Nirogacestat oral tablet

DRUG2 trials

Sponsors

SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany

Conditions

Aggressive FibromatosisDesmoid Tumor

Phase 2

A Study of Nirogacestat in Japanese Adults With Desmoid Tumors/Aggressive Fibromatosis (DT/AF)

Active, not recruitingNCT07170644

SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, GermanyAggressive Fibromatosis, Desmoid Tumor

Start: 2025-08-08End: 2029-10-09Updated: 2026-09-15

Phase 3

Nirogacestat for Adults With Desmoid Tumor/Aggressive Fibromatosis (DT/AF)

CompletedNCT03785964

SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, GermanyAggressive Fibromatosis, Desmoid Tumor

Start: 2019-04-17End: 2024-10-17Updated: 2026-08-20

Related Papers

Efficacy and Safety of Long-Term Continuous Nirogacestat Treatment in Adults With Desmoid Tumors: Results From the DeFi Trial.

2025-10-20

Nirogacestat in patients with desmoid tumors and mutations of adenomatous polyposis coli ( <i>APC</i> ): Findings from the DeFi trial.

Journal of Clinical Oncology2025-01-27

Nirogacestat-the pathway to approval of the first treatment for desmoid tumors, a rare disease.

2025-01-012 citations

Efficacy and safety of nirogacestat in patients with desmoid tumor and <i>adenomatous polyposis coli</i><i> (APC)</i> mutation: Phase 3 DeFi analyses.

Journal of Clinical Oncology2024-06-014 citations

Efficacy of nirogacestat in participants with poor prognostic factors for desmoid tumors: Analyses from the randomized phase 3 DeFi study.

Journal of Clinical Oncology2024-06-011 citations

Monitoring ovarian function in oncology studies: Results and insights from the DeFi phase 3 study of nirogacestat in desmoid tumor.

Journal of Clinical Oncology2024-06-011 citations

Onset and resolution of ovarian toxicity with nirogacestat treatment in females with desmoid tumors: Updated safety analyses from the DeFi phase 3 study

Cancer2024-05-048 citations

GOunder/Desmoid Tumor Research Foundation DEsmoid Symptom/Impact Scale (GODDESS<sup>©</sup>): psychometric properties and clinically meaningful thresholds as assessed in the Phase 3 DeFi randomized controlled clinical trial.

2023-06-226 citations

Impact of nirogacestat on pain, a key symptom in patients with desmoid tumors (DT): Results from the phase 3 DeFi study.

Journal of Clinical Oncology2023-06-011 citations

Tumor volume and T2 hyperintensity changes from DeFi: A phase 3, randomized, controlled trial of nirogacestat in patients with desmoid tumors.

Journal of Clinical Oncology2023-06-01

Nirogacestat, a γ-Secretase Inhibitor for Desmoid Tumors

New England Journal of Medicine2023-03-08206 citations

Extended progression-free survival and long-term safety of nirogacestat in patients with desmoid tumors.

Journal of Clinical Oncology2022-06-015 citations

Current management and recent progress in desmoid tumors.

2022-04-1621 citations

The Evaluation of Health-Related Quality of Life Issues Experienced by Patients with Desmoid-Type Fibromatosis (The QUALIFIED Study)—A Protocol for an International Cohort Study

Cancers2021-06-2216 citations