ACKNOWLEDGMENTS AND FUNDING
ICH, Cancer
CANCER
Institute for Drug Development, Cancer Therapy and Research Center at University of Texas Health Science Center San Antonio; San Antonio, TX. Cancer Center Support Grant P30CA054174. Bill and Ella Owens foundation grant. Christos Fountzilas was a recipient of a Cancer Research Training Award (RP 140105) funded by the Cancer Prevention and Research Institute of Texas. Metformin and matched color placebo for this study was provided by Pharmascience, Inc., Canada.
Conceptualization and design: Mahalingam, Thompson. Study Selection and Data Acquisition: Mahalingam, Hanni, Fountzilas, Michalek, Hernandez, Sarantopoulous, Datta, Romero, Pillair, Kun, Pollak, Thompson. Data analysis/Statistical Analysis: Mahalingam, Hanni, Fountzilas, Michalek, Hernandez, Sarantopoulous, Datta, Romero, Pillair, Kun, Pollak, Thompson, Serritella. Manuscript writing and revision: Mahalingam, Hanni, Fountzilas, Michalek, Hernandez, Sarantopoulous, Datta, Romero, Pillair, Kun, Pollak, Thompson, Serritella. Supervision: Mahalingam, Thompson.
Mahalingam- research funding from Merck, Oncolytics and Amgen. Scientific Advisory board- Qurient, OncoOne. Advisory/speaker bureau for Amgen, BMS, Eisai and Exelixis.
This study was conducted upon approval of the Institutional Review Board (IRB) at the University of Texas (IRB Number: HSC20110273) and in accordance with current U.S. Food and Drug Administration (FDA) regulations, the International Conference on Harmonization (ICH), Good Clinical Practices (GCPs), the Declaration of Helsinki, and local ethical and legal requirements. Eligible patients who provided written informed consent were recruited at one center in the United States between July of 2011 through July of 2015. The review boards of all participating institutions approved the study. All patients signed a written informed consent before the conduct of any study procedures and after a full explanation of the study to the patient by the study investigator.