NCT00332280终止2 期
A Prospective, Randomised, Multicenter Phase II/III Clinical Trial to Evaluate the Clinical Benefit Response in Cancer Patients With Advanced Disease With AMT Versus Placebo
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
- 67
- 试验地点
- 2
- 主要终点
- Improvement in clinical benefit response
研究概览
简要总结
The purpose of the study is to evaluate the efficacy and the safety of AMT2003 in cancer patients with advanced disease.
The primary evaluation criterion is clinical benefit response.
详细描述
The study will include patients with a variety of solid tumors (i.e. esophageal, colon, pancreatic, bronchial, gastric, hepatocellular, gall bladder, prostate and gynaecological carcinomas.)
The clinical benefit response - CBR, is an end point that provides a clinical measure for symptom improvement in patients. The key evaluation parameters for CBR will be assessment of pain, the ability to perform daily activities and weight change.
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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cancer confirmed by histology or cytology
- •At least one measurable lesion
- •Advanced disease refractory to standard therapy or for which no standard therapy exists
- •Life expectancy at least 3 months
排除标准
- •Known secondary neoplasia or central nervous system (CNS) metastases, acute or chronic leukemia, lymphoma or multiple myeloma
- •Body weight below 45 kg
- •Female patients who are pregnant or breast feeding or adults of reproductive potential not employing effective birth control methods
- •Concurrent severe or uncontrolled medical disease
- •Acute or chronic liver disease
- •Confirmed diagnosis of HIV
- •Insulin dependent diabetes mellitus/abnormal glucose tolerance test (GTT)/latent diabetes mellitus type I or II
- •Chemotherapy or radiotherapy less than 4 weeks prior to entry
- •Surgery less than 2 weeks prior to entry (or not recovered from effects of surgery)
- •Participation in a clinical trial less than 30 days prior to entry into this study
研究组 & 干预措施
AMT2003
Experimental
干预措施: AMT2003 (Drug)
结局指标
主要结局
Improvement in clinical benefit response
时间窗: Jan 2010
次要结局
- Progression free survival(Jan 2010)
- Overall survival(Jan 2010)
- Overall response rate(2010)
- Duration of response(January 2010)
- Quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ-C30])(Jan 2010)
- Safety and tolerability(Jan 2010)
研究者
研究点 (2)
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