Why should I participate in the PRIMA clinical research trial?
By participating in PRIMA, you are helping to advance our knowledge of cancer and improve care for people who are affected by ovarian cancer.
What is the purpose of the PRIMA clinical trial?
The PRIMA clinical trial is being done to find out if niraparib, an investigational drug called a PARP inhibitor, can help delay the worsening of ovarian, peritoneal, or fallopian tube cancer among patients who have been previously treated with a platinum-based therapy and who have an HRD-positive tumor. (Potential participants will have their tumor tested first, at no cost, to see if PRIMA is a good fit for them.)
What is niraparib?
Niraparib is a PARP inhibitor. PARP inhibitors are a class of medications that were found in early studies to be effective against recurrent ovarian cancer. PARP inhibitors block an enzyme used by cancer cells to repair breaks in their DNA. When they can’t mend their DNA, the cancer cells die. Theoretically, these drugs should spare healthy (non-cancerous) cells. Because niraparib is not yet approved by any regulatory body, it is not available outside clinical trials.
To learn more about PARP inhibitors, click here.
What is an HRD-positive tumor?
Tumors that are less able to repair breaks in their DNA may be the most likely to respond to PARP inhibitors. An HRD test measures the amount of DNA damage in a tumor. A high level of damage indicates that the tumor has a defect in its ability to make DNA repairs. The PRIMA study will evaluate whether HRD-positive tumors are likely to respond to PARP inhibitors.
What happens during the trial?
About 305 people will participate in the clinical research trial. Two out of three will receive the study medication (the PARP inhibitor, niraparib), and one out of three will receive a placebo. Neither the participants nor their doctors will know who is and is not receiving the study medication. Participants will take up to three pills once a day. Treatment will continue until the disease progresses or the participant chooses to discontinue.
What are the benefits of being in the trial?
When you participate in a clinical research trial, you are playing an important role in advancing science that can result in effective treatments for individuals like you who are affected by ovarian cancer.
For more information on the PRIMA clinical research trial, please contact a research site near you.