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NCT03605550 · ClinicalTrials.gov registry record · Phase 1

A Phase 1b Study of PTC596 in Children With Newly Diagnosed Diffuse Intrinsic Pontine Glioma and High Grade Glioma

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

Active
Registry status
Phase 1
Development phase
64
Enrollment target
10
Study locations

NCT03605550 is a Phase 1 study of High Grade Glioma and Diffuse Intrinsic Pontine Glioma that is active but no longer recruiting, run by Nationwide Children's Hospital. The registered enrollment target is 64 participants, roughly in line with the 64-participant average among 42 other High Grade Glioma trials with a reported enrollment target. The trial reports 10 study locations across 9 states.

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The verdict

NCT03605550, a Phase 1 study of High Grade Glioma and Diffuse Intrinsic Pontine Glioma, is active but no longer recruiting, sponsored by Nationwide Children's Hospital.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
64 participants
Enrollment target
10
Study locations

Study Summary

The goal of this study is to evaluate the safety of the study drug PTC596 (Unesbulin) taken in combination with radiotherapy (RT) when given to pediatric patients newly diagnosed with High-Grade Glioma (HGG) including diffuse intrinsic pontine glioma (DIPG). The main aims of the study are to: * Find the safe dose of the study drug PTC596that can be given without causing serious side effects. * Find out the amount of drug that enters blood (in all patients) and tumor (in patients who receive drug prior to a planned surgery for removal of their brain tumor) During the first cycle (6-7weeks), patients will receive drug orally twice a week in combination with daily RT. During subsequent cycles (4 weeks each), they will receive only the study drug orally twice a week. Funding Source - FDA OOPD

Conditions Studied

High Grade Glioma Diffuse Intrinsic Pontine Glioma

Interventions

  • RADIATION Radiotherapy
  • DRUG PTC596

Study Locations (10)

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 Medical Center - Durham

Pennsylvania

  • The Children's Hospital of Philadelphia - Philadelphia

Texas

  • Texas Children's Hospital - Houston

Trial Details

FieldValue
Enrollment Target 64 participants
Start Date 2018-08-01
Est. Completion 2029-03-01
Phase Phase 1

Sponsor

Nationwide Children's Hospital

188 total trials

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What the Registry Record Tells You About NCT03605550

The ClinicalTrials.gov registry entry for NCT03605550 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 64-participant average among 42 other High Grade Glioma trials with a reported enrollment target. 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 Radiotherapy is the first listed.

NCT03605550 reports 10 study locations spanning 9 distinct geographic areas - top geographies include Ohio, Colorado, District of Columbia.

Frequently Asked Questions

What is clinical trial NCT03605550 about?

NCT03605550 is a clinical study titled "A Phase 1b Study of PTC596 in Children With Newly Diagnosed Diffuse Intrinsic Pontine Glioma and High Grade Glioma". The goal of this study is to evaluate the safety of the study drug PTC596 (Unesbulin) taken in combination with radiotherapy (RT) when given to pediatric patients newly diagnosed with High-Grade Glioma (HGG) including diffuse intrinsic pontine glioma (DIPG). The main aims of the study are to: * Fi...

What is the current status of trial NCT03605550?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 64 participants. The study started on 2018-08-01. Estimated completion is 2029-03-01.

What conditions does trial NCT03605550 study?

This clinical trial studies the following conditions: High Grade Glioma, Diffuse Intrinsic Pontine Glioma.

What interventions are being tested in trial NCT03605550?

The interventions under investigation include: Radiotherapy (RADIATION), PTC596 (DRUG).

Who is sponsoring clinical trial NCT03605550?

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

Where is trial NCT03605550 being conducted?

This trial has 10 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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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.