Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Early Phase 1

A Pilot Study of Larotrectinib for Newly-Diagnosed High-Grade Glioma With NTRK Fusion

NCT04655404 · View on ClinicalTrials.gov ↗

Study Summary

This is a pilot study that will evaluate disease status in children that have been newly diagnosed high-grade glioma with TRK fusion. The evaluation will occur after 2 cycles of the medication (Larotrectinib) have been given. The study will also evaluate the safety of larotrectinib when given with chemotherapy in your children; as well as the safety larotrectinib when given post-focal radiation therapy.

Interventions

  • DRUG Larotrectinib
  • PROCEDURE Larotrectinib surgical

Study Locations (20)

Other

  • University Medical Center Augsburg — Augsburg
  • University Hospital Berlin — Berlin
  • University Hospital Koln — Cologne
  • University Medical Center Gottingen — Göttingen

Ohio

  • Cincinnati Children's Hospital Medical Center — Cincinnati
  • Nationwide Children's Hospital — Columbus

Colorado

  • Children's Hospital Colorado — Aurora

District of Columbia

  • Children's National Medical Center — Washington D.C.

Illinois

  • Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago

Massachusetts

  • Dana-Farber Cancer Institute — Boston

North Carolina

  • Duke University Health System — Durham

Pennsylvania

  • Children's Hospital of Philadelphia — Philadelphia

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2021-04-08
Est. Completion 2036-12-01
Phase Early Phase 1

Sponsor

Nationwide Children's Hospital

239 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04655404

The ClinicalTrials.gov registry entry for NCT04655404 describes a study currently listed as recruiting. It is categorized as Early Phase 1, 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 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nationwide Children's Hospital, which has 239 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with High Grade Glioma appearing as the primary indexed condition, and to 2 interventions — of which Larotrectinib 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: NCT04655404 reports 20 study locations spanning 16 distinct geographic areas — top geographies include Other, Ohio, 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 NCT04655404 about?

NCT04655404 is a clinical study titled "A Pilot Study of Larotrectinib for Newly-Diagnosed High-Grade Glioma With NTRK Fusion". This is a pilot study that will evaluate disease status in children that have been newly diagnosed high-grade glioma with TRK fusion. The evaluation will occur after 2 cycles of the medication (Larotrectinib) have been given. The study will also evaluate the safety of larotrectinib when given with ...

What is the current status of trial NCT04655404?

This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 15 participants. The study started on 2021-04-08. Estimated completion is 2036-12-01.

What conditions does trial NCT04655404 study?

This clinical trial studies the following conditions: High Grade Glioma, Diffuse Intrinsic Pontine Glioma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04655404?

The interventions under investigation include: Larotrectinib (DRUG), Larotrectinib surgical (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04655404?

This trial is sponsored by Nationwide Children's Hospital, which has 239 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04655404 being conducted?

This trial has 20 study locations across Colorado, District of Columbia, Illinois, Massachusetts, North Carolina. 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