Clinical trial NCT01418729: Efficacy and Safety Study of Sorafenib Plus Pravastatin to Treat Advanced Hepatocarcinoma
Official title: Phase-II, Multicenter, Randomized, Double-Blind, Parallel-Group Trial to Compare the Efficacy and Safety of Sorafenib Plus Pravastatin Against Sorafenib Plus Placebo in Patients With Advanced Hepatocarcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced Hepatocarcinoma
Lead sponsor: Hospital Donostia
Sponsor class: OTHER
Collaborators: name: INSTITUTO BIODONOSTIA
First posted: 2011-08-17
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Overall survival
timeFrame: 18 months
Secondary outcomes:
measure: Time to progression
timeFrame: 18 months
measure: time to symptomatic progression (TTSP).
timeFrame: 18 months
Other outcomes:
Locations:
city: San Sebastian
country: Spain
facility: Hospital Donostia, Instituto Biodonostia
state: Gipuzkoa
Study officials:
affiliation: Hospital Donostia
name: Juan I Arenas, MD,PHD
role: STUDY_CHAIR
affiliation: Hospital de Cruces
name: Javier Bustamante Scheneider, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clínico Universitario Lozano Blesa
name: Trinidad Serrano Aullo, MD, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clínica Universitaria de Navarra
name: Mercedes Iñarrairaegui Bastarrica, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Basurto
name: Sonia Blanco Sampascual, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Central de Asturias
name: Maria Varela, MD, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Infanta Sofia
name: Oscar Nuñez, MD
role: PRINCIPAL_INVESTIGATOR
References: