Study of Metformin, Digoxin, and Simvastatin Combined with Gemcitabine in Advanced Pancreatic Cancer

What this Trial Is About

This trial investigates the safety and tolerability of a combination treatment called C3, which includes metformin, digoxin, and simvastatin, given alongside the chemotherapy drug Gemcitabine for people with advanced pancreatic cancer that has returned or not responded to prior treatments. The study aims to find out if this combination is safe, tolerable, and effective in reducing disease and potentially extending the lives of these patients. It is a phase 2, open-label, single-center trial focusing on patients with metastatic pancreatic ductal adenocarcinoma. Participants will receive oral doses of metformin 850 mg twice daily, digoxin 0.25 mg once daily, and simvastatin 20 mg once daily combined with Gemcitabine according to standard care. The first three participants will be closely monitored for 28 days at this dose to check for toxic effects before enrolling the remaining participants. If toxicities are observed, dose adjustments will be considered. Patients who decline Gemcitabine may choose to take only the C3 medications. Treatment with C3 continues every 28 days for up to two years or until disease progression or death. During the study, participants will undergo regular safety assessments including physical exams, vital signs, performance status, blood tests including digoxin levels, and tumor imaging to monitor disease response. Biomarker levels will be measured at baseline and after two months of treatment to assess molecular changes. Researchers will track adverse events, laboratory abnormalities, and tumor response over time. Participation lasts up to two years, with ongoing monitoring of safety and disease status throughout the trial.

Phase 2A Pilot C3 Trial of Recurrent/Refractory Metastatic Advanced Pancreatic Cancer