drugset / Trial / NCT07158164
DPYD Pharmacogenomics and Fluoropyrimidine (FP) Dose-Adjustment
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2025-08-27
- Primary completion
- 2027-07-07
- Completion
- 2029-07-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | — | Oral |
| Subject | fluorouracil | Small molecule | 200 mg/m2 | — |
| Subject | fluorouracil | Small molecule | 1200 mg/m2 | — |