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Pharmacokinetics and Pharmacogenomics of Ribociclib in Race-based Cohorts

NCT04657679 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2024-11-26

Study results available
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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.

Conditions

Interventions

DRUG

Ribociclib

Patients will receive ribociclib 600 mg oral (PO) daily for 21 consecutive days of 28-day cycles and endocrine therapy with either letrozole or fulvestrant. Fulvestrant 500 mg intramuscular (IM) will be administered on days 1, 15, 29 of cycle one, and then monthly. Letrozole 2.5 mg oral daily continuously. If premenopausal women have not undergone bilateral salpingo- oophorectomy, they will receive a luteinizing hormone-releasing hormone (LHRH) agonist (e.g., goserelin leuprolide) for ovarian suppression in combination with fulvestrant or letrozole and ribociclib.

Sponsors & Collaborators

  • Medstar Health Research Institute

    collaborator OTHER

  • Breast Cancer Research Foundation

    collaborator OTHER

  • Georgetown-Howard Universities Center for Clinical and Translational Science (GHUCCTS)

    collaborator OTHER

  • National Cancer Institute (NCI)

    collaborator NIH

  • Georgetown University

    lead OTHER

Principal Investigators

  • Sandra Swain, MD · Georgetown University

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-20
Primary Completion
2023-10-30
Completion
2023-10-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04657679 on ClinicalTrials.gov