Bladder CancerPhase 2NCT02360618
Metformin and Simvastatin Use in Bladder Cancer
A Phase 2 study testing Metformin and Simvastatin in people with Bladder Cancer, run by London Health Sciences Centre at 1 site in Canada.
Trial summary
A single arm, single center window of opportunity trial of using a combination of metformin and simvastatin as a neoadjuvant treatment for patients with invasive bladder cancer who are to undergo cystectomy. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Metformin and Simvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2015to Jan 2018
- Phase
- Phase 2
- 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
- Age ≥18 years and 85≤.
- Patients must have biopsy proven invasive bladder cancer by TURBT, previously untreated prior to TURBT by systemic chemotherapy.
- Patients must be able to swallow and tolerate oral medication
- Hemoglobin A1c ≤ 6.5%.
- Able to comprehend written and verbal study instructions related to study protocol and provide informed consent.
- Any women with childbearing potential must use a highly effective contraception method, of which include: hormonal contraceptives (e.g. combined oral contraceptives, patch, vaginal ring, injectables, and implants); intrauterine device (IUD) or intrauterine system (IUS); vasectomy and tubal ligation.
Who cannot join
- Patient has been treated for a prior cancer diagnosis with cisplatin-derived chemotherapy regimens or has had pelvic radiation therapy.
- Previous or current diagnosis of type 1 or 2 diabetes mellitus.
- Metformin exposure within the previous 12 months.
- Expected or simultaneous use of sulfonylureas, thiazolidinediones, or insulin.
- Known metformin allergy or intolerance.
- Participation in another drug trial either within 30 days prior to study enrollment or during the time when they are on study protocol.
Show all 16Show fewer
- Serious cardiovascular disease including myocardial infarction within 6 months, unstable angina, serious cardiac arrythmias excluding atrial fribrillation, or cerebrovascular accident within 6 months prior to screening visit.
- Abnormal liver function tests: Total bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase (ALP) > 1.8 X upper limit of normal
- Estimated glomerular filtration rate (eGFR) of ≤40 mL/min.
- History of other malignancy, except non-muscle invasive bladder cancer, treated non-melanoma skin cancer, stage I melanoma and solid tumors adequately treated, with no persistent evidence of disease for 5 years.
- Concomitant medical condition predisposing to metformin hydrochloride-associated lactic acidosis; examples include NYHA class III or IV congestive heart failure, history of acidosis and chronic alcohol intake averaging ≥ 4 beverages per day.
- A history of rhabdomyolysis.
- The use of medications including niacin and colchicine, as well as strong inhibitors of cytochrome p-450 3A4 (see list in section 4.2).
- Untreated hypothyroidism.
- Pregnancy.
- Breastfeeding
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
London Health Sciences Center; Victoria Hospital
London, Ontario, N6A 5W9
Jonathan Izawa, MD
About this study
Official title: A Window of Opportunity Study to Evaluate the Role of the Combination of Metformin and Simvastatin as a Neoadjuvant Therapy in Invasive Bladder Cancer
A single arm, single center window of opportunity trial of using a combination of metformin and simvastatin as a neoadjuvant treatment for patients with invasive bladder cancer who are to undergo cystectomy. The study will assess the feasibility of conducting window of opportunity trials in invasive bladder cancer the drug combination's affects on a variety of important clinicopathologic variables.
The goal is to enroll 44 patients within 18 months. An interim analysis will be conducted at 12 months, and the study will be prematurely closed if fewer than 10 patients have been enrolled at that time. Patients will be administered 850mg of metformin twice daily along with 20mg of Simvastatin. Patients will be enrolled following the formal diagnosis of invasive bladder cancer or at first visit following referral to the London Health Sciences Center (LHSC). Patient's will receive metformin and simvastatin from the time of enrollment until the night prior to their operation in the absence of safety or tolerability concerns.
