NCT00737360终止2 期
Phase II Study of TAS-106 in Patients With Recurrent or Metastatic Head and Neck Cancer Refractory to Platinum Based Chemotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 27
- 试验地点
- 5
- 主要终点
- Progression Free Survival(PFS)
研究概览
简要总结
The purpose of this study is to determine whether TAS-106 is effective to patients with recurrent or metastatic head and neck cancer refractory to 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
- •Age 18 ≤ years old at study entry
- •Histologically confirmed head and neck carcinoma
- •Received prior platinum based regimen and developed disease progression or recurrence
- •Measurable disease according to RECIST guidelines
排除标准
- •Radiological or clinical evidence of brain involvement or leptomeningeal disease
- •≥ grade 2 peripheral neuropathy
- •History of another malignancy
研究组 & 干预措施
1
Experimental
干预措施: TAS-106 (Drug)
结局指标
主要结局
Progression Free Survival(PFS)
时间窗: From the date of registration until the earliest date of documented disease progression, death, or censoring event.
PFS was calculated as days from the date of registration until the earliest date of documented disease progression, death, or censoring event.
次要结局
- Antitumor Activity(Obtain a contrast-enhanced CT scan of the chest, abdomen and pelvis (if clinically indicated) within 28 days prior to study entry and repeat at the end of every 2 courses thereafter.)
- Overall Survival(12 months after enrollment of the last patient)
- Safety(Monitor patients for untoward medical events from the time of signed informed consent form, including toxicities from previous treatment and any ongoing or newly reported AEs or SAEs during the 30 days after the last dose of study medication.)
研究者
研究点 (5)
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