Real-world Exploratory Evaluation of the Potential Drug-drug Interaction Between Anticancer Small Molecule Inhibitors and Direct Oral Anticoagulants in Patients With Solid Tumours and Exploration of the Role of Therapeutic Drug Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- DOAC trough concentration
研究概览
简要总结
The main objective of this study is to investigate the effect of small molecule inhibitors (SMIs), used in targeted therapy for tumours, on direct oral anticoagulants (DOACs).
详细描述
Patients who receive anticoagulant therapy in the form of a direct oral anticoagulant (DOAC) and simultaneously receive anti-cancer targeted therapy with a small molecule inhibitor (SMI), potentially have an increased risk on thromboembolic complications and bleeding events due to interfering drug-drug interactions. Some SMIs influence CYP3A4 and/or p-glycoprotein (p-gp) for which DOACs are substrates. In this study, the effect of theoretically relevant SMIs on the pharmacokinetics, efficacy and safety of DOACs in patients with solid tumours will be investigated. For this purpose, plasma concentration analyses will be performed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with a solid tumour
- •18 years of age or older
- •Patients receive or start treatment with an SMI-DOAC combination, that may cause a clinically significant DDI at the level of CYP3A4 and/or P-gp, based on the SmPC
- •Combined use of a DOAC-SMI combination is expected to be continued at the same dose for at least three weeks
- •The DOAC is used for at least seven days and the SMI has already been used for at least 21 days at time of blood collection to ensure steady-state
- •Patients receive a DOAC at maintenance dose
排除标准
- •Unable to understand the information in the patient information letter
- •Any concurrent medication beside the SMI and DOAC that is known to strongly inhibit or induce CYP3A4 or P-gp
- •Patients who are pregnant or lactating
结局指标
主要结局
DOAC trough concentration
时间窗: At least 7 days after start DOAC use and in combination with an SMI at steady-state (after at least 21 days)
DOAC trough concentration before and during concomitant use with an SMI
DOAC peak concentration
时间窗: At least 7 days after start DOAC use and in combination with an SMI at steady-state (after at least 21 days)
DOAC peak concentration before and during concomitant use with an SMI
次要结局
- Thromboembolic and bleeding events during follow-up(within 6 months after the last blood sampling)
- SMI trough concentration during concomitant use with a DOAC(After the start of the DOAC use in combination with an SMI at steady-state (after at least 21 days))