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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: Active Phase 1 study of High Grade Glioma and Diffuse Intrinsic Pontine Glioma, sponsored by Nationwide Children's Hospital.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
To determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of PTC596 given concurrently with radiation in newly-diagnosed patients with DIPG or HGG (Parts A and C)
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2018-08-01 |
| Est. Completion | 2029-03-01 |
| Phase | Phase 1 |
What the registry record for NCT03605550 still lists
NCT03605550 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, roughly in line with the 64-participant average among 42 other High Grade Glioma trials with a reported enrollment target.
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 lists 10 locations in 9 states (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.
Learn More About Clinical Trials
Similar trials for High Grade Glioma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03605550's enrollment target sits among peer trials
64 9th of 42 higher than 34 of 42 other High Grade Glioma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other High Grade 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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