RSH_PR-30-5017-C

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Niraparib Maintenance Treatment in Patients With HRD-Positive Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy

Main Inclusion Criteria:

Patients must be able to understand the study procedures and agree to participate in the study by providing written informed consent.
Patients must be female ≥18 years of age
Patients must have histologically diagnosed ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that is Stage III or IV according to FIGO criteria Stage III patients who have undergone debulking surgery must have had residual disease after debulking surgery unless the patient has undergone neoadjuvant therapy
Patients must meet the following front-line therapy requirements:
Patients must have had at least 4 cycles of platinum-based (eg, carboplatin, oxaliplatin, or cisplatin) therapy
Patients must have achieved a complete or partial (no measurable lesion >2 cm) tumor response to platinum-based regimen per RECIST criteria
Patients must have either CA-125 in the normal range or CA-125 decrease by more than 90% during their front-line therapy
Patients must agree to undergo HRD testing This test result must show that patients have an HRD-positive tumor
Patients of childbearing potential must have a negative serum pregnancy test (beta human chorionic gonadotropin [hCG]) within 72 hours prior to receiving the first dose of study treatment
Patients must be postmenopausal, free from menses for >1 year, surgically sterilized, willing to use adequate contraception to prevent pregnancy, or agree to abstain from activities that could result in pregnancy -
Main Exclusion Criteria:

Patients must not be pregnant, breastfeeding, or expecting to conceive children while receiving study treatment and for 3 months after the last dose of study treatment
Patients must not have a known hypersensitivity to the components of niraparib or the excipients
Patients must not be simultaneously enrolled in any clinical trial of niraparib or any other investigational therapy
Patients must not have received prior treatment with a known PARP inhibitor or have participated in a study where any treatment arm included administration of a known PARP inhibitor
Patients must not have had investigational therapy administered within 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is longer, prior to the first scheduled day of dosing in this study
Patients must not have had any known, persistent (>4 weeks), ≥Grade 3 hematological toxicity or fatigue from prior cancer therapy
Patients must not have any known history of myelodysplastic syndrome (MDS) or a pre-treatment cytogenetic testing result at risk for a diagnosis of MDS/acute myeloid leukemia (AML) -
Phase III
NCT02655016
Cancer, All Other
Gynecologic
Ying Zhuo, M.D.
Tesaro, Inc.
xBrianna Harty
  • Kadlec Research