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NCT04195399 · ClinicalTrials.gov registry record · Phase 2
A Study of a New Drug, Nirogacestat, for Treating Desmoid Tumors That Cannot be Removed by Surgery
A Phase 2 study of Desmoid Fibromatosis and Recurrent Desmoid Fibromatosis, sponsored by Children's Oncology Group.
- Active
- Registry status
- Phase 2
- Development phase
- 35
- Enrollment target
- 20
- Study locations
NCT04195399: Active Phase 2 study of Desmoid Fibromatosis and Recurrent Desmoid Fibromatosis, sponsored by Children's Oncology Group.
NCT04195399 is a Phase 2 study of Desmoid Fibromatosis and Recurrent Desmoid Fibromatosis that is active but no longer recruiting, run by Children's Oncology Group. The registered enrollment target is 35 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04195399, a Phase 2 study of Desmoid Fibromatosis and Recurrent Desmoid Fibromatosis, is active but no longer recruiting, sponsored by Children's Oncology Group.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 35 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial studies the side effects and how well nirogacestat works in treating patients less than 18 years of age with desmoid tumors that has grown after at least one form of treatment by mouth or in the vein that cannot be removed by surgery. Nirogacestat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Primary Outcome
Will be estimated using the Kaplan-Meier method with the 95% confidence interval estimated by the Peto-Peto method.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Magnetic Resonance Imaging
- PROCEDURE Echocardiography Test
- DRUG Nirogacestat
Study Locations (20)
California
- Kaiser Permanente Downey Medical Center - Downey
- Loma Linda University Medical Center - Loma Linda
- Children's Hospital Los Angeles - Los Angeles
- Mattel Children's Hospital UCLA - Los Angeles
- UCSF Benioff Children's Hospital Oakland - Oakland
- Kaiser Permanente-Oakland - Oakland
- Lucile Packard Children's Hospital Stanford University - Palo Alto
- University of California Davis Comprehensive Cancer Center - Sacramento
- Rady Children's Hospital - San Diego - San Diego
- UCSF Medical Center-Mission Bay - San Francisco
Alabama
- Children's Hospital of Alabama - Birmingham
- USA Health Strada Patient Care Center - Mobile
Colorado
- Children's Hospital Colorado - Aurora
- Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center - Denver
District of Columbia
- MedStar Georgetown University Hospital - Washington D.C.
- Children's National Medical Center - Washington D.C.
Arizona
- Banner Children's at Desert - Mesa
Arkansas
- Arkansas Children's Hospital - Little Rock
Connecticut
- Connecticut Children's Medical Center - Hartford
Delaware
- Alfred I duPont Hospital for Children - Wilmington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2020-10-07 |
| Est. Completion | 2032-12-31 |
| Phase | Phase 2 |
What the registry record for NCT04195399 still lists
NCT04195399 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).
The record links to 3 conditions, with Desmoid Fibromatosis appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT04195399 names 20 study sites across 8 states, led by California, Alabama, Colorado.
Frequently Asked Questions
What is clinical trial NCT04195399 about?
NCT04195399 is a clinical study titled "A Study of a New Drug, Nirogacestat, for Treating Desmoid Tumors That Cannot be Removed by Surgery". This phase II trial studies the side effects and how well nirogacestat works in treating patients less than 18 years of age with desmoid tumors that has grown after at least one form of treatment by mouth or in the vein that cannot be removed by surgery. Nirogacestat may stop the growth of tumor cel...
What is the current status of trial NCT04195399?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 35 participants. The study started on 2020-10-07. Estimated completion is 2032-12-31.
What conditions does trial NCT04195399 study?
This clinical trial studies the following conditions: Desmoid Fibromatosis, Recurrent Desmoid Fibromatosis, Unresectable Desmoid Fibromatosis.
What interventions are being tested in trial NCT04195399?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Echocardiography Test (PROCEDURE), Nirogacestat (DRUG).
Who is sponsoring clinical trial NCT04195399?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04195399 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Desmoid Fibromatosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04195399's enrollment target sits among peer trials
35 1524th of 2000 higher than 462 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
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