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NCT05843253 · ClinicalTrials.gov registry record · Phase 2
Study of Ribociclib and Everolimus in HGG and DIPG or Ribociclib and Temozolomide in DHG, H3G34-mutant
A Phase 2 study of Glioblastoma and Glioblastoma Multiforme, sponsored by Nationwide Children's Hospital.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 20
- Study locations
NCT05843253: Recruiting Phase 2 study of Glioblastoma and Glioblastoma Multiforme, sponsored by Nationwide Children's Hospital.
NCT05843253 is a Phase 2 study of Glioblastoma and Glioblastoma Multiforme that is actively recruiting participants, run by Nationwide Children's Hospital. The registered enrollment target is 120 participants, above the 108-participant average among 199 other Glioblastoma trials with a reported enrollment target (11% higher). The trial reports 20 study locations across 19 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05843253, a Phase 2 study of Glioblastoma and Glioblastoma Multiforme, is actively recruiting participants, sponsored by Nationwide Children's Hospital.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
- 20
- Study locations
Study Summary
The goal of this study is to determine the efficacy of the 1) ribociclib and everolimus to treat pediatric and young adult patients newly diagnosed with a high-grade glioma (HGG), including DIPG, that have genetic changes in pathways (cell cycle, PI3K/mTOR) that these drugs target or 2) ribociclib and temozolomide to treat pediatric and young adult patients newly diagnosed with diffuse hemispheric glioma (DHG), H3G34-mutant. The main question the study aims to answer is whether the combinations of ribociclib and everolimus or ribociclib and temozolomide can prolong the life of patients diagnosed with HGG/DIPG or DHG H3G34-mutant.
Primary Outcome
To assess the efficacy of ribociclib and everolimus in pediatric and young adult patients newly diagnosed with HGG by estimating the distribution of PFS compared to molecularly-stratified and matched historical controls.
Conditions Studied
Interventions
- DRUG Everolimus
- DRUG Ribociclib
- DRUG Temozolomide (TMZ)
Study Locations (20)
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
Michigan
- C.S. Mott Children's Hospital - Ann Arbor
North Carolina
- Duke University Health System - Durham
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2024-08-22 |
| Est. Completion | 2034-08-28 |
| Phase | Phase 2 |
What NCT05843253 shows while recruiting
NCT05843253 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, above the 108-participant average among 199 other Glioblastoma trials with a reported enrollment target (11% higher).
The record links to 10 conditions, with Glioblastoma appearing as the primary indexed condition, and to 3 interventions - of which Everolimus is the first listed.
NCT05843253 names 20 study sites across 19 states, led by Ohio, Colorado, District of Columbia.
Frequently Asked Questions
What is clinical trial NCT05843253 about?
NCT05843253 is a clinical study titled "Study of Ribociclib and Everolimus in HGG and DIPG or Ribociclib and Temozolomide in DHG, H3G34-mutant". The goal of this study is to determine the efficacy of the 1) ribociclib and everolimus to treat pediatric and young adult patients newly diagnosed with a high-grade glioma (HGG), including DIPG, that have genetic changes in pathways (cell cycle, PI3K/mTOR) that these drugs target or 2) ribociclib a...
What is the current status of trial NCT05843253?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2024-08-22. Estimated completion is 2034-08-28.
What conditions does trial NCT05843253 study?
This clinical trial studies the following conditions: Glioblastoma, Glioblastoma Multiforme, High Grade Glioma, Anaplastic Astrocytoma, Diffuse Intrinsic Pontine Glioma.
What interventions are being tested in trial NCT05843253?
The interventions under investigation include: Everolimus (DRUG), Ribociclib (DRUG), Temozolomide (TMZ) (DRUG).
Who is sponsoring clinical trial NCT05843253?
This trial is sponsored by Nationwide Children's Hospital, which has 188 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05843253 being conducted?
This trial has 20 study locations across Colorado, District of Columbia, Illinois, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT05843253's enrollment target sits among peer trials
120 41st of 199 higher than 158 of 199 other Glioblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioblastoma 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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