Nirogacestat in Ovarian Granulosa Cell Tumors

About

Brief Summary

This phase 2 clinical trial will study the effectiveness of nirogacestat in ovarian granulosa cell tumors (OvGCTs). Nirogacestat is a gamma secretase inhibitor (GSI) which is hypothesized to decrease the growth and activity of ovarian granulosa tumors.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase II

Eligibility

Gender

Female

Healthy Volunteers

Minimum Age

18 Years

Maximum Age

N/A

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

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