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NCT03355794 · ClinicalTrials.gov registry record · Phase 1
A Study of Ribociclib and Everolimus Following Radiation Therapy in Children With Newly Diagnosed Non-biopsied Diffuse Pontine Gliomas (DIPG) and RB+ Biopsied DIPG and High Grade Gliomas (HGG)
A Phase 1 study of Glioblastoma and High Grade Glioma, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
- 7
- Study locations
NCT03355794: Completed Phase 1 study of Glioblastoma and High Grade Glioma, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT03355794 is a Phase 1 study of Glioblastoma and High Grade Glioma that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 19 participants, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (83% lower). The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03355794, a Phase 1 study of Glioblastoma and High Grade Glioma, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
- 7
- Study locations
Study Summary
In this research study, we want to learn about the safety of the study drugs, ribociclib and everolimus, when given together at different doses after radiation therapy. We also want to learn about the effects, if any, these drugs have on children and young adults with brain tumors. We are asking people to be in this research study who have been diagnosed with a high grade glioma, their tumor has been screened for the Rb1 protein, and they have recently finished radiation therapy. If a patient has DIPG or a Bi-thalamic high grade glioma, they do not need to have the tumor tissue screened for the Rb1 protein, but do need to have finished radiation therapy. Tumor cells grow and divide quickly. In normal cells, there are proteins that control how fast cells grow but in cancer cells these proteins no longer work correctly making tumor cells grow quickly. Both study drugs work in different ways to slow down the growth of tumor cells. The researchers think that if the study drugs are given together soon after radiation therapy, it may help improve the effect of the radiation in stopping or slowing down tumor growth. The study drugs, ribociclib and everolimus, have been approved by the United States Food and Drug Administration (FDA). Ribociclib is approved to treat adults with breast cancer and everolimus is approved for use in adults and children who have other types of cancers. The combination of ribociclib and everolimus has not been tested in children or in people with brain tumors and is considered investigational. The goals of this study are: * Find the safest dose of ribociclib and everolimus that can be given together after radiation. * Learn the side effects (both good and bad) the study drugs have on the body and tumor. * Measure the levels of study drug in the blood over time. * Study the changes in the endocrine system that may be caused by the tumor, surgery or radiation.
Primary Outcome
Number of individual toxicities and incidence of significant delays
Conditions Studied
Interventions
- DRUG Everolimus
- DRUG ribociclib
Study Locations (7)
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
- Nationwide Children's Hospital - Columbus
District of Columbia
- Children's National Medical Center - Washington D.C.
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago
North Carolina
- Levine Cancer Institute - Charlotte
Texas
- Texas Children's Hospital - Houston
Washington
- Seattle Children's Hospital - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2017-11-14 |
| Est. Completion | 2022-07-31 |
| Phase | Phase 1 |
What the finished NCT03355794 record still lists
NCT03355794 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (83% lower).
The record links to 7 conditions, with Glioblastoma appearing as the primary indexed condition, and to 2 interventions - of which Everolimus is the first listed.
NCT03355794 lists 7 locations in 6 states (Ohio, District of Columbia, Illinois).
Frequently Asked Questions
What is clinical trial NCT03355794 about?
NCT03355794 is a clinical study titled "A Study of Ribociclib and Everolimus Following Radiation Therapy in Children With Newly Diagnosed Non-biopsied Diffuse Pontine Gliomas (DIPG) and RB+ Biopsied DIPG and High Grade Gliomas (HGG)". In this research study, we want to learn about the safety of the study drugs, ribociclib and everolimus, when given together at different doses after radiation therapy. We also want to learn about the effects, if any, these drugs have on children and young adults with brain tumors. We are asking pe...
What is the current status of trial NCT03355794?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2017-11-14. Estimated completion is 2022-07-31.
What conditions does trial NCT03355794 study?
This clinical trial studies the following conditions: Glioblastoma, High Grade Glioma, Anaplastic Astrocytoma, Diffuse Intrinsic Pontine Glioma, Brainstem Glioma.
What interventions are being tested in trial NCT03355794?
The interventions under investigation include: Everolimus (DRUG), ribociclib (DRUG).
Who is sponsoring clinical trial NCT03355794?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03355794 being conducted?
This trial has 7 study locations across District of Columbia, Illinois, North Carolina, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03355794's enrollment target sits among peer trials
19 155th of 199 higher than 42 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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