At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 142 enrolled
Drug / intervention
Nirogacestat oral tablet +1 moredrug
Likely dose
Placebo Oral Tablet 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Nirogacestat Versus Placebo in Adult Patients With Progressing Desmoid Tumors/Aggressive Fibromatosis (DT/AF)
In Brief
A Phase 3 clinical trial evaluating Nirogacestat oral tablet and Placebo Oral Tablet for Desmoid Tumor and Aggressive Fibromatosis. Completed, enrolled 142 participants across 52 sites in 7 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDesmoid Tumor, Aggressive Fibromatosis
CountriesBelgium, Canada, Germany, Italy, Netherlands, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedDec 2018
Enrollment StartApr 2019
Primary CompletionApr 2022
Study CompletionOct 2024
TodayJul 2026
First PostedDec 24, 2018
Enrollment StartApr 17, 2019
Primary CompletionApr 7, 2022
Study CompletionOct 17, 2024
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 7.5 years ago
Interventions
Nirogacestat oral tabletdrug
Nirogacestat tablet
Placebo Oral Tabletdrug
Sugar pill manufactured to mimic nirogacestat 50 mg tablet