OncoMatch/Clinical Trials/NCT06030622
Phase 2A Pilot C3 Trial of Recurrent/Refractory Metastatic Advanced Pancreatic Cancer
Is NCT06030622 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Gemcitabine and C3 (Metformin, Simvastatin, and Digoxin) and C3 (Metformin, Simvastatin, and Digoxin) only for pancreatic cancer metastatic.
Treatment: Gemcitabine and C3 (Metformin, Simvastatin, and Digoxin) · C3 (Metformin, Simvastatin, and Digoxin) only — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Pancreatic Cancer
Biomarker criteria
Required: BIRC5 protein level evaluation required
Pretreatment biopsy and/or adequate archival tissue available for BIRC5 protein level evaluation
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: standard of care regimen
Refractory, intolerant to, or with disease progression after at least one standard of care regimen
Cannot have received: anti-cancer chemotherapy, biologic therapy or immunotherapy
Exception: within 3 weeks of first investigational product administration
Anti-cancer chemotherapy, biologic therapy or immunotherapy within 3 weeks or radiation therapy within 2 weeks of first investigational product administration
Cannot have received: radiation therapy
Exception: within 2 weeks of first investigational product administration
radiation therapy within 2 weeks of first investigational product administration
Lab requirements
Blood counts
absolute granulocyte count ≥1,000/mm3, platelets ≥100,000/mm3
Kidney function
creatinine <1.5 mg/dL or calculated creatinine clearance > 60ml / min (Cockcroft-Gault Equation)
Liver function
total bilirubin ≤ institutional upper normal limit, AST/ALT ≤2x institutional upper limit of normal
Adequate organ and marrow function: absolute granulocyte count ≥1,000/mm3, platelets ≥100,000/mm3, total bilirubin ≤ institutional upper normal limit, AST/ALT ≤2x institutional upper limit of normal, and creatinine <1.5 mg/dL or calculated creatinine clearance > 60ml / min (Cockcroft-Gault Equation)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- SUNY Downstate Health Sciences University · Brooklyn, New York
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