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NCT04264143 · ClinicalTrials.gov registry record · Phase 1

CED of MTX110 Newly Diagnosed Diffuse Midline Gliomas

A Phase 1 study of Diffuse Intrinsic Pontine Glioma and Diffuse Midline Glioma, sponsored by Luca Szalontay.

Completed
Registry status
Phase 1
Development phase
9
Enrollment target
1
Study location

NCT04264143 is a Phase 1 study of Diffuse Intrinsic Pontine Glioma and Diffuse Midline Glioma that has completed, run by Luca Szalontay. The registered enrollment target is 9 participants, below the 135-participant average among 28 other Diffuse Intrinsic Pontine Glioma trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04264143, a Phase 1 study of Diffuse Intrinsic Pontine Glioma and Diffuse Midline Glioma, has completed, sponsored by Luca Szalontay.

COMPLETED
Registry status
Phase 1
Development phase
9 participants
Enrollment target
1
Study location

Study Summary

The blood brain barrier (BBB) prevents some drugs from successfully reaching the target source. Convection-Enhanced Delivery (CED) is a method of direct infusion of drugs under controlled pressure to the tumor that may reduce systemic side effects of drugs in the patient. The purpose of this Phase I study is to find the maximum tolerated dose of MTX110 (a water-soluble Panobinostat nanoparticle formulation) and Gadolinium that can be given safely in children with newly diagnosed diffuse midline gliomas. All patients enrolled in the study will receive infusion of MTX110 and Gadolinium delivered with a pump directly into the tumor over 9-11 days.

Interventions

  • DRUG Infusate with MTX110 and gadolinium
  • DEVICE Convection-Enhanced Delivery (CED)

Study Locations (1)

New York

  • Columbia University Irving Medical Center - New York

Trial Details

FieldValue
Enrollment Target 9 participants
Start Date 2020-03-10
Est. Completion 2023-11-22
Phase Phase 1

Sponsor

Luca Szalontay

1 total trials

What the Registry Record Tells You About NCT04264143

The ClinicalTrials.gov registry entry for NCT04264143 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 135-participant average among 28 other Diffuse Intrinsic Pontine Glioma trials with a reported enrollment target (93% lower). The listed sponsor is Luca Szalontay, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Diffuse Intrinsic Pontine Glioma appearing as the primary indexed condition, and to 2 interventions - of which Infusate with MTX110 and gadolinium is the first listed.

NCT04264143 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.

Frequently Asked Questions

What is clinical trial NCT04264143 about?

NCT04264143 is a clinical study titled "CED of MTX110 Newly Diagnosed Diffuse Midline Gliomas". The blood brain barrier (BBB) prevents some drugs from successfully reaching the target source. Convection-Enhanced Delivery (CED) is a method of direct infusion of drugs under controlled pressure to the tumor that may reduce systemic side effects of drugs in the patient. The purpose of this Phase ...

What is the current status of trial NCT04264143?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2020-03-10. Estimated completion is 2023-11-22.

What conditions does trial NCT04264143 study?

This clinical trial studies the following conditions: Diffuse Intrinsic Pontine Glioma, Diffuse Midline Glioma, Diffuse Pontine and Thalamic Gliomas.

What interventions are being tested in trial NCT04264143?

The interventions under investigation include: Infusate with MTX110 and gadolinium (DRUG), Convection-Enhanced Delivery (CED) (DEVICE).

Who is sponsoring clinical trial NCT04264143?

This trial is sponsored by Luca Szalontay, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04264143 being conducted?

This trial has 1 study location across New York. 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

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