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Metformin + Digoxin + Simvastatin for Pancreatic Cancer

Phase 1
Recruiting
Led By John J. Nemunaitis, MD
Research Sponsored by Danae Hamouda
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Normal organ and marrow function: absolute granulocyte count ≥1,000/mm3, absolute lymphocyte count ≥400/mm3, platelets ≥100,000/mm3, total bilirubin ≤ institutional upper normal limit, AST/ASL ≤2x institutional upper limit of normal, GFR >60 mL/min/1.73 m2 and creatinine <1.5 mg/dL
Subject has recovered to CTCAE Grade 1 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
Must not have
Women 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
Known HIV or chronic Hepatitis B or C infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to one year
Awards & highlights

Summary

This trial is for people with pancreatic cancer and other advanced solid tumors. It's an open-label, single arm dose escalation Phase IB trial, which means that subjects are accrued in a 3 subject dose escalation cohort.

Who is the study for?
Adults (≥18 years) with advanced solid tumors, including pancreatic cancer, that are not responding to standard treatments can join. They must have a performance status indicating they're still relatively active and able to care for themselves. Women who can bear children need a negative pregnancy test. Participants should be recovered from previous therapies' side effects and have normal organ/marrow function.
What is being tested?
This trial is testing the combination of Metformin, Digoxin, and Simvastatin in patients with advanced solid tumors including pancreatic cancer. It's an open-label study where everyone gets the same treatment but at different doses to find out how much can be given safely.
What are the potential side effects?
Potential side effects include those common to diabetes medications like Metformin such as digestive issues or lactic acidosis; heart-related issues from Digoxin like irregular heartbeat; and muscle pain or weakness which could signal serious problems due to Simvastatin.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My blood tests show normal organ function and healthy blood cell counts.
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I have recovered from side effects of previous treatments, except for some nerve issues.
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I can take care of myself but might not be able to do active work.
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I am 18 or older with a confirmed solid tumor diagnosis.
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My condition hasn't improved with standard treatments.
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I have enough stored tissue samples for the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am pregnant or nursing.
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I have HIV or chronic Hepatitis B or C.
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I am showing signs of an active infection.
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I have a history of rhabdomyolysis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximum Tolerated Dose and/or Recommended Dose within the tested C3 dose range
Secondary study objectives
Assess BIRC5 levels of expression in tumor tissue
Assess molecular changes induced by C3 administration in the blood for biomarker sensitivity/resistance assessment
Efficacy (Disease Response)
+1 more

Side effects data

From 2015 Phase 3 trial • 33 Patients • NCT02030041
11%
Myalgia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vitamin D and Placebo
Simvastatin and Placebo
Simvastatin and Vitamin D

Trial Design

1Treatment groups
Experimental Treatment
Group I: Dose EscalationExperimental Treatment3 Interventions
C3 (Metformin, Simvastatin and Digoxin) will be dosed each day of a 28 calendar day cycle. The starting dose level will be increased with each cohort. There are 3 cohorts. Upon reaching maximum tolerated dose, an expansion cohort will be opened. Cohort 1 - Metformin 850mg po/day, Simvastatin 5mg po/day, Digoxin 0.0625 mg po/day. Cohort 2 - Metformin 850 mg po/day for two weeks and 1,700 mg po/day for next two weeks, Simvastatin 20 mg po/day, Digoxin 0.25 mg po/day. Cohort 3 - Metformin 850 mg po/day for two weeks and 1,700 mg po/day for next two weeks, Simvastatin 40 mg po/day, Digoxin 0.25 mg po/day for two weeks, 0.375 mg po/day for the next two weeks for cycle 1. Subjects will receive 0.50 mg po/day in Cohort 3, Cycle 2 and beyond. Metformin to be taken at Breakfast and Dinner time (as applicable), Simvastatin at Bed time and Digoxin once daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metformin
2006
Completed Phase 4
~2430
Simvastatin
2012
Completed Phase 4
~1270
Digoxin
2017
Completed Phase 4
~670

Find a Location

Who is running the clinical trial?

Danae HamoudaLead Sponsor
Danae Hamouda, MDLead Sponsor
John J. Nemunaitis, MDPrincipal InvestigatorThe University of Toledo
1 Previous Clinical Trials
25 Total Patients Enrolled

Media Library

Digoxin (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03889795 — Phase 1
Pancreatic Cancer Research Study Groups: Dose Escalation
Pancreatic Cancer Clinical Trial 2023: Digoxin Highlights & Side Effects. Trial Name: NCT03889795 — Phase 1
~3 spots leftby Dec 2025
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