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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Advanced Hepatocarcinoma

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Description:

To evaluate the overall survival (OS) in order to assess the efficacy and safety of pravastatin as adjuvant treatment to sorafenib.

Outcome Time Frame:

18 months

Safety Issue:

Yes

Principal Investigator

Juan I Arenas, MD,PHD

Investigator Role:

Study Chair

Investigator Affiliation:

Hospital Donostia

Authority:

Spain: Agencia Española de Medicamentos y Productos Sanitarios

Study ID:

ESTAHEP-2010

NCT ID:

NCT01418729

Start Date:

September 2011

Completion Date:

September 2014

Related Keywords:

  • Advanced Hepatocarcinoma
  • Carcinoma, Hepatocellular

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