The effects of the proton pump inhibitor esomeprazole alone or in combination with Coca-Cola on the absorption of Capecitabine in patients with cancer 'the COCA study'

Phase 1

Conditions: Colorectal carcinoma or other solid tumours
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2017-004465-27-NL

Lead Sponsor: Erasmus MC Cancer Institute

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 28

Inclusion Criteria

1.Age = 18 years.
2.Histologically or cytologically confirmed diagnosis of a solid tumour for which capecitabine is an appropriate treatment option.
3.Planned treatment with capecitabine.
4.ECOG Performance Status =2
5.Able and willing to sign the informed consent form prior to screening evaluations.
6.No concurrent (over the counter) use of other acid reducing drugs (PPIs, H2As and/or antacids) other than esomeprazole 40 mg once daily during the study.
7.Abstain from acid beverage (on study days, except for the Coca-Cola in Phase C according to study procedures), grapefruit, grapefruit juice, grapefruit-related citrus fruits, herbal dietary supplements and herbal tea during the study period.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 7

Exclusion Criteria

1.Prior treatment with capecitabine is allowed, however, patients with a documented history of = grade 3 toxicities with capecitabine are excluded.
2.Patients with known impaired drug absorption (e.g. gastrectomy and achlorhydria)
3.Known serious illness or medical unstable conditions (e.g. instable diabetes mellitus) that could interfere with the study medication/liquid.
4.Patients who are clinical dependent of use of PPIs or other acid reducing drugs.
5.Known complete deficiency of dihydropyrimidine dehydrogenase (DPD) activity.
6.Known poor metabolizers of cytochrome P450 2C19.
7.Use of cytochrome P450 2C19/ 3A4 inducers and or inhibitors.
8.Use of medicines/supplements wich can interact by capecitabine or esomeprazole