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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 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.
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.
Interventions
- DRUG Ribociclib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2016-04 |
| Est. Completion | 2018-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02607124
The ClinicalTrials.gov registry entry for NCT02607124 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Ribociclib is the first listed.
NCT02607124 reports 0 study locations.
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.
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