Read the detailed description
This is a single centre window of opportunity trial. A total of 44 patients with a diagnosis of invasive bladder cancer diagnosed by pathologic evaluation of transurethral resection of bladder tumor (TURBT) specimens and meeting all eligibility criteria will be enrolled in the study. Study participants will receive Metformin 850mg twice daily and simvastatin 20mg once daily until the night before of their scheduled cystectomy, which is a time period which will last approximately 12 weeks or less. Pre-treatment TURBT tissue samples and the Cystectomy post-therapy tissue samples will be analyzed and compared. Samples will be analyzed for cell proliferation markers and to determine whether or not the combination of metformin and simvastatin is able to produce a synergistic effect that will result in the decrease of the growth of these aggressive cancer cells. The anticipated recruitment period will be approximately 18 months. Participants in this study will be asked to attend the following clinic visits for this study:
Baseline Visit:
During this visit, the study doctor will conduct a physical exam and take vital signs as well as height and weight measurements. Blood will also be drawn for analysis and research purposes. Females that are of child bearing potential will have a pregnancy test to confirm that they are not pregnant. Pregnant women will be removed from the study. We will also be collecting blood samples.
Clinic Visits Participants will have follow-up clinic visits or phone interviews scheduled every 4 weeks until the time of their surgery. At least 1 visit will be in person before surgery. At these times they will have blood drawn for analysis, have their medication reviewed, and confirm that they are taking the medication in adherence with the study protocol.
Day of Surgery On the day of surgery, the participants will have their height and weight measured, have blood drawn for analysis and research purposes, and drug compliance will be assessed.
This is a feasibility study, and an interim analysis of enrollment is planned at 12 months after the first patient is enrolled. The trial will be prematurely closed if it fails to enroll 10 patients by the 12 month time point. A preliminary pathological analysis will be performed following the completion of 12 months from the time of study initiation.
In the event that the enrolled patient underwent a TURBT for diagnosis prior to referral, either tissue will be obtained from the peripheral center where the TURBT was performed or they will be consented for repeat TURBT, or withdrawn from the study.
Based upon the documentation at the time of TURBT, an attempt will be made, where possible, to obtain tissue sections from the same tumor contained in the cystectomy sections. Where this is not possible, representative slides will be obtained from another tumor, if available.
Study Objectives The aim of this study is to evaluate feasibility of window of opportunity neoadjuvant trials for invasive bladder cancer in our center, and to determine the effect of the combination of metformin and simvastatin on clinicopathologic markers of drug activity in our patient cohort.
Primary Objectives - Feasibility and Tumor Proliferation Rate The primary endpoint of this trial will be the assessment of the tumor proliferation rate. This will be investigated through the analysis of the change in Ki67 tissue staining between the TURBT tissue samples and the cystectomy tissue.
Marker of cell proliferation;
- Ki67 staining This trial is also designed to establish the framework and evaluate the feasibility of performing neoadjuvant window of opportunity trials using drugs with potential bioactivity against invasive bladder cancer at the London Health Sciences Center. The goal is to accrue 44 patients within 18 months to the trial. A midterm analysis at 12 months will be performed, at which time the trial will be prematurely closed if there have been fewer than 10 patients enrolled.
- Feasibility - goal to accrue 44 patients in 18 months.
Secondary Objectives This study will assess the rate of grade 3 or higher toxicity as defined by the CTCAE 4.03 (Common Terminology Criteria for Adverse Events). If 41 patients are enrolled and complete the study, the study will have an 85% power at an of 0.05 to detect if the toxicity rate is >20% with an assumed baseline of ≤5%.
