A trial of olaparib and cediranib after platinum chemotherapy for ovarian cancer that has come back (ICON9)

The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.

Who can take part
You may be able join this trial if all of the following apply:

• you have a type of ovarian cancer, fallopian tube cancer or peritoneal cancer that is high grade serous or endometroid – this means the cancer is more likely to come back
• your ovarian cancer got worse more than 6 months after the start of the final cycle of chemotherapy that included a platinum drug
• a CT or MRI scan shows the cancer has come back or you had surgery to remove the cancer after it came back or blood tests using tumour markers show the cancer has come back
• you need further treatment with chemotherapy that will include a platinum drug such as cisplatin or carboplatin (this will be your second course of chemotherapy)
• there is a sample of your cancer available from a previous surgery or a biopsy for the trial team to test
• you can swallow and absorb tablets
• your thyroid is working well
• you have blood pressure that is well controlled with no more than 2 different types of blood pressure medication
• are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
• are at least 18 years old

After your second course of chemotherapy, the following must also apply:

• you had between 4 and 6 cycles of second course of chemotherapy that included a platinum drug
• you had a recent scan that showed your cancer had shrunk
• if it wasn’t possible to measure the cancer on a scan then you had a blood test for tumour markers that showed the chemotherapy worked or if you had surgery after the cancer came back the first time, there are no signs of it on a scan or using other ways your doctor might monitor your cancer
• you can start treatment within 7 days of being put into a treatment group and this is within 4 to 8 weeks of starting the final cycle of chemotherapy
• you have satisfactory blood test results
• you don’t have a high level of protein in your urine
• you have had a test for the BRCA 1 and BRCA 2 gene change and you and the trial team know the results

Who can’t take part
You cannot join this trial if any of these apply.

Cancer related
You:

• have a type of ovarian cancer called clear cell, mucinous, sarcoma or ovarian cancer that is not epithelial
• have cancer that has spread to your brain or the tissues surrounding your brain and is causing symptoms unless you are on a stable dose of steroids that you started at least 4 weeks before joining the trial
• have spinal cord compression
• have had a bone marrow transplant from somebody else (an allogenic transplant) or a transplant using blood from an umbilical cord
• have myelodysplastic syndrome or acute myeloid leukaemia
• have had another cancer in the last 5 years apart from carcinoma insitu of the cervix, early breast cancer or early cancer of the womb lining that was successfully treated
• are having or have had another experimental drug as part of a clinical trial within 28 days of joining this trial

Medical conditions
You:

• have had a heart attack, a stroke or a mini stroke (TIA) in the last 12 months
• have had a blockage of your bowel within 3 months of starting trial treatment
• have had an area of pus (an abscess) in your tummy area (abdomen) within 3 months of starting trial treatment
• have had tears or holes (perforations) in your stomach or bowel – you might be able to take part if you had an abnormal opening (fistula) in your abdominal area and you had surgery to repair it at least 6 months ago and it is unlikely to come back
• have inflammatory bowel disease such as Chron’s or ulcerative colitis
• have an ileostomy
• have problems with your heart, such as a heart attack or angina that is not controlled with medication in the last 6 months, an abnormal rhythm of your heart or congestive heart failure
• have a heart condition called QTc prolongation or a family history of QT syndrome
• have a bleeding problem that means you are more likely to have a bleed, you have had a large bleed in the last 3 months or you have coughed up more than a teaspoon of blood in the last 4 weeks
• have already had a targeted cancer drug called a tyrosine kinase inhibitor such as axitinib or a PARP inhibitor such as niraparib
• have ongoing moderate to severe side effects from past treatments apart from hair loss or tingling and numbness in your hands or feet
• have had surgery in the 14 days before starting treatment
• have an active hepatitis B or hepatitis C infection
• have HIV
• have any other medical condition or mental health problem that the trial team think could affect you taking part

Other
You:

• are pregnant or breastfeeding
• are allergic to cediranib or olaparib or anything they contain
• have taken drugs that affect enzymes called CYP3A in the last 2 to 5 weeks