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Exploratory Study of CAPEcitabine pharmacokinetics and hand-foot syndrome in CES1 variant carriers: the ESCAPE study
EU CTIS ID: 2024-516788-96-00
What this study is testing
to demonstrate an increase of 25% in the area under the curve (AUC) 0-6h of 5-FU at the last day of capecitabine administration in cycle 1 between carriers of the CES1 1165–33 C>A (rs2244613) SNP and wild type patients.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- ≥18 years of age;
- Planned to start treatment with capecitabine monotherapy or capecitabine-containing combination regimens according to standard of care (irrespective of dose);
- Fit for treatment with capecitabine as judged by the treating physician;
- Capable of understanding and complying with protocol requirements and able to understand and sign the informed consent form.
You likely can't join if
- 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.
- Prior treatment with fluoropyrimidines;
- Use of DPD-inhibitors and/or allopurinol;
- Known pregnancy at baseline.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.