Phase 2A Pilot C3 Trial of Recurrent/Refractory Metastatic Advanced Pancreatic Cancer
Summary
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.
Timeline
- Start
- 2024-04-17
- Primary completion
- 2024-12
- Completion
- 2024-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Digoxin | Other / unclassified | 0.0625 mg | Oral |
| Subject | Digoxin | Other / unclassified | 0.25 mg | Oral |
| Subject | Metformin | Small molecule | 850 mg | Oral |
| Subject | Simvastatin | Small molecule | 5 mg | Oral |
| Subject | Simvastatin | Small molecule | 20 mg | Oral |
| Background | Gemcitabine | Small molecule | — | — |