CancerPhase 3METRICSNCT02201381
Study of the Safety, Tolerability and Efficacy of Metabolic Combination Treatments on Cancer
A Phase 3 study testing Metabolic treatment in people with Cancer and Overall Survival, run by Health Clinics Limited at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cancer, Overall Survival
- What is being tested?
- Metabolic treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 May 2022to 23 Sep 2027
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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;
- 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;
- Direct employee of the study site.
Trial locations and contacts
1 site in 1 country.
About this study
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 Matched Controls
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).
Read the detailed description
*This study has been designed to collect data prospectively and to retrospectively analyse data on the metabolic treatments within the cancer clinic. The retrospective study is ongoing, while the prospective study has not yet started.*
This is a real world study since this gives the best opportunity to properly examine the effect of multi-drug regimens in representative populations. Including a standard of care arm is inappropriate, in a population in which that standard of care has already been shown to be ineffective or intolerable.
Patients will be sent to the study clinic directly by their Health Care Professionals ("HCP's") .
The study will consist of a pre-screening visit to determine eligibility for inclusion into the study, an initiation visit and then a follow up visit every three months thereafter. If required, unscheduled visits may take place. Day 0 (baseline) for each patient will be the initiation visit when study treatment is started.
Prior to conducting any study-related procedures, subjects will provide written informed consent, eligibility will be assessed, a medical history and past medical records will be taken and vital signs will be measured. These records will include the stage of their disease, response to previous cancer therapy, their prior and current medications and any specific regimen they are currently on for their cancer. If prior medical records do not contain sufficient information to determine a baseline for the patient, additional blood tests and scans will be undertaken as appropriate.
Patients will be monitored quarterly thereafter when blood tests (e.g. safety parameters, glucose, cholesterol, immune response and cancer markers where applicable) and scans (where applicable) will be taken.
All patients will be on the same drug regimen (see below) at the same doses throughout the study. All patients will be followed up until they choose to leave the study, or death.
Data from all patients recruited to the study will be analysed using an Intention-to-treat (ITT) philosophy, so data will be included in the primary analysis irrespective of whether the dose regimen was followed throughout the study. If appropriate, and numbers allow, analysis will also be conducted on the Per Protocol population, comprising those patients who adhere to the regimen as prescribed.
Survival analysis methods will be used to estimate the Overall survival associated with the study regimen for each type of cancer. These estimates will be interpreted in the light of data obtained from the literature, and from eliciting expert opinion. Bayesian methods may be used where appropriate.
Tumour response, where applicable, will be summarised in tables and graphs. Estimates of response rates will be presented for each cancer type with confidence intervals.
The relationship between changes in biochemistry values (glucose, lipids) and efficacy outcomes (Progression Free Survival (PFS), Overall Survival (OS) and HRQoL) will be investigated graphically, or using other methods as appropriate.
Further exploratory analysis to investigate the effects of other factors such as age , ethnic backgrounds , cancer stage, and response to prior therapy, will also be conducted in order to try and characterise the profile of patients most likely to benefit from the study regimen.
The characteristics of patients on the regimen and those who do not stay on the regimen, for whatever reason, will be summarised to see whether there is any observed bias. If appropriate, methods will be used to adjust for any observed bias, for example using propensity scores. OS can then be assessed adjusted for this to try and mitigate for any possible risk of bias which can occur in uncontrolled studies. Furthermore, by enrolling all eligible patients over a specified time frame, it is hoped that the risk of bias should be further reduced. In addition, a large number of patients are expected to participate in the study.
- Conditions
- Cancer, Overall Survival
- Being tested
- Metabolic treatment
- 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
- Medical subject headings
- Neoplasms, Breast Neoplasms, Triple Negative Breast Neoplasms, Colonic Neoplasms, Brain Neoplasms, Ovarian Neoplasms, Pancreatic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metabolic treatmentDrug
Also called Metformin, Atorvastatin, Doxycycline, Mebendazole
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Metabolic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Overall survival for all cancer types and for each cancer type (years and months)
Measured: up to 5 years
Secondary outcomes (4)
Change in primary tumour size cancer types and by cancer type.
Tumour size for all cancer types and for each cancer type. Units of size vary depending on cancer type.
Measured: up to 5 years
Change in tumour spread (metastasis)
Tumour spread (metastasized) to other tissues/organs, for all cancer types and for each cancer type. This is measured as either 0 for no spread or 1 for confirmed spread.
Measured: up to 5 years
Change in tumour number
Tumour number for all cancer types and for each cancer type
Measured: up to 5 years
Change in cancer biomarkers (blood, urine or biopsy)
Cancer biomarkers for all cancer types and for each cancer type. Units of measurement vary depending on the cancer type. When biomarkers, either alone or in combination with other biomarkers, are raised above normal they are seen as predictive of cancer of progression. If returned to normal are indicative of treatment response.
