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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: Completed Phase 1 study of Diffuse Intrinsic Pontine Glioma and Diffuse Midline Glioma, sponsored by Luca Szalontay.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Safety of repeated convection-enhanced delivery (CED) of MTX110 will be reported by summarizing the incidence rate of adverse events observed or reported. Adverse events will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2020-03-10 |
| Est. Completion | 2023-11-22 |
| Phase | Phase 1 |
What the finished NCT04264143 record still lists
NCT04264143 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 135-participant average among 28 other Diffuse Intrinsic Pontine Glioma trials with a reported enrollment target (93% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT04264143's enrollment target sits among peer trials
9 28th of 28 higher than 1 of 28 other Diffuse Intrinsic Pontine Glioma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diffuse Intrinsic Pontine Glioma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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