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Nirogacestat in Ovarian Granulosa Cell Tumors

A Phase 2 Trial of Nirogacestat in Patients With Recurrent Ovarian Granulosa Cell Tumors

  • Clinical Trial Information

    Trial Contact: Durand, Jennifer; Ribacchi, Stephanie

    Trial Phone: 321.843.2026 ; 321-841-1077

  • IRB No: Pro00061189

    Protocol Abbrev: NIR-OGT-201

    Principal Investigator: Shelly Marie Seward, MD

    Phase: Drug: Phase II

    Age Group: Adult

    Treatment: Experimental: Nirogacestat Open-Label All participants will receive open-label nirogacestat

    Therapies Involved: Medication

    ClinicalTrials.gov ID: NCT05348356

  • Objective

    To determine the anti-tumor activity of nirogacestat in adult participants with relapsed/refractory OvGCT

  • Key Eligibility

    Key Inclusion Criteria:
    -Has histologically confirmed recurrent adult-type granulosa cell tumor of the ovary prior to first dose of study treatment
    -Have documented radiological evidence of relapse after at least one systemic therapy that is not amenable to surgery, or radiation and have measurable disease by RECIST v1.1 criteria
    -Have adequate bone marrow, renal and hepatic function as defined by screening visit laboratory values

    Key Exclusion Criteria:
    -Has signs of bowel obstruction requiring parental nutrition, malabsorption syndrome or preexisting gastrointestinal conditions that may impair absorption of nirogacestat
    -Has had a major cardio or thrombo-embolic event within 6 months of signing informed consent
    -Has abnormal QT interval at Screening, or has congenital or acquired long QT syndrome or a history of additional risk factors for Torsades de Pointes
    -Has current or chronic history of liver disease or known hepatic or biliary abnormalities
    -Has received any treatment for OvGCT including but not limited to the following within 28 days (or 5 half-lives, whichever is longer) prior to the first dose of study treatment: anti-angiogenic therapy, hormonal therapy, chemotherapy, immunotherapy, targeted therapy or any investigational treatment