EUCTR2016-001830-91-GB进行中（未招募）1 期
A NON RANDOMISED, NON BLINDED REAL WORLD STUDY OF THE SAFETY, TOLERABILITY AND EFFECTIVENESS OF METABOLIC MEDICINES FOR THE TREATMENT OF CANCER COMPARED AGAINST HISTORICAL CONTROLS - STUDY ON THE EFFECTIVENESS OF METABOLIC MEDICINES FOR CANCER
Health Clinics Limited0 个研究点目标入组 207 人开始时间: 2016年11月8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
- 207
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
入选标准
- •Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study;
- •1.Male or female 18-85 years old;
- •2.Diagnosed with cancer and have had such diagnosis confirmed by scan, blood markers and/or biopsy;
- •3.Is receiving or will shortly receive standard of care therapy or has completed standard of care treatment; and
- •4.Signed and dated written informed consent from the participant or LAR.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 57
排除标准
- •Subjects meeting any of the following exclusion criteria will not be included in the study;
- •1.Pregnant or lactating females or females who are planning a pregnancy during the course of the study;
- •2.Major organ failure, renal, lung and liver failure;
- •3. Participants having active liver disease or unexplained persistent elevation of serum
- •transaminases > 3 times the upper limit of normal;
- •4. Participants with diabetic ketoacidosis or diabetic pre-coma;
- •5. Participants with a creatinine clearance < 60mL/min;
- •6. History of cardiac or respiratory failure;
- •7. History of recent myocardial infarction;
- •8. Ileum, colon or stomach part or full removal rendering them unable to take the study
- •9. Unable to eat or keep food or medicines down or is being fed intravenously;
- •10. Is too frail and weak to withstand the study medicines in the opinion of the study doctor;
- •11. Is Unlikely to survive more than 1 month under standard of care, in the opinion of the study doctor
- •12. Hypersensitivity to any of the treatment drugs or excipients;
- •13. If the patient is on any medicines contraindicated with the study medicines (see Appendix
- •14. Mentally incapacitated and no guardian able to sign on patients behalf;
- •15. History or presence of alcohol or substance abuse;
- •16. Participation in a clinical trial of an investigational medicinal product that is viewed by the
- •Study Physician to be a significant risk to the participant’s safety;
- •17. Direct employee of the study site.
研究者
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