NCT02968810CompletedPhase 2
Simvastatin in Preventing Liver Cancer in Patients With Liver Cirrhosis
Statin Therapy to Reduce Disease Progression From Liver Cirrhosis to Cancer
Source: ClinicalTrials.gov · Last updated 9 Sept 2026
Brief summary (registry, in English)
This phase II trial studies how well simvastatin works in preventing liver cancer in patients with liver cirrhosis. Simvastatin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 52 (actual)
- First submitted
- 18 Nov 2016
- Start date
- 21 Jun 2017
- Primary completion date
- 3 May 2023
- Lead sponsor
- National Cancer Institute (NCI)
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT02968810
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 52
- From 21 Jun 2017 to the primary completion date, 3 May 2023
- 5 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior or current use of statin medication
- Current use of any other investigational agents
- 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
- Prior liver transplant
- Prior known or suspected hepatocellular carcinoma
- Prior cholangiocarcinoma
- Prior germ cell cancer
- Concurrent illness which in the opinion of the investigators would compromise either the patient or the integrity of the data
Other illness
- Current systemic use of medications known to interact with statins and potentially increase toxicity, including gemfibrozil, cyclosporine, danazol, lomitapide, verapamil, diltiazem, dronedarone, amiodarone, amlodipine, ranolazine, strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, posaconazole, voriconazole, human immunodeficiency virus \[HIV\] protease inhibitors, boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin, nefazodone, or cobicistat-containing products), or strong CYP3A4 inducers (e.g., carbamazepine, phenytoin, rifampin, St. John's wort, bosentan, efavirenz, etravirine, modafinil, nafcillin)
- History of adverse effects, intolerance, or allergic reactions attributed to compounds of similar chemical or biologic composition to simvastatin (i.e., other statin medications)
- Model for end-stage liver disease (MELD) \> 20
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- History of chronic myopathy
- History of active malignancy within the past 5 years (excluding basal/squamous cell skin cancer or prostate cancer with a Gleason score 6 or less)
- Known active infection with HIV
Other
- Any lab results that do not meet inclusion criteria after the Screen 1 blood tests
- Medical contraindications to blood draw (e.g., hemophilia)
- Current excessive alcohol consumption (average alcohol consumption of more than 5 drinks per day)
Who the study is looking for
- Confirmed diagnosis of liver cirrhosis assessed by the presence of clinical signs, symptoms, body imaging (ultrasound, computed tomography \[CT\], or magnetic resonance imaging \[MRI\]), or liver biopsy
- Age \>= 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 (Karnofsky \>= 70%)
- Leukocytes \>= 2,500/microliter
- Absolute neutrophil count \>= 1,500/microliter
- Platelets \>= 50,000/microliter
- Hemoglobin \>= 8 g/dL
- Total bilirubin =\< 3 x institutional upper limit of normal (ULN)
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 5 x institutional ULN
- Creatinine =\< 1.5 x institutional ULN
- Women who are able to become pregnant must have a confirmed negative pregnancy test result prior to enrollment; women \>= 50 years of age who have not had a menstrual period in the past year; and women who have had a hysterectomy, both ovaries removed, or a tubal ligation; will not be required to have a pregnancy test
- The effects of simvastatin on the developing human fetus at the recommended therapeutic dose are unknown; for this reason, women who are able to become pregnant must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately
- Ability to understand and the willingness to sign a written informed consent document and medical release
- Willing and able to comply with trial protocol and follow-up
- Have had an abdominal imaging test (CT, MRI, or ultrasound) within the past 18 months
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centro Comprensivo de Cancer de UPR Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
| University of Puerto Rico Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
| Northwestern University Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Cedars-Sinai Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| MedStar Georgetown University Hospital Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.