The SOLO3 study is a Phase 3 clinical trial looking at whether giving olaparib — a type of investigational medication known as a PARP inhibitor — to women with relapsed or recurrent cancer of the ovaries, peritoneum (the lining of the inside of the abdomen), or fallopian tubes can help stop the cancer from getting worse, and help them live longer. ‘Relapsed’ or ‘recurrent’ means the cancer has previously been diagnosed and treated but now it has come back.
All women in the SOLO3 study must have received at least two prior courses of platinum-based chemotherapy (platinum agents are carboplatin, cisplatin, and oxalaplatin), and must be platinum-sensitive or partially platinum-sensitive. This means that their tumors must have shrunk, or disappeared, after treatment with platinum-based chemotherapy, and they must not have grown for at least six months after treatment. This applies to their last course of platinum-based chemotherapy received. They must also carry an inherited mutation in their BRCA genes.
To understand whether olaparib helps women with ovarian cancer, it needs to be compared to another treatment. In the SOLO3 study, olaparib will be tested against a single non-platinum-based chemotherapy treatment chosen by a doctor who is involved in the study. In the SOLO3 study, women will be twice as likely to receive olaparib as chemotherapy, because for every three women who take part in the trial, two will receive olaparib and one will receive chemotherapy.
To join the SOLO3 study, a woman must:
- Have relapsed or recurrent cancer of the ovaries, peritoneum, or fallopian tubes
- Have certain inherited changes (mutations) in their BRCA genes. Women who do not know their BRCA status must be tested before starting study medication to make sure they have BRCA-mutated ovarian cancer. Your doctor will arrange this test for you when assessing whether you can take part in the trial. If you do not have the BRCA mutation, you will not be able to participate in the study
- Have received at least two prior courses of platinum-based chemotherapy (eg carboplatin, cisplatin, and oxalaplatin) and have completed the last course of platinum-based chemotherapy at least six months prior to starting the SOLO3 study
- Have a tumor that is sensitive or partially sensitive to platinum-based chemotherapy. This means that the tumor must have shrunk, or disappeared, following platinum-based chemotherapy and must not have grown again for at least six months after that course of chemotherapy has finished. This applies to the last course of platinum-based chemotherapy received
- Be willing and able to participate in the study by taking two tablets twice each day by mouth for those taking olaparib, or by receiving intravenous doses of chemotherapy between every week and every four weeks, depending on the chemotherapy chosen by the doctor (paclitaxel, topotecan, pegylated liposomal doxorubicin, or gemcitabine). Women should not have received the chosen chemotherapy previously as a single therapy
- Be willing and able to attend regular clinic visits for as long as the study continues
- Be willing and able to provide blood samples for the study
For further details, please see Can I take part?
If you would like to volunteer for an ovarian cancer clinical trial, you will need to speak to your doctor to check if you are able to join the study. If you take part in the SOLO3 study, you will need to either take two tablets containing the study medication olaparib twice a day, or receive intravenous chemotherapy between every week and every four weeks, depending on the chemotherapy chosen by the doctor, for as long as your study doctor thinks it is appropriate. You will need to come into the clinic to undergo various health assessments at the start of the study and at regular intervals to see if your ovarian cancer is improving, staying the same, or getting any worse. This includes scans being taken regularly to monitor the disease. Even if you stop taking the study medication, you will be encouraged to stay in the SOLO3 study so that your progress can be followed. Participating in the follow-up program means that your study doctor will be able to continue to monitor your progress and well-being at regular intervals (approximately every three months).
All medicines can have side effects. For olaparib, we are still learning about these side effects through our clinical studies. Your doctor will discuss these with you before you agree to enter the study. Throughout the study, your doctor will ask you how you are feeling when taking the study medication and you will be asked to complete questionnaires about how you are doing.
Although it is hoped that olaparib will help you, this cannot be guaranteed. The trial is designed to help us find out if olaparib can help women with ovarian cancer. Out of every three women who take part in this study, two will receive olaparib and one will receive chemotherapy. Both you and the study doctor will know which treatment you are receiving due to the different administration route and schedule, and different tolerability of each treatment. Scans will be taken regularly to monitor the course of the cancer and to help decide on future courses of treatment. Your participation in this study will help scientists to understand whether or not olaparib can help other women with ovarian cancer in the future.
AstraZeneca plans to recruit approximately 411 patients for the SOLO3 study.
Further information about ovarian cancer research and advice about participating in ovarian cancer clinical trials can be found through the links on the Additional information page.