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

Radboud University Nijmegen Medical Center0 个研究点目标入组 7 人开始时间: 2014年6月4日最近更新: 2022年4月19日

试验速览

暂无简介。

•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

•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

发起方

Radboud University Nijmegen Medical Center