Alternative Dosing Of Niraparib To Decrease Dose Interruption In First Line Maintenance Treatment For Ovarian Cancer

Exclusion Criteria

• •1. Patient's age is \<18 years.
• •2. Patient who are pregnant, breastfeeding, or expecting to conceive children during the study treatment of for 6 months after completion of the study treatment.
• •3. Patients with a known hypersensitivity to niraparib or any of its components
• •4. Patients who have received a poly adenosine diphosphate-ribose polymerase (PARP) inhibitor as part of their previous treatment or participated in a trial where PARP inhibitors were administered in one arm of the trial.
• •5. Patients enrolled in another investigational trial
• •6. Patients who received another investigational therapy within 4 weeks or 5 halflives of the investigational agent, whichever is longer
• •7. Patients with previous persistent (\>4 weeks) or \>/= grade 3 hematologic toxicity or fatigue from prior cancer therapy.
• •8. Patients with known history of myelodysplastic syndrome or pre-treatment cytogenetic testing at risk for myelodysplastic syndrome or acute myeloid leukemia
• •9. Patients receiving concurrent, prohibited medications
• •10. Patients with previous major surgery within 3 weeks of starting study treatment and must have recovered from any effects of previous surgery.
• •11. Patients with ascites drained within 4 weeks of starting study treatment
• •12. Patients receiving palliative radiotherapy to \>20% of bone marrow within 2 weeks or any other radiotherapy within 1 week of study treatment
• •13. Patients receiving a transfusion (platelets or red blood cells) within 4 weeks of treatment
• •14. Patients planning to donate blood during the study or 90 days after treatment.
• •15. Patients with a diagnosis of another invasive cancer (other than ovarian cancer), within 2 years prior to randomization (except basal or squamous cell carcinoma of the skin that has been definitively treated i. Patients with uncontrolled brain or leptomeningeal metastases. Controlled brain or leptomeningeal metastasis is defined as: ii. Central nervous system disease that has undergone treatment with radiation or chemotherapy \> 1 month before study entry
• •16. No new or progressive signs or symptoms, stable steroid dose x 4 weeks or not taking steroids
• •17. Patients considered poor medical risk due to serious, uncontrolled medical disorder, non-malignant systemic disease, or active uncontrolled infection i. Patients with known HIV considered high risk for serious and fatal outcome
• •18. Patients with evidence of any condition, therapy, or laboratory abnormality that might confound study results or patient participation for full duration of study (Ex. Myelodysplastic syndrome, anemia, leukopenia, neutropenia, thrombocytopenia, etc)
• •19. Patients who are immunocompromised (Patients with splenectomy are allowed)
• •20. Patients with known, active hepatic disease (Ex. Hepatitis B or C), active biliary disease (exceptions for Gilbert's syndrome, asymptomatic gallstones, liver metastases or otherwise stable chronic liver disease as per investigator assessment)
• •21. Patients with QT prolongation \>470 milliseconds at screening
• •22. Patients with a known breast cancer susceptibility gene (BRCA1 and 2) mutation (as they routinely receive olaparib at our institution) If BRCA unknown they are not excluded.
• •23. Patients with a history of posterior reversible encephalopathy syndrome (PRES)
• •24. Patients who have had a live vaccine within 30 days of planned start date of study treatment
• •25. Patients with gastrointestinal abnormalities that may limit absorption
• •26. Patients with significant cardiovascular disease
• •27. Patients undergoing serial blood counts to achieve a value to meet eligibility
• •28. Patients receiving blood product transfusions in order to meet eligibility criteria