"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
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.
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 often responds well to chemotherapy that includes a
Olaparib is a type of biological therapy called a PARP-1 inhibitor. This means it blocks an
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
- 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
menopauseor 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
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
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 (
There will be twice as many women in the group taking olaparib as in the group taking the dummy drug.
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.
You see the trial team and have some tests before you start the trial treatment. The tests include
The trial team will ask if you would be willing to have another
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.
All medicines have side effects. As olaparib is new drug, we are still learning about the side effects through
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Jonathan Ledermann
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer