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NCT05348356 (nirogacestat in Ovarian Granulosa Cell Tumors): BVCT ex-ante prediction vs. reported outcome

On 27 Aug 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 6 Mar 2026 readout is classified on the dashboard as False Positive (FP), a missed prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT05348356
Drug Name
nirogacestat
Drug MoA
gamma-secretase inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Ovarian Granulosa Cell Tumors
Human Patients
53
Sponsor
SpringWorks Therapeutics
Phase
Phase 2

Prediction of , index 1114

Prospective Prediction
Prediction Index
1114
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit in OS)
Technical Prediction
SUCCESS (statistically significant clinical benefit ORR/PFS)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
556 days in advance
Readout Data Interpretation
nirogacestat achieved 0% ORR and further development has been discontinued
Press Release
Prediction Result
Prediction Accuracy
Missed Prediction
Due to
due to suboptimal disease modeling of granulosa cell tumors that have been permanently improved
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient
Prediction Classification
False Positive (FP)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Phase 2 Trial of Nirogacestat in Patients With Recurrent Ovarian Granulosa Cell Tumors
Phase
Phase 2
Status
Completed
Enrollment
53
Lead sponsor
SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany
Conditions
Ovarian Granulosa-Stromal Tumor; Ovarian Granulosa Cell Tumor; Ovarian Cancer
Interventions
DRUG: Nirogacestat
Design
Single group · None
Primary purpose
Treatment
Start
2022-08-30
Primary completion
2025-07-08
Completion
2025-07-14
Results first posted
2026-08-25
Primary outcomes
  • Objective Response Rate (ORR) (2.5 years)

NCT05348356 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials