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Nirogacestat in Ovarian Granulosa Cell Tumors
Nirogacestat in Ovarian Granulosa Cell Tumors

NCT05348356

CompletedPhase 2

Sponsor: SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany

Conditions: Ovarian Granulosa-Stromal Tumor, Ovarian Granulosa Cell Tumor, Ovarian Cancer

Interventions: Nirogacestat

Countries: United States, Canada, Poland

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.

Eligibility overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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 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
Locations (21)
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Orlando, Florida, United States
  • Orlando, Florida, United States
  • Tampa, Florida, United States
  • Covington, Louisiana, United States
  • Baltimore, Maryland, United States
  • Boston, Massachusetts, United States
  • St Louis, Missouri, United States
  • Albuquerque, New Mexico, United States
  • New York, New York, United States
  • New York, New York, United States
  • Kettering, Ohio, United States
  • Oklahoma City, Oklahoma, United States
  • Seattle, Washington, United States
  • Milwaukee, Wisconsin, United States
  • Edmonton, Alberta, Canada
  • Bialystok, Poland
  • Krakow, Poland
  • Poznan, Poland
  • Warsaw, Poland