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NCT04655404 · ClinicalTrials.gov registry record · Early Phase 1
A Pilot Study of Larotrectinib for Newly-Diagnosed High-Grade Glioma With NTRK Fusion
A Early Phase 1 study of High Grade Glioma and Diffuse Intrinsic Pontine Glioma, sponsored by Nationwide Children's Hospital.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 15
- Enrollment target
- 20
- Study locations
NCT04655404: Recruiting Early Phase 1 study of High Grade Glioma and Diffuse Intrinsic Pontine Glioma, sponsored by Nationwide Children's Hospital.
NCT04655404 is a Early Phase 1 study of High Grade Glioma and Diffuse Intrinsic Pontine Glioma that is actively recruiting participants, run by Nationwide Children's Hospital. The registered enrollment target is 15 participants, below the 65-participant average among 42 other High Grade Glioma trials with a reported enrollment target (77% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04655404, a Early Phase 1 study of High Grade Glioma and Diffuse Intrinsic Pontine Glioma, is actively recruiting participants, sponsored by Nationwide Children's Hospital.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 15 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a pilot study that will evaluate disease status in children that have been newly diagnosed high-grade glioma with TRK fusion. The evaluation will occur after 2 cycles of the medication (Larotrectinib) have been given. The study will also evaluate the safety of larotrectinib when given with chemotherapy in your children; as well as the safety larotrectinib when given post-focal radiation therapy.
Primary Outcome
To assess the disease control rate (Complete Response \[CR\], Continued Complete Response \[CCR\], Partial Response \[PR\] and Stable Disease \[SD\]) of larotrectinib in young children newly diagnosed with HGG carrying NTRK fusion after 2 cycles of larotrectinib monotherapy.
Conditions Studied
Interventions
- DRUG Larotrectinib
- PROCEDURE Larotrectinib surgical
Study Locations (20)
Other
- University Medical Center Augsburg - Augsburg
- University Hospital Berlin - Berlin
- University Hospital Koln - Cologne
- University Medical Center Gottingen - Göttingen
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 Health System - Durham
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2021-04-08 |
| Est. Completion | 2036-12-01 |
| Phase | Early Phase 1 |
What NCT04655404 shows while recruiting
NCT04655404 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 65-participant average among 42 other High Grade Glioma trials with a reported enrollment target (77% lower).
The record links to 2 conditions, with High Grade Glioma appearing as the primary indexed condition, and to 2 interventions - of which Larotrectinib is the first listed.
NCT04655404 names 20 study sites across 16 states, led by Other, Ohio, Colorado.
Frequently Asked Questions
What is clinical trial NCT04655404 about?
NCT04655404 is a clinical study titled "A Pilot Study of Larotrectinib for Newly-Diagnosed High-Grade Glioma With NTRK Fusion". This is a pilot study that will evaluate disease status in children that have been newly diagnosed high-grade glioma with TRK fusion. The evaluation will occur after 2 cycles of the medication (Larotrectinib) have been given. The study will also evaluate the safety of larotrectinib when given with ...
What is the current status of trial NCT04655404?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 15 participants. The study started on 2021-04-08. Estimated completion is 2036-12-01.
What conditions does trial NCT04655404 study?
This clinical trial studies the following conditions: High Grade Glioma, Diffuse Intrinsic Pontine Glioma.
What interventions are being tested in trial NCT04655404?
The interventions under investigation include: Larotrectinib (DRUG), Larotrectinib surgical (PROCEDURE).
Who is sponsoring clinical trial NCT04655404?
This trial is sponsored by Nationwide Children's Hospital, which has 188 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04655404 being conducted?
This trial has 20 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
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Where NCT04655404's enrollment target sits among peer trials
15 38th of 42 higher than 4 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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