DPYD Pharmacogenomics and Fluoropyrimidine (FP) Dose-Adjustment

Recruiting now · Phase 4

Conditions studied: Colorectal Neoplasms, Breast Neoplasms, Head and Neck Neoplasms, Gastro-Intestinal Intraepithelial Neoplasia

In brief

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.

Key facts

Study ID

NCT07158164

Run by

Rutgers, The State University of New Jersey

People needed

100

Starts

2025-08-27

Expected to finish

2029-07-07

Last updated by the study team

2025-11-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of cancer in either the adjuvant or metastatic setting requiring initial therapy with 5-FU or Capecitabine.
• DPYD testing performed by a CLIA-certified laboratory (i.e., Guardant 360 or Caris blood testing for genomic profiling, DPYD testing by the Mayo Clinic or other certified laboratory) with results available before starting chemotherapy.
• DPYD testing results falling into one of the following cohorts for first-line therapy with a fluoropyridine:
• Study Cohort: Patients with one DPYD variant in one gene (heterozygotes).
• Control Arm: Patients with normal or wild-type DPYD genes, for comparison, will be treated at the usual 100% dose.
• -FOLFOX regimen (N=50)
• ECOG Performance Status 0-2.
• Measurable disease or non-measurable disease allowed, including adjuvant 5-FU-based regimens.

You may not qualify if…

• Patients for whom 5-FU or Capecitabine therapy is contraindicated or not deemed appropriate in the judgment of the treating physician.
• Patients with two DPYD variants (homozygous deletions or non-functional genetic variants, or double heterozygotes with two different abnormalities) should not receive 5-FU or Capecitabine and are therefore excluded from the study.
• Pregnant Women and Children

Where it is running

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

Full record on ClinicalTrials.gov

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