EUCTR2019-002748-25-DK进行中（未招募）1 期
Repurposing disulfiram as treatment for metastatic colorectal cancerAn investigator initiated clinical phase II trial - Disulfiram colorectal cancer
Department of Oncology, Odense Universitetshospital0 个研究点目标入组 28 人开始时间: 2019年7月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 28
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •--Age = 18 years.
- •-Histologically verified colorectal adenocarcinoma.
- •-Non-resectable mCRC.
- •-Measurable or no-measurable disease according to RECIST version 1.1.
- •-Performance status (WHO) of 0-1 and a life expectancy > 3 months.
- •-Documented early* progressive disease following at least 2months of irinotecan (+/-fluoropyrimidines). **on treatment or within 6 mons after ended treatment.
- •-Adequate haematological function defined as neutrophils ? 1.5 x 109/l and platelets = 100 x 109/l.
- •-Adequate organ function (normal bilirubin, GFR (may be calculated) > 60 ml/min).
- •-Willingness to refrain from alcohol consumption of alcohol during the trial and 14 days after the last treatment with Disulfiram.
- •-Woman of childbearing potential must have been tested negative in a serum pregnancy test within 5 days prior to randomisation. Male and female patients who have the potential to reproduce must agree to use a highly effective method of birth control. (i.e., pregnancy rate of less than 1 % per year) during the study and for 6 months after the discontinuation of study medication.
- •-Has provided written informed consent prior to performance of any study procedure.
- •-Written informed consent must be obtained according to the local Ethics Committee requirements.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 14
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 14
排除标准
- •-Known UGT-1A1 polymorphism.
- •-Known CNS metastases
- •-Prior history of cancer, except cervix in situ carcinoma, in situ urothelial carcinoma or previously treated and cured skin basocellular, and any other cancer in complete remission for at least 2 years.
- •-Uncontrolled hypertension (systolic blood pressure > 169 mmHg or diastolic blood pressure > 100 mmHg)
- •-Any other condition or therapy, which in the investigator’s opinion may pose a risk to the patient or interfere with the study objectives (e.g. known CNS metastasis; infection; drainage of ascites or pleural effusion within 4 weeks; intestinal obstruction; uncontrolled diabetes; AMI within 12 months; severe/unstable angina; known HIV or hepatitis B or C; major surgery within 4 weeks; uncontrolled hypertension).
- •-Known allergy or intolerance to any of the drugs used (irinotecan, disulfiram, and copper).
研究者
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