A Maintenance Study With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer
Condition: Ovarian Neoplasms; Platinum Sensitive Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Hypersensitivity
Intervention: Active comparator: Niraparib; placebo
Intervention description: Niraparib vs placebo 2:1 ratio
Intervention MeSH terms: Niraparib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 596.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ovarian cancer; platinum sensitive; gBRCAmut; BRCA; high-grade serous histology; PARP inhibitor

Summary:

      This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of
      niraparib as maintenance in platinum sensitive ovarian cancer patients who have either
      gBRCAmut or a tumor with high-grade serous histology and who have responded to their most
      recent chemotherapy containing a platinum agent. Niraparib is an orally active PARP
      inhibitor. Niraparib or placebo (in a 2:1 ratio) will be administered once daily continuously
      during a 28-day cycle. Health-related quality of life will be measured by the Functional
      Assessment of Cancer Therapy - Ovarian Symptom Index (FOSI), European Quality of Life scale,
      5-Dimensions (EQ-5D), and a neuropathy questionnaire. Safety and tolerability will be
      assessed by clinical review of adverse events (AEs), physical examinations,
      electrocardiograms (ECGs), and safety laboratory values.

      The primary objective of this study is to evaluate efficacy of niraparib as maintenance
      therapy in patients who have platinum sensitive ovarian cancer as assessed by the
      prolongation of progression free survival (PFS).
    

Eligibility criteria:

        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