Ovarian Cancer Clinical Trial
Official title:
A Phase 2 Trial of Nirogacestat in Patients With Recurrent Ovarian Granulosa Cell Tumors
Verified date | November 2023 |
Source | SpringWorks Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 53 |
Est. completion date | December 2027 |
Est. primary completion date | July 2026 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Cross Cancer Institute | Edmonton | Alberta |
Poland | Maria Sklodowska-Curie Bialystok Oncology Center | Bialystok | |
Poland | Jagiellonian Innovation Centre Clinical Research Centre | Kraków | |
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 | |
United States | University of New Mexico Comprehensive Cancer Center | Albuquerque | New Mexico |
United States | Greater Baltimore Medical Center | Baltimore | Maryland |
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
United States | Women's Cancer Care | Covington | Louisiana |
United States | Women's Cancer Center at Kettering | Kettering | Ohio |
United States | UCLA-JCCC Dept. of OBGYN - Women's Health Clinical Research Unit | Los Angeles | California |
United States | USC/Norris Comprehensive Cancer Center | Los Angeles | California |
United States | Froedtert and Medical College of Wisconsin | Milwaukee | Wisconsin |
United States | Columbia University Medical Center | New York | New York |
United States | Memorial Sloan Kettering Cancer Institute | New York | New York |
United States | OU Health Stephenson Cancer Center | Oklahoma City | Oklahoma |
United States | AdventHealth Orlando | Orlando | Florida |
United States | Orlando Health Cancer Institute | Orlando | Florida |
United States | David C. Pratt Cancer Center | Saint Louis | Missouri |
United States | UW/Fred Hutch Cancer Center | Seattle | Washington |
United States | H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
SpringWorks Therapeutics, Inc. |
United States, Canada, Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Objective Response Rate (ORR) | The proportion of participants with complete response (CR) + partial response (PR) assessed using RECIST v1.1 criteria. | 2.5 years | |
Secondary | Progression Free Survival at 6 months (PFS-6) | The number of participants without progression according to RECIST v1.1 or death at 6 months. | First day of cycle 7 (approximately 6 months after the first dose of study treatment). Each cycle is 28 days. | |
Secondary | Overall Survival | The number of participants who have not died of any cause. | 2 years after first dose of study treatment | |
Secondary | Participant reported ovarian cancer symptoms | Change from baseline as measured by Functional Assessment of Cancer Therapy - Ovarian Symptom Index (FOSI). | At each study visit until study completion (estimated to be an average of 2.5 years) | |
Secondary | Duration of Response | The time from response (CR + PR using RECIST v.1.) to disease progression and/or death | First day of every other cycle (each cycle is 28 days) for the first year, and then every 3 cycles thereafter until study completion (estimated to be an average of 2.5 years). |
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