for females ages 18 years and up (full criteria)
study started
estimated completion
Principal Investigator
by Ritu Salani, MD (ucla)



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.

Official Title

A Phase 2 Trial of Nirogacestat in Patients With Recurrent Ovarian Granulosa Cell Tumors


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.


Ovarian Granulosa-Stromal Tumor, Ovarian Granulosa Cell Tumor, Ovarian Cancer, Neoplasms, Granulosa Cell Tumor, Nirogacestat, Nirogacestat Open-Label


You can join if…

Open to females ages 18 years and up

  • 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

You CAN'T join if...

  • Has signs of bowel obstruction requiring parenteral 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 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


  • UCLA-JCCC Dept. of OBGYN - Women's Health Clinical Research Unit accepting new patients
    Los Angeles California 90095 United States
  • USC/Norris Comprehensive Cancer Center accepting new patients
    Los Angeles California 90033 United States

Lead Scientist at UC Cancer

  • Ritu Salani, MD (ucla)
    Professor, Obstetrics and Gynecology, Medicine. Authored (or co-authored) 138 research publications


accepting new patients
Start Date
Completion Date
SpringWorks Therapeutics, Inc.
Phase 2 research study
Study Type
Expecting 43 study participants
Last Updated