Nirogacestat in Ovarian Granulosa Cell Tumors
A Phase 2 Trial of Nirogacestat in Patients With Recurrent Ovarian Granulosa Cell Tumors
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Clinical Trial Information
Trial Contact: Durand, Jennifer; Ribacchi, Stephanie
Trial Phone: 321.843.2026 ; 321-841-1077
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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
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Objective
To determine the anti-tumor activity of nirogacestat in adult participants with relapsed/refractory OvGCT
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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
