Spots Global Cancer Trial Database for Nirogacestat in Ovarian Granulosa Cell Tumors
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Trial Identification
Brief Title: Nirogacestat in Ovarian Granulosa Cell Tumors
Official Title: A Phase 2 Trial of Nirogacestat in Patients With Recurrent Ovarian Granulosa Cell Tumors
Study ID: NCT05348356
Interventions
Study Description
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.
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 (70%). Treatment of granulosa cell tumors with nirogacestat is expected to inhibit Notch-induced granulosa cell proliferation. 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
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, Saint 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, Białystok, , Poland
Jagiellonian Innovation Centre Clinical Research Centre, Kraków, , Poland
University Teaching Hospital Poznan, Department of Oncological Gynaecology, Poznań, , Poland
Maria Sklodowska-Curie National Institute of Oncology-National Research Institute, Clinic of Oncological Gynecology, Warsaw, , Poland
Contact Details
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