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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 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.

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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.

Conditions Studied

Glioblastoma Glioblastoma Multiforme High Grade Glioma Anaplastic Astrocytoma Diffuse Intrinsic Pontine Glioma Diffuse Midline Glioma, H3 K27M-Mutant WHO Grade III Glioma Metastatic Brain Tumor WHO Grade IV Glioma Diffuse Hemispheric Glioma, H3 G34-Mutant

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

FieldValue
Enrollment Target 120 participants
Start Date 2024-08-22
Est. Completion 2034-08-28
Phase Phase 2

Sponsor

Nationwide Children's Hospital

188 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05843253

The ClinicalTrials.gov registry entry for NCT05843253 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 108-participant average among 199 other Glioblastoma trials with a reported enrollment target (11% higher). The listed sponsor is Nationwide Children's Hospital, which has 188 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 19 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.