Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2026-02-23 @ 3:02 PM
Study NCT ID:
NCT05348356
Status:
COMPLETED
Last Update Posted:
2025-12-15
First Post:
2022-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nirogacestat in Ovarian Granulosa Cell Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Spain']}, 'conditionBrowseModule': {'meshes': [{'id': 'C537296', 'term': 'Granulosa cell tumor of the ovary'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C550722', 'term': 'nirogacestat'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-03-19', 'size': 2264071, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-05-23T16:27', 'hasProtocol': True}, {'date': '2024-10-28', 'size': 1499822, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-05-23T16:19', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-07-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-05', 'studyFirstSubmitDate': '2022-04-13', 'studyFirstSubmitQcDate': '2022-04-20', 'lastUpdatePostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': '2.5 years', 'description': 'The proportion of participants with complete response (CR) + partial response (PR) assessed using RECIST v1.1 criteria.'}], 'secondaryOutcomes': [{'measure': 'Progression Free Survival at 6 months (PFS-6)', 'timeFrame': 'First day of cycle 7 (approximately 6 months after the first dose of study treatment). Each cycle is 28 days.', 'description': 'The number of participants without progression according to RECIST v1.1 or death at 6 months.'}, {'measure': 'Overall Survival', 'timeFrame': '2 years after first dose of study treatment', 'description': 'The number of participants who have not died of any cause.'}, {'measure': 'Participant reported ovarian cancer symptoms', 'timeFrame': 'At each study visit until study completion (estimated to be an average of 2.5 years)', 'description': 'Change from baseline as measured by Functional Assessment of Cancer Therapy - Ovarian Symptom Index (FOSI).'}, {'measure': 'Duration of Response', 'timeFrame': '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).', 'description': 'The time from response (CR + PR using RECIST v.1.) to disease progression and/or death'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ovarian Granulosa-Stromal Tumor', 'Ovarian Granulosa Cell Tumor', 'Ovarian Cancer']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Has histologically confirmed recurrent adult-type granulosa cell tumor of the ovary prior to first dose of study treatment\n* 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\n* Have adequate bone marrow, renal and hepatic function as defined by screening visit laboratory values\n\nKey Exclusion Criteria:\n\n* Has signs of bowel obstruction requiring parenteral nutrition, malabsorption syndrome or preexisting gastrointestinal conditions that may impair absorption of nirogacestat\n* Has had a major cardiac or thrombo-embolic event within 6 months of signing informed consent\n* 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\n* Has current or chronic history of liver disease or known hepatic or biliary abnormalities\n* 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;\n* 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'}, 'identificationModule': {'nctId': 'NCT05348356', 'briefTitle': 'Nirogacestat in Ovarian Granulosa Cell Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'SpringWorks Therapeutics, Inc.'}, 'officialTitle': 'A Phase 2 Trial of Nirogacestat in Patients With Recurrent Ovarian Granulosa Cell Tumors', 'orgStudyIdInfo': {'id': 'NIR-OGT-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nirogacestat Open-Label', 'description': 'Nirogacestat 150 mg by mouth, twice daily\n\nNirogacestat oral tablet: Nirogacestat tablet', 'interventionNames': ['Drug: Nirogacestat']}], 'interventions': [{'name': 'Nirogacestat', 'type': 'DRUG', 'otherNames': ['PF-03084014'], 'description': 'nirogacestat oral tablet', 'armGroupLabels': ['Nirogacestat Open-Label']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'USC/Norris Comprehensive Cancer Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': "UCLA-JCCC Dept. of OBGYN - Women's Health Clinical Research Unit", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '32804', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'AdventHealth Orlando', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Orlando Health Cancer Institute', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'H. Lee Moffitt Cancer Center and Research Institute', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '70433', 'city': 'Covington', 'state': 'Louisiana', 'country': 'United States', 'facility': "Women's Cancer Care", 'geoPoint': {'lat': 30.47549, 'lon': -90.10042}}, {'zip': '21204', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Greater Baltimore Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'David C. Pratt Cancer Center', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '87102', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico Comprehensive Cancer Center', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Institute', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '45429', 'city': 'Kettering', 'state': 'Ohio', 'country': 'United States', 'facility': "Women's Cancer Center at Kettering", 'geoPoint': {'lat': 39.6895, 'lon': -84.16883}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'OU Health Stephenson Cancer Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'UW/Fred Hutch Cancer Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Froedtert and Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': 'T6G 1Z2', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Cross Cancer Institute', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': '15-027', 'city': 'Bialystok', 'country': 'Poland', 'facility': 'Maria Sklodowska-Curie Bialystok Oncology Center', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'zip': '30-348', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Jagiellonian Innovation Centre Clinical Research Centre', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '60-569', 'city': 'Poznan', 'country': 'Poland', 'facility': 'University Teaching Hospital Poznan, Department of Oncological Gynaecology', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '02-781', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Maria Sklodowska-Curie National Institute of Oncology-National Research Institute, Clinic of Oncological Gynecology', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SpringWorks Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}