NCT02328261Unknown2 期
Icotinib in Treating Patients With Advanced Nasopharyngeal Carcinoma: A Phase II, Multi-center, Open-label Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 66
- 主要终点
- Disease control rate(DCR)
研究概览
简要总结
This is a phase 2 study to evaluate the efficacy of single-agent icotinib in patients with advanced nasopharyngeal carcinoma.
详细描述
This phase 2 study is aimed to evaluate the efficacy of single-agent icotinib in patients with pretreated, advanced nasopharyngeal carcinoma. The primary endpoint is disease control rate (DCR).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed advanced NPC
- •Patients must be platinum-resistant defined as recurrence or progression of disease <6 months since previous treatment with a platinum based treatment regimen.
- •Measurable disease per RECIST
- •Adequate organ and marrow function
- •Capable of understanding and complying with the protocol, and written informed consent
排除标准
- •Prior treatment with gefitinib, erlotinib, or other drugs that target EGFR
- •Patients must not be receiving any other investigational agents
- •Other serious illness or medical condition including unstable cardiac disease requiring treatment, history of significant neurologic or psychiatric disorders (including psychotic disorders, dementia, or seizures), or active uncontrolled infection
- •Women who are pregnant or breast-feeding
研究组 & 干预措施
Icotinib
Experimental
Icotinib (125 mg tablet) is orally administered three times daily
干预措施: Icotinib (Drug)
结局指标
主要结局
Disease control rate(DCR)
时间窗: At least 8 weeks
次要结局
- Progression-free survival(At least 8 weeks)
研究者
相似试验
终止
2 期
Ponatinib for Squamous Cell Lung and Head and Neck CancersNon-Small Cell Lung Cancer, Head and Neck CancerNCT01761747Dana-Farber Cancer Institute3
已完成
3 期
Icotinib in Advanced Metastatic Patients With NSCLC Previously Treated With ChemotherapyNon-small Cell Lung CancerNCT02486354Betta Pharmaceuticals Co., Ltd.128
Unknown
4 期
High Dose Icotinib in Advanced Non-small Cell Lung Cancer With EGFR 21 Exon MutationNSCLCNCT02404675Betta Pharmaceuticals Co., Ltd.240
招募中
2 期
A Study of Icotinib With Chemotherapy as Neoadjuvant Therapy for Patients With EGFRm Positive Resectable Non-Small Cell Lung CancerNon-Small Cell Lung CancerNCT05104788Peking University Cancer Hospital & Institute27
Unknown
2 期
High-dose Icotinib Treatment Beyond Progression in EGFR Mutant NSCLCCarcinoma, Non-Small-Cell LungNCT02960607Chinese Academy of Medical Sciences25