GIST and mCRC patients
Conditions
Interventions
Trade Name: Stivarga
Pharmaceutical Form: Tablet
Trade Name: Nexium
Pharmaceutical Form: Tablet
Sponsors
Erasmus MC cancer institute
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the area under the curve (AUC) of regorafenib compared to regorafenib concomitantly used with esomeprazole and to regorafenib used with esomeprazole 3 hours prior in patients with mCRC or GIST.;Secondary Objective: 1. Other pharmacokinetic outcomes (i.e. clearance, maximum concentration (Cmax) and time to Cmax (tmax)). 2. To evaluate the incidence and severity of side-effects of treatment with regorafenib in absence and presence of esomeprazole;Primary end point(s): To evaluate the area under the curve (AUC) of regorafenib compared to regorafenib concomitantly used with esomeprazole and to regorafenib used with esomeprazole 3 hours prior in patients with mCRC or GIST.;Timepoint(s) of evaluation of this end point: End of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Other pharmacokinetic outcomes (i.e. clearance, maximum concentration (Cmax) and time to Cmax (tmax)). 2. To evaluate the incidence and severity of side-effects of treatment with regorafenib in absence and presence of esomeprazole;Timepoint(s) of evaluation of this end point: End of study | — |
Countries
Netherlands
Contacts
Public ContactF.M. de Man, MD
Erasmus MC cancer institute
Outcome results
None listed