The Pharmacokinetic Variability of Sunitinib in Patients With Metastatic Renal Cancer: Searching for Pharmacogenetic Determinants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 3
- 主要终点
- The percentage of patients with a plasma concentration of sunitinib remaining at equilibrium ([Suni]REq) greater than 100 ng / ml
研究概览
简要总结
The primary objective of this study is to determine the percentage of patients with a plasma concentration of sunitinib remaining at equilibrium ([Suni]REq) greater than 100 ng / ml (effective concentration according to the current literature).
详细描述
The secondary objectives of this study are:
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To describe the distribution of constitutional genetic determinants related to sunitinib pharmacokinetics, and to study their correlation with
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the [Suni]REq,
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the advent of toxicity,
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the tumor response.
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To describe the variation in the [Suni]REq and the plasma concentration of the active entity remaining at equilibrium ([ActEnt]REq) at:
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the interindividual level,
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overtime, between chemotherapy cycles.
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To describe the variation in the ratio of the plasma concentration of the metabolite remaining at equilibrium ([Metab]REq) to the [Suni]REq at:
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the interindividual level,
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overtime, between chemotherapy cycles.
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To explore potential correlations between the [Suni]REq and
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
- •The patient was correctly informed concerning the implementation of the study, its objectives, constraints and patient rights
- •The patient must have given his/her informed and signed consent
- •The patient must be insured or beneficiary of a health insurance plan
- •The patient has kidney cancer and should begin treatment with sunitinib (Sutent) at the time of inclusion
排除标准
- •The patient started treatment with sunitinib (Sutent) before inclusion
- •The patient is participating in another interventional study
- •The patient has participated in another interventional study within the last month
- •The patient is in an exclusion period determined by a previous study
- •The patient is under judicial protection, under tutorship or curatorship
- •The patient refuses to sign the consent
- •It is impossible to correctly inform the patient
- •The patient is pregnant, parturient, or breastfeeding
- •The patient has a contraindication (or an incompatible drug combination) for a treatment used in this study
研究组 & 干预措施
The study population
Patients with kidney cancer and will be starting treatment via sunitinib at the study start will be included.
Intervention: Blood drawn for genotyping Intervention: Blood drawn for pharmacokinetic measures
干预措施: Blood drawn for genotyping (Genetic)
The study population
Patients with kidney cancer and will be starting treatment via sunitinib at the study start will be included.
Intervention: Blood drawn for genotyping Intervention: Blood drawn for pharmacokinetic measures
干预措施: Blood drawn for pharmacokinetic measures (Biological)
结局指标
主要结局
The percentage of patients with a plasma concentration of sunitinib remaining at equilibrium ([Suni]REq) greater than 100 ng / ml
时间窗: Between C1D15* and C1D28*
\*Each patient will undergo several cycles of treatment with sunitinib during the monitoring period as part of routine care (= 18 months; the number of cycles per patient can vary, which is normal). Each cycle and each day of the cycle will be annotated with the letters C and D, respectively, followed by a number in chronological order. Thus C1D1 refers to to the first day of the first cycle; CmDn will be the nth day of the mth cycle.
次要结局
- Mean [Metab]REq / [Suni]REq for all cures(18 months)
- Toxicity (yes/no) for each type of toxic event per cure(Between CmD15* and CmD28* for 18 months)
- For each cure, the average [Suni]REq for cure 1 to cure m(18 months)
- Genotype: genetic polymorphisms of enzymes of phase I, phase II (conjugation), carriers of Phases 0 and III, the nuclear receptors PXR and CAR, pharmacological targets of sunitinib (tyrosine kinase receptors).(Baseline (day 0))
- [Suni]REq at the 1st cure, averaged per initial dosing (37.5mg, 50 mg, 75 mg, 100mg)(Between C1D15* and C1D28*)
- the average [Suni]REq over all cures(18 months)
- Mean [ActEnt]REq for all cures(18 months)
- For each cure, the average [ActEnt]REq for cure 1 to cure m(18 months)
- Tumor response per cure(18 months)
- For each cure, the ratio of the plasma concentration of the metabolite remaining at equilibrium ([Metab]REq) / [Suni]REq(Between CmD15* and CmD28* for 18 months)
- [ActEnt]REq(Between C1D15* and C1D28*)
- Presence/absence of side effects noted in the summary of product characteristics for sunitinib(18 months)
- The presence/absence of grade I, II, III, IV, V (CTCAE version 4.0) toxicities per cure(18 months)
- [Metab]REq / [Suni]REq(Between C1D15* and C1D28*)
- [Metab]REq / [Suni]REq averaged per initial dosing(Between C1D15* and C1D28*)
- For each cure, the average [Metab]REq / [Suni]REq for cure 1 to cure m(18 months)
- For each cure, the plasma concentration of the active entity remaining at equilibrium ([ActEnt]REq)(18 months)
- For each cure, the % of patients whose dosings were modified since the beginning of the study(18 months)
- [Suni]REq per cure(Between CmD15* and CmD28* for 18 months)
- [ActEnt]REq averaged per initial dosing(Between C1D15* and C1D28*)