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Metformin + Digoxin + Simvastatin for Pancreatic Cancer

Phase 1

Waitlist Available

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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

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%

Study treatment Arm

Vitamin D and Placebo

Simvastatin and Placebo

Simvastatin and Vitamin D

Awards & Highlights

No Placebo-Only Group

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

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