Clinical trial · Interventional
Nirogacestat in Ovarian Granulosa Cell Tumors
A Phase 2 Trial of Nirogacestat in Patients With Recurrent Ovarian Granulosa Cell Tumors
NCT05348356CI-TRIAL-00123689completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Ovarian Granulosa Cell Tumor | Ovarian Granulosa Cell Tumor | ONTOLOGY_EXACT | 0.90 |
| Ovarian Granulosa-Stromal Tumor | Ovarian Granulosa-Stromal Cell Tumor | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nirogacestat | Drug | Nirogacestat | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Nirogacestat Open-Label
- description
- Nirogacestat 150 mg by mouth, twice daily Nirogacestat oral tablet: Nirogacestat tablet
- interventionNames
- Drug: Nirogacestat
Primary outcomes (1)
- measure
- Objective Response Rate (ORR)
- timeFrame
- 2.5 years
- description
- The percentage of participants with complete response (CR) + partial response (PR) assessed using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
Secondary outcomes (9)
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * 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 Key Exclusion Criteria: * 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
References
Publications (1)
- DERIVEDGrisham RN, Hopp E, Pennington K, Holloway R, Wenham RM, Blecharz P, Dockery L, Matsuo K, Salani R, Bidzinski M, Braly P, Celano P, Reid T, Seward S, Lewis J, Johnson M, DuBose R, Ahn S, Cheng S, Alvero C, Konstantinopoulos PA. Phase II clinical trial of nirogacestat in patients with relapsed ovarian granulosa cell tumours. Clin Transl Med. 2026 Jan;16(1):e70568. doi: 10.1002/ctm2.70568. PMID 41518037