NCT05348356

Nirogacestat in Ovarian Granulosa Cell Tumors

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: SpringWorks Therapeutics, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Ovarian Granulosa-Stromal Tumor
• Ovarian Granulosa Cell Tumor
• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Nirogacestat	nirogacestat oral tablet

Timeline

• Start date: 2022-08-30
• Primary completion: 2025-07-08
• Completion: 2025-07-14
• First posted: 2022-04-27
• Last updated: 2025-12-15

Locations

21 sites across 3 countries: United States, Canada, Poland

Regulatory

• FDA-regulated drug study