A pharmacokinetic study of edoxaban in patients with breast cancer using the P-glycoprotein inhibitor tamoxifen - PHIX-IT

Tergooi Hospital, dep of internal medicine0 个研究点目标入组 26 人开始时间: 2019年5月13日最近更新: 2019年11月25日

适应症

试验速览

暂无简介。

•-Age > 18 years
•-Patients with oestrogen receptor positive breast cancer who are scheduled for adjuvant or palliative tamoxifen treatment
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 13
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 13

•-Inability to provide informed consent
•-Inherited bleeding disorder (e.g. von Willebrand disease)
•-Major bleeding16 or clinically relevant non-major bleeding17 in the past 3 months (see appendix A)
•- History of intracranial bleeding
•-Gastric or duodenal ulcer in the past 5 years
•- Uncontrolled blood pressure with systolic pressure >180 mmHg
•-Use of antiplatelet or anticoagulant therapy
•- Chronic NSAID use
•-Major surgery in the past 3 weeks (surgery which penetrates and exposes a body cavity or produces substantial impairment of physical function)
•-Pregnancy, puerperium, or current breast feeding
•-Use of strong P-gp inhibitors or inducers (see appendix B)
•-Brain metastases
•-Use of chemotherapy in the past 7 days or in the upcoming 32 days
•-AST or ALT >3x of the upper limit in the past 7 days
•- Liver cirrhosis Child Pugh A, B, or C
•-Creatinine clearance of <50mL/min calculated with the Cockcroft and Gault formula in the past 7 days
•-Body weight <60kg
•-Platelet count <50,000/mL in the past 7 days

发起方

Tergooi Hospital, dep of internal medicine