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.
NOTE: ENROLLMENT GOAL HAS BEEN REACHED.
THIS STUDY IS NO LONGER ENROLLING NEW PARTICIPANTS.
- All Stage IV patients are eligible, regardless of remaining disease, after primary or interval debulking. Stage III patients must have visible remaining disease after primary surgery. Patients with inoperable Stage III and IV disease are eligible.
- Patient must have a complete response or partial response following completion of their first line platinum based chemotherapy.
- Patient must be randomized within 12 weeks of the first day of their last cycle of chemotherapy.
- 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 180 days 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: firstname.lastname@example.org or use the form above.
To find additional information on PRIMA see: clinicaltrials.gov