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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: Clinical Trial Phase 4 study, sponsored by Georgetown University.
NCT04657679 is a Phase 4 study that was terminated before completion, run by Georgetown University. The registered enrollment target is 21 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Compare the exposure (i.e., AUC) of ribociclib at steady-state between CYP3A5 poor metabolizers (PM) and CYP3A5 intermediate or normal metabolizers (IM/NM) in each independent race-based cohort of women with advance breast cancer
Interventions
- DRUG Ribociclib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2021-05-20 |
| Est. Completion | 2023-10-30 |
| Phase | Phase 4 |
Why NCT04657679 stopped before completion
NCT04657679 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Ribociclib is the first listed.
NCT04657679 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04657679's enrollment target sits among peer trials
21 1742nd of 2000 higher than 248 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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