RecruitingPhase 1Phase 2NCT06030622

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

Phase 2A Pilot Trial of Metformin, Digoxin, Simvastatin (C3) in Combination With Gemcitabine in Subjects With Recurrent / Refractory Metastatic Advanced Pancreatic Cancer

Sponsor

State University of New York - Downstate Medical Center

Enrollment

25 participants

Start Date

Apr 17, 2024

Study Type

INTERVENTIONAL

Conditions

Pancreatic Cancer Metastatic

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new experimental treatment for pancreatic cancer that has come back or stopped responding to standard therapies. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of pancreatic cancer - Your cancer has progressed after or you could not tolerate at least one standard treatment - You are in good physical condition (able to carry out daily activities) - Your blood counts and organ function (liver, kidneys) are within acceptable ranges - You are willing and able to follow the study schedule **You may NOT be eligible if...** - You have received chemotherapy or radiation within the past 2–3 weeks - You have another active cancer (other than certain skin cancers) - You have an active infection - You are pregnant (a negative pregnancy test is required) - You are unable to understand or sign the consent form Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGemcitabine and C3 (Metformin, Simvastatin, and Digoxin)

Combination treatment of Metformin, Simvastatin and Digoxin with Gemcitabine (Arm 1)

DRUGC3 (Metformin, Simvastatin, and Digoxin) only

C3 only (Metformin, Simvastatin, and Digoxin) if patients decline Gemcitabine (Arm 2).

Locations(1)

SUNY Downstate Health Sciences University

Brooklyn, New York, United States

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NCT06030622

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