Therapy Detail
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| Therapy Name | Metformin |
| Synonyms | |
| Therapy Description |
Glucophage (metformin) inhibits part of the mitochondrial respiratory chain and may exert antineoplastic effects through inhibition of mTOR (NCI Drug Dictionary). Glucophage (metformin) is FDA approved for type 2 diabetes (FDA.gov). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Metformin | Glucophage | Apo-Metformin | mTOR Inhibitor 51 | Glucophage (metformin) inhibits part of the mitochondrial respiratory chain and may exert antineoplastic effects through inhibition of mTOR and is FDA approved for type 2 diabetes (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| Unknown unknown | Indication other than cancer | not applicable | Metformin | FDA approved | Actionable | Glucophage (metformin) is FDA approved for use in patients with type-2 diabetes (FDA.gov). | detail... detail... |
| IDH1 R132H | colorectal cancer | sensitive | Metformin | Preclinical | Actionable | In a preclinical study, colorectal carcinoma cells expressing IDH1 R132H were sensitive to Glucophage (metformin), resulting in decreased cell proliferation in culture (PMID: 26363012). | 26363012 |
| ERBB2 positive | Her2-receptor positive breast cancer | predicted - sensitive | Metformin | Phase III | Actionable | In a Phase III trial, ERBB2 (HER2) positive breast cancer patients with diabetes demonstrated a greater disease free survival and overall survival when treated with Glucophage (metformin) compared to ERBB2 (HER2) positive breast cancer patients with diabetes not treated with Glucophage (metformin) (PMID: 28375706). | 28375706 |
| Unknown unknown | head and neck squamous cell carcinoma | not applicable | Metformin | Clinical Study | Actionable | In a meta-analysis, Glucophage (metformin) treatment decreased recurrence and metastasis and improved overall survival of head and neck squamous cell carcinoma patients (PMID: 25636350). | 25636350 |
| STK11 loss | Advanced Solid Tumor | no benefit | Metformin | Preclinical - Cell culture | Actionable | In a preclinical study, Glucophage (metformin) was unable to inhibit cancer cell growth in cancer cell lines with biallelic loss of STK11 (PMID: 17062558, PMID: 18006825). | 18006825 17062558 |
| Unknown unknown | prostate cancer | not applicable | Metformin | Phase II | Actionable | In a Phase II trial, Glucophage (metformin) demonstrated safety and preliminary efficacy in patients with castration-resistant prostate cancer (PMID: 24412228). | 24412228 |
| HRAS mutant | urinary bladder cancer | sensitive | Metformin | Preclinical | Actionable | In a preclinical study, mouse models of bladder cancer harboring an HRAS mutation were sensitive to Glucophage (metformin), resulting in tumor growth reduction and prevention of hyperplasia regression (PMID: 26921394). | 26921394 |
| PIK3CA H1047R | breast cancer | sensitive | Metformin | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Glucophage (metformin) inhibited cell proliferation of a dietary restriction-resistant PIK3CA H1047R-harboring human breast cancer cell line in culture, and inhibited tumor growth in xenograft models (PMID: 23986086). | 23986086 |
| PIK3CA H1047R | colorectal cancer | sensitive | Metformin | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Glucophage (metformin) demonstrated efficacy in treating dietary restriction-resistant human colorectal cancer cell line xenograft tumors harboring PIK3CA H1047R (PMID: 23986086). | 23986086 |
| Unknown unknown | breast cancer | not applicable | Metformin | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Glucophage (metformin) inhibited the growth of a breast cancer cell line in culture and resulted in decreased tumor volume in a cell line xenograft model (PMID: 26351208). | 26351208 |
| STK11 wild-type | Advanced Solid Tumor | sensitive | Metformin | Preclinical - Cell culture | Actionable | In a preclinical studies, Glucophage (metformin) inhibited cancer cell growth by activating the AMP kinase pathway in a variety of cancer cell lines that retained one functional allele of STK11 (PMID: 17062558, PMID: 18006825). | 18006825 17062558 |
| Unknown unknown | lung cancer | not applicable | Metformin | Preclinical - Cell culture | Actionable | In a preclinical study, Glucophage (metformin) inhibited proliferation of several lung cancer cell lines in culture, including squamous, adenocarcinoma, large cell, and small celll lung cancer cell lines (PMID: 22576795). | 22576795 |
