Ovarian Cancer Clinical Trial

Nirogacestat in Ovarian Granulosa Cell Tumors

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.

View Full Description

Full 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 or unacceptable toxicity.

View Eligibility Criteria

Eligibility Criteria

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 parental nutrition, malabsorption syndrome or preexisting gastrointestinal conditions that may impair absorption of nirogacestat
Has had a major cardio 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 any 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: anti-angiogenic therapy, hormonal therapy, chemotherapy, immunotherapy, targeted therapy or any investigational treatment

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

43

Study ID:

NCT05348356

Recruitment Status:

Recruiting

Sponsor:

SpringWorks Therapeutics, Inc.

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 28 Locations for this study

See Locations Near You

USC/Norris Comprehensive Cancer Center
Los Angeles California, 90033, United States More Info
Kimberly Arieli
Contact
323-865-0459
[email protected]
Koji Matsuo, MD
Principal Investigator
SpringWorks Clinical Site
Los Angeles California, 90095, United States More Info
Rachel Gray
Contact
310-825-3931
[email protected]
Jennifer Lester
Contact
SpringWorks Clinical Site
Palo Alto California, 94304, United States
Orlando Health Cancer Institute
Orlando Florida, 32806, United States More Info
Adult Oncology Patient Referral
Contact
[email protected]
H. Lee Moffitt Cancer Center and Research Institute
Tampa Florida, 33612, United States More Info
Brittany Boyce
Contact
813-745-5417
[email protected]
Robert Wenham, MD
Principal Investigator
Women's Cancer Care
Covington Louisiana, 70433, United States More Info
Patricia Braly, MD
Contact
985-892-2252
Jennifer Aldana
Contact
[email protected]
Patricia Braly, MD
Principal Investigator
Greater Baltimore Medical Center
Baltimore Maryland, 21204, United States More Info
GBMC Clinical Trials
Contact
[email protected]
Paul Celano, MD
Principal Investigator
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States More Info
DFCI Clinical Trials Hotline
Contact
877-338-7425
Panagiotis Konstantinopoulos, MD
Principal Investigator
SpringWorks Clinical Site
Saint Louis Missouri, 63141, United States
SpringWorks Clinical Site
Albuquerque New Mexico, 87106, United States
SpringWorks Clinical Site
New York New York, 10032, United States
Memorial Sloan Kettering Cancer Institute
New York New York, 10065, United States More Info
Jade Cohen
Contact
646-888-4408
[email protected]
Pooja Shah
Contact
Rachel Grisham, MD
Principal Investigator
Women's Cancer Center at Kettering
Kettering Ohio, 45429, United States More Info
Allison Dymacek
Contact
[email protected]
SpringWorks Clinical Site
Oklahoma City Oklahoma, 73104, United States
SpringWorks Clinical Site
Houston Texas, 77030, United States
SpringWorks Clinical Site
Seattle Washington, 98195, United States
SpringWorks Clinical Site
Milwaukee Wisconsin, 53226, United States
SpringWorks Clinical Site
Winnipeg Manitoba, R3E 0, Canada
SpringWorks Clinical Site
Montréal Quebec, H2W 1, Canada
SpringWorks Clinical Site
Sherbrooke Quebec, J1H 5, Canada
SpringWorks Clinical Site
Białystok , 15-02, Poland
SpringWorks Clnical Site
Kraków , 30-37, Poland
SpringWorks Clinical Site
Poznań , 60-56, Poland
SpringWorks clinical Site
Warsaw , 02-03, Poland
SpringWorks Clinical Site
Barcelona , 08036, Spain
SpringWorks Clinical Site
Madrid , 28040, Spain
SpringWorks Clinical Site
Madrid , 28050, Spain
SpringWorks Clinical Site
Valencia , 46009, Spain

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

43

Study ID:

NCT05348356

Recruitment Status:

Recruiting

Sponsor:


SpringWorks Therapeutics, Inc.

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.