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
Other trials for Ovarian Cancer
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
This is further along than 68% of similar trials
Other trials for Ovarian Cancer
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: DrugTrial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2.5 years
Closest Location: SpringWorks Clinical Site · Milwaukee, WI
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 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.
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Conditions
Cancer Related
Treatments