A trial of olaparib after chemotherapy for advanced ovarian cancer with a change to a BRCA gene (SOLO1)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Ovarian cancer

Status:

Closed

Phase:

Phase 3

This trial is looking at a drug called olaparib for women who have ovarian cancer, fallopian tube cancer or primary peritoneal cancer with a change to a gene called BRCA1 or BCRA2.

Ovarian cancer, fallopian tube cancer and primary peritoneal cancer are all treated in the same way, so when we use the term ovarian cancer in this summary, we are referring to all 3.

If ovarian cancer has grown outside the area between your hips (your pelvis), or spread to another part of your body when it is diagnosed, it isn’t possible to remove it completely with surgery. You may have surgery to remove as much of the cancer as possible, but doctors would usually recommend that you also have chemotherapy.

The women taking part in this trial have already had chemotherapy and their cancer responded to the treatment. In this situation, you wouldn’t usually have any other treatment unless your cancer comes back or starts to grow again. But researchers want to see if taking a drug called olaparib after chemotherapy helps stop the cancer coming back as quickly.

Olaparib is a type of biological therapy called a PARP-1 inhibitor. This means it blocks an enzyme Open a glossary item called PARP-1, which helps damaged cells to repair themselves.

The cells in your cancer already have problems repairing cell damage, because of the BRCA gene fault. Doctors hope that if they can also stop PARP-1 working, the cancer cells will not be able to repair themselves and will die.

The aim of the study is to see if taking olaparib after chemotherapy helps women with ovarian cancer, and delays the cancer coming back or starting to grow again.

Who can enter

You may be able to enter this trial if you

Have been diagnosed with ovarian cancer, fallopian tube cancer or primary peritoneal cancer that has grown outside the area surrounded by your hip bones (your pelvis ), or has spread to another part of your body (stage 3 or 4)
Have cancer that is serous or endometrioid type and is high grade
Have a change to a gene called BRCA1 or BRCA2. If it isn't known whether you have a change to either of these genes, you can have a test to check this as part of the trial screening process
Have finished chemotherapy that included a platinum drug in the last 8 weeks and your cancer got smaller or disappeared as a result of this treatment
Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
Have satisfactory blood test results
Are at least 18 years old
Have been through the menopause or would not be able to become pregnant because you’ve had surgery to remove your ovaries or your womb. Or you are willing to use at least 2 forms of reliable contraception during the trial and for 3 months afterwards if you are sexually active and there is any chance you could become pregnant

To be able to take part in this trial, the researchers need a sample of your cancer that was taken when you had surgery or a biopsy. If there isn’t a sample available, you won’t be able to take part.

As well as the above, if your cancer is stage 3, you must have had surgery to try to remove as much of the cancer as possible. This is called debulking. If your cancer is stage 4, you must have had either a biopsy or debulking surgery.

You cannot enter this trial if you

Have cancer that stayed the same size or got worse during chemotherapy
Have had surgery to remove as much of your cancer as possible (debulking) more than once
Have cancer that has spread to your brain and is causing symptoms. If you take steroids for cancer spread to the brain, you must have been taking a stable dose for at least 4 weeks
Have cancer that is pressing on your spine (spinal cord compression) unless this was successfully treated and has not got any worse for at least 4 weeks
Have had major surgery in the last 2 weeks, or haven’t recovered from earlier surgery
Have had chemotherapy or radiotherapy in the last 3 weeks (apart from radiotherapy to relieve symptoms)
Have been diagnosed and had treatment for an earlier stage of ovarian cancer, fallopian tube cancer of primary peritoneal cancer in the past
Have had chemotherapy for any other cancer in your pelvis, or in the area below the lungs and above the hip bones (your abdomen )
Have myelodysplastic syndrome or acute myeloid leukaemia
Have cancer of the womb (endometrial cancer). There are some exceptions to this that trial team can advise you about
Have had any other cancer in the last 5 years apart from early stage, low grade womb cancer, carcinoma in situ of the cervix or non melanoma skin cancer that was successfully treated. If you have had early breast cancer, you may be able to take part as long as you finished treatment at least 3 years ago and remain free of breast cancer
Still have side effects from chemotherapy unless they are only mild (apart from hair loss)
Have a build up of fluid in your abdomen (ascites) that you had drained during your last 2 cycles of chemotherapy
Have had a drug called bevacizumab
Have already had olaparib or a similar drug
Had an experimental drug as part of another clinical trial during your chemotherapy treatment
Have blood test results that show you have a higher than normal level of a marker called CA125 and that the level is rising
Have certain heart problems (the trial team can advise you about this)
Have any other medical condition that the trial team think could affect you taking part
Take other medication that can affect body substances called CYP enzymes
Have had a bone marrow transplant using cells from a donor
Have had a whole blood transfusion in the last 3 months
Are unable to swallow or absorb tablets for any reason
Are known to be HIV positive
Have hepatitis B or hepatitis C
Are known to be very sensitive to olaparib or anything it contains
Are pregnant or breastfeeding

Trial design

This phase 3 trial will recruit more than 300 women in a number of different countries. It is a randomised trial. The women taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. And neither of you will know which group you are in. This is called a double blind trial.

Women in one group take olaparib tablets twice every day. Women in the other group take dummy tablets (placebos Open a glossary item ).

There will be twice as many women in the group taking olaparib as in the group taking the dummy drug.

SOLO trial diagram

As long as you don’t have bad side effects, and the trial tablets appear to be helping, you can carry on taking them for up to 2 years. If your cancer hasn’t got worse, the trial doctor may talk to you about taking the tablets for longer than 2 years. But if your cancer has disappeared completely after 2 years, you will stop the trial treatment.

The trial team will ask you to fill out a questionnaire before you start treatment, every 4 weeks during treatment and after you finish treatment. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.

Hospital visits

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

Physical examination
Blood tests
Urine test
Heart trace (ECG )
CT scan or MRI scan

The trial team will ask if you would be willing to have another biopsy Open a glossary item at this time and a further biopsy if your cancer gets worse. You don’t have to agree to this if you don’t want to. You can still take part in the trial.

You see the trial team once a week for 4 weeks and then every 4 weeks until you stop the trial treatment.

You have a CT or MRI scan every 3 months during treatment for up to 2 years. If you carry on having the trial treatment for longer than 2 years, you then have a scan every 6 months.

When you finish treatment, you see the trial team again about a month later. They will then contact you by phone every 3 months to see how you are.

Also, if you stop the trial treatment for any reason other than your cancer growing, the trial team will ask you to see them and have a scan every 3 months until your cancer does start to get worse.

Side effects

All medicines have side effects. As olaparib is new drug, we are still learning about the side effects through clinical trials Open a glossary item . Your doctor will discuss the possible side effects with you before you agree to enter the trial. And throughout the trial, your doctor will ask how you are feeling.