nirogacestat
nirogacestat: 12 clinical trials tracked.
nirogacestat evidence translation
What we can confirm
12 tracked trials
What it means
What to watch
Prepared research question
What is verified about nirogacestat, and what remains unknown?
Traceable citations · Unknowns marked
See linked entities and source evidence5 indications · 3 study sponsors
Clinical Trial Registry Records (12)showing 10 most recent
Individual Patient Compassionate Use of Nirogacestat
A Phase 1, Single-Sequence, Two-Period Crossover, Open-Label Study to Determine the Potential Induction Effect of Multiple 100 mg BID Oral Doses of Nirogacestat on a Cocktail of CYP Probe Substrates CYP2B6 (Bupropion), CYP2C8 (Repaglinide), CYP2C9 (Flurbiprofen), CYP2C19 (Omeprazole), and CYP3A4 (Midazolam) in Healthy Males
Primary endpoint: Plasma area under the concentration-time curve from dosing extrapolated to infinity (AUCinf) and maximum observed plasma concentration (Cmax) for the CYP cocktail probes alone, and coadministered with nirogacestat.
A Single-Arm, Open-Label Phase 4 Study of Nirogacestat in Adult Premenopausal Females With Desmoid Tumors/Aggressive Fibromatosis (DT/AF)
Primary endpoint: Ovarian function recovery rate of ovarian toxicity (OT) treatment-emergent adverse events (TEAEs)
A Phase 1, Single-Sequence, 3 Period Crossover, Open-Label Study to Determine the Effect of Rabeprazole or H2 Blocker Famotidine on the Pharmacokinetics of Nirogacestat in Healthy Adult Male Participants
Primary endpoint: Area under the concentration-time curve from time zero to infinity of nirogacestat.
A Single-arm, Open-label Phase 2 Study of Nirogacestat in Adult Japanese Patients With Progressing Desmoid Tumors/Aggressive Fibromatosis (DT/AF)
Primary endpoint: Objective response rate (ORR)
Evaluation of the Response and Non-response of Nirogacestat in Desmoid Tumors- Clinical Study
Primary endpoint: Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Phase II Study of Cryoablation and Nirogacestat for Desmoid Tumor
Primary endpoint: Clinical Benefit per RECIST v1.1
A Phase 2 Trial of Nirogacestat in Patients With Recurrent Ovarian Granulosa Cell Tumors
Primary endpoint: Objective Response Rate (ORR)
Phase 1b Study of REGN5458 (Anti-BCMA x Anti-CD3 Bispecific Antibody) Plus Other Cancer Treatments for Patients With Relapsed/Refractory Multiple Myeloma
Primary endpoint: Incidence of Dose Limiting Toxicities (DLTs) for each study regimen during the observation period
A Multi-arm Phase 1b Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma
Primary endpoint: Number of Participants with Incidence of Adverse Events (AEs)