Testing Niraparib for ovarian cancer

Exclusion

• −Patients with a known hypersensitivity to niraparib or any of its components
• −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
• −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 investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → assessment)
• −Patient's age is \<18 years.
• −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 armArmOne of the groups in a study, each receiving something different.Read more → of the trial.
• −Patients enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more → in another investigational trial
• −Patients who received another investigational therapy within 4 weeks or 5 halflives of the investigational agent, whichever is longer
• −Patients with previous persistent (\>4 weeks) or \>/= grade 3 hematologic toxicity or fatigue from prior cancer therapy.
• −Patients with known history of myelodysplastic syndrome or pre-treatment cytogenetic testing at risk for myelodysplastic syndrome or acute myeloid leukemia
• −Patients receiving concurrent, prohibited medications
• −Patients with ascites drained within 4 weeks of starting study treatment
• −Patients receiving palliative radiotherapy to \>20% of bone marrow within 2 weeks or any other radiotherapy within 1 week of study treatment
• −Patients receiving a transfusion (platelets or red blood cells) within 4 weeks of treatment
• −Patients planning to donate blood during the study or 90 days after treatment.
• −No new or progressive signs or symptoms, stable steroid dose x 4 weeks or not taking steroids
• −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)
• −Patients who are immunocompromised (Patients with splenectomy are allowed)
• −Patients with QT prolongation \>470 milliseconds at screeningScreeningThe checks done before joining, to see whether a study fits.Read more →
• −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.
• −Patients with a history of posterior reversible encephalopathy syndrome (PRES)
• −Patients who have had a live vaccine within 30 days of planned start date of study treatment
• −Patients with gastrointestinal abnormalities that may limit absorption
• −Patients with significant cardiovascular disease
• −Patients undergoing serial blood counts to achieve a value to meet eligibilityEligibility criteriaThe full list of requirements for taking part in a study.Read more →
• −Patients receiving blood product transfusions in order to meet eligibility criteria
• −Patient who are pregnant, breastfeeding, or expecting to conceive children during the study treatment of for 6 months after completion of the study treatment.
• −Patients with previous major surgery within 3 weeks of starting study treatment and must have recovered from any effects of previous surgery.
• −Patients with a diagnosis of another invasive cancer (other than ovarian cancer), within 2 years prior to randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → (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