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Gamma Secretase Inhibitor

Nirogacestat for Ovarian Cancer

Phase 2
Waitlist Available
Research Sponsored by SpringWorks Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2.5 years
Awards & highlights

Study Summary

This trial will study the effectiveness of nirogacestat, a drug that inhibits the growth of ovarian granulosa tumors, in treating women with this type of cancer.

Who is the study for?
This trial is for adults with recurrent ovarian granulosa cell tumors who've had at least one systemic therapy and can't have surgery or radiation. They must have measurable tumor growth, no major heart events or abnormal QT intervals recently, and not be on certain treatments like monoclonal antibodies within the last 28 days.Check my eligibility
What is being tested?
The trial is testing Nirogacestat, a drug thought to slow down the growth of ovarian granulosa cell tumors. It's a phase 2 study which means it focuses on the effectiveness of this treatment for patients who meet specific criteria.See study design
What are the potential side effects?
Potential side effects may include issues related to bowel function due to absorption concerns, risks associated with heart health such as abnormal heartbeat rhythms, and possibly liver-related complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My ovarian cancer is a confirmed adult-type granulosa cell tumor.
Select...
My cancer returned after treatment and can't be removed by surgery or treated with radiation, but it can be measured.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response Rate (ORR)
Secondary outcome measures
Duration of Response
Overall Survival
Participant reported ovarian cancer symptoms
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Nirogacestat Open-LabelExperimental Treatment1 Intervention
All participants will receive open-label nirogacestat

Find a Location

Who is running the clinical trial?

SpringWorks Therapeutics, Inc.Lead Sponsor
12 Previous Clinical Trials
913 Total Patients Enrolled

Media Library

Nirogacestat (Gamma Secretase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05348356 — Phase 2
Ovarian Granulosa Cell Tumor Research Study Groups: Nirogacestat Open-Label
Ovarian Granulosa Cell Tumor Clinical Trial 2023: Nirogacestat Highlights & Side Effects. Trial Name: NCT05348356 — Phase 2
Nirogacestat (Gamma Secretase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05348356 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many medical facilities are carrying out this clinical investigation?

"This clinical trial has 27 recruiting sites, which consist of renowned healthcare centres such as Memorial Sloan Kettering Cancer Institute in New york, H. Lee Moffitt Cancer Center and Research Institute in Tampa, and SpringWorks Clinical Site in Oklahoma City - alongside 24 other medical facilities."

Answered by AI

What is the current enrollment size for this research experiment?

"43 subjects who qualify under the given criteria are necessary to take part in this trial. They have the opportunity to join at various sites, such as Memorial Sloan Kettering Cancer Institute in New york and H. Lee Moffitt Cancer Center and Research Institute in Tampa, Florida."

Answered by AI

Are there still opportunities for interested parties to join in this research?

"In accordance with the clinicaltrials.gov database, this research project is currently enlisting participants. This trial was first made available on September 27th 2022 and has had its details modified as recently as November 18th of that same year."

Answered by AI

Is Nirogacestat a secure option for humans?

"Due to the Phase 2 status of Nirogacestat, which has data confirming safety but not efficacy yet, our experts at Power gave it a rating of 2."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
California
British Columbia
How old are they?
18 - 65
What site did they apply to?
SpringWorks Clinical Site
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

Why did patients apply to this trial?

2018년 2월경 응급으로 복강경 수술 실시함 혹 28cm, 그 후 삼성서울병원으로 전원하여 18년 5월에 자궁 및 난소 전체 제거 수술 함. 19년 7월 CT결과 혹3개 발견 개복 수술로 혹 10cm 그중 한개는 터진상태였음, 그후 페마라정 2년 복용함 다른 항암은 실시하지 않음. 23년 12월 22일 CT촬영에서 혹이 3cm짜리 2개가 있으며 좁쌀 같은 것이 있을 걸로 생각 된다는 주치의 재발소견이 있고 현재 페마라정을 복용중입니다. 다음 CT촬영은 24년 03월 30일 예정되어 있음. 결과에 따라 수술할 수 있음. 현재 과립막세포 치료방법이 없는 상태에서 누군가는 실험에 참여하여 약의 효능을 알아봐야 하는데 이러한 부분에 참여를 원한다. 많은 긴장감과 기대감가 든다.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Nirogacestat in Ovarian Granulosa Cell Tumors
2022. "Nirogacestat in Ovarian Granulosa Cell Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05348356.
~29 spots leftby Jul 2026
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