A Study of Niraparib Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy
Why is the prima study being done?
The trial will look at how well niraparib works compared with placebo as maintenance treatment in patients with Stage III or IV ovarian cancer (including fallopian and peritoneal cancers) following front-line platinum-based chemotherapy.
- Must have had at least 4 cycles of platinum-based chemotherapy (i.e. carboplatin, oxaliplatin, cisplatin).
- Debulking surgery and intraperitoneal therapy are allowed.
- Must have either a CA-125 in the normal range or a decrease in CA-125 by more than 90% during front-line therapy that is stable for at least 7 days.
- Must not have had treatment with a known PARP inhibitor or participated in a study where any treatment arm included a known PARP inhibitor.
- Must not have any known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
- Must not be pregnant, breastfeeding, or expecting to conceive children while on study treatment and for 3 months after the last dose of study treatment.
HOW DO I KNOW IF THE PRIMA TRIAL IS RIGHT FOR ME?
The best next step is to contact the research site that would be the most convenient for you in order to discuss your medical history and whether the PRIMA clinical trial would be a good fit.
To find sites in your area, contact: email@example.com or use the form above.
To find additional information on PRIMA see: clinicaltrials.gov