| Unknown unknown | lung non-small cell carcinoma | not applicable | Metformin | Preclinical - Cell culture | Actionable | In a preclinical study, Glucophage (metformin) inhibited proliferation and induced cell-cycle arrest and apoptosis in non-small cell lung cancer cell lines in culture, independent of STK11 (LKB1) status (PMID: 26847819). | 26847819 |
| PIK3CA act mut | Advanced Solid Tumor | sensitive | Metformin | Preclinical | Actionable | In a preclinical study, Glucophage (metformin) demonstrated efficacy in treating dietary restriction-resistant human xenograft tumors harboring a PIK3CA-activating mutation (PMID: 23986086). | 23986086 |
| Unknown unknown | pancreatic cancer | no benefit | Metformin | Preclinical - Pdx | Actionable | In a preclinical study, long term treatment (28 days) of Glucophage (metformin) did not result in decreased tumor growth in patient-derived pancreatic cancer xenograft models (PMID: 26760500). | 26760500 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status |
|---|---|---|---|---|
| NCT01717482 | Phase II | Metformin | Metformin as a Chemoprevention Agent in Non-small Cell Lung Cancer | Terminated |
| NCT01310231 | Phase II | Metformin | A Trial of Standard Chemotherapy With Metformin (vs Placebo) in Women With Metastatic Breast Cancer | Completed |
| NCT02019979 | Phase II | Metformin | Metformin and Carbohydrate Restriction With Platinum Based Chemotherapy In Stage IIIB/IV Non-Squamous Non-Small Cell Lung Cancer (NS-NSCLC) (METRO) | Terminated |
| NCT01528046 | Phase I | Metformin Irinotecan + Temozolomide + Vincristine Sulfate | Metformin in Children With Relapsed or Refractory Solid Tumors | Active, not recruiting |
| NCT02278965 | Phase I | Metformin | Metformin and Omega-3 Fatty Acids in Woman With a History of Early Stage Breast Cancer | Active, not recruiting |
| NCT02035787 | Phase I | Metformin | Metformin With the Levonorgestrel-Releasing Intrauterine Device for the Treatment of Complex Atypical Hyperplasia (CAH) and Endometrial Cancer (EC) in Non-surgical Patients | Recruiting |
| NCT02285855 | Phase II | Metformin | Metformin in Non Small Cell Lung Cancer (NSCLC) | Terminated |
| NCT02780024 | Phase II | Metformin | Metformin, Neo-adjuvant Temozolomide and Hypo- Accelerated Radiotherapy Followed by Adjuvant TMZ in Patients With GBM | Recruiting |
| NCT02176161 | Phase II | Metformin | Metformin Prostate Cancer Adjuvant Trial | Recruiting |
| NCT01793948 | Phase I | Metformin | Metformin Hydrochloride vs. Placebo in Overweight or Obese Patients at Elevated Risk for Breast Cancer | Completed |
| NCT01324180 | Phase I | Metformin Dexamethasone + Doxorubicin + Pegaspargase + Vincristine Sulfate | Vincristine, Dexamethasone, Doxorubicin, and PEG-asparaginase (VPLD) and Metformin for Relapsed Childhood Acute Lymphoblastic Leukemia (ALL) | Completed |
| NCT03053544 | Phase II | Metformin | Metformin With Neoadjuvant Chemoradiation to Improve Pathologic Responses in Rectal Cancer | Completed |
| NCT01750567 | Phase II | Metformin | A Pilot Study of Metformin Therapy in Patients With Relapsed Chronic Lymphocytic Leukemia (CLL) and Untreated CLL | Suspended |
| NCT01488552 | Phase Ib/II | Oxaliplatin Fluorouracil + Irinotecan + Leucovorin Gemcitabine + Nab-paclitaxel Metformin | Gemcitabine+Nab-paclitaxel and FOLFIRINOX and Molecular Profiling for Patients With Advanced Pancreatic Cancer | Completed |
| NCT02531308 | Phase II | Metformin Cyclophosphamide + Doxorubicin + Prednisone + Vincristine Sulfate Pegfilgrastim Rituximab | Metformin in Combination With Standard Induction Therapy for Large B-cell Lymphoma (DLBCL) | Terminated |
| NCT01578551 | Phase II | Metformin Carboplatin + Paclitaxel Bevacizumab | A Randomized Phase II Study of Metformin Plus Paclitaxel/Carboplatin/Bevacizumab in Patients With Adenocarcinoma. | Terminated |
| NCT01864096 | Phase III | Metformin | The Metformin Active Surveillance Trial (MAST) Study | Recruiting |
| NCT03076281 | Phase II | Doxycycline Doxycycline + Metformin Metformin | Metformin Hydrochloride and Doxycycline in Treating Patients With Head and Neck Squamous Cell Carcinoma That Can Be Removed by Surgery | Active, not recruiting |
| NCT02437812 | Phase II | Paclitaxel Carboplatin Metformin | Study of Paclitaxel, Carboplatin and Oral Metformin in the Treatment of Advanced Stage Ovarian Carcinoma | Recruiting |
| NCT02376166 | Phase I | Metformin | Metformin for Rising PSA Remote Trial | Completed |
| NCT02040376 | Phase III | Metformin | Placebo Controlled Double Blind Crossover Trial of Metformin for Brain Repair in Children With Cranial-Spinal Radiation for Medulloblastoma | Completed |
