Efficacy and Safety Study of Sorafenib Plus Pravastatin to Treat Advanced Hepatocarcinoma

• Status: Completed
• Trial end date: 2017-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the overall survival (OS) in order to assess the efficacy and safety of pravastatin as adjuvant treatment to sorafenib.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Donostia
• Collaborator: INSTITUTO BIODONOSTIA
• Treatments: Niacinamide; Pravastatin; Sorafenib

Criteria

Inclusion Criteria:

• Patients who have been diagnosed with advanced hepatocarcinoma (HCC), confirmed histologically or with non-invasive criteria, according to the clinical practice guidelines by the American Association for the Study of Liver Diseases (AASLD) during a maximum period of 15 days prior to the baseline visit.

• Males and females, over 18 years of age.

• Patients who have not previously received treatment with sorafenib.

• Have an ECOG ≤ 2.

• Liver function: Child A and B7.

• Life expectancy greater than 12 weeks.

• Adequate kidney function: serum creatinine concentration less than or equal to 1.5 times the upper limit of normal (ULN).

• Sign the written informed consent before starting any procedure, including randomization.

Exclusion Criteria:

• Patients who routinely (more than 3 times a week) take some sort of statin.

• Patients with hypersensitivity to statins.

• Pregnant or breastfeeding women.

• Peripheral neuropathy: grade 2 or higher

• Patients who have been diagnosed, within the previous 5 years, with another type of tumor, except for non-melanoma skin cancer, or in situ carcinoma of the cervix or the urinary bladder.

• Patients receiving chemotherapy or radiotherapy for another type of tumor.

• Patients with heart failure greater than NYHA grade II, hypertension that is uncontrolled with medication, uncontrolled arrhythmias or AMI within the previous six months.

• A history of perforation or hemorrhage due to a gastroduodenal ulcus within the last month.

• Greater hemorrhagic diseases.

• Asthmatic patients uncontrolled with medication.

• Any other contraindication associated to the use of statins.

• Physical or psychological inability to participate in the trial.

• Treatment with another investigational drug or participation in another clinical trial within 6 months prior to inclusion in the study.