NL-OMON23145招募中不适用
A pharmacokinetic study of edoxaban in patients with breast cancer using the P-glycoprotein inhibitor tamoxifen
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 26
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •Age > 18 years
- •-Patients with oestrogen receptor positive breast cancer who are scheduled for adjuvant or palliative tamoxifen treatment
排除标准
- •-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 P-gp inhibitors or inducers and CYP3A4 inhibitors (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
研究者
相似试验
进行中（未招募）
1 期
The interaction between the blood thinner edoxaban and the hormonal treatment tamoxifen in breast cancer patientsIf there are increased plasma levels of edoxaban when used concomitantly with the P-glycoproteïne inhibitor tamoxifen for the treatment of venous thromboembolism in patients with breast cancer.EUCTR2018-004450-24-NLTergooi Hospital, dep of internal medicine26
已完成
不适用
A pharmacokinetic study of edoxaban in patients with breast cancer using the P-glycoprotein inhibitor tamoxifevenous thromboembolismNL-OMON49411Tergooiziekenhuizen26
已完成
不适用
A pharmacokinetics study of edoxaban in non-small cell lung cancer patients harboring EGFR mutation combined with venous thromboembolismon-small cell lung cancerJPRN-UMIN000021160Shimane University Faculty of Medicine20
进行中（未招募）
1 期
Pharmacokinetics of edoxaban in patients with advanced chronic kidney disease (CKD) treated for stroke preventioonvalvular Atrial FibrillationMedDRA version: 20.0Level: PTClassification code 10003658Term: Atrial fibrillationSystem Organ Class: 10007541 - Cardiac disordersEUCTR2019-003100-13-DEMartin-Luther-Universität Halle-Wittenberg72
招募中
不适用
Pharmacokinetics of edoxaban in patients with advanced chronic kidney disease (CKD) treated for stroke preventioMedDRA - Atrial fibrillation (10003658)DRKS00022562Medizinische Fakultät der Martin-Luther-Universität72