NCT01249547已完成2 期
Phase 2 Study of Axitinib in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy (clinical benefit rate) of single-agent axitinib in patients with recurrent or metastatic NPC, and its impact on disease progression.
研究概览
简要总结
This is an open-label, single arm, phase 2 clinical trial evaluating the activity and safety of single-agent axitinib in recurrent or metastatic NPC patients who failed at least one line of platinum based chemotherapy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diagnosis of nasopharyngeal carcinoma (NPC) (either at initial diagnosis or at recurrence).
- •Patients with recurrent or metastatic NPC that has progressed following one line of prior platinum-based chemotherapy.
- •Disease must be not amenable to potentially curative radiotherapy or surgery.
- •Measurable disease according to RECIST.
- •Age 18 or above; ECOG performance 0 or
- •Adequate bone marrow, renal and hepatic reserve.
排除标准
- •Presence of local recurrence
- •Presence of neck lymph node recurrence invading vascular structure;
- •Presence of central lung lesions involving major blood vessels;
- •History of hemoptysis or epistaxis within 4 weeks;
- •Preexisting uncontrolled hypertension defined as more than 140/90 mmHg despite adequate medical therapy;
- •Gastrointestinal abnormalities, including inability to take oral medication or malabsorption syndrome;
- •Concurrent use or anticipated need for treatment with known potent CYP3A4 inhibitors or CYP3A4 /CYP1A2 inducers.
研究组 & 干预措施
axitinib arm
Experimental
干预措施: axitinib (Drug)
结局指标
主要结局
To evaluate the efficacy (clinical benefit rate) of single-agent axitinib in patients with recurrent or metastatic NPC, and its impact on disease progression.
时间窗: 3 years
次要结局
- To assess objective response rate(3 years)
- To assess duration of response(3 years)
- To assess progression-free survival(3 Years)
- To assess overall survival(3 Years)
- To evaluate the safety and tolerability of axitinib(3 years)
- To evaluate axitinib plasma pharmacokinetics and to correlate these plasma concentrations with efficacy and safety parameters(3 years)
- To study blood and tissue biomarkers and correlate with cancer- and treatment-related outcomes(3 years)
研究者
CCTU
Comprehensive Clinical Trial Unit
Chinese University of Hong Kong
研究点 (1)
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