PRIMA is being conducted 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 with Grade III or IV cancer, have been previously treated with 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.)
Is PRIMA right for you? To qualify to participate in the study, you should:
- Be at least 18 years old
- Have histologically diagnosed ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that is Stage III or IV
- Have completed at least 4 cycles of front-line platinum-based (i.e. carboplatin, oxaliplatin, cisplatin) therapy
- Agree to undergo HRD testing
There are other eligibility criteria that your doctor will discuss with you to see if PRIMA is a good fit for you.
What to Expect
About 305 people will participate in this maintenance trial. Two out of three will receive the study medication (the PARP inhibitor, niraparib), and one out of three will receive a placebo (a pill with no medicine in it). Neither the participants nor their doctors will know who is and is not receiving the study medication. Doctors don’t typically prescribe any medication for patients after they have responded to a course of chemotherapy (during the maintenance phase), so patients receiving the placebo are actually being treated the same way they would be if they were not in the trial.
Participants will take up to three pills once a day.
Throughout the trial, the doctor will continue to monitor the health of those who are participating.
Treatment will continue until the disease progresses or the participant chooses to end her participation in the study.
For more information on the PRIMA clinical research trial, please contact a research site near you.
For more information on HRD, please contact your doctor.
For more information on the HRD test itself, please contact mychoiceHRD@myriad.com.