drugset / Trial / NCT05325281

CPI-613 (Devimistat) in Combination With Chemoradiation in Patients With Pancreatic Adenocarcinoma

NCT05325281

Non-randomizedSequentialOpen-labelTreatment

Summary

This is a single-center, open-label, phase I study designed to determine the maximum tolerated dose (MTD) and safety profile of CPI-613® when used concomitantly with chemoradiation for local control of pancreatic adenocarcinoma (PDAC).

Timeline

Start
2022-10-31
Primary completion
2025-07-08
Completion
2025-07-08

Drugs

EvaluationDrugModalityDoseRoute
Subject CPI-613 Small molecule 250 mg/m2 Intravenous
Subject CPI-613 Small molecule 500 mg/m2 Intravenous
Subject CPI-613 Small molecule 1000 mg/m2 Intravenous
Subject CPI-613 Small molecule 1500 mg/m2 Intravenous
Background Gemcitabine Small molecule 400 mg/m2 Intravenous