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    Association details:
    Biomarker:HRD
    Cancer:Peritoneal Cancer
    Drug:Zejula (niraparib) (PARP inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    New
    Source:
    FDA
    Excerpt:
    ZEJULA is a poly(ADP-ribose) polymerase (PARP) inhibitor indicated:...for the treatment of adult patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either:...a deleterious or suspected deleterious BRCA mutation, or...genomic instability and who have progressed more than six months after response to the last platinum-based chemotherapy.
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Japan Phase 2 Study of Niraparib in Participants With Advanced, Relapsed Ovarian Cancer

    Excerpt:
    ...Participants must agree to undergo tumor homologous recombination deficiency/deficient (HRD) testing, and this test result must show that participants have an HRD-positive tumor (defined by the presence of a deleterious or suspected deleterious breast cancer gene (BRCA) mutation or be positive for genomic instability) by the central laboratory selected by the sponsor....
    Trial ID:
    NCT03759600
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Study of Niraparib Combined With Bevacizumab Maintenance Treatment in Participants With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy

    Excerpt:
    ...- Participants must have high-grade serous or endometrioid or high-grade predominantly serous or endometrioid histology, regardless of homologous recombination deficiency (HRD) or germline breast cancer susceptibility gene (gBRCA) mutation status....
    Trial ID:
    OVARIO
    More C2 evidence
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Phase II Randomized, Open Label Non-inferiority Study of NiraParib Maintenance After 3 vs. 6 Cycles of Platinum-based Chemotherapy in completeLy debUlked Advanced HRDpositive High-grade Ovarian Cancer patientS in First Line Therapy

    Excerpt:
    ......
    Trial ID:
    N-Plus
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Study of Niraparib in Patients With Ovarian Cancer Who Have Received Three or Four Previous Chemotherapy Regimens

    Excerpt:
    ...Duration of Response (DoR)`ORR by HRD Status and Breast Cancer Gene (BRCA) Status`Disease Control Rate (DCR)`Progression Free Survival`Overall Survival`Time to First Subsequent Therapy (TFST)...
    Trial ID:
    QUADRA