Summary

Eligibility
for females ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

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.

Official Title

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

Details

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.

Keywords

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

Eligibility

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 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

Locations

  • SpringWorks Clinical Site accepting new patients
    Los Angeles California 90095 United States
  • USC/Norris Comprehensive Cancer Center accepting new patients
    Los Angeles California 90033 United States
  • SpringWorks Clinical Site not yet accepting patients
    Palo Alto California 94304 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
SpringWorks Therapeutics, Inc.
ID
NCT05348356
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 43 study participants
Last Updated