Clinical trialNCT07158164RecruitingPhase 4Interventional

DPYD Pharmacogenomics and Fluoropyrimidine (FP) Dose-Adjustment

SponsorRutgers, The State University of New JerseyEnrollment100Breast NeoplasmsColorectal NeoplasmsGastro-Intestinal Intraepithelial NeoplasiaHead and Neck Neoplasms

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

To prospectively evaluate the efficacy and safety of DPYD-guided dosing strategies in a real-world clinical setting, specifically by comparing the incidence of severe (Grade 3 and 4) fluoropyrimidine-related toxicities of heterozygous DPYD variant patients assigned to DPYD-guided reduced dosing versus patients with standard dosing in the control arm.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Howard S. Hochster, MD
Study Principal Investigator
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

12 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Rwjbarnabas Health Clara Maas Medical Center
Belleville, New Jersey, United States
Recruiting
Trinitas Hospital and Comprehensive Cancer Center
Elizabeth, New Jersey, United States
Recruiting
Rwjbarnabas Health - Robert Wood Johnson University Hospital, Hamilton
Hamilton, New Jersey, United States
Recruiting
Rwjbarnabas Health Jersey City Medical Center
Jersey City, New Jersey, United States
Recruiting
Cooperman Barnabas Medical Center
Livingston, New Jersey, United States
Recruiting
Jack and Sheryl Morris Cancer Center
New Brunswick, New Jersey, United States
Recruiting
Rwjbarnabas Health - Robert Wood Johnson University Hospita
New Brunswick, New Jersey, United States
Recruiting
Cancer Center Initiative
Newark, New Jersey, United States
Recruiting
Rwjbarnabas Health Newark Beth Israel Medical Center
Newark, New Jersey, United States
Recruiting
University Hospital
Newark, New Jersey, United States
Recruiting
Rwjbarnabas Health - Robert Wood Johnson University Hospital Somerset
Somerville, New Jersey, United States
Recruiting
Rwjbarnabas Health - Community Medical Center
Toms River, New Jersey, United States
Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Fluorouracil →Capecitabine →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 27 Aug 2025
Primary completion: 7 Jul 2027
Completion: 7 Jul 2029
Last update posted: 13 Nov 2025
Registered enrollment: 100
Registry id: NCT07158164

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.