CTRI/2024/01/061126招募中不适用
Precision Therapy of Gefitinib in Non-Small Cell Lung Cancer Patients: An Integrated Pharmacogenomic and Population Pharmacokinetic Approach
Intramural Funding, MAHE, Manipal1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2024年1月8日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- The current research aims to develop an appropriate gefitinib population pharmacokinetic model for deriving an individualized gefitinib dosing strategy for NSCLC patients in tertiary care hospitals.
研究概览
简要总结
In our study, we intend to collect the blood samples of lung cancer patients and record the associated demographic and clinical details.
The pharmacogenomic analysis will be conducted using these samples, where we intend to look at the single nucleotide polymorphisms in genes that are associated with chemotherapeutic toxicities and the efficacy of gefitinib.
A non-linear mixed effect population pharmacokinetic model will be generated.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Non-Small Cell Lung Cancer patients (both males and females) with EGFR positive mutation.
- •Age group of 18-80 years.
- •Patients who are willing to give informed consent.
排除标准
- •HIV positive patients.
- •Patients with seriously ill conditions (eg: COVID 19 etc.,) or clinically unstable patients.
结局指标
主要结局
The current research aims to develop an appropriate gefitinib population pharmacokinetic model for deriving an individualized gefitinib dosing strategy for NSCLC patients in tertiary care hospitals.
时间窗: 3 years
次要结局
- Development of such a Population pharmacokinetic model for gefitinib will aid in the implementation of precision therapy for the management of NSCLC. Thus, this study would comprehensively analyse precision therapy of lung cancer patients in our settings.(3 years)
研究者
Dr Mahadev Rao
Manipal College of Pharmaceutical Sciences, MAHE, Manipal
研究点 (1)
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