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      A Phase III open-label trial to evaluate efficacy and safety of CPI-613 plus modified FOLFIRINOX (mFFX) versus FOLFIRINOX (FFX) in patients with metastatic adenocarcinoma of the pancreas

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          Abstract

          Devimistat (CPI-613 ®) is a novel lipoate analog that inhibits the tricarboxcylic acid cycle at two key carbon entry points. Through its inhibition of pyruvate dehydrogenase and a-ketoglutarate dehydrogenase complexes, devimistat inhibits the entry of glucose and glutamine derived carbons, respectively. Pancreatic cancer is dependent on mitochondrial function for enhanced survival and aggressiveness. In a Phase I study of modified FOLFIRINOX, in combination with devimistat for metastatic pancreatic cancer patients, there was a 61% objective response rate including a 17% complete response rate. This report outlines the rationale and design of the AVENGER 500 study, a Phase III clinical trial of devimistat in combination with modified FOLFIRINOX compared with FOLFIRINOX alone for patients with previously untreated metastatic adenocarcinoma of the pancreas. Clinical trial registration: NCT03504423

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          Author and article information

          Journal
          Future Oncol
          Future Oncol
          FON
          Future Oncology
          Future Medicine Ltd (London, UK )
          1479-6694
          1744-8301
          12 September 2019
          October 2019
          : 15
          : 28
          : 3189-3196
          Affiliations
          [1 ]Karmanos Cancer Institute, Wayne State University, Department of Oncology, Detroit, MI 48331, USA
          [2 ]International Drug Development Institute, Louvain-La-Neuve, Belgium
          [3 ]Morristown Medical Center of Atlantic Health System, Morristown, NJ 07152, USA
          [4 ]Wake Forest Baptist Comprehensive Cancer Center of Wake Forest University, Department of Oncology, Winston Salem, NC 27157, USA
          [5 ]Rafael Pharmaceuticals, Cranbury, NJ 08512, USA
          [6 ]University Hospitals & KU Leuven, Department of Digestive Oncology, Leuven, Belgium
          Author notes
          [* ]Author for correspondence: philipp@ 123456karmanos.org
          Article
          PMC6854438 PMC6854438 6854438
          10.2217/fon-2019-0209
          6854438
          31512497
          ee087e7e-4c13-4fb6-80cc-3ae0156dbc3a
          © 2019 Future Medicine Ltd
          History
          : 08 April 2019
          : 25 July 2019
          : 12 September 2019
          Page count
          Pages: 8
          Categories
          Clinical Trial Protocol

          Phase III,FOLFIRINOX,pancreatic cancer,metastatic,CPI-613
          Phase III, FOLFIRINOX, pancreatic cancer, metastatic, CPI-613

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