NCT07114627
Impact of CES1 Genotype on Capecitabine Exposure in Cancer Patients
Recruiting · Not specified · Erasmus Medical Center · registry updated 2025-08-11
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
In this study, the drug capecitabine is investigated. Capecitabine is commonly used to treat breast, colon, and stomach cancers. Capecitabine is taken in tablet form. In the body, capecitabine is converted into the active molecule that has anti-cancer effects. This molecule is called 5-FU. The transformation of capecitabine to 5-FU occurs through specific proteins in the liver, also known as enzymes. Unfortunately, capecitabine can also cause side effects. One of the most common side effects is hand-foot syndrome. In hand-foot syndrome, the palms of the hands and soles of the feet become red and painful. Previous research has shown that patients in whom one of the enzymes responsible for converting capecitabine in the liver does not function properly experience an increase in side effects frequency, particularly severe hand-foot syndrome. This specific enzyme is called CES1. It is believed that side effects occur more frequently because capecitabine is transformed more slowly, eventually leading to a prolonged exposure to 5-FU in the body. In roughly one in three people, this enzyme functions less efficiently....
Exclusion
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Carrier of a known clinically relevant DPYD variant (i.e. \*2A, \*7, \*13, c.1236G\>A or c.2846A\>T);
- Any medical condition that is known to influence capecitabine absorption (i.e. a Roux-en-Y gastric bypass operation or complete gastric resection; an esophagectomy is not considered to impair absorption);
- Prior treatment with fluoropyrimidines;
- Use of DPD-inhibitors and/or allopurinol;
- Known pregnancy at baseline.