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

  • STATUS
    Not Recruiting
  • End date
    Mar 31, 2023
  • participants needed
    118
  • sponsor
    SpringWorks Therapeutics, Inc.
Updated on 9 May 2021
Investigator
Nicole H Leedom
Primary Contact
Arkansas Children's Hospital (2.3 mi away) Contact
+127 other location
nonsteroidal anti-inflammatory drugs
NSAID
line of therapy
fibromatosis

Summary

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.

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.

Details
Condition Aggressive fibromatosis, Desmoid Tumors
Treatment Placebo Oral Tablet, Nirogacestat oral tablet
Clinical Study IdentifierNCT03785964
SponsorSpringWorks Therapeutics, Inc.
Last Modified on9 May 2021

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