Nirogacestat for Ovarian Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
SpringWorks Clinical Site, Milwaukee, WI
Ovarian Cancer+4 More
Nirogacestat - Drug
Eligibility
18+
Female
What conditions do you have?
Select

Study 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.

Eligible Conditions

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

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 2.5 years

Year 2
Overall Survival
2.5 years
Objective Response Rate (ORR)
Year 5
Participant reported ovarian cancer symptoms
Month 6
Progression Free Survival at 6 months (PFS-6)
Year 5
Duration of Response

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

Nirogacestat Open-Label
1 of 1
Experimental Treatment

43 Total Participants · 1 Treatment Group

Primary Treatment: Nirogacestat · No Placebo Group · Phase 2

Nirogacestat Open-Label
Drug
Experimental Group · 1 Intervention: Nirogacestat · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2.5 years
Closest Location: SpringWorks Clinical Site · Milwaukee, WI
Photo of Milwaukee 1Photo of Milwaukee 2Photo of Milwaukee 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Ovarian Cancer
0 CompletedClinical Trials

Who is running the clinical trial?

SpringWorks Therapeutics, Inc.Lead Sponsor
8 Previous Clinical Trials
528 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Female Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have documented evidence of disease by radiologic criteria.
You have adequate bone marrow, renal and hepatic function as defined by screening visit laboratory values.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.