Trial ID:NCT05348356
Protocol #:22-277
Condition(s):Ovarian Cancer, Ovarian Granulosa Cell Tumor, Ovarian Granulosa-Stromal Tumor
Phase:II
Principal Investigator:Konstantinopoulos, Panagiotis, A.
Site Research Nurse(s):Belavusava, Vera,
Bowes, Brittany, N.
Doherty, Kelsie,
Hindenach, Sarah,
Morrissey, Stephanie, C.
Neals, Allison,
Thistle, Katrina, M.
Trial Description:
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.
Eligibility Requirements:
Key - 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
Protocol #: 22-277