A Non Randomised, Non Blinded Real World Trial of the Safety, Tolerability and Effectiveness of Metabolic Medicines for the Treatment of Cancer Compared Against Matched Controls
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
The purpose of this study is to determine the effectiveness of a regimen of selected metabolic treatments for patients with cancer in a real world setting and to conduct exploratory analysis on the relationship between the degree of response and changes in biochemical markers (such as glucose and lipid levels).
详细描述
*This study has been designed to collect data prospectively and to retrospectively analyse data on the metabolic treatments within the cancer clinic. The retrospective study is ongoing, while the prospective study has not yet started.*
This is a real world study since this gives the best opportunity to properly examine the effect of multi-drug regimens in representative populations. Including a standard of care arm is inappropriate, in a population in which that standard of care has already been shown to be ineffective or intolerable.
Patients will be sent to the study clinic directly by their Health Care Professionals ("HCP's") .
The study will consist of a pre-screening visit to determine eligibility for inclusion into the study, an initiation visit and then a follow up visit every three months thereafter. If required, unscheduled visits may take place. Day 0 (baseline) for each patient will be the initiation visit when study treatment is started.
Prior to conducting any study-related procedures, subjects will provide written informed consent, eligibility will be assessed, a medical history and past medical records will be taken and vital signs will be measured. These records will include the stage of their disease, response to previous cancer therapy, their prior and current medications and any specific regimen they are currently on for their cancer. If prior medical records do not contain sufficient information to determine a baseline for the patient, additional blood tests and scans will be undertaken as appropriate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Pregnant or lactating females or females who are planning a pregnancy during the course of the study;
- •Major organ failure, renal, lung and liver failure;
- •Participants having active liver disease or unexplained persistent elevation of serum transaminases > 3 times the upper limit of normal;
- •Participants with diabetic ketoacidosis or diabetic pre-coma;
- •Participants with a creatinine clearance < 60mL/min;
- •History of cardiac or respiratory failure;
- •History of recent myocardial infarction;
- •Ileum, colon or stomach part or full removal rendering them unable to take the study medicines;
- •Unable to eat or keep food or medicines down or is being fed intravenously;
- •Is too frail and weak to withstand the study medicines in the opinion of the study doctor;
- •Is Unlikely to survive more than 1 month under standard of care, in the opinion of the study doctor
- •Hypersensitivity to any of the treatment drugs or excipients;
- •If the patient is on any medicines contraindicated with the study medicines (see Appendix 3);
- •Mentally incapacitated and no guardian able to sign on patients Clinical study protocol, version 5.0 METRICS TRIAL, Metabolic Cancer 001 5th Apr 2016 Confidential Page 5 of 65 behalf;
- •History or presence of alcohol or substance abuse;
- •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;
- •Direct employee of the study site.
研究组 & 干预措施
Metabolic Treatment
Subjects will take the following treatments and have their data collected from their medical records every 3 months.
- Oral atorvastatin up to 80mg uid, for study duration.
- Oral metformin up to 1000mg uid, increased to bid if tolerated after 2 weeks, for study duration.
- Oral doxycycline 100mg uid, for study duration.
- Oral Mebendazole 100mg uid, for study duration.
干预措施: Metabolic treatment (Drug)
结局指标
主要结局
Overall survival
时间窗: up to 5 years
Overall survival for all cancer types and for each cancer type (years and months)
次要结局
- Change in cancer biomarkers (blood, urine or biopsy)(up to 5 years)
- Change in tumour spread (metastasis)(up to 5 years)
- Change in primary tumour size cancer types and by cancer type.(up to 5 years)
- Change in tumour number(up to 5 years)