A trial of olaparib for ovarian cancer with a change to a BRCA gene that responded to platinum chemotherapy (SOLO2)

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 ovarian cancer, fallopian tube cancer or primary peritoneal cancer that has a change to a gene called BRCA1 or BCRA2.

More about this trial

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.

Doctors can treat ovarian cancer with surgery and chemotherapy.

Ovarian cancer often responds well to chemotherapy that includes a platinum drug Open a glossary item . But after a while it may start growing again. If this happens you may have more chemotherapy. The cancer may get smaller or completely disappear. But it can start growing again later on. Researchers are looking for new treatments to help stop ovarian cancer coming back after you’ve had chemotherapy twice. In this trial, they are looking a drug called olaparib.

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 women taking part in this trial have had chemotherapy at least twice and their cancer responded well each time. The aim of the study is to see if taking olaparib helps women in this situation, and whether it delays the cancer coming back again.

Who can enter

You may be able to enter this trial if

You have ovarian cancer, fallopian tube cancer or primary peritoneal cancer that is high grade
You have a change to a gene called BRCA1 or BRCA2. If it is not 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
Your cancer is serous or endometrioid type (your doctor can tell you this)
You’ve had chemotherapy at least twice and both times it included a platinum drug
Your cancer came back after the first platinum chemotherapy you had, but not for at least 6 months
Your cancer also responded well to the most recent chemotherapy you had and either got smaller or has completely disappeared
You finished your most recent chemotherapy in the last 8 weeks
You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
You have satisfactory blood test results
You are at least 18 years old
You 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 primary cancer that was taken when you had surgery or a biopsy Open a glossary item . If there isn’t a sample available, you won’t be able to take part.

You cannot enter this trial if you

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 in the last 3 weeks (this may be longer depending on the drugs you had and the trial team can advise you about this)
Have had radiotherapy in the last 3 weeks (apart from radiotherapy to relieve symptoms)
Had a drug called bevacizumab during your most recent chemotherapy (you may have had it with earlier chemotherapy)
Have a build up of fluid in your abdomen (ascites) that you had drained during your last 2 cycles of chemotherapy
Still have side effects from chemotherapy unless they are only mild (apart from hair loss)
Have already had olaparib or a similar drug
Had an experimental drug during your last chemotherapy
Have blood test results that show that you have a higher than normal level of a marker called CA125 and that the level is rising
Have myelodysplastic syndrome or acute myeloid leukaemia
Have had any other cancer in the last 5 years apart from early stage, low grade womb cancer, a very early form of breast cancer called DCIS, carcinoma in situ of the cervix or non melanoma skin cancer that was successfully treated
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
Take other medication that can affect body substances called CYP enzymes
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
Are known to be HIV positive
Have hepatitis B or helpatitis 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 260 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, you can take the tablets for as long as they appear to be helping you.

The trial team will ask you to fill out a questionnaire before you start treatment, each time you see the trial team 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 the first 4 weeks of treatment
Then every 4 weeks up to 18 months
Then every 3 months until you stop the trial treatment

You have a CT or MRI scan every 3 months for 18 months, then every 6 months after that for as long as you continue having the trial treatment.

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.