Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
53 participants
INTERVENTIONAL
2022-08-30
2025-07-14
Brief Summary
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Detailed Description
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This is a multi-center, single-arm, Phase 2 open label treatment study to determine the efficacy, safety, tolerability, and pharmacokinetics of nirogacestat in adult participants with relapsed/refractory OvGCT. The participants will continue treatment until disease progression as determined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (unless the participants meet criteria for continued treatment) or unacceptable toxicity.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Nirogacestat Open-Label
Nirogacestat 150 mg by mouth, twice daily
Nirogacestat oral tablet: Nirogacestat tablet
Nirogacestat
nirogacestat oral tablet
Interventions
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Nirogacestat
nirogacestat oral tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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SpringWorks Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
UCLA-JCCC Dept. of OBGYN - Women's Health Clinical Research Unit
Los Angeles, California, United States
AdventHealth Orlando
Orlando, Florida, United States
Orlando Health Cancer Institute
Orlando, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Women's Cancer Care
Covington, Louisiana, United States
Greater Baltimore Medical Center
Baltimore, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
David C. Pratt Cancer Center
St Louis, Missouri, United States
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, United States
Columbia University Medical Center
New York, New York, United States
Memorial Sloan Kettering Cancer Institute
New York, New York, United States
Women's Cancer Center at Kettering
Kettering, Ohio, United States
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
UW/Fred Hutch Cancer Center
Seattle, Washington, United States
Froedtert and Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Cross Cancer Institute
Edmonton, Alberta, Canada
Maria Sklodowska-Curie Bialystok Oncology Center
Bialystok, , Poland
Jagiellonian Innovation Centre Clinical Research Centre
Krakow, , Poland
University Teaching Hospital Poznan, Department of Oncological Gynaecology
Poznan, , Poland
Maria Sklodowska-Curie National Institute of Oncology-National Research Institute, Clinic of Oncological Gynecology
Warsaw, , Poland
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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NIR-OGT-201
Identifier Type: -
Identifier Source: org_study_id
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