The POLO clinical trial is a Phase 3 study in metastatic pancreatic cancer. The POLO study will investigate whether giving olaparib — a type of investigational medication known as a poly (ADP-ribose) polymerase (PARP) inhibitor — to people with metastatic cancer of the pancreas can help to control the disease between chemotherapy treatments. Metastatic means the cancer has spread from the part of the body where it began to another part of the body.
Olaparib is being investigated as a metastatic pancreatic cancer ‘maintenance therapy’. A maintenance therapy is a medication that is given to people following their initial treatment to further control the cancer and to try to stop it from growing or returning. All people in the POLO study must have received initial platinum-based chemotherapy, which has improved or stabilized their cancer.
To understand whether olaparib helps people with metastatic pancreatic cancer, it will be tested against a ‘sugar pill’ or dummy medication called a ‘placebo’. A placebo does not contain any active medication. In the POLO study, for every five people who take part in the trial, three will receive olaparib and two will receive placebo. It is important to note that at the time of enrollment onto the POLO study, patients should have reached a point in their chemotherapy where both they and their doctor believe that a break from chemotherapy is appropriate.
To be eligible to join the POLO study, you must:
- Be at least 18 years of age
- Have metastatic adenocarcinoma of the pancreas
- Have specific changes (mutations) in your BRCA genes (deleterious germline BRCA mutations). People who do not know their BRCA status must be tested before starting study treatment to make sure they have germline BRCA mutation-positive pancreatic cancer. Your doctor can 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
- Must be receiving your first course of chemotherapy treatment for metastatic disease with a platinum-containing regimen*, and have received the platinum component for a minimum of 16 weeks. If you are no longer receiving the platinum component, the remaining chemotherapy must be continued until you enroll in the trial. Other drugs can be dropped if your doctor recommends this but no new chemotherapy drugs can be added and your last dose of chemotherapy must have been completed 4-8 weeks before you start treatment with the study drug
*Acceptable platinum agents include carboplatin, cisplatin, and oxaliplatin
- There must be no sign that your disease has worsened at any time while you have been receiving your initial course of chemotherapy; your tumor must have stabilized or improved during treatment
- Have reached a point in your chemotherapy where both you and your doctor believe having a pause or break in your chemotherapy treatment is appropriate
- Be willing and able to participate in the study by taking two tablets twice each day by mouth, which may be either the PARP inhibitor, olaparib, or placebo
- Be willing and able to attend regular clinic visits and undergo associated laboratory tests to assess your health status
You will also need to meet other study requirements (assessed by the study doctor or nurse) to be eligible for the POLO study. For further details, please see Can I take part?
- Nausea (feeling sick)
- Vomiting (being sick)
- Fatigue (tiredness)
- Anemia (low level of red blood cells)
Further information about pancreatic cancer research and advice about participating in pancreatic cancer clinical trials can be found through the links on the Additional information page.