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NCT04655404 · ClinicalTrials.gov registry record · Early Phase 1

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

A Early Phase 1 study of High Grade Glioma and Diffuse Intrinsic Pontine Glioma, sponsored by Nationwide Children's Hospital.

Recruiting
Registry status
Early Phase 1
Development phase
15
Enrollment target
20
Study locations

NCT04655404 is a Early Phase 1 study of High Grade Glioma and Diffuse Intrinsic Pontine Glioma that is actively recruiting participants, run by Nationwide Children's Hospital. The registered enrollment target is 15 participants, below the 65-participant average among 42 other High Grade Glioma trials with a reported enrollment target (77% lower). The trial reports 20 study locations across 16 states.

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The verdict

NCT04655404, a Early Phase 1 study of High Grade Glioma and Diffuse Intrinsic Pontine Glioma, is actively recruiting participants, sponsored by Nationwide Children's Hospital.

RECRUITING
Registry status
Early Phase 1
Development phase
15 participants
Enrollment target
20
Study locations

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.

Conditions Studied

High Grade Glioma Diffuse Intrinsic Pontine Glioma

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

188 total trials

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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, categorized as Early Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 65-participant average among 42 other High Grade Glioma trials with a reported enrollment target (77% lower). The listed sponsor is Nationwide Children's Hospital, which has 188 total studies on file at ClinicalTrials.gov.

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.

NCT04655404 reports 20 study locations spanning 16 distinct geographic areas - top geographies include Other, Ohio, Colorado.

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.

What interventions are being tested in trial NCT04655404?

The interventions under investigation include: Larotrectinib (DRUG), Larotrectinib surgical (PROCEDURE).

Who is sponsoring clinical trial NCT04655404?

This trial is sponsored by Nationwide Children's Hospital, which has 188 total clinical trials registered on ClinicalTrials.gov.

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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.