- Toxicity The following parameters will be investigated through the analysis of any differences in their tissue staining between the TURBT tissue samples and the cystectomy tissue. This should aid in the delineation of any therapeutic effects of the combination of metformin and simvastatin therapy on urothelial carcinoma (UC). Marker of Apoptosis;
- Terminal deoxynucleotidyl Transferase-mediated deoxy uridine triphosphate (dUTP) nick end labeling (TUNEL) staining Phosphoinositide-3 kinase/protein kinase B/mammalian target of rapamycin (PI3K/Akt/mTOR) pathway readouts;
- p-mTOR staining
- p-Akt staining
- survivin Metformin stimulates activation;
- phosphorylated adenosine monophosphate-activated protein kinase (p-AMPK) The following parameters will be investigated through the analysis of their tissue staining in the cystectomy sample, as they are assumed to be dependent on the underlying tumor biology and will not be affected by metformin therapy: PI3K/Akt/mTOR pathway regulator, frequently mutated in UC, could affect metformin response;
- Phosphatase and tensin homolog (PTEN) staining Cell cycle regulator, frequently inactivated in invasive UC, affects metformin response;
- p53 staining
Tertiary Endpoints The following parameters will be investigated through the analysis of any differences in either their values between the time of enrollment and the day of surgery or differences in the frequency between the treatment and control groups.
Between time of enrollment and date of surgery;
- Serum Insulin
- Fasting glucose levels
- Body mass index
- Changes in serum prostate specific antigen (PSA) Clinical Marker of efficacy, has been shown to affect prognosis:
- Pathologic T0 rate at cystectomy vs. historical rates Potential Novel Biomarkers:
- Number of circulating tumor cells or tumor microparticles before and after treatment with metformin The following additional stratification analyses of the data will be performed in order to assess our results in light of prior research findings: Stratification of Pathologic Markers;
- Stratification of pAKT and Survivin expression levels by the presence or absence of PTEN expression
- Stratification of TUNEL and Ki67 by the status of p53 staining
- Stratification of pathologic markers by the use or absence of administration of neoadjuvant chemotherapy
- Conditions
- Bladder Cancer
- Being tested
- Metformin, Simvastatin
- Keywords
- Bladder Cancer, Metformin, Simvastatin, Combination Therapy
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called No other names
See Group Description
SimvastatinDrug
Also called No other names
See Group Description
| Study group | Role | What they receive |
|---|---|---|
| Metformin and Simvastatin Treatment | Experimental | Patients in this group will receive 850 mg of Metformin and 20 mg of Simvastatin daily from the time they are enrolled in the study until the day before their surgery (approximately 12 weeks), in the absence of any safety or tolerability concerns. Receives: Drug: Metformin; Drug: Simvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bladder tumor proliferation rate
The primary endpoint of this trial will be the assessment of the tumor proliferation rate. This will be investigated through the analysis of the change in Ki67 (cellular marker of cell proliferation) tissue staining between the TURBT tissue samples and the cystectomy tissue.
Measured: The participant will be followed for the duration of the pre-surgical preparation period. This is expected to be fewer than 12 weeks
Feasibility of performing neoadjuvant window of opportunity trials using drugs with potential bioactivity against invasive bladder cancer
This trial is also designed to establish the framework and evaluate the feasibility of performing neoadjuvant window of opportunity trials using drugs with potential bioactivity against invasive bladder cancer at the London Health Sciences Center. The goal is to accrue 44 patients within 18 months to the trial, and the study will be prematurely closed if fewer than 10 patients are recruited within 12 months.
Measured: The participant will be followed for the duration of the pre-surgical preparation period. This is expected to be fewer than 12 weeks
Secondary outcomes (3)
Toxicity in patients who participate in the treatment regimen of Metformin and Simvastatin therapy
This study will assess the rate of grade 3 or higher toxicity caused by the study drug combination as defined by the CTCAE 4.03.
Measured: The participant will be followed for the duration of the pre-surgical preparation period. This is expected to be fewer than 12 weeks
Level of apoptosis observed in tumor cells of patients who undergo Metformin and Simvastatin therapy before cystectomy.
Tissue will be analyzed for the change in the marker of apoptosis Terminal deoxynucleotidyl Transferase-mediated dUTP nick end labeling (TUNEL) staining between TURBT and cystectomy tissue samples.
