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

NCT02201381 | Withdrawn Phase 3 DMC

• 1 other identifier: Metabolic Cancer 001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Cancer; Overall Survival

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Overall survival for all cancer types and for each cancer type (years and months)

  up to 5 years

Secondary Outcomes (4)

• Change in primary tumour size cancer types and by cancer type.

  up to 5 years

• Change in tumour spread (metastasis)

  up to 5 years

• Change in tumour number

  up to 5 years

• Change in cancer biomarkers (blood, urine or biopsy)

  up to 5 years

Other Outcomes (1)

• Incidence of treatment related adverse events

  5 years

Study Arms (1)

Metabolic Treatment

EXPERIMENTAL

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

Interventions

Metabolic treatment DRUG

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

Also known as: Metformin, Atorvastatin, Doxycycline, Mebendazole

Metabolic Treatment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female 18-85 years old;
• Diagnosed with cancer and have had such diagnosis confirmed by scan, blood markers and/or biopsy;
• Is receiving or will shortly receive standard of care therapy or has completed standard of care treatment; and
• Signed and dated written informed consent from the participant or LAR.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Health Clinics Limited: lead

Study Sites (1)

Care Oncology Clinic

London, W1G 9PP, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms; Breast Neoplasms; Triple Negative Breast Neoplasms; Colonic Neoplasms; Brain Neoplasms; Ovarian Neoplasms; Pancreatic Neoplasms; Neoplasm Metastasis

Interventions

Metformin; Atorvastatin; Doxycycline; Mebendazole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Pancreatic Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Carbamates; Acids, Acyclic; Carboxylic Acids; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Samir Agrawal, MRCP FRCPath

  Care Oncology Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Matched historical control comparison

Study Record Dates

• First Submitted: July 22, 2014
• First Posted: July 28, 2014
• Study Start: May 23, 2022
• Primary Completion (Estimated): May 23, 2027
• Study Completion (Estimated): September 23, 2027
• Last Updated: July 18, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)