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ACTIVE NOT RECRUITING Phase 2

A Study of a New Drug, Nirogacestat, for Treating Desmoid Tumors That Cannot be Removed by Surgery

NCT04195399 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 35 participants
Start Date 2020-10-07
Est. Completion 2032-12-31
Phase Phase 2

Sponsor

Children's Oncology Group

318 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04195399

The ClinicalTrials.gov registry entry for NCT04195399 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Oncology Group, which has 318 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04195399 reports 20 study locations spanning 8 distinct geographic areas — top geographies include California, Alabama, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04195399?

This trial is sponsored by Children's Oncology Group, which has 318 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial