NCT05348356

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2022

Typical duration for phase_2

Geographic Reach
3 countries

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 27, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

August 30, 2022

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2025

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 14, 2025

Completed
Last Updated

December 15, 2025

Status Verified

December 1, 2025

Enrollment Period

2.9 years

First QC Date

April 13, 2022

Last Update Submit

December 5, 2025

Conditions

Ovarian Granulosa-Stromal TumorOvarian Granulosa Cell TumorOvarian Cancer

Outcome Measures

Primary Outcomes (1)

  • Objective Response Rate (ORR)

    The proportion of participants with complete response (CR) + partial response (PR) assessed using RECIST v1.1 criteria.

    2.5 years

Secondary Outcomes (4)

  • Progression Free Survival at 6 months (PFS-6)

    First day of cycle 7 (approximately 6 months after the first dose of study treatment). Each cycle is 28 days.

  • Overall Survival

    2 years after first dose of study treatment

  • Participant reported ovarian cancer symptoms

    At each study visit until study completion (estimated to be an average of 2.5 years)

  • Duration of Response

    First day of every other cycle (each cycle is 28 days) for the first year, and then every 3 cycles thereafter until study completion (estimated to be an average of 2.5 years).

Study Arms (1)

Nirogacestat Open-Label

EXPERIMENTAL

Nirogacestat 150 mg by mouth, twice daily Nirogacestat oral tablet: Nirogacestat tablet

Drug: Nirogacestat

Interventions

NirogacestatDRUG

nirogacestat oral tablet

Also known as: PF-03084014
Nirogacestat Open-Label

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 may not qualify if:

  • Has signs of bowel obstruction requiring parenteral nutrition, malabsorption syndrome or preexisting gastrointestinal conditions that may impair absorption of nirogacestat
  • Has had a major cardiac 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 bevacizumab treatment or other monoclonal antibody therapy with targeted anti-angiogenic activity for OvGCT within 28 days (or 5 half-lives, whichever is shorter) prior to the first dose of study treatment;
  • Has received 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: hormonal therapy, chemotherapy, immunotherapy, targeted therapy or any investigational treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

UCLA-JCCC Dept. of OBGYN - Women's Health Clinical Research Unit

Los Angeles, California, 90095, United States

Location

AdventHealth Orlando

Orlando, Florida, 32804, United States

Location

Orlando Health Cancer Institute

Orlando, Florida, 32806, United States

Location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Women's Cancer Care

Covington, Louisiana, 70433, United States

Location

Greater Baltimore Medical Center

Baltimore, Maryland, 21204, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

David C. Pratt Cancer Center

St Louis, Missouri, 63141, United States

Location

University of New Mexico Comprehensive Cancer Center

Albuquerque, New Mexico, 87102, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Memorial Sloan Kettering Cancer Institute

New York, New York, 10065, United States

Location

Women's Cancer Center at Kettering

Kettering, Ohio, 45429, United States

Location

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

Location

UW/Fred Hutch Cancer Center

Seattle, Washington, 98109, United States

Location

Froedtert and Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

Maria Sklodowska-Curie Bialystok Oncology Center

Bialystok, 15-027, Poland

Location

Jagiellonian Innovation Centre Clinical Research Centre

Krakow, 30-348, Poland

Location

University Teaching Hospital Poznan, Department of Oncological Gynaecology

Poznan, 60-569, Poland

Location

Maria Sklodowska-Curie National Institute of Oncology-National Research Institute, Clinic of Oncological Gynecology

Warsaw, 02-781, Poland

Location

MeSH Terms

Conditions

Granulosa cell tumor of the ovaryOvarian Neoplasms

Interventions

nirogacestat

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2022

First Posted

April 27, 2022

Study Start

August 30, 2022

Primary Completion

July 8, 2025

Study Completion

July 14, 2025

Last Updated

December 15, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

SpringWorks Therapeutics is committed to data transparency and sharing data to further research while maintaining the privacy and confidentiality of research participants. Pertinent patient-level data from completed clinical trials will be made available by SpringWorks to qualified researchers upon approval of reasonable requests following de-identification/anonymization pursuant to applicable law.

Locations

PL(4)US(16)CA(1)