NCT00048529暂停2 期
Study of T900607-Sodium in Subjects With Previously Treated Gastric Cancer or Adenocarcinoma of the Esophagus
Tularik10 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2002年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 发起方
- 入组人数
- 70
- 试验地点
- 10
研究概览
简要总结
This is a clinical research study of T900607-sodium to determine if it is effective and safe in treating gastric cancer and adenocarcinoma of the esophagus. Patients will be treated on a weekly basis with an intravenous injection of the study drug.
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
- •Histologically or cytologically confirmed diagnosis of gastric cancer or adenocarcinoma of the esophagus
- •Subjects must have received 1-2 regimens of prior chemotherapy
- •At least 18 years of age
- •Bidimensionally measurable disease amenable to CT scanning. At least one lesion must be least 1 X 1 cm in size.
- •Karnofsky performance status of at least 70%
- •Estimated life expectancy of at least 12 weeks
- •Females of childbearing potential must have a negative pregnancy test and agree to use an effective contraceptive
- •Subject must be able to comply with study procedures and follow-up examinations.
- •Signed written informed consent
- •Lab Values (obtained ≤ 7 days prior to study enrollment):
- •ANC at least 1.5x10e9/L, * Platelet count at least 100x10e9/L,
- •Creatinine within 2 times upper limit of normal * AST and ALT within 5 times upper limit of normal
- •Bilirubin within 1.5 times upper limit of normal
- •Albumin great than 2.5 g/dL
排除标准
- •Severe, concurrent disease, infection or co-morbidity that, in the judgment of the investigator, would make the subject inappropriate for enrollment
- •NYHA Class III/IV cardiac disease, left ventricular ejection fraction (LVEF) of <50%, or acute anginal symptoms
- •Patients who have received any investigational agent within 4 weeks of enrollment
- •Patients who are pregnant or breast-feeding
- •History of prior malignancy other than gastric cancer or adenocarcinoma of the esophagus within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- •History of central nervous system metastases or carcinomatous meningitis
- •Major surgery within 4 weeks of enrollment
研究者
研究点 (10)
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