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| Identification & Title | Primary Goals | Status |
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| NCT01340300 | | |
| Randomized Phase II study of exercise and metformin in colorectal cancer survivors | Randomized study will compare interventions with exercise and/or metformin, with a control arm. Insulin levels and other blood markers will be estimated which may indicate ecurrences | Not yet recruiting |
| NCT01266486 | | |
| A Phase 2 single arm study to examine the effects of metformin on cancer metabolism in patients with early stage breast cancer receiving neoadjuvant chemotherapy | Pre-surgery metformin will be given to patients for 3 weeks. Lipid metabolism of the tumor will be studied. Patients will have option of taking metformin along with neoadjuvant chemotherapy. Metformin induced effects in phosphorylation of S6K, 4E-BP-1 and AMPK will be estimated by IHC | Recruiting |
| NCT01302002 | | |
| A Phase 0 study regarding the biological effects of use of metformin in early breast cancer patients pre-surgery | After 3 weeks of metformin intake, in situ effects of metformin will be determined in women with operable stage I or II breast cancer. Pre and post tissues will be compared for proliferation (Ki67), apoptosis (TUNEL) and fosforilate AKT | Recruiting |
| NCT00897884 | | |
| Interventional study of clinical and biologic effects of metformin in early stage breast cancer | After 2-3 weeks of metformin intake, pre- and post-operative biopsy samples will be compared for proliferation | Recruiting |
| NCT01210911 | | |
| A Phase II, randomized, placebo controlled study to evaluate the efficacy of the combination of gemcitabine, erlotinib and metformin in patients with locally advanced and metastatic pancreatic cancer | Survival after 6 months of combinational therapy will be determined | Recruiting |
| NCT01440127 | | |
| Phase I randomized clinical trial evaluating the impact of pretreatment with metformin on colorectal cancer stem cells and related pharmacodynamic markers | Pateints will randomly receive metformin pre-procedure for approximately 1 week. Cancer stem cells will be isolated from blood. Glucose will be measured | Recruiting |
| NCT01205672 | | |
| Interventional non-randomized evaluation of the molecular effects of metformin on the endometrium in patients with endometrial cancer | 30 days before surgery patients will be given metformin. Molecular effects of metformin will be measured by changes in insulin/glucose metabolism on the mTOR signaling in endometrium of women with endometrial cancer and high body mass index | Recruiting |
| NCT00984490 | | |
| Interventional pre-surgical trial of metformin in patients with operable breast cancer | After 1–3 weeks of metformin intake, pre- and post-operative biopsy samples will be compared for proliferation ( Ki67) in women with stage I or stage II breast cancer that can be removed by surgery | Recruiting |
| NCT01310231 | | |
| A randomized Phase II, double blind, trial of standard chemotherapy with metformin (vs. placebo) in women with metastatic breast cancer receiving first or second line chemotherapy with anthracycline, taxane, platinum or capecitabine based regimens | Metformin will be given along with standard chemotherapy. Progression free survival will be assessed up to 3 years | Recruiting |
| NCT01433913 | | |
| Phase II study of metformin in a pre-prostatectomy prostate cancer cohort | Metformin will be given for 4 to 12 weeks before surgical removal of the prostate gland. Levels of metformin will be detected in prostate tissue. Physiological and cellular abnormalities in prostate tissue removed at surgery will be measured | Not yet recruiting |
| NCT01333852 | | |
| Randomized Phase II study of paclitaxel plus metformin or placebo for the treatment of platinum-refractory, recurrent or metastatic head and neck neoplasms | Various combinations will be given to patients and Disease Progression-free survival at 12 weeks and 6 months will be recorded | Recruiting |
| NCT00659568 | | |
| A Phase I study of temsirolimus in combination with metformin in advanced solid tumours | Maximum tolerated dose and recommended phase II dose of metformin along with temsirolimus will be estimated. Antitumor activity, including tumor response rate and time to progression will be recorded | Completed |
| NCT01215032 | | |
| Prospective study of metformin in castration-resistant prostate cancer | Metformin will be given along with androgen deprivation therapy in a 2-year study. PSA (prostate specific antigen) response will be monitored | Recruiting |
| NCT01101438 | | |
| A Phase III randomized trial of metformin versus placebo on recurrence and survival in early stage breast cancer | Patients will intake metformin for 5 years. Invasive disease-free survival and Overall survival will be recorded | Recruiting |
