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

Philip A. Philip, Marc E. Buyse, Angela T. Alistar, Caio Mspr Lima, Sanjeev Luther, Timothy S. Pardee, Eric Van Cutsem

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Pages (from-to)3189-3196
Number of pages8
JournalFuture Oncology
Volume15
Issue number28
DOIs
StatePublished - Jan 1 2019

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Pancreatic Neoplasms
Pancreas
Adenocarcinoma
Carbon
Ketoglutarate Dehydrogenase Complex
Safety
Phase III Clinical Trials
Glutamine
Pyruvic Acid
Oxidoreductases
Glucose
Acids
Survival
CPI 613

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

Cite this

Philip, Philip A. ; Buyse, Marc E. ; Alistar, Angela T. ; Lima, Caio Mspr ; Luther, Sanjeev ; Pardee, Timothy S. ; Cutsem, Eric Van. / 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. In: Future Oncology. 2019 ; Vol. 15, No. 28. pp. 3189-3196.
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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. / Philip, Philip A.; Buyse, Marc E.; Alistar, Angela T.; Lima, Caio Mspr; Luther, Sanjeev; Pardee, Timothy S.; Cutsem, Eric Van.

In: Future Oncology, Vol. 15, No. 28, 01.01.2019, p. 3189-3196.

Research output: Contribution to journalArticle

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AU - Cutsem, Eric Van

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