Measured: The participant will be followed for the duration of the pre-surgical preparation period. This is expected to be fewer than 12 weeks
Impact of Metformin and Simvastatin therapy on the signalling pathways involved in invasive urothelial carcinoma.
Various signalling pathways involved in cell proliferation and metformin response that may be affected by the combination of study drugs will be evaluated by analyzing tissue samples obtained from the patient during TURBT and then cystectomy. These experiments will be done to assess whether the combination of study drugs are able to inhibit the cellular signalling pathways that contribute to cancer cell growth by comparing the signaling levels between pre and post treatment samples. These pathways include PI3K/Akt/mTOR and AMPK. We will also evaluate the effect of the levels of PTEN and p53 on the cell response to therapy.
Measured: The participant will be followed for the duration of the pre-surgical preparation period. This is expected to be fewer than 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2015 (estimated)
- Study startOct 2015
- Primary completionJan 2018 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Jonathan Izawa, London Health Sciences Centre
- Investigators
- Jonathan Izawa, MD, Principal investigator, London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02360618
- Sponsor's protocol ID
- MS_1
- Status last verified
- Jul 2016
- First submitted
- 13 Jan 2015
- Last updated
- 11 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Window of Opportunity Study to Evaluate the Role of the Combination of Metformin and Simvastatin as a Neoadjuvant Therapy in Invasive Bladder Cancer
- ClinicalTrials.gov ID
- NCT02360618
- Acronym / sponsor ID
- MS_1
- Conditions
- Bladder Cancer
- Keywords
- Bladder Cancer, Metformin, Simvastatin, Combination Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- London Health Sciences CentreUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 10 Feb 2015 (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.
A single arm, single center window of opportunity trial of using a combination of metformin and simvastatin as a neoadjuvant treatment for patients with invasive bladder cancer who are to undergo cystectomy. The study will assess the feasibility of conducting window of opportunity trials in invasive bladder cancer the drug combination's affects on a variety of important clinicopathologic variables.
The goal is to enroll 44 patients within 18 months. An interim analysis will be conducted at 12 months, and the study will be prematurely closed if fewer than 10 patients have been enrolled at that time. Patients will be administered 850mg of metformin twice daily along with 20mg of Simvastatin. Patients will be enrolled following the formal diagnosis of invasive bladder cancer or at first visit following referral to the London Health Sciences Center (LHSC). Patient's will receive metformin and simvastatin from the time of enrollment until the night prior to their operation in the absence of safety or tolerability concerns.
Detailed description
This is a single centre window of opportunity trial. A total of 44 patients with a diagnosis of invasive bladder cancer diagnosed by pathologic evaluation of transurethral resection of bladder tumor (TURBT) specimens and meeting all eligibility criteria will be enrolled in the study. Study participants will receive Metformin 850mg twice daily and simvastatin 20mg once daily until the night before of their scheduled cystectomy, which is a time period which will last approximately 12 weeks or less. Pre-treatment TURBT tissue samples and the Cystectomy post-therapy tissue samples will be analyzed and compared. Samples will be analyzed for cell proliferation markers and to determine whether or not the combination of metformin and simvastatin is able to produce a synergistic effect that will result in the decrease of the growth of these aggressive cancer cells. The anticipated recruitment period will be approximately 18 months. Participants in this study will be asked to attend the following clinic visits for this study:
Baseline Visit:
During this visit, the study doctor will conduct a physical exam and take vital signs as well as height and weight measurements. Blood will also be drawn for analysis and research purposes. Females that are of child bearing potential will have a pregnancy test to confirm that they are not pregnant. Pregnant women will be removed from the study. We will also be collecting blood samples.
Clinic Visits Participants will have follow-up clinic visits or phone interviews scheduled every 4 weeks until the time of their surgery. At least 1 visit will be in person before surgery. At these times they will have blood drawn for analysis, have their medication reviewed, and confirm that they are taking the medication in adherence with the study protocol.
Day of Surgery On the day of surgery, the participants will have their height and weight measured, have blood drawn for analysis and research purposes, and drug compliance will be assessed.
