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NCT04657679 · ClinicalTrials.gov registry record · Phase 4
Pharmacokinetics and Pharmacogenomics of Ribociclib in Race-based Cohorts
A Phase 4 study, sponsored by Georgetown University.
- Terminated
- Registry status
- Phase 4
- Development phase
- 21
- Enrollment target
NCT04657679 is a Phase 4 study that was terminated before completion, run by Georgetown University. The registered enrollment target is 21 participants.
The verdict
NCT04657679, a Phase 4 study, was terminated before completion, sponsored by Georgetown University.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 21 participants
- Enrollment target
Study Summary
The aim is to determine the pharmacological and biochemical association between ribociclib exposure and CYP3A variants in African American/Blacks and Non-Hispanic White patients. The investigators hypothesize that patients treated with ribociclib who are CYP3A5 poor metabolizers may be exposed to higher levels of ribociclib than CYP3A5 intermediate or normal metabolizers. The findings could allow clinicians to tailor treatments to maintain therapeutic doses while limiting toxicities.
Interventions
- DRUG Ribociclib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2021-05-20 |
| Est. Completion | 2023-10-30 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04657679
The ClinicalTrials.gov registry entry for NCT04657679 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Georgetown University, which has 227 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Ribociclib is the first listed.
NCT04657679 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04657679 about?
NCT04657679 is a clinical study titled "Pharmacokinetics and Pharmacogenomics of Ribociclib in Race-based Cohorts". The aim is to determine the pharmacological and biochemical association between ribociclib exposure and CYP3A variants in African American/Blacks and Non-Hispanic White patients. The investigators hypothesize that patients treated with ribociclib who are CYP3A5 poor metabolizers may be exposed to hi...
What is the current status of trial NCT04657679?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 21 participants. The study started on 2021-05-20. Estimated completion is 2023-10-30.
What interventions are being tested in trial NCT04657679?
The interventions under investigation include: Ribociclib (DRUG).
Who is sponsoring clinical trial NCT04657679?
This trial is sponsored by Georgetown University, which has 227 total clinical trials registered on ClinicalTrials.gov.
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