Effect of liver metastases from gastrointestinal stromal tumour (GIST) on imatinib pharmacokinetics: an observational pharmacokinetic study

Azienda Unita Sanitaria Locale Di Ravenna (Italy)0 个研究点目标入组 46 人开始时间: 2009年9月18日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. Histologically or cytologically confirmed diagnosis of GIST or CML
•2. Indication for imatinib treatment
•3. Aged greater than or equal to 18 years, either sex
•4. Performance status (Karnofsky scale): 60 to 100
•5. Written informed consent
•6. Adequate haematological functions (absolute neutrophil count [ANC] greater than 1.5 x 10^9/L, platelets greater than 100 x 10^9/L)
•7. Adequate renal functions (creatinine less than 120 µmol/L or calculated clearance [Cockroft method] greater than 65 mL/min)
•8. Bilirubin less than 5 times upper limit of normal (UNL)
•9. Complete work-up within 2 - 4 weeks prior to therapy

•1. Pregnant or lactating patients; patients must use adequate contraceptive if required
•2. Patients pretreated with imatinib
•3. Symptomatic central nervous system (CNS) metastases
•4. Other serious illness or medical unstable condition requiring treatment or history of psychiatric disorder that would prohibit the understanding and giving of informed consent
•5. Previous history of severe cardiovascular disease
•6. Major surgery within the last 2 weeks before start of the protocol
•7. Unwillingness to change medication, or no adequate alternatives available, when drugs, which are known to interact with liver CYP450 3A4/5 enzyme system, are taken

发起方

Azienda Unita Sanitaria Locale Di Ravenna (Italy)