Rafael Pharmaceuticals, initiates a phase III trial of CPI 613 to treat metastatic adenocarcinoma of the pancreas.
Rafael Pharmaceuticals, Inc. announced the initiation of a phase III multicenter, open-label, randomized pivotal trial (AVENGER 500) to evaluate the efficacy and safety of its lead compound CPI 613 (devimistat) in combination with modified FOLFIRINOX (mFFX) as first-line therapy in patients with metastatic adenocarcinoma of the pancreas.
AVENGER 500 will compare the efficacy and safety of FOLFIRINOX (FFX, control arm) with CPI 613 in combination with mFFX. Patients 18-75 years old of both sexes with metastatic (stage IV) pancreatic adenocarcinoma, not previously treated for metastatic disease and with ECOG performance status of 0 � 1 are eligible for enrollment in this study. The interim analysis of the study is expected to be completed as early as Q2 2020. More information on the trial is available at www.clinicaltrials.gov (NCT03504423)
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