drugset / Trial / NCT04657679
Pharmacokinetics and Pharmacogenomics of Ribociclib in Race-based Cohorts
Phase 4
Terminated
21 enrolled
Georgetown University
Breast Cancer Research Foundation · collabGeorgetown-Howard Universities Center for Clinical and Translational Science (GHUCCTS) · collabMedstar Health Research Institute · collabNational Cancer Institute (NCI) · collab
Non-randomizedParallel-groupOpen-labelBasic science
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.
Timeline
- Start
- 2021-05-20
- Primary completion
- 2023-10-30
- Completion
- 2023-10-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ribociclib | Small molecule | 600 mg | Oral |