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DPYD Pharmacogenomics and Fluoropyrimidine (FP) Dose-Adjustment

NCT07158164 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-11-13

No results posted yet for this study

Summary

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.

Conditions

  • Colorectal Neoplasms
  • Breast Neoplasms
  • Head and Neck Neoplasms
  • Gastro-Intestinal Intraepithelial Neoplasia

Interventions

DRUG

Fluorouracil injection

Experimental arm Fluorouracil injection with possible escalation to 75 or 100 percent if tolerated.

DRUG

Xeloda

Experimental arm Fluorouracil injection with possible escalation to 75 or 100 percent if tolerated.

Sponsors & Collaborators

  • Rutgers, The State University of New Jersey

    lead OTHER

Principal Investigators

  • Howard S. Hochster, MD · Study Principal Investigator

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-27
Primary Completion
2027-07-07
Completion
2029-07-07
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT07158164 on ClinicalTrials.gov