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
- Conditions
- CancerTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-001830-91-GB
- Lead Sponsor
- Health Clinics Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 207
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
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
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 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: This is a prospective study to determine the effects of a combination of four drugs (that inhibit metabolic pathways) in cancer patients, with any type of cancer, looking at their effect on the overall survival of those patients. This data will be compared to the known survival outcomes for each of the cancer types from historical controls. ;Secondary Objective: This study will also assess the effect of the combination of four drugs (that inhibit metabolic pathways) on tumour size, tumour spread and number of tumours and/or Blood Cancer Markers, and to assess the safety and tolerability of the medicine combinations. ;Primary end point(s): Overall survival for all cancer types and by cancer type.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Tumour size, spread and number and/or Blood Cancer Markers for all cancer types and by cancer type.