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NCT02607124 · ClinicalTrials.gov registry record · Phase 1
A Phase I/II Study of Ribociclib,a CDK4/6 Inhibitor, Following Radiation Therapy
A Phase 1 study, sponsored by Children's Hospital Medical Center, Cincinnati.
- Terminated
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
NCT02607124: Clinical Trial Phase 1 study, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT02607124 is a Phase 1 study that was terminated before completion, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 11 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02607124, a Phase 1 study, was terminated before completion, sponsored by Children's Hospital Medical Center, Cincinnati.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
Study Summary
In this research study the investigators want to learn more about the effects, both good and bad, when the study drug Ribociclib is given after radiation therapy. The investigators are asking people to be in this research study that have been newly diagnosed with a high grade glioma, and the tumor has been screened for the Rb1 protein, and have recently finished radiation therapy. Patients with a DIPG or a Bi-thalamic high grade glioma do not need to have 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 called cyclin-dependent kinases (CDK 4 and 6) that control cell division. Another protein Rb1 also controls cell division and works to stop cells from dividing so they do not become cancer cells. But in cancer, the CDK 4 and 6 proteins are out of control making the cells divide and grow quickly. The study drug, ribociclib stops the CDK 4 and 6 proteins. When the CDK 4 and 6 proteins are stopped, the normal Rb1 protein can now work to slow cell growth. For patients with HGG, to be in this study tumor tissue must have a normal Rb1 protein. The researchers think that if the study drug is given soon after radiation therapy, it may help improve the effect of the radiation in stopping the tumor from growing. The study drug, Ribociclib is considered investigational as it has not yet been approved by the United States Food and Drug Administration. The study drug has been tested in children and adults with cancer in prior research studies.
Primary Outcome
Primary feasibility endpoint is the number of individual toxicities and incidence of significant delays
Interventions
- DRUG Ribociclib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2016-04 |
| Est. Completion | 2018-08 |
| Phase | Phase 1 |
Why NCT02607124 stopped before completion
NCT02607124 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 1 intervention - of which Ribociclib is the first listed.
NCT02607124 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02607124 about?
NCT02607124 is a clinical study titled "A Phase I/II Study of Ribociclib,a CDK4/6 Inhibitor, Following Radiation Therapy". In this research study the investigators want to learn more about the effects, both good and bad, when the study drug Ribociclib is given after radiation therapy. The investigators are asking people to be in this research study that have been newly diagnosed with a high grade glioma, and the tumor ...
What is the current status of trial NCT02607124?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2016-04. Estimated completion is 2018-08.
What interventions are being tested in trial NCT02607124?
The interventions under investigation include: Ribociclib (DRUG).
Who is sponsoring clinical trial NCT02607124?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02607124's enrollment target sits among peer trials
11 1911th of 2000 higher than 88 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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