NCT00405561终止2 期
A Prospective, Open, Single-Arm, Multicenter Phase II Clinical Trial to Evaluate the Progression Free Survival and Safety in Patients With Advanced Colorectal Carcinoma Treated With AMT2003
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
- 1
- 主要终点
- Progression free survival;at 18 weeks after registration
研究概览
简要总结
The purpose of the study is to evaluate efficacy and safety of AMT2003 in cancer patients with advanced colorectal carcinoma.
The primary endpoint is progression free survival rate at 18 weeks after registration
详细描述
The study will include patients with advanced colorectal carcinoma that is refractory to standard therapy or for which no effective standard therapy exists. Eligible patients must have had at least second-line chemotherapy.
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 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 of 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 method of birth control
- •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 in the study
研究组 & 干预措施
AMT2003
Experimental
干预措施: AMT2003 (Drug)
结局指标
主要结局
Progression free survival;at 18 weeks after registration
时间窗: 2010
次要结局
- Best overall response rate (ORR, CR and PR) within 18 weeks after registration(2010)
- Progression Free survival time (PFS), over complete observation period(2010)
- Overall Survival (OS) time(2010)
- Quality of Life (EORTC QLQ-C30) and Performance Status (Karnofsky Index)(2010)
- Safety and Tolerability(2010)
研究者
研究点 (1)
Loading locations...
相似试验
终止
2 期
Study to Evaluate Tumour Response in Cancer Patients With Advanced Hepatocellular Carcinoma (Liver Cancer) With AMT2003Hepatocellular CarcinomaNCT00405873Auron Healthcare GmbH73
终止
2 期
Study to Evaluate the Clinical Benefit Response in Cancer Patients With Advanced Disease With AMT2003 Versus PlaceboGastrointestinal CancerGenital Neoplasms, FemaleProstate CancerNCT00332280Auron Healthcare GmbH67
已完成
2 期
The Protégé Study - Clinical Trial of MGA031 in Children and Adults With Recent-Onset Type 1 Diabetes MellitusType 1 Diabetes MellitusNCT00385697MacroGenics554
进行中（未招募）
1 期
AZD9291 in Combination With Ascending Doses of Novel TherapeuticsAdvanced Non Small Cell Lung CancerNCT02143466AstraZeneca344
已完成
1 期
Study of AM003 in Patients With Locally Advanced and Metastatic Solid TumorsSolid TumorNCT06258330Aummune Ltd.12