Simvastatin for Preventing Liver Cancer in Patients With Cirrhosis

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen byMarc T Goodman

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial studies if simvastatin can prevent liver cancer in patients with liver cirrhosis. Simvastatin, usually used to lower cholesterol, might block enzymes that cancer cells need to grow. The trial targets patients with liver disease. Simvastatin has been shown to reduce the risk of liver cancer and improve outcomes in these patients.

Research Team

Marc T Goodman

Principal Investigator

Northwestern University

Eligibility Criteria

Adults with liver cirrhosis who are not pregnant or breastfeeding, have not had a liver transplant or certain cancers, and do not drink excessively can join. They must be in fairly good health otherwise, with specific blood test results within acceptable ranges and able to use birth control if necessary.

Inclusion Criteria

Have had an abdominal imaging test (CT, MRI, or ultrasound) within the past 18 months

Platelets >= 50,000/microliter

Hemoglobin >= 8 g/dL

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Exclusion Criteria

Model for end-stage liver disease (MELD) > 20

Any lab results that do not meet inclusion criteria after the Screen 1 blood tests

Women who are pregnant or breastfeeding; pregnant women are excluded from this study because simvastatin is a lipid-lowering agent with the potential for teratogenic or abortifacient effects; it is not known whether simvastatin is excreted into human milk; however, a small amount of another drug in this class does pass into breast milk; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with simvastatin, breastfeeding should be discontinued if the mother is treated with simvastatin

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Treatment Details

Interventions

Simvastatin (HMG-CoA Reductase Inhibitor)

Trial OverviewThe trial is testing whether simvastatin can prevent liver cancer in patients with liver cirrhosis. Participants will either receive simvastatin or a placebo while undergoing regular monitoring through imaging tests like CT scans and MRIs, as well as providing biospecimens.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Group I (simvastatin)Experimental Treatment5 Interventions

Patients receive simvastatin PO QD. Treatment continues for up to 6 months in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood on study and CT/MRI throughout the trial.

Group II: Group II (placebo)Placebo Group5 Interventions

Patients receive placebo PO QD. Treatment continues for up to 6 months in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood on study and CT/MRI throughout the trial.

Simvastatin is already approved in Canada, Japan for the following indications: