Clinical trial · Interventional
Pharmacogenomic and Pharmacokinetic Safety and Cost-saving Analysis in Patients Treated With Fluoropyrimidines
NCT00838370CI-TRIAL-00013930completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary purpose of this study is to prospectively determine whether capecitabine and 5-FU-induced toxicity is preventable by dose reduction prior to start of the first administration in patients heterozygous or homozygous mutant for DPYD\*2A, and to determine whether this strategy is cost-effective. Secondly, an individualized treatment algorithm for capecitabine and 5-FU therapy in DPYD\*2A mutant patients will be developed and the pharmacokinetic profile of capecitabine and 5-FU will be assessed.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine, 5-fluorouracil | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- DPYD*2A
- description
- Patients are screened for a DPD-deficiency. Patients with a DPYD\*2A mutation are eligible for intervention with capecitabine/5-FU .
- interventionNames
- Drug: Capecitabine, 5-fluorouracil
Primary outcomes (1)
- measure
- safety
- timeFrame
- during fluoropyrimidine treatment of the patient
Secondary outcomes (1)
- measure
- cost-effectiveness
- timeFrame
- during fluoropyrimidine treatment of the patient
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histological proof of cancer * patient is considered for treatment with capecitabine or 5-FU * hetero- or homozygous mutant for DPYD\*2A * able and willing to give written informed consent * able and willing to undergo blood sampling for pharmacokinetic analysis * life expectancy 3 months or longer * acceptable safety laboratory values (ANC, platelet count, ASAT, ALAT, creatinine, * WHO performance status 0-2 * no radio- or chemotherapy within the last 3 weeks prior to study entry Exclusion Criteria: * patients with known alcoholism, drug addiction and/or psychotic disorders that are not suitable for adequate follow-up * women who are pregnant or breast-feeding
References
Publications (3)
- DERIVEDKnikman JE, Lopez-Yurda M, Meulendijks D, Deenen MJ, Schellens JHM, Beijnen J, Cats A, Guchelaar HJ. A Nomogram to Predict Severe Toxicity in DPYD Wild-Type Patients Treated With Capecitabine-Based Anticancer Regimens. Clin Pharmacol Ther. 2024 Feb;115(2):269-277. doi: 10.1002/cpt.3100. Epub 2023 Nov 29. PMID 37957132
- DERIVEDMeulendijks D, van Hasselt JGC, Huitema ADR, van Tinteren H, Deenen MJ, Beijnen JH, Cats A, Schellens JHM. Renal function, body surface area, and age are associated with risk of early-onset fluoropyrimidine-associated toxicity in patients treated with capecitabine-based anticancer regimens in daily clinical care. Eur J Cancer. 2016 Feb;54:120-130. doi: 10.1016/j.ejca.2015.10.013. Epub 2016 Jan 4. PMID 26761784
- DERIVEDDeenen MJ, Meulendijks D, Cats A, Sechterberger MK, Severens JL, Boot H, Smits PH, Rosing H, Mandigers CM, Soesan M, Beijnen JH, Schellens JH. Upfront Genotyping of DPYD*2A to Individualize Fluoropyrimidine Therapy: A Safety and Cost Analysis. J Clin Oncol. 2016 Jan 20;34(3):227-34. doi: 10.1200/JCO.2015.63.1325. Epub 2015 Nov 16. PMID 26573078