Impact of Sunitinib Bioavailability on Toxicity and Treatment Efficacy in Patients Treated for Metastatic Renal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib
研究概览
简要总结
Patients treated on the first line of Sunitinib-targeted therapy for metastatic kidney cancer.
Collection of additional blood tubes during routine blood tests for patient follow-up, to evaluate the plasma concentration of Sunitinib and its active metabolite desethyl-Sunitinib (DES)
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
- •Patient at least 18 years old
- •Patient who read and understood the newsletter and signed the consent form
- •Renal cell carcinoma histologically proven stage IV
- •Metastatic stage proven on CT, synchronous or metachronous examination
- •Patient operated on or not from the primary tumor
- •Eligible for first-line systemic therapy with Sunitinib-targeted therapy for oncology urology
- •Affiliation to a social security scheme
- •Effective contraception (as defined by the WHO) for at least 3 months at the inclusion visit, during treatment and for 1 month after the end of the research (negative pregnancy test)
- •Postmenopausal woman: confirmatory diagnosis (amenorrhea not clinically induced for more than 12 months at inclusion visit)
- •General condition WHO 0 to 2
- •Life expectancy estimated at more than 6 months at baseline
排除标准
- •Non-metastatic disease
- •Other cancer proven histologically, or in complete remission for less than 2 years
- •Contraindication to SUTENT 50 mg hard capsules: Hypersensitivity to the active substance or to any of the excipients
- •History of immunotherapy treatment for kidney cancer, previous treatment with targeted therapies for the same or previous cancer
- •Pregnant or lactating woman or wishing to breastfeed within 6 months after the last treatment or no known contraception,
- •Person deprived of liberty by an administrative or judicial decision or person placed under the protection of justice / sub-guardianship or curatorship
- •Patient currently involved in an interventional trial
结局指标
主要结局
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib
时间窗: At the end of Cycle 6 (each cycle is 28 days)
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib
时间窗: At the end of Cycle 6 (each cycle is 28 days)
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib
时间窗: At the end of Cycle 1 (each cycle is 28 days)
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib
时间窗: At the end of Cycle 2 (each cycle is 28 days)
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib
时间窗: At the end of Cycle 3 (each cycle is 28 days)
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib
时间窗: At the end of Cycle 4 (each cycle is 28 days)
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib
时间窗: At the end of Cycle 5 (each cycle is 28 days)
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib
时间窗: At the end of Cycle 1 (each cycle is 28 days)
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib
时间窗: At the end of Cycle 2 (each cycle is 28 days)
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib
时间窗: At the end of Cycle 3 (each cycle is 28 days)
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib
时间窗: At the end of Cycle 4 (each cycle is 28 days)
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib
时间窗: At the end of Cycle 5 (each cycle is 28 days)
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib
次要结局
- plasma Sunitinib concentration(Cycle6 Day28 (each cycle is 28 days))
- plasma DES concentration(Cycle6 Day28 (each cycle is 28 days))
- plasma desethyl-Sunitinib (DES) concentration(Cycle1 Day14 (each cycle is 28 days))
- plasma Sunitinib concentration(Cycle1 Day14 (each cycle is 28 days))
- plasma Sunitinib concentration(Cycle1 Day28 (each cycle is 28 days))
- plasma DES concentration(Cycle1 Day28 (each cycle is 28 days))
- plasma Sunitinib concentration(Cycle2 Day28(each cycle is 28 days))
- plasma DES concentration(Cycle2 Day28 (each cycle is 28 days))
- plasma Sunitinib concentration(Cycle3 Day28 (each cycle is 28 days))
- plasma DES concentration(Cycle3 Day28 (each cycle is 28 days))