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ACTIVE NOT RECRUITING Phase 1

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

NCT03605550 · View on ClinicalTrials.gov ↗

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

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

239 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03605550

The ClinicalTrials.gov registry entry for NCT03605550 describes a study currently listed as active not recruiting. It is categorized as 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 64 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 Radiotherapy 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: NCT03605550 reports 10 study locations spanning 9 distinct geographic areas — top geographies include Ohio, Colorado, District of Columbia. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03605550?

The interventions under investigation include: Radiotherapy (RADIATION), PTC596 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03605550?

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 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.

Related

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