CTRI/2025/07/090989尚未招募不适用
Phase I, Open-Label study to Assess Feasibility of CYP3A4 Inhibition on Reducing the Dosage of Osimertinib in EGFR mutant NSCLC to Reduce Financial Toxicity
Department of pulmonary and critical care medicine1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2025年7月31日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- To determine the pharmacokinetic profile of Osimertinib (80mg and 40mg) when co-administered with Itraconazole in EGFR-positive NSCLC patients.
研究概览
简要总结
To assess the feasibility of Osimertinib and Itraconazole combination in reducing the dose of osimertinib and thus reducing the financial toxicity of patients diagnosed to have EGRF mutant positive Non-small cell carcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •pathologically confirmed advanced metastatic adenocarcinoma 2) No prior treatment with Itraconazole.
排除标准
- •Previous receipt of EGFR-TKI.
- •Untreated HIV, HBV, HCV infections.
- •Previous or co-existing malignancy
- •Pregnant or lactating women
- •Any type of systemic anticancer therapy (chemotherapy or experimental drugs) within 2 weeks of starting treatment on protocol.
- •Any radiotherapy within 1 week of starting treatment on protocol.
- •Any major surgery within 4 weeks of starting treatment on protocol.
- •Known hypersensitivity to any component of Osimertinib or Itraconazole
- •Concomitant use of certain drugs due to serious or life-threatening interactions from CYP3A4 inhibition, such as antiarrhythmics, sedatives, sildenafil, antifungals etc.
结局指标
主要结局
To determine the pharmacokinetic profile of Osimertinib (80mg and 40mg) when co-administered with Itraconazole in EGFR-positive NSCLC patients.
时间窗: To determine the pharmacokinetic profile of Osimertinib (80mg and 40mg) when co-administered with Itraconazole in EGFR-positive NSCLC patients.
次要结局
- 1. To assess the safety and tolerability (using predefined drug-limiting toxicities) of Osimertinib-Itraconazole combination in EGFR-positive NSCLC patients.(2. To investigate the relationship between plasma Osimertinib concentrations and clinical efficacy, including tumor response, disease control rates, and progression-free survival)
研究者
Dr Pawan Kumar Singh
Pandit B.D Sharma, PGIMS, Rohtak
研究点 (1)
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