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

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