Status:
COMPLETED
Efficacy and Safety Study of Sorafenib Plus Pravastatin to Treat Advanced Hepatocarcinoma
Lead Sponsor:
Hospital Donostia
Collaborating Sponsors:
INSTITUTO BIODONOSTIA
Conditions:
Advanced Hepatocarcinoma
Eligibility:
All Genders
18-100 years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2017
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT01418729
Start Date
September 1 2011
End Date
June 1 2017
Last Update
September 20 2017
Active Locations (1)
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1
Hospital Donostia, Instituto Biodonostia
Donostia / San Sebastian, Gipuzkoa, Spain, 20014