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

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

Trial Details

NCT ID
NCT06030622
Phase
PHASE1 / PHASE2
Sponsor
State University of New York - Downstate Medical Center
Status
RECRUITING
Cancer Type
Pancreatic Cancer
Interventions
  • Gemcitabine and C3 (Metformin, Simvastatin, and Digoxin)
  • C3 (Metformin, Simvastatin, and Digoxin) only
Locations (sample)
  • Brooklyn, New York, United States|40.6501,-73.94958

Key Eligibility Criteria

  • 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.

For full eligibility, visit ClinicalTrials.gov.

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