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2014 (estimated)
- Study start23 May 2022 (estimated)
- Primary completion23 May 2027 (estimated)
- Study completion23 Sep 2027 (estimated)
Why it stopped: Prospective recruitment not possible
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Matched historical control comparison
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Health Clinics Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Samir Agrawal, MRCP FRCPath, Principal investigator, Care Oncology Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02201381
- Sponsor's protocol ID
- Metabolic Cancer 001
- Acronym
- METRICS
- Status last verified
- Jul 2022
- First submitted
- 22 Jul 2014
- Last updated
- 18 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 Matched Controls
- ClinicalTrials.gov ID
- NCT02201381
- Acronym / sponsor ID
- METRICS / Metabolic Cancer 001
- Conditions
- Cancer, Overall Survival
- Keywords
- Cancer, Cancer Treatments, Cancer Palliative Care, Metabolic, Metabolism, Existing Medicines, Licensed Medicines, Real World
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Prospective recruitment not possible
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Health Clinics LimitedIndustry (pharma, biotech, devices)
- Study start
- 23 May 2022 (estimated)
- Primary completion
- 23 May 2027 (estimated)
- Study completion
- 23 Sep 2027 (estimated)
- First posted
- 28 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
*This study has been designed to collect data prospectively and to retrospectively analyse data on the metabolic treatments within the cancer clinic. The retrospective study is ongoing, while the prospective study has not yet started.*
This is a real world study since this gives the best opportunity to properly examine the effect of multi-drug regimens in representative populations. Including a standard of care arm is inappropriate, in a population in which that standard of care has already been shown to be ineffective or intolerable.
Patients will be sent to the study clinic directly by their Health Care Professionals ("HCP's") .
The study will consist of a pre-screening visit to determine eligibility for inclusion into the study, an initiation visit and then a follow up visit every three months thereafter. If required, unscheduled visits may take place. Day 0 (baseline) for each patient will be the initiation visit when study treatment is started.
Prior to conducting any study-related procedures, subjects will provide written informed consent, eligibility will be assessed, a medical history and past medical records will be taken and vital signs will be measured. These records will include the stage of their disease, response to previous cancer therapy, their prior and current medications and any specific regimen they are currently on for their cancer. If prior medical records do not contain sufficient information to determine a baseline for the patient, additional blood tests and scans will be undertaken as appropriate.
Patients will be monitored quarterly thereafter when blood tests (e.g. safety parameters, glucose, cholesterol, immune response and cancer markers where applicable) and scans (where applicable) will be taken.
All patients will be on the same drug regimen (see below) at the same doses throughout the study. All patients will be followed up until they choose to leave the study, or death.
Data from all patients recruited to the study will be analysed using an Intention-to-treat (ITT) philosophy, so data will be included in the primary analysis irrespective of whether the dose regimen was followed throughout the study. If appropriate, and numbers allow, analysis will also be conducted on the Per Protocol population, comprising those patients who adhere to the regimen as prescribed.
Survival analysis methods will be used to estimate the Overall survival associated with the study regimen for each type of cancer. These estimates will be interpreted in the light of data obtained from the literature, and from eliciting expert opinion. Bayesian methods may be used where appropriate.
Tumour response, where applicable, will be summarised in tables and graphs. Estimates of response rates will be presented for each cancer type with confidence intervals.
The relationship between changes in biochemistry values (glucose, lipids) and efficacy outcomes (Progression Free Survival (PFS), Overall Survival (OS) and HRQoL) will be investigated graphically, or using other methods as appropriate.
Further exploratory analysis to investigate the effects of other factors such as age , ethnic backgrounds , cancer stage, and response to prior therapy, will also be conducted in order to try and characterise the profile of patients most likely to benefit from the study regimen.
The characteristics of patients on the regimen and those who do not stay on the regimen, for whatever reason, will be summarised to see whether there is any observed bias. If appropriate, methods will be used to adjust for any observed bias, for example using propensity scores. OS can then be assessed adjusted for this to try and mitigate for any possible risk of bias which can occur in uncontrolled studies. Furthermore, by enrolling all eligible patients over a specified time frame, it is hoped that the risk of bias should be further reduced. In addition, a large number of patients are expected to participate in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Matched historical control comparison
| Arm | Type | Receives |
|---|---|---|
| Metabolic Treatment | Experimental | Drug: Metabolic treatmentSubjects 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (17 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metabolic treatmentAlso: Metformin, Atorvastatin, Doxycycline, MebendazoleWhile 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 | Drug | Metabolic Treatment |
Primary outcome
Overall survival
Time frame: up to 5 years
Overall survival for all cancer types and for each cancer type (years and months)
4 secondary outcomes
Change in primary tumour size cancer types and by cancer type.
Time frame: up to 5 years
Change in tumour spread (metastasis)
Time frame: up to 5 years
Change in tumour number
Time frame: up to 5 years
Change in cancer biomarkers (blood, urine or biopsy)
Time frame: up to 5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samir Agrawal, MRCP FRCPath principal investigator
Care Oncology Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Metabolic treatment in people with Cancer and Overall Survival, run by Health Clinics Limited at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2022.