Study of the Safety, Tolerability and Efficacy of Metabolic Combination Treatments on Cancer

• Status: Not yet recruiting
• Trial end date: 2027-09-23
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Health Clinics Limited
• Treatments: Atorvastatin; Doxycycline; Mebendazole; Metformin

Criteria

Inclusion criteria

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.

Exclusion Criteria:

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 medicines;

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 3);

14. 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;

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.