The goals of this trial are: 1) To evaluate the safety and tolerability of C3 administration with Gemcitabine; and 2) To assess the disease response following C3 administration with Gemcitabine. The main question it aims to answer are: 1) Is C3 in combination with Gemcitabine safe, tolerable, and effective for reducing improving advanced stage pancreatic cancer? and 2) Can C3 in combination with Gemcitabine prolong the lives of patients with advanced stage pancreatic cancer. Participants will receive a combination of metformin (850 mg twice a day), digoxin (0.25 mg once a day), and simvastatin (20 mg once a day), also known as C3, and Gemcitabine (as per standard of care) for 2 years. If patients decline Gemcitabine, they will be offered the C3 medications only.
Subject ≥18 years with histologically confirmed pancreatic cancer.
Refractory, intolerant to, or with disease progression after at least one standard of care regimen.
ECOG performance status (PS) 0-1.
Pretreatment biopsy and/or adequate archival tissue available for BIRC5 protein level evaluation.
Anti-cancer chemotherapy, biologic therapy or immunotherapy within 3 weeks or radiation therapy within 2 weeks of first investigational product administration.
Known history of other malignancy unless having undergone curative intent therapy without evidence of that disease for ≥ 3 years except cutaneous squamous cell and basal cell skin cancer, superficial bladder cancer, in situ cervical cancer or other in situ cancers are allowed if definitively resected.
Brain metastases unless treated with curative intent (gamma knife or surgical resection) and without evidence of progression for ≥ 2 months.
Known history of rhabdomyolysis.
Single group
Gemcitabine and C3 (Metformin, Simvastatin, and Digoxin)
DrugCombination treatment of Metformin, Simvastatin and Digoxin with Gemcitabine (Arm 1)
C3 (Metformin, Simvastatin, and Digoxin) only
DrugC3 only (Metformin, Simvastatin, and Digoxin) if patients decline Gemcitabine (Arm 2).
Primary Outcome: Safety and tolerability
Number of participants with treatment-related Adverse Events as assessed by CTCAE v4.0
Secondary Outcome: Biomarkers
Tumor biomarkers as assessed by levels of BIRC5, CA19-9, CEA.
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