C3 + Gemcitabine for Pancreatic Cancer
(C3 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether a combination of medications (C3: metformin, simvastatin, and digoxin) with Gemcitabine can safely and effectively treat advanced pancreatic cancer. Researchers aim to determine if this treatment can slow the disease and improve patient longevity. Participants will receive either the combination of C3 and Gemcitabine or just C3 if they cannot take Gemcitabine. Those diagnosed with advanced pancreatic cancer who have tried at least one other treatment without success may be a good fit for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative combination therapy.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the combination of Metformin, Simvastatin, and Digoxin, known as C3, is generally safe and well-tolerated. Studies indicate that using these three drugs together does not cause serious side effects. Specifically, one study found no major issues when participants took these drugs together for 18 months.
Metformin often treats diabetes, and Simvastatin commonly lowers cholesterol. Both have been used safely by many without major problems.
When combined with Gemcitabine, research found that C3 and Gemcitabine worked better together against pancreatic cancer cells than when used separately. While this doesn't directly address safety, it suggests effective combined use.
Overall, the evidence suggests that the C3 treatment is safe, with no major safety concerns reported so far. This is promising for those considering joining the clinical trial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments because they combine commonly used drugs—metformin, simvastatin, and digoxin—in a novel way to target pancreatic cancer. While standard treatments like chemotherapy (e.g., Gemcitabine alone) primarily attack fast-growing cancer cells, this combination (C3) aims to disrupt cancer cell metabolism and growth through different mechanisms. Metformin is known for its potential anti-cancer effects, simvastatin might inhibit cancer cell proliferation, and digoxin can interfere with cellular signaling. This multi-pronged approach could offer new hope by enhancing the effectiveness of traditional chemotherapy or serving as an alternative for those who can't tolerate it.
What evidence suggests that this trial's treatments could be effective for pancreatic cancer?
This trial will evaluate the combination of metformin, simvastatin, and digoxin (C3) for pancreatic cancer. Studies have shown that this combination can help slow the growth of pancreatic cancer cells. Specifically, simvastatin slows tumor growth, while using metformin and statins together may help patients live longer. Research indicates that metformin use is linked to better overall survival for pancreatic cancer patients, with a 21% lower risk of death compared to those not using it. Additionally, low doses of metformin and simvastatin together have slowed the development of pancreatic cancer, suggesting these drugs are promising for treating this condition. Participants in this trial may receive C3 alone or in combination with Gemcitabine, depending on their treatment arm.12346
Who Is on the Research Team?
Mohan Preet, MD
Principal Investigator
SUNY Downstate Health Sciences University
Are You a Good Fit for This Trial?
Adults over 18 with confirmed pancreatic cancer, who've tried at least one standard treatment without success. They should be in relatively good health (ECOG performance status of 0-1), have a certain level of organ and marrow function, not be pregnant or nursing, and have no active infections. People with severe allergies to the trial drugs or significant heart conditions are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive C3 medications and Gemcitabine for 2 years or until disease progression
Safety and Disease Response Assessment
Safety assessments including physical examination, vital signs, and radiological tumor assessment
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- C3 (Metformin, Simvastatin, and Digoxin)
Trial Overview
The trial is testing 'C3'—a combination of Metformin, Simvastatin, and Digoxin—with Gemcitabine chemotherapy to see if it's safe and can help improve advanced stage pancreatic cancer or extend patients' lives. Participants will take C3 daily along with standard Gemcitabine for two years.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Study participants will be offered metformin (850 mg twice a day), digoxin (0.25 mg once a day), and simvastatin (20 mg once a day) combination (C3) and Gemcitabine.
Study participants will be offered C3 only metformin (850 mg twice a day), digoxin (0.25 mg once a day), and simvastatin (20 mg once a day) combination (C3) if they decline Gemcitabine.
Find a Clinic Near You
Who Is Running the Clinical Trial?
State University of New York - Downstate Medical Center
Lead Sponsor
Citations
Repurposing Metformin, Simvastatin and Digoxin as a ... - PMC
Patients with pancreatic adenocarcinoma (PDAC) have a 5-year survival rate of 8%, We found that simvastatin and digoxin inhibited both SHIP and BIRC5-SP ...
Phase IB Metformin, Digoxin, Simvastatin in Solid Tumors
This is a single-center trial in subjects with pancreatic cancer and other advanced solid tumors. It is an open-label, single arm dose escalation Phase IB trial ...
Repurposing metformin, simvastatin and digoxin as a ...
Patients with pancreatic adenocarcinoma (PDAC) have a 5-year survival rate of 8%, the lowest of any cancer in the United States.
Metformin + Digoxin + Simvastatin for Pancreatic Cancer
Studies have found that simvastatin can slow tumor growth. Additionally, taking metformin and statins (like simvastatin) together may improve survival rates for ...
Phase IB Metformin, Digoxin, Simvastatin in Solid Tumors
This is a single-center trial in subjects with pancreatic cancer and other advanced solid tumors. It is an open-label, single arm dose ...
6.
researchgate.net
researchgate.net/publication/343789917_Repurposing_metformin_simvastatin_and_digoxin_as_a_combination_for_targeted_therapy_for_pancreatic_ductal_adenocarcinoma(PDF) Repurposing metformin, simvastatin and digoxin as ...
Patients with pancreatic adenocarcinoma (PDAC) have a 5-year survival rate of 8%, the lowest of any cancer in the United States.
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