Rafael Pharmaceuticals has commenced a Phase II trial to investigate the efficacy and safety of CPI-613 in combination with modified folfirinox (mFFX) for the treatment of patients with localised borderline and unresectable pancreatic cancer.
CPI-613 is a drug developed by Rafael to target the altered regulation of metabolic processes of cancer cells, while mFFX is a standard combination of drugs.
Rafael plans to enrol 33 subjects with Eastern Cooperative Oncology Group (ECOG) performance status 0-1 as part of the open-label, single-armed trial.
Patients will receive the study drug combination over a period of six months and will be followed until death or three years from the date of completion of the trial.
The trial’s primary endpoint is to identify the potential increase in overall survival (OS) and to further evaluate the safety of the CPI-613+ mFFX combination.
Its secondary endpoints comprise progression-free survival (PFS), time to progression (TTP), resection margins and others.
The Phase II trial will be conducted in collaboration with University Hospitals Cleveland Medical Center in the US.
The trial’s lead investigator Jeffery Hardacre said: “Through this trial, we hope to identify a strategy to extend the lives of patients with pancreatic cancer, and increase the patient eligibility for surgery for those with locally advanced disease.”
Rafael previously assessed the safety, tolerability, and efficacy of the CPI-613 and mFFX combination in patients with first-line metastatic pancreatic cancer.
The study included a single-centre, open-label, dose-escalation design and included 20 patients.