Influence of an Acidic Beverage (Coca-Cola) on the exposure to Imatinib (GLIvec) after major gastrecTomY in patients with Gastrointestinal Stromal Tumors (ABILITY)

Completed

Conditions: Gastro-Intestinal Stromal Tumor/Gastro-intestinal Cancer
10017990
10017998

Registration Number: NL-OMON41047

Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 12

Inclusion Criteria

1. Male or female patients >= 18 years of age
2. Patients with GIST, who previously underwent major gastrectomy
3. Eastern Cooperative Oncology Group (ECOG) performance
status (PS) of 0*1
4.Already selected to receive imatinib therapy in a dose of 400*800mg imatinib daily, as judged by the treating physician and with respect for and in agreement with the registration guidelines
5. Subject is able and willing to sign the Informed Consent Form prior to screening

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. Unwillingness to use Coca*Cola
5. Inability to comply with the requirements of the protocol
6. Inability to understand the nature and extent of the study and the procedures required
7. Participation in a drug study within 60 days prior to the first day of this study

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To assess the effect of Coca*Cola on the exposure to imatinib in patients with<br /><br>major gastrectomy.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To assess the effect of Coca*Cola on the frequency and severity of the adverse<br /><br>events reported while on imatinib therapy<br /><br>(safety parameter; study is not powered for a significant result)</p><br>