Phase IIB Randomized, Placebo-Controlled Trial of ACTOplus met® XR in Subjects with Stage I-IV Squamous Cell Carcinoma of the Oral Cavity of Oropharynx Prior to Definitive Treatment

拟定的临床试验应解决吡格列酮和二甲双胍（ACTOplus met® XR）联合用药是否具有预防口腔癌和口咽癌的潜在效用。这是一项IIb期机会窗试验，在接受手术、放疗或放化疗确定性治疗前的I-IV期口腔癌或口咽癌患者中评价二甲双胍XR 1，000 mg和吡格列酮30 mg/天的市售复方制剂给药14-21天。目的是确定药物组合对肿瘤和周围视觉正常上皮中各种组织生物标志物的影响。试验应在明尼苏达大学、罗切斯特大学、约翰霍普金斯大学和威斯康星州大学进行，并由威斯康星州大学监督。

The proposed clinical trial shall address whether the combination of pioglitazone and metformin (ACTOplus met® XR) has potential utility in the prevention of oral and oropharyngeal cancer. It is a phase IIb window of opportunity trial of the marketed combination of metformin XR 1,000 mg and pioglitazone 30 mg per day given for 14-21 days in patients with stage I-IV oral cavity or oropharyngeal cancer prior to definitive therapy with surgery, radiation, or chemoradiation. The goal is to determine the effects of the drug combination on a variety of tissue biomarkers, both in the tumor and in the surrounding visually normal epithelium. The trial shall be performed at the University of Minnesota, University of Rochester, Johns Hopkins University, and University of Wisconsin under the oversight of the University of Wisconsin.