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

Phase 2

Completed

• Conditions: Advanced Hepatocarcinoma
• Interventions: Drug: Pravastatin

• Registration Number: NCT01418729
• Lead Sponsor: Hospital Donostia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-08-15
• Study First Submitted QC: 2011-08-16
• Study First Posted: 2011-08-17
• Study Start: 2011-09
• Primary Completion: 2015-12
• Study Completion: 2017-06
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-19
• Last Update Posted: 2017-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 216

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sorafenib plus Pravastatin	Pravastatin	The treatment received will be sorafenib 400 mg/12 h + pravastatin 40 mg/24 h.
Sorafenib plus Placebo	Pravastatin	The treatment received will be sorafenib 400 mg/12 h + placebo/24 h.

Primary Outcome Measures

Name	Time	Method
Overall survival	18 months	To evaluate the overall survival (OS) in order to assess the efficacy and safety of pravastatin as adjuvant treatment to sorafenib.

Secondary Outcome Measures

Name	Time	Method
Time to progression	18 months	To evaluate the time to progression (TTP).
time to symptomatic progression (TTSP).	18 months	To evaluate the time to symptomatic progression (TTSP).

Trial Locations

Locations (1)

Hospital Donostia, Instituto Biodonostia; 🇪🇸 San Sebastian, Gipuzkoa, Spain