DPYD Pharmacogenomics and Fluoropyrimidine (FP) Dose-Adjustment
Recruiting
Phase 4
Interventional Study
Colorectal Neoplasms
Breast Neoplasms
Head and Neck Neoplasms
Gastro-Intestinal Intraepithelial Neoplasia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 100 (estimated)
- Sponsor
- Rutgers, The State University of New Jersey · Other
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About This Trial
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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 ot…
Contacts