This is a feasibility study, and an interim analysis of enrollment is planned at 12 months after the first patient is enrolled. The trial will be prematurely closed if it fails to enroll 10 patients by the 12 month time point. A preliminary pathological analysis will be performed following the completion of 12 months from the time of study initiation.
In the event that the enrolled patient underwent a TURBT for diagnosis prior to referral, either tissue will be obtained from the peripheral center where the TURBT was performed or they will be consented for repeat TURBT, or withdrawn from the study.
Based upon the documentation at the time of TURBT, an attempt will be made, where possible, to obtain tissue sections from the same tumor contained in the cystectomy sections. Where this is not possible, representative slides will be obtained from another tumor, if available.
Study Objectives The aim of this study is to evaluate feasibility of window of opportunity neoadjuvant trials for invasive bladder cancer in our center, and to determine the effect of the combination of metformin and simvastatin on clinicopathologic markers of drug activity in our patient cohort.
Primary Objectives - Feasibility and Tumor Proliferation Rate The primary endpoint of this trial will be the assessment of the tumor proliferation rate. This will be investigated through the analysis of the change in Ki67 tissue staining between the TURBT tissue samples and the cystectomy tissue.
Marker of cell proliferation;
- Ki67 staining This trial is also designed to establish the framework and evaluate the feasibility of performing neoadjuvant window of opportunity trials using drugs with potential bioactivity against invasive bladder cancer at the London Health Sciences Center. The goal is to accrue 44 patients within 18 months to the trial. A midterm analysis at 12 months will be performed, at which time the trial will be prematurely closed if there have been fewer than 10 patients enrolled.
- Feasibility - goal to accrue 44 patients in 18 months.
Secondary Objectives This study will assess the rate of grade 3 or higher toxicity as defined by the CTCAE 4.03 (Common Terminology Criteria for Adverse Events). If 41 patients are enrolled and complete the study, the study will have an 85% power at an of 0.05 to detect if the toxicity rate is >20% with an assumed baseline of ≤5%.
- Toxicity The following parameters will be investigated through the analysis of any differences in their tissue staining between the TURBT tissue samples and the cystectomy tissue. This should aid in the delineation of any therapeutic effects of the combination of metformin and simvastatin therapy on urothelial carcinoma (UC). Marker of Apoptosis;
- Terminal deoxynucleotidyl Transferase-mediated deoxy uridine triphosphate (dUTP) nick end labeling (TUNEL) staining Phosphoinositide-3 kinase/protein kinase B/mammalian target of rapamycin (PI3K/Akt/mTOR) pathway readouts;
- p-mTOR staining
- p-Akt staining
- survivin Metformin stimulates activation;
- phosphorylated adenosine monophosphate-activated protein kinase (p-AMPK) The following parameters will be investigated through the analysis of their tissue staining in the cystectomy sample, as they are assumed to be dependent on the underlying tumor biology and will not be affected by metformin therapy: PI3K/Akt/mTOR pathway regulator, frequently mutated in UC, could affect metformin response;
- Phosphatase and tensin homolog (PTEN) staining Cell cycle regulator, frequently inactivated in invasive UC, affects metformin response;
- p53 staining
Tertiary Endpoints The following parameters will be investigated through the analysis of any differences in either their values between the time of enrollment and the day of surgery or differences in the frequency between the treatment and control groups.
