Status:
COMPLETED
Nirogacestat in Ovarian Granulosa Cell Tumors
Lead Sponsor:
SpringWorks Therapeutics, Inc.
Conditions:
Ovarian Granulosa-Stromal Tumor
Ovarian Granulosa Cell Tumor
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 ...
Detailed Description
Ovarian granulosa cell tumors (OvGCTs) represent 5-7% of all ovarian cancers (\~1.5 to 2k newly diagnosed patients/year in the United States) and are the most common subtype of ovarian sex cord tumors...
Eligibility Criteria
Inclusion
- 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
- 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 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 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
Key Trial Info
Start Date :
August 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 14 2025
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT05348356
Start Date
August 30 2022
End Date
July 14 2025
Last Update
December 15 2025
Active Locations (21)
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1
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
2
UCLA-JCCC Dept. of OBGYN - Women's Health Clinical Research Unit
Los Angeles, California, United States, 90095
3
AdventHealth Orlando
Orlando, Florida, United States, 32804
4
Orlando Health Cancer Institute
Orlando, Florida, United States, 32806