| NCT00881725 | | |
| A Phase II, open label assessment of neoadjuvant intervention with metformin against tumour expression of signaling prostate cancer | Patients will take metformin for 4–12 weeks prior to Radical Prostatectomy. Difference in P-AKT staining and other parameters will be measured under pre- and post-surgery conditions | Active, not recruiting |
| NCT01087983 | | |
| Phase 1 trial of lapatinib in combination with (1) sirolimus or (2) metformin in advanced cancer | Maximum Tolerated Dose (MTD) of Lapatinib with the combinations will be calculated | Recruiting |
| NCT01243385 | | |
| Metformin in castration resistant prostate cancer. A multicenter Phase II trial | Safety of giving metformin as first-line therapy in treating patients with locally advanced or metastatic prostate cancer will be assesed. Progression-free survival (PFS) at 12 weeks and at later time points with continuation of therapy will be recorded | Recruiting |
| NCT01341886 | | |
| Effect of metformin on decrement in levothyroxin dose required for thyroid stimulating hormone (TSH) suppression in patients with differentiated thyroid cancer | Metformin will be given as an additional drug to levothyroxin in order to decrease levothyroxine dosage by 30%. Metformin’s effect in inducing TSH suppression without change in T3 and T4 concentration will be estimated | Completed |
| NCT01430351 | | |
| A Phase I lead-in to a 2 × 2 × 2 factorial rrial of dose dense temozolomide (TMZ), memantine (MEMTN), mefloquine (MFLOQ), and metformin as post-radiation adjuvant therapy of glioblastoma multiforme | The study will determine the safety and tolerability of TMZ in combination with Metformin and/or (MFLOQ) and/or MEMTN in patients receiving adjuvant therapy after completing external beam radiotherapy for newly diagnosed glioblastoma multiforme. Median progression free survival at 6, 12, and 18 months will be measured | Recruiting |
| NCT01167738 | | |
| A randomized Phase II study of chemotherapy and/or not metformin in metastatic pancreatic cancer | Studying giving cisplatin, epirubicin, capecitabine, and gemcitabine together with metformin to see how well it works compared to chemotherapy alone in treating patients with metastatic pancreatic cancer. Progression-free survival at 6 months and overall survival will be estimated | Recruiting |
| NCT01447927 | | |
| A Phase II trial of metformin in preventing esophageal cancer in patients with barrett esophagus | Effect of metformin intake for 2–12 weeks in preventing esophageal cancer in patients with Barrett esophagus will be observed. Percent change in the mean pS6K1 immunostaining will be taken as marker | Not yet recruiting |
| NCT01312467 | | |
| A Phase IIA trial of metformin for colorectal cancer risk reduction among patients with a history of colorectal adenomas and elevated body mass index | To determine if a 12-week intervention of oral metformin treatment among obese patients with a history of colorectal adenomas results in at least a 35% decrease in colorectal mucosa. Activated pS6serine235 from baseline as assessed via immunostaining in pre and post biopsies | Recruiting |
| NCT00909506 | | |
| A Phase II trial of efficacy and safety of adjuvant metformin for operable breast cancer patients | Metformin will be given to patients of operable breast cancer patients with overweight or pre-DM for 24 weeks, to test the efficacy and safety of adjuvant metformin and weight loss | Recruiting |
| NCT00930579 | | |
| A Phase II pre-surgical intervention study for evaluating the effect of metformin on breast cancer proliferation | Effects of metformin on AMPK/mTOR signaling pathway and insulin levels will be measured after 2 weeks on metformin | Recruiting |
| NCT01442870 | | |
| A Phase I prospective evaluation of clinical safety of combining metformin with anticancer chemotherapy | Cytologically documented cancer patients will be given metformin for 3 weeks to determine whether metformin can be safely added to a chemotherapy regimen that is previously well tolerated. The rate of dose limiting toxicities will be compared | Recruiting |
| NCT01324180 | | |
| A Phase I window, dose escalating and safety trial of metformin in combination with induction chemotherapy in relapsed refractory acute lymphoblastic leukemia: metformin with induction chemotherapy of vincristine, dexamethasone, doxorubicin, and PEG-asparaginase (VPLD) | Clinical and biological effects of metformin in combination with standard systemic chemotherapy in relapsed ALL patients that have a dismal outcome will be estimated. A dose escalation study to find the Maximum Tolerated Dose (MTD) of metformin in conjunction with ALL therapy. Complete Remission will be taken as end point | Recruiting |
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