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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT03785964

Public ClinicalTrials.gov record NCT03785964. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 24, 2026, 11:03 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official 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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This study evaluates nirogacestat (PF-03084014) in the treatment of desmoid tumor/aggressive fibromatosis (DT/AF). In the double-blind phase, half of the participants will receive nirogacestat while the other half will receive placebo. Once participants are eligible to roll into the open-label phase, they will receive nirogacestat.

Study identification

NCT ID
NCT03785964
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Enrollment
142 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 17, 2019 (Actual)
Primary completion
Apr 7, 2022 (Actual)
Completion
Oct 17, 2024 (Actual)
Last update posted
Aug 20, 2026

2019 – 2024

United States locations

U.S. sites
34
U.S. states
21
U.S. cities
30
Facility City State ZIP Site status
Arkansas Children's Hospital Little Rock Arkansas 72202 —
USC/Norris Comprehensive Cancer Center Los Angeles California 90033 —
Ronald Regan UCLA Medical Center Los Angeles California 90095 —
Stanford Cancer Center Palo Alto California 94304 —
UCSF Mission Bay San Francisco California 94158 —
Sarcoma Oncology Research Center Santa Monica California 90403 —
University of Colorado Hospital-Anschutz Cancer Pavilion (ACP) Aurora Colorado 80045 —
Smilow Cancer Hospital at Yale-New Haven New Haven Connecticut 06510 —
Washington Cancer Institute at MedStar Washington Hospital Center Washington D.C. District of Columbia 20010 —
Mayo Clinic Florida Jacksonville Florida 32224 —
Sylvester Comprehensive Cancer Center Miami Florida 33136 —
Northwestern Memorial Hospital Chicago Illinois 60611 —
Johns Hopkins Hospital Baltimore Maryland 21287 —
Massachusetts General Hosptial (MGH) Boston Massachusetts 02114 —
Dana-Farber Cancer Institute (DFCI) Boston Massachusetts 02215 —
University of Michigan Ann Arbor Michigan 48109 —
Mayo Clinic Rochester Rochester Minnesota 55905 —
Washington University School of Medicine St Louis Missouri 63110 —
Northwell Health Lake Success New York 11042 —
Columbia University Medical Center New York New York 10032 —
Memorial Sloan Kettering Cancer Center New York New York 10065 —
DUMC/Duke Cancer Center Durham North Carolina 27710 —
Cincinnati Children's Hospital Medical Center Cincinnati Ohio 45229 —
James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center Columbus Ohio 43210 —
Oregon Health & Science University-Center for Health & Healing Portland Oregon 97201 —
Abramson Cancer Center at Pennsylvania Hospital Philadelphia Pennsylvania 19106 —
Fox Chase Cancer Center Philadelphia Pennsylvania 19111 —
UPMC Hillman Cancer Center Pittsburgh Pennsylvania 15232 —
Henry-Joyce Cancer Clinic Nashville Tennessee 37232 —
UT Southwestern Medical Center Dallas Texas 75390 —
The University of Texas MD Anderson Cancer Center Houston Texas 77030 —
Seattle Cancer Care Alliance Seattle Washington 98109 —
University of Wisconsin Clinical Science Center Madison Wisconsin 53792 —
Froedtert Hospital & the Medical College of Wisconsin Milwaukee Wisconsin 53226 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 18 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03785964, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 20, 2026 · Synced Oct 24, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03785964 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →