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

niversitair Medisch Centrum Sint Radboud0 个研究点目标入组 12 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•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

•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

发起方

niversitair Medisch Centrum Sint Radboud