| NCT02420652 | Phase II | Metformin | Metformin Hydrochloride and Aspirin in Treating Patients With Hormone-Dependent Prostate Cancer That Has Progressed After Surgery or Radiation Therapy | Active, not recruiting |
| NCT02042495 | Phase II | Metformin | Endometrial Cancer Biomarker Changes Following Exposure to Metformin | Withdrawn |
| NCT01996696 | Phase II | Metformin | A Study With or Without Metformin to Determine if Metformin Can Prevent Weight Gain and Other Problems (i.e. Diabetes, Increased Cholesterol, Etc.) That Can Arise From the Use of Hormonal Therapy in Combination With Radiation Therapy When Treating Aggressive Localized Prostate Cancer. | Recruiting |
| NCT02122185 | Phase II | Metformin Carboplatin + Docetaxel + Paclitaxel | Metformin Hydrochloride and Combination Chemotherapy in Treating Patients With Stage III-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer | Recruiting |
| NCT02394652 | Phase II | Cisplatin Metformin | The Potential for Metformin to Improve Tumor Oxygenation in Locally Advanced Cervix Cancer | Recruiting |
| NCT01666730 | Phase II | Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Metformin | Metformin Plus Modified FOLFOX 6 in Metastatic Pancreatic Cancer | Completed |
| NCT02153450 | Phase I | Metformin | Stereotactic Radiosurgery and Metformin Hydrochloride in Treating Patients With Borderline-Resectable or Locally-Advanced Pancreatic Cancer | Completed |
| NCT01877564 | Phase II | Metformin | A Randomized Pilot Study to Evaluate the Effects of a Short Course of Metformin Versus No Therapy in the Period Prior to Hysterectomy for Grade 1-2 Adenocarcinoma of the Endometrium in Obese Non-Diabetic Women | Completed |
| NCT01302379 | Phase I | Metformin | Reach for Health Study: Obesity-related Mechanisms and Mortality in Breast Cancer Survivors | Completed |
| NCT03109873 | Phase I | Metformin | Metformin Hydrochloride in Affecting Cytokines and Exosomes in Patients With Head and Neck Cancer | Active, not recruiting |
| NCT01620593 | Phase II | Metformin | Castration Compared to Castration Plus Metformin as First Line Treatment for Patients With Advanced Prostate Cancer | Completed |
| NCT03086733 | Phase II | Metformin | Phase II Lung Metcore - Preoperative Metformin for Lung Cancer (Metcore) | Recruiting |
| NCT02186847 | Phase II | Metformin Carboplatin + Paclitaxel | Chemotherapy and Radiation Therapy With or Without Metformin Hydrochloride in Treating Patients With Stage III Non-small Cell Lung Cancer | Active, not recruiting |
| NCT02614859 | Phase II | Bicalutamide Metformin | Bicalutamide With or Without Metformin for Biochemical Recurrence in Overweight or Obese Prostate Cancer Patients | Recruiting |
| NCT02083692 | Phase I | Metformin | Pilot Study of Metformin in Head and Neck Squamous Cell Cancer and Its Effects on Stromal-epithelial Metabolic Uncoupling | Completed |
| NCT02402348 | Phase I | Metformin | Pilot Study of Metformin in HNSCC to Investigate the Effects of MF, Tumor Genotype and MF-genotype Interactions, on Tumor Metabolism and Anoikis | Terminated |
| NCT02978547 | Phase II | Metformin | The Effects of Neoadjuvant Metformin on Tumour Cell Proliferation and Tumour Progression in Pancreatic Ductal Adenocarcinoma (Metformin 001) | Not yet recruiting |
| NCT02115464 | Phase II | Metformin | Advanced Lung Cancer Treatment With Metformin and Chemo-Radiotherapy | Terminated |
| NCT01797523 | Phase II | Letrozole Everolimus Metformin | RAD/Letrozole/Metformin | Active, not recruiting |
| NCT01340300 | Phase II | Metformin | Exercise and Metformin in Colorectal and Breast Cancer Survivors | Completed |
| NCT01697566 | Phase III | Metformin | An Endometrial Cancer Chemoprevention Study of Metformin | Active, not recruiting |
| NCT02815397 | Phase II | Metformin | DA-EPOCH-Rituximab/Metformin (RM) for Double Hit Lymphoma | Terminated |
| NCT02048384 | Phase Ib/II | Metformin + Sirolimus Metformin | A Study of Metformin With or Without Rapamycin as Maintenance Therapy After Induction Chemotherapy in Subjects With Pancreatic Cancer | Completed |
| NCT03477162 | Phase 0 | Metformin | Metformin Pharmacology in Human Cancers: A Proof of Principle Study | Recruiting |
| NCT01954732 | Phase I | Metformin | Metformin Hydrochloride in Treating Patients With Pancreatic Cancer That Can be Removed by Surgery | Withdrawn |
| NCT01579812 | Phase II | Metformin | Evaluation of Metformin, Targeting Cancer Stem Cells for Prevention of Relapse in Gynecologic Patients | Completed |
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