Between time of enrollment and date of surgery;
- Serum Insulin
- Fasting glucose levels
- Body mass index
- Changes in serum prostate specific antigen (PSA) Clinical Marker of efficacy, has been shown to affect prognosis:
- Pathologic T0 rate at cystectomy vs. historical rates Potential Novel Biomarkers:
- Number of circulating tumor cells or tumor microparticles before and after treatment with metformin The following additional stratification analyses of the data will be performed in order to assess our results in light of prior research findings: Stratification of Pathologic Markers;
- Stratification of pAKT and Survivin expression levels by the presence or absence of PTEN expression
- Stratification of TUNEL and Ki67 by the status of p53 staining
- Stratification of pathologic markers by the use or absence of administration of neoadjuvant chemotherapy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metformin and Simvastatin Treatment | Experimental | Drug: Metformin, Drug: SimvastatinPatients in this group will receive 850 mg of Metformin and 20 mg of Simvastatin daily from the time they are enrolled in the study until the day before their surgery (approximately 12 weeks), in the absence of any safety or tolerability concerns. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years and 85≤.
- Patients must have biopsy proven invasive bladder cancer by TURBT, previously untreated prior to TURBT by systemic chemotherapy.
- Patients must be able to swallow and tolerate oral medication
- Hemoglobin A1c ≤ 6.5%.
- Able to comprehend written and verbal study instructions related to study protocol and provide informed consent.
Key exclusion criteria (16 listed)
- Patient has been treated for a prior cancer diagnosis with cisplatin-derived chemotherapy regimens or has had pelvic radiation therapy.
- Previous or current diagnosis of type 1 or 2 diabetes mellitus.
- Metformin exposure within the previous 12 months.
- Expected or simultaneous use of sulfonylureas, thiazolidinediones, or insulin.
- Known metformin allergy or intolerance.
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 |
|---|---|---|
| MetforminAlso: No other namesSee Group Description | Drug | Metformin and Simvastatin Treatment |
| SimvastatinAlso: No other namesSee Group Description | Drug | Metformin and Simvastatin Treatment |
Primary outcome
Bladder tumor proliferation rate
Time frame: The participant will be followed for the duration of the pre-surgical preparation period. This is expected to be fewer than 12 weeks
The primary endpoint of this trial will be the assessment of the tumor proliferation rate. This will be investigated through the analysis of the change in Ki67 (cellular marker of cell proliferation) tissue staining between the TURBT tissue samples and the cystectomy tissue.
Feasibility of performing neoadjuvant window of opportunity trials using drugs with potential bioactivity against invasive bladder cancer
Time frame: The participant will be followed for the duration of the pre-surgical preparation period. This is expected to be fewer than 12 weeks
This trial is also designed to establish the framework and evaluate the feasibility of performing neoadjuvant window of opportunity trials using drugs with potential bioactivity against invasive bladder cancer at the London Health Sciences Center. The goal is to accrue 44 patients within 18 months to the trial, and the study will be prematurely closed if fewer than 10 patients are recruited within 12 months.
3 secondary outcomes
Toxicity in patients who participate in the treatment regimen of Metformin and Simvastatin therapy
Time frame: The participant will be followed for the duration of the pre-surgical preparation period. This is expected to be fewer than 12 weeks
Level of apoptosis observed in tumor cells of patients who undergo Metformin and Simvastatin therapy before cystectomy.
Time frame: The participant will be followed for the duration of the pre-surgical preparation period. This is expected to be fewer than 12 weeks
Impact of Metformin and Simvastatin therapy on the signalling pathways involved in invasive urothelial carcinoma.
Time frame: The participant will be followed for the duration of the pre-surgical preparation period. This is expected to be fewer than 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2016.
- Individual participant dataSharing planned: No
Related trials for Bladder Cancer
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
RecruitingPhase 3
A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) and Pembrolizumab (MK-3475A) in Participants With Bladder Cancer (MK-2870-055)
Bladder Cancer
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
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.
Jonathan Izawa, MD principal investigator
London Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Metformin and Simvastatin in people with Bladder Cancer, run by London Health Sciences Centre at 1 site in Canada.
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 6 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 11 Jul 2016. 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 Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jonathan Izawa, MD (519-685-8500 ext. 58551, jonathan.izawa@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bladder tumor proliferation rate (time frame: The participant will be followed for the duration of the pre-surgical preparation period. This is expected to be fewer than 12 weeks). The study lists 2 primary outcomes in all. 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 11 Jul 2016.