The effects of the proton pump inhibitor esomeprazole on the bioavailability of regorafenib

Phase 1

• Conditions: GIST and mCRC patients; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-005784-17-NL
• Lead Sponsor: Erasmus MC cancer institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-09
• Last Update Posted: 12 March 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

1. Age = 18 years
2. Histological or cytological confirmed diagnosis of mCRC or GIST
3. ECOG Performance Status = 1
4. Signed Informed Consent Form prior to screening evaluations
5. No concurrent (over the counter) use of other acid reducing drugs, other than esomeprazole 40mg (PPIs, H2As and/or antacids) once daily during the study.
6. No concurrent medication or supplements which can interact with esomeprazole or regorafenib during the study period.
7. Abstain from grapefruit, grapefruit juice, herbal dietary supplements, and herbal tea during the study period.
8. Adequate baseline patient characteristics
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 12
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

1. Pregnant or lactating patients.
2. Patients with known impaired drug absorption (e.g. gastrectomy and achlorhydria).
3. Known serious illness or medical unstable conditions that could interfere with this study
4. Patients with evidence or history of any bleeding diathesis, irrespective of severity
5. Cardiac history ( recent myocardial infarction, unstable or new-onset angina, uncontrolled cardiac arrhythmias)
6. Uwillingness to abstain from grapefruit (juice), (herbal) dietary supplements, herbals, over-the-counter medication (except for paracetamol and ibuprofen) and other drugs known to seriously interact with esomeprazole and regorafenib during the study period.
7. Unwillingness to abstain from acid beverages such as jus d’orange and other acidic beverages in the morning during regorafenib treatment in this study.
8. Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation.
9. Symptomatic CNS metastases or history of psychiatric disorder that would prohibit the understanding and giving of informed consent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified