Relation Between Safety Endpoints and Everolimus Trough Blood Level in Advanced Renal Cell Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 41
- 试验地点
- 4
- 主要终点
- Find a relationship between everolimus through blood level and treatment safety.
研究概览
简要总结
The investigators hypothesize everolimus toxicities are linked to pharmacokinetic variabilities of everolimus. Thus, early detection of clinical or biological risk factors will lead to personalized dosage treatment and permit a better tolerance without altering efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients aged ≥ 18 year-old.
- •Histologically documented renal cell carcinoma whatever the type.
- •One or two prior therapy with cytokines and/or VEFG-ligand inhibitors are permitted.
- •Patients with an indication to receive everolimus treatment
- •Patients able and willing to give written informed consent, before the first screening procedure.
排除标准
- •Patients currently receiving chemotherapy or immunotherapy
- •Prior treatment with temsirolimus
- •Contraindication in everolimus :
- •Hypersensitivity to the active substance, to other rapamycin derivatives or to any of the excipients.
- •Patients with severe hepatic impairment (Child-Pugh class C)
- •Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
- •Pregnant or breastfeeding women
- •Patients unwilling to or unable to comply with the protocol.
研究组 & 干预措施
Afinitor
The recommended dose of Afinitor is 10 mg everolimus once daily, at fixed hour.Treatment should continue as long as clinical benefit is observed or until unacceptable toxicity occurs.
In case of frail patients, treatment could be initiated at a lower daily-dose (5mg/d for example) and then increase if tolerance is acceptable.
干预措施: Blood sample (Other)
结局指标
主要结局
Find a relationship between everolimus through blood level and treatment safety.
时间窗: 2 years
We hypothesize everolimus toxicities are linked to pharmacokinetic variabilities of everolimus. Thus, early detection of clinical or biological risk factors will lead to personalised dosage treatment and permit a better tolerance without altering efficacy.
次要结局
未报告次要终点