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

NCT03785964 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2026-08-20

Study results available
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Summary

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.

Conditions

  • Desmoid Tumor
  • Aggressive Fibromatosis

Interventions

DRUG

Nirogacestat oral tablet

Nirogacestat tablet

DRUG

Placebo Oral Tablet

Sugar pill manufactured to mimic nirogacestat 50 mg tablet

Sponsors & Collaborators

  • SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany

    lead INDUSTRY

Principal Investigators

  • Bernd Kasper, MD · Mannheim University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-17
Primary Completion
2022-04-07
Completion
2024-10-17
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • Germany
  • Italy
  • Netherlands
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03785964 on ClinicalTrials.gov