Can three common drugs boost chemotherapy against pancreatic cancer?
NCT ID NCT06030622
First seen Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time
Summary
This pilot trial is testing whether adding a combination of three widely used drugs—metformin, digoxin, and simvastatin (called C3)—to standard chemotherapy (gemcitabine) can safely help people with advanced pancreatic cancer that has not responded to prior treatment. The study will enroll about 25 adults with metastatic pancreatic cancer. Participants will receive C3 along with gemcitabine for up to two years, or C3 alone if they decline chemotherapy. The main goals are to assess safety and tolerability, and to see if the combination can reduce tumor burden or prolong life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A combination of three common drugs—metformin, digoxin, and simvastatin (called C3)—given with or without the chemotherapy gemcitabine.
- What this could lead to
- If this approach works, it could offer a new, relatively inexpensive treatment option for advanced pancreatic cancer, potentially slowing tumor growth and extending survival.
- What could go wrong
- This is an early, small pilot study, so results may not be conclusive. The combination may cause side effects or may not be more effective than standard treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 25 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2024
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Subject ≥18 years with histologically confirmed pancreatic cancer. 2. Refractory, intolerant to, or with disease progression after at least one standard of care regimen. 3. ECOG performance status (PS) 0-1. 4. Pretreatment biopsy and/or adequate archival tissue available for BIRC5 protein level evaluation. 5. 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). 6. Subject has recovered to CTCAE Grade 1 (except for alopecia) or better from all adverse events associated with prior therapy or surgery. Pre-existing motor or sensory neurologic pathology or symptoms must be recovered to CTCAE Grade 2 or better. 7. If participant of childbearing potential, has a negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a negative serum test will be required for study entry. Serum pregnancy tests will be conducted at the time of screening, when other blood draws are obtained (See Appendix III: Time-Table of Procedures). 8. Ability to understand and the willingness to sign a written informed protocol specific consent. 9. Willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up. 10. No known active infections at the time of enrollment as determined by negative procalcitonin level. Exclusion Criteria: 1. Anti-cancer chemotherapy, biologic therapy or immunotherapy within 3 weeks or radiation therapy within 2 weeks of first investigational product administration. 2. Known history of other malignancy unless having undergone curative intent therapy without evidence of that disease for ≥ 3 years except cutaneous squamous cell and basal cell skin cancer, superficial bladder cancer, in situ cervical cancer or other in situ cancers are allowed if definitively resected. 3. Brain metastases unless treated with curative intent (gamma knife or surgical resection) and without evidence of progression for ≥ 2 months. 4. Known history of rhabdomyolysis. 5. History of or current evidence of any condition (including medical, psychiatric or substance abuse disorder), therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the Investigator. 6. Known chronic Hepatitis B or C infection. 7. Have current active infection requiring systemic antibiotic treatment. 8. History of severe allergic, anaphylactic, hypersensitivity reactions or previous intolerance to Metformin, Simvastatin, and/or Digoxin. 9. Patients with significant cardiac disease or condition listed below (unless clearance obtained by cardiology): 1. Wolff-Parkinson-White Syndrome. 2. Previous MI within last 6 months of C1D1. 3. Evidence of residual electrographic pattern consistent with heart block., for example atrio-ventricular (AV) heart block (currently ongoing). 4. History of ventricular fibrillation. 5. Sick Sinus Syndrome or Sinus bradycardia thought to be caused by sinus node disease, unless effectively treated. 6. Heart failure with preserved LVEF, including constructive pericarditis, and amyloid heart disease. 10. Acute cor pulmonale, restrictive cardiomyopathy, and Amyloid heart muscle disease. 11. Participants of childbearing potential who are found to be pregnant as evidenced by positive serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) or nursing. 12. Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or trial results. 13. Cognitively impaired and diminished capacity.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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SUNY Downstate Health Sciences University
RECRUITINGBrooklyn, New York, 11203, United States
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