NCT02402348 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Bonanni B, Puntoni M, Cazzaniga M, Pruneri G, Serrano D, Guerrieri-Gonzaga A, Gennari A, Trabacca MS, Galimberti V, Veronesi P, Johansson H, Aristarco V, Bassi F, Luini A, Lazzeroni M, Varricchio C, Viale G, Bruzzi P, Decensi A
Dual effect of metformin on breast cancer proliferation in a randomized presurgical trial. J Clin Oncol. 2012 Jul 20;30(21):2593-600. doi: 10.1200/JCO.2011.39.3769.
Frisch SM, Schaller M, Cieply B
Mechanisms that link the oncogenic epithelial-mesenchymal transition to suppression of anoikis. J Cell Sci. 2013 Jan 1;126(Pt 1):21-9. doi: 10.1242/jcs.120907. Review.
Sandulache VC, Hamblin JS, Skinner HD, Kubik MW, Myers JN, Zevallos JP
Association between metformin use and improved survival in patients with laryngeal squamous cell carcinoma. Head Neck. 2014 Jul;36(7):1039-43. doi: 10.1002/hed.23409.

Pilot Study of Metformin (MF) IN HNSCC (Head and Neck Squamous Cell Carcinoma) as Window Trial Design in Operable HNSCC, to Investigate the Effects of MF, Tumor Genotype and MF Genotype Interactions, on Tumor Metabolism and Anoikis

Details for clinical trial NCT02402348

Clinical trial NCT02402348 - References