RPCEC00000209已完成1 期
CIGB-370 administration in malignant tumors . Repeated dose study, dose escalation.
Center for Genetic Engineering and Biotechnology (CIGB), in Havana0 个研究点目标入组 18 人开始时间: 2016年2月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study. Masking: Open. Control Group: Uncontrolled. Assignment: Other. Purpose: Treatment
入排标准
- 年龄范围
- 18 years 至 65 years（—）
- 性别
- All
入选标准
- •1. Compliance with the diagnostic criteria (histological diagnosis of a malignant tumor from any location, solid or hematopoietic, advanced clinical stage, they are not eligible for other therapeutic procedures).
- •2. Age between 18-65 years inclusive.
- •3. Patient with a life expectancy = 6 months.
- •4. According to ECOG performance status = 2.
- •5. Voluntariness of the patient by signing the informed consent.
排除标准
- •1. Decompensated chronic diseases (hypertension, diabetes mellitus, chronic renal failure, heart failure, hyperthyroidism, epilepsy).
- •2. Moderate or severe systemic infections that interfere with patient evaluation.
- •3. Have received chemoradiotherapy in the past 4 weeks.
- •4. Patients who have received any investigational biological therapy or are involved in a clinical trial.
- •5. History of chronic liver disease (chronic hepatitis, liver cirrhosis and hepatocellular carcinoma).
- •6. History of cancer in situ of the uterine cervix.
- •7. History of allergy to any ingredient of the product under consideration.
- •8. Pregnancy or breastfeeding at the time of inclusion in the study.
- •9. Mental incapacity evident to issue consent and act accordingly to the study.
- •1. Decompensated chronic diseases (hypertension, diabetes mellitus, chronic renal failure, heart failure, hyperthyroidism, epilepsy).
- •2. Moderate or severe systemic infections that interfere with patient evaluation.
- •3. Have received chemoradiotherapy in the past 4 weeks.
- •4. Patients who have received any investigational biological therapy or are involved in a clinical trial.
- •5. History of chronic liver disease (chronic hepatitis, liver cirrhosis and hepatocellular carcinoma).
- •6. History of cancer in situ of the uterine cervix.
- •7. History of allergy to any ingredient of the product under consideration.
- •8. Pregnancy or breastfeeding at the time of inclusion in the study.
- •9. Mental incapacity evident to issue consent and act accordingly to the study.
研究者
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