Nirogacestat in Ovarian Granulosa Cell Tumors

Prior treatment

• Has received bevacizumab treatment or other monoclonal antibody therapy with targeted anti-angiogenic activity for OvGCT within 28 days (or 5 half-lives, whichever is shorter) prior to the first dose of study treatment;
• Has received 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: hormonal therapy, chemotherapy, immunotherapy, targeted therapy or any investigational treatment

Other illness

• Has signs of bowel obstruction requiring parenteral nutrition, malabsorption syndrome or preexisting gastrointestinal conditions that may impair absorption of nirogacestat
• Has had a major cardiac or thrombo-embolic event within 6 months of signing informed consent
• Has current or chronic history of liver disease or known hepatic or biliary abnormalities

Lab values

• 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 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