IRB #

STUDY00019313

Title

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Nirogacestat Versus Placebo in Adult Patients with Progressing Desmoid Tumors/Aggressive Fibromatosis (DT/AF)

Principal Investigator

Lara Davis

Study Purpose

The purpose of this study is to compare the effectiveness and safety of the study drug, nirogacestat, versus placebo on desmoid tumors.

Medical Condition(s)

Progressing Desmoid Tumors/Aggressive Fibromatosis

Eligibility Criteria

1. Must be at least 18 years of age
2. Must have clinically confirmed progressing Desmoid Tumors/Aggressive Fibromatosis (DT/AF)

Other eligibility criteria will apply.

Age Range

18 - 100

Healthy Volunteers Needed

No

Duration of Participation

Participants will receive the study drug until their disease gets worse or they develop intolerable side effects, this may last for up to 2 years.

An open-label extension will be offered to those participants that qualify.



Minors Included

No

Contact

Knight Cancer Institute Clinical Trials
trials@ohsu.edu
503 494-1080

Sponsor

SpringWorks Therapeutics

Recruitment End

03/29/2025

Compensation Provided

No


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