Last updated on July 2020

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


Brief description of study

This study evaluates nirogacestat in the treatment of desmoid tumor/aggressive fibromatosis (DT/AF). Half of the participants will receive nirogacestat while the other half will receive placebo.

Detailed Study Description

Desmoid tumors, also referred to as aggressive fibromatosis, are rare, locally invasive, slow growing soft tissue tumors. Although considered benign because of their inability to metastasize, desmoid tumors can cause significant morbidity and occasionally mortality in patients.

Nirogacestat (PF-03084014) is a potent, small molecule, selective, reversible, noncompetitive inhibitor of -secretase (GS) with a potential antitumor activity.

Nirogacestat is being investigated for the treatment of desmoid tumors due to its ability to bind to GS, blocking proteolytic activation of Notch receptors. Previous clinical study data have shown that Notch signaling plays an important role in cancer development. Hence, inhibition of Notch signaling is an important strategy for therapeutic treatment.

Clinical Study Identifier: NCT03785964

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Ronald Regan UCLA Medical Center

Los Angeles, CA United States
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Palo Alto, CA United States
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Sarcoma Oncology Research Center

Santa Monica, CA United States
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Durham, NC United States
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Cincinnati, OH United States
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Columbus, OH United States
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Portland, OR United States
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Philadelphia, PA United States
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Pittsburgh, PA United States
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Seattle, WA United States
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Madison, WI United States
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Milwaukee, WI United States
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Montréal, QC Canada
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Bordeaux Cedex, France
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Montpellier Cedex 5, France
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Saint-Herblain, France
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Amsterdam, Netherlands
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Leiden, Netherlands
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Nijmegen, Netherlands
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Birmingham, United Kingdom
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London, United Kingdom
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Preston, United Kingdom
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SpringWorks'site

New Haven, CT United States
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Mayo Clinic Florida

Jacksonville, FL United States
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Montréal, QC Canada
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Montréal, QC Canada
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Montréal, QC Canada
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Montréal, QC Canada
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Montréal, QC Canada
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Montréal, QC Canada
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Montréal, QC Canada
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Montréal, QC Canada
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Northwell Health

Lake Success, NY United States
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Fox Chase Cancer Center

Philadelphia, PA United States
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Montréal, QC Canada
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Montréal, QC Canada
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Stanford Cancer Center

Palo Alto, CA United States
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University of Michigan

Ann Arbor, MI United States
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Montréal, QC Canada
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Montréal, QC Canada
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Montréal, QC Canada
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Montréal, QC Canada
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DUMC/Duke Cancer Center

Durham, NC United States
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UPMC Hillman Cancer Ceter

Pittsburgh, PA United States
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Johns Hopkins Hospital

Baltimore, MD United States
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UZ Leuven

Leuven, Belgium
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SpringWorks' site

Tampa, FL United States
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UZ Gent

Gent, Belgium
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Arkansas Children's Hospital

Little Rock, AR United States
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Henry-Joyce Cancer Clinic

Nashville, TN United States
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UCSF Mission Bay

San Francisco, CA United States
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Mayo Clinic Rochester

Rochester, MN United States
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Recruitment Status: Open


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