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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05348356
Other study ID # NIR-OGT-201
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date August 30, 2022
Est. completion date December 2027

Study information

Verified date November 2023
Source SpringWorks Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Nirogacestat
nirogacestat oral tablet

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
SpringWorks Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Canada,  Poland, 

Outcome

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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