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This study compares the drug Niraparib with placebo as maintenance therapy in patients with platinum-sensitive ovarian, fallopian tube, or peritoneal cancer. It included patients with high-grade serous histology or a BRCA mutation who had responded to their last platinum regimen. It was a Phase 3 study and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
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Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * 18 years of age or older, female, any race * Histologically diagnosed ovarian cancer, fallopian tube cancer or primary peritoneal cancer * High grade (or grade 3) serous histology or known to have gBRCAmut * Has received at least 2 previous courses of platinum-containing therapy, and has disease that was considered platinum sensitive following the penultimate (next to last) platinum course (more than 6 month period between penultimate platinum regimen and progression of disease) * Has responded to last the platinum regimen, remains in response and is enrolled on study within 8 weeks of completion of the last platinum regimen * ECOG 0-1 * Adequate bone marrow, kidney and liver function Exclusion Criteria: * Known hypersensitivity to the components of niraparib * Invasive cancer other than ovarian cancer within 2 years (except basal or squamous cell carcinoma of the skin that has been definitely treated) * Symptomatic uncontrolled brain metastasis * Is pregnant or breast feeding * Immunocompromised patients * Known active hepatic disease * Prior treatment with a known PARP inhibitor