Optimization of Targeted Anticancer Therapies: a Systematic Collection and Modeling of Pharmacokinetic Data and Elaboration of an Adherence Program
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Blood concentrations of targeted anticancer drugs
研究概览
简要总结
The study includes an observational pharmacokinetic study and an interventional medication adherence study. The purpose of this study is 1) to describe the concentration-time profiles of targeted anticancer drugs and to characterize the concentration-effect/toxicity relationships in the target population of patients (observational study) and 2) to characterize patterns of adherence to oral targeted anticancer drugs and identify key-driver modifiable adherence factors in patients participating in an adherence program (interventional study).
详细描述
Targeted anticancer therapies are often prescribed at the same dosage regimen in all patients. However, it is known that the marked interindividual variability in drug level may affect treatment outcomes. Several factors are known to modulate drug levels, such as weight, genetics host-drug and drug-drug interaction. The identification of these factors could give the possibility to propose better adjusted dosage regimens according to patient's individual characteristics. Moreover, the presence of high or low drug concentrations may partially explain toxicity or lack of efficacy of targeted anticancer drugs in some patients. The characterization of the relationship between drug levels and treatment response (efficacy and toxicity) would allow an optimized and a more individualized patient management with targeted anticancer drugs.
Oral targeted therapies must be taken on the long term and adherence issues have been shown to compromise treatment efficacy. Side effects and lifestyle management are among factors affecting treatment adherence. The characterization of adherence over time and the identification of factors susceptible to improve it will represent a great benefit for healthcare professionals and patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Cancer patients to whom a targeted anticancer therapy is prescribed
排除标准
- •Patients incapable of judgment or participants under tutelage
结局指标
主要结局
Blood concentrations of targeted anticancer drugs
时间窗: A maximum of 8 blood samples are collected within 2 years after the inclusion (at maximum 1 blood sample per month).
During their medical visits, from 1 to 8 blood samples will be collected per patients at the same moment as routine blood sampling. Drug concentration will be measured by HPLC-MS/MS.
Change from treatment start in efficacy of targeted anticancer drugs
时间窗: The cancer progression is evaluated at each PET-scan (once per 3 months) from the inclusion in the study during 2 years maximum or from the inclusion in the study to the end of the treatment.
The progression free survival (PFS) is used to evaluate the drug efficacy. The PFS is defined as the time interval between the first dose of drug and the date of progression or any cause death. Patient without progression at the study end will be censored.
Apparition of adverse events of targeted anticancer drugs
时间窗: Adverse events are monitored at each medical visit (once per month) from the inclusion in the study during 2 years maximum or from the inclusion in the study to the end of the treatment.
Adverse events are assessed during the routine medical visits according the National Cancer Institute Common Toxicity Criteria (NCI-CTCAE scale).
次要结局
- Medication adherence : persistence rate and daily implementation of targeted anticancer drugs(12 months)
研究者
Chantal Csajka
Director and Professor of the Center for Research and Innovation in Clinical Pharmaceutical Sciences
Centre Hospitalier Universitaire Vaudois