RecruitingPhase 4NCT07158164
DPYD Pharmacogenomics and Fluoropyrimidine (FP) Dose-Adjustment
Sponsor
Rutgers, The State University of New Jersey
Enrollment
100 participants
Start Date
Aug 27, 2025
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria8
- 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.
Exclusion Criteria3
- 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
Interventions
DRUGFluorouracil injection
Experimental arm Fluorouracil injection with possible escalation to 75 or 100 percent if tolerated.
DRUGXeloda
Experimental arm Fluorouracil injection with possible escalation to 75 or 100 percent if tolerated.
Locations(12)
View Full Details on ClinicalTrials.gov
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NCT07158164
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