NL-OMON49411已完成不适用
A pharmacokinetic study of edoxaban in patients with breast cancer using the P-glycoprotein inhibitor tamoxifen - PHIX-IT study
Tergooiziekenhuizen0 个研究点目标入组 26 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 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
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •-Women with breast cancer who will start with tamoxifen
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
- •- 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
- •- 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
招募中
不适用
De wisselwerking tussen edoxaban en tamoxifen behandeling bij vrouwen met borstkankerPatients with oestrogen receptor positive breast cancer who are scheduled for adjuvant or palliative tamoxifen treatmentNL-OMON23145Daiichi Sankyo26
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