EUCTR2016-001830-91-GB
Active, not recruiting
Phase 1
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 sites207 target enrollmentNovember 8, 2016
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Health Clinics Limited
- Enrollment
- 207
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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