Ignite Creation Date:
2024-05-06 @ 3:30 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04657679
Status:
TERMINATED
Last Update Posted:
2024-02-05
First Post:
2020-11-20
Brief Title:
Pharmacokinetics and Pharmacogenomics of Ribociclib in Race-based Cohorts
Sponsor:
Georgetown University
Organization:
Georgetown University
Study Overview
Official Title:
evaLuation of Variations pharmacokinEtics and phArmacogeNOmics of Ribociclib in rAce-based Cohorts The LEANORA Study
Status:
TERMINATED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sufficient accrual into the African AmericanBlack patient cohort and insufficient accrual into the NHW patient cohort
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LEANORA
Brief Summary:
The aim is to determine the pharmacological and biochemical association between ribociclib exposure and CYP3A variants in African AmericanBlacks 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
Detailed Description:
This prospective multicenter cohort study will assess ribociclib 600 mg PO daily pharmacokinetics and pharmacogenomics in female patients with HRHER2- metastatic breast cancer This design will be used for two independent race-based cohorts 18 African AmericanBlack patients and 18 Non-Hispanic White patients Women are eligible if they are older than 18 have HRHER2- mBC and are candidates for treatment with a CDK 46 inhibitor and endocrine therapy Patients are ineligible if currently prescribed a medication that inhibits or induces the CYP3A isoenzymes have baseline electrocardiogram abnormalities or are otherwise considered to be ineligible for ribociclib Participants will provide serial blood samples during the first cycle collected immediately prior to the ribociclib dose and 05hr 5min 1hr 5min 2hr 15min 4hr 15min 6hr 15min after the daily dose of ribociclib Plasma samples will be analyzed via mass spectrometry to characterize the pharmacokinetics eg AUC0-24 Cmax Pharmacogenetic testing will be performed using the PharmacoScanTM microarray which tests 4627 markers in 1191 genes including variants in CYP3A4 and CYP3A5
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None