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

This study is currently recruiting participants.
Verified June 2017 by Health Clinics Limited
Sponsor:
ClinicalTrials.gov Identifier:
NCT02201381
First Posted: July 28, 2014
Last Update Posted: June 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Health Clinics Limited
  Purpose
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).

Condition Intervention Phase
Cancer Overall Survival Drug: Metabolic treatment Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Intervention Model Description:
Matched historical control comparison
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Non Randomised, Non Blinded Real World Trial of the Safety, Tolerability and Effectiveness of Metabolic Medicines for the Treatment of Cancer Compared Against Historical Controls

Resource links provided by NLM:


Further study details as provided by Health Clinics Limited:

Primary Outcome Measures:
  • Overall survival [ Time Frame: up to 5 years ]
    Overall survival for all cancer types and for each cancer type


Secondary Outcome Measures:
  • Tumour size cancer types and by cancer type. [ Time Frame: up to 5 years ]
    Tumour size for all cancer types and for each cancer type

  • Tumour Spread [ Time Frame: up to 5 years ]
    Tumour spread for all cancer types and for each cancer type

  • Tumour number [ Time Frame: up to 5 years ]
    Tumour number for all cancer types and for each cancer type

  • Blood cancer markers [ Time Frame: up to 5 years ]
    Blood cancer markers for all cancer types and for each cancer type


Other Outcome Measures:
  • Safety [ Time Frame: 5 years ]

    Adverse events reported by the subject or their HCP.

    • Quarterly assessment of routine laboratory tests



Estimated Enrollment: 207
Actual Study Start Date: May 22, 2017
Estimated Study Completion Date: October 22, 2023
Estimated Primary Completion Date: May 22, 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: Metabolic treatment
While subjects are being treated with the four metabolic drugs, every 3 months they will bring in their medical records and data will be collected to determine the effect of the intervention
Other Names:
  • Metformin
  • Atorvastatin
  • Doxycycline
  • Mebendazole

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02201381


Contacts
Contact: Robin Bannister, PhD +44 207 153 6577 robin.bannister@seekacure.com
Contact: Gregory Stoloff +44 207 580 3266 info@careoncologyclinic.com

Locations
United Kingdom
Care Oncology Clinic Recruiting
London, United Kingdom, W1G 9PP
Contact: Gregory Stoloff    +44 207 580 3266    info@careoncologyclinic.com   
Contact: Robin Bannister, PhD    +44 207 153 6577    robin.bannister@seekacure.com   
Sponsors and Collaborators
Health Clinics Limited
Investigators
Principal Investigator: Samir Agrawal, MRCP FRCPath Care Oncology Clinic
  More Information

Responsible Party: Health Clinics Limited
ClinicalTrials.gov Identifier: NCT02201381     History of Changes
Other Study ID Numbers: Metabolic Cancer 001
First Submitted: July 22, 2014
First Posted: July 28, 2014
Last Update Posted: June 14, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Health Clinics Limited:
Cancer
Cancer Treatments
Cancer Palliative Care
Metabolic
Metabolism
Existing Medicines
Licensed Medicines
Real World
Breast Cancer
Triple Negative Breast Cancer
Colon Cancer
Prostrate Cancer
Brain Cancer
Ovarian Cancer
Pancreatic Cancer
AML
CML
Leukemea
Metformin
Statins
Mebendazole
Doxycycline
Ibuprofen
Metastatic

Additional relevant MeSH terms:
Metformin
Atorvastatin Calcium
Doxycycline
Piperazine
Piperazine citrate
Mebendazole
Hypoglycemic Agents
Physiological Effects of Drugs
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Antinematodal Agents
Anthelmintics
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents


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