Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03785964 · ClinicalTrials.gov registry record · Phase 3
Nirogacestat for Adults With Desmoid Tumor/Aggressive Fibromatosis (DT/AF)
A Phase 3 study, sponsored by SpringWorks Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 142
- Enrollment target
NCT03785964: Completed Phase 3 study, sponsored by SpringWorks Therapeutics.
NCT03785964 is a Phase 3 study that has completed, run by SpringWorks Therapeutics. The registered enrollment target is 142 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03785964, a Phase 3 study, has completed, sponsored by SpringWorks Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 142 participants
- Enrollment target
Study 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.
Primary Outcome
Progression will be determined radiographically using RECIST v1.1 (Eisenhauer, 2009) or clinically as assessed by the investigator. Clinical progression is defined as the onset or worsening of symptoms resulting in a global deterioration of health status causing the permanent discontinuation from study treatment and the initiation of emergent treatment (e.g., radiotherapy, surgery, or systemic therapy including chemotherapy or tyrosine kinase inhibitors) for DT/AF. Events of clinical progression
Interventions
- DRUG Placebo Oral Tablet
- DRUG Nirogacestat oral tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 142 participants |
| Start Date | 2019-04-17 |
| Est. Completion | 2024-10-17 |
| Phase | Phase 3 |
What the finished NCT03785964 record still lists
NCT03785964 is an interventional study that assigns participants to a tested intervention. The registered 142 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo Oral Tablet is the first listed.
NCT03785964 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03785964 about?
NCT03785964 is a clinical study titled "Nirogacestat for Adults With Desmoid Tumor/Aggressive Fibromatosis (DT/AF)". 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...
What is the current status of trial NCT03785964?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 142 participants. The study started on 2019-04-17. Estimated completion is 2024-10-17.
What interventions are being tested in trial NCT03785964?
The interventions under investigation include: Placebo Oral Tablet (DRUG), Nirogacestat oral tablet (DRUG).
Who is sponsoring clinical trial NCT03785964?
This trial is sponsored by SpringWorks Therapeutics, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03785964's enrollment target sits among peer trials
142 1559th of 2000 higher than 438 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03933631 · 142 participants · Phase 3
Pilocarpine Use After Kahook Goniotomy
- NCT04938349 · 142 participants · NA
Dual Task Perturbation Training for OAwMCI
- NCT06117254 · 142 participants · NA
Hearing Aids for Veterans With Functional Hearing Difficulties
- NCT06463665 · 142 participants · Phase 2
Efficacy & Safety of Olvimulogene Nanivacirepvec & Platinum-doublet + Physician's Choice of Immune Checkpoint Inhibitor Compared to Docetaxel in NSCL Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI