NCT00359476终止2 期
A Multicenter, Single-Arm, Phase II Study of Single-Agent Vinflunine in the Second-line Treatment of Patients With Gastric Cancer
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2007年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- The Response Rate (RR: Complete Response [CR]+Partial Response [PR], as defined by Response Evaluation Criteria in Solid Tumors [RECIST]
研究概览
简要总结
The purpose of this study is to learn if vinflunine can shrink or slow the growth of cancer in patients with advanced or metastatic stomach cancer who have progressed on a prior treatment with a fluoropyrimidine or taxane-containing chemotherapy regimen. The safety of this treatment will also be studied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Patients with locally advanced or metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction who have progressed on a fluoropyrimidine or taxane-containing regimen in any combination in one prior first line treatment.
- •EGOC performance status of 0,1 or 2
- •Men and women, 18 years of age and older
排除标准
- •Patients having received more than one previous systemic chemotherapy regimen in any setting.
- •Major abdominal surgery within 2 months or any other surgery under general anesthesia within 4 weeks
- •Unresolved occlusive or sub-occlusive intestinal disease or any significant chronic intestinal disease (e.g. ulcerative colitis)
- •Prior radiation to >=30% of the bone marrow and/or radiation within 4 weeks prior to enrollment
- •Acute or chronic hepatitis
- •Known HIV infection
- •A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms
- •A history of additional risk factors for Torsade de Pointes (e.g., heart failure hypokalemia, family history of Long QT Syndrome)
研究组 & 干预措施
1
Experimental
干预措施: Vinflunine (Drug)
结局指标
主要结局
The Response Rate (RR: Complete Response [CR]+Partial Response [PR], as defined by Response Evaluation Criteria in Solid Tumors [RECIST]
时间窗: throughout the study
次要结局
- Estimation of the progression free survival and overall survival(At the end of the study)
- The estimation of the disease control rate(At the end of the study)
- The time to response and the duration of response(At the end of the study)
- The evaluation of the safety profile of vinflunine(At the end of the study)
研究者
研究点 (1)
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