Open AccessA 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
Author(s) -
Philip A. Philip,
Marc Buyse,
Angela Alistar,
Caio Mspr Rocha Lima,
Sanjeev Luther,
Timothy S. Pardee,
Éric Van Cutsem
Publication year - 2019
Publication title -
future oncology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.857
H-Index - 72
eISSN - 1744-8301
pISSN - 1479-6694
DOI - 10.2217/fon-2019-0209
Subject(s) - folfirinox , medicine , pancreatic cancer , adenocarcinoma , metastatic adenocarcinoma , oncology , phases of clinical research , clinical trial , irinotecan , pharmacology , gastroenterology , cancer , colorectal cancer
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.