCA gene mutation (group1). And 6 people who have any type of solid tumour (group 2).

The people in group 1 will be put into different treatment groups by a computer. This is called randomisation. Neither you nor your doctor can decide which treatment you have.

Half the people will have AZD2281 tablets twice a day. The other half will have AZD2281 capsules twice a day. Everybody will have a physical examination every 4 weeks. People in group 1 can carry on taking the tablets or capsules for as long as they help, even after the trial has finished.

For the 6 people in group 2, the treatment is slightly different. Half the people will take AZD2281 capsules for one week, followed by tablets for a second week. The other half will have the tablets in the first week, followed by capsules in the second week. This part of the trial is also randomised so neither you, nor your doctor can decide which way round you have the treatment.

After the first 2 weeks, people in group 2 can continue to take AZD2281 tablets for as long as the treatment helps them, even after the trial has finished.

You cannot eat or drink anything for 2 hours before and 2 hours after you take the AZD2281 capsules or tablets. You have to swallow them whole with a small glass of water.

Hospital visits

You will see the trial doctors and have some tests before you start treatment. The tests include

Physical examination
Blood tests
Urine tests
Heart trace (ECG)
CT scan or MRI scan (people in group 1)

If you are in group 1, you go to hospital to have blood tests once a week for the first 3 weeks. And you have a hospital visit the day after you finish 4 weeks of treatment. During this visit, you have a number of blood tests throughout the day. This takes up to 12 hours and you may have to stay in hospital overnight.

If you are in group 2, you spend one day at hospital in each of the first 2 weeks. You have a number of blood tests throughout the day. This takes up to 12 hours and you may have to stay in hospital overnight.

For the next 5 months, people in both groups go to hospital every 4 weeks to see the trial doctors. At each visit you have blood tests, urine tests and an ECG. People in group 1 will have a scan every 2 months.

After 6 months, if you are still taking AZD2281, you have a hospital visit every 2 months. And people in group 1 will continue to have scans every 2 months.

Everybody taking part in the trial will go back to see the trial doctors a month after finishing AZD2281.

Side effects

AZD2281 is a new drug and there may be some side effects we don’t know about yet. In trials so far, side effects have included

A drop in the number of blood cells causing an increased risk of infection, tiredness, shortness of breath, bleeding or bruising problems
Sickness
Tiredness (fatigue)