Patients who are treated or will be treated with imatinib, who previously underwent major gastrectomy. MedDRA version: 17.0 Level: LLT Classification code 10062427 Term: Gastrointestinal stromal tumor System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Glivec
Pharmaceutical Form:
Sponsors
Radboud University Nijmegen Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients = 18 years of age 2. Patients with imatinib dosage 400-800mg daily 3. Patients who previously underwent major gastrectomy 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1 5. In adequate condition to receive imatinib therapy as judged by the treating physician and with respect for and in agreement with the reg- istration guidelines 6. Patients must be able to swallow tablets 7. Subject is able and willing to sign the Informed Consent Form prior to screening Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 7 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 4
Exclusion criteria
Exclusion criteria: 1. Concomitant administration of any anti-cancer therapies (e.g. chemo-therapy, other targeted therapy, experimental drug, etc) other than imatinib 2. Concomittant use of medication which strongly inhibits or induces CYP3A4 3. Refractory nausea and vomiting, malabsorption with other causes than gastrectomy or external biliary shunt that would preclude adequate absorption. 4. Pregnant or lactating women 5. Unwillingness to practice effective birth control 6. Unwillingness to use Coca-Cola 7. Inability to comply with the requirements of the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effects of Coca-Cola on the exposure to imatinib in patients with major gastrectomy. ;Secondary Objective: To assess the effect of Coca-Cola on the frequency and severity of the adverse events reported while on imatinib therapy ;Primary end point(s): The exposure to imatinib in patients with major gastrectomy, when intake is done with Coca-Cola compared to water. ;Timepoint(s) of evaluation of this end point: after trial day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Part A: To explore, quantify and describe the correlation in the occurrence of side effects when imatinibis ingested with Coca-Cola. ;Timepoint(s) of evaluation of this end point: after trial day 14 | — |
Countries
Netherlands
Contacts
Public ContactCarli Wilmer
Radboud University Nijmegen Medical Center
Outcome results
None listed