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Impact of CES1 Genotype on Capecitabine Exposure in Cancer Patients

Recruitingn/aAges 18 Years - anyAllErasmus Medical Center
NCT07114627 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 belie

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📋 Eligibility rules (as published)
In order to be eligible to participate in this study, a subject must meet all of the following criteria: * 18 years of age or older; * Planned to start treatment with concomitant capecitabine and oxaliplatin according to standard of care (irrespective of dose); * Fit for treatment with capecitabine and oxaliplatin as judged by the treating physician; * Capable of understanding and complying with protocol requirements and able to understand and sign the informed consent form. Exclusion Criteria: 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.
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What it tests

  • Blood sampling for pharmacokinetics
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Where

1 site
Erasmus MC Cancer Institute
Rotterdam, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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