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C3 + Gemcitabine for Pancreatic Cancer (C3 Trial)

Phase 1 & 2

Recruiting

Led By Mohan Preet, MD

Research Sponsored by State University of New York - Downstate Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pretreatment biopsy and/or adequate archival tissue must be available for BIRC5 protein level evaluation

Must have 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)

Must not have

History of severe allergic, anaphylactic, hypersensitivity reactions or previous intolerance to Metformin, Simvastatin, and/or Digoxin

Known history of rhabdomyolysis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up before and 2 months after c3 treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to find if a combination of 3 drugs and Gemcitabine can reduce/treat pancreatic cancer, and if it can extend patients' lives.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include digestive issues from Metformin; muscle pain or weakness from Simvastatin; and dizziness, changes in heartbeat, or fatigue from Digoxin. When combined with chemotherapy like Gemcitabine, there may also be increased risk of infection due to lowered white blood cell counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a biopsy or tissue sample available for protein level testing.

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My blood counts and liver/kidney functions are within normal ranges.

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I have recovered from side effects of previous treatments, except for hair loss.

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I am willing and able to follow the study's treatment plan and attend all visits.

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I am 18 or older with confirmed pancreatic cancer.

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I am fully active or can carry out light work.

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My condition didn't improve after trying at least one standard treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had severe allergic reactions to Metformin, Simvastatin, or Digoxin.

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I have a history of rhabdomyolysis.

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I have a long-term hepatitis B or C infection.

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I am currently taking antibiotics for an active infection.

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I do not have serious heart conditions or have been cleared by a cardiologist.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ before and 2 months after c3 treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~before and 2 months after c3 treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and before and 2 months after c3 treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

: Safety and tolerability

Secondary study objectives

: Biomarkers

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Gemcitabine and C3 (Combination Digoxin, Simvastatin, and Metformin)Experimental Treatment1 Intervention

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.

Group II: C3 (Combination Digoxin, Simvastatin, and Metformin) onlyExperimental Treatment1 Intervention

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.

0 / 12Eligibility criteria met