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Efficacy and Safety Study of Sorafenib Plus Pravastatin to Treat Advanced Hepatocarcinoma (ESTAHEP-2010)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01418729
First Posted: August 17, 2011
Last Update Posted: September 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
INSTITUTO BIODONOSTIA
Information provided by (Responsible Party):
Juan I. Arenas Ruiz-Tapiador, Hospital Donostia
  Purpose
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.

Condition Intervention Phase
Advanced Hepatocarcinoma Drug: Pravastatin Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Juan I. Arenas Ruiz-Tapiador, Hospital Donostia:

Primary Outcome Measures:
  • Overall survival [ Time Frame: 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:
  • Time to progression [ Time Frame: 18 months ]
    To evaluate the time to progression (TTP).

  • time to symptomatic progression (TTSP). [ Time Frame: 18 months ]
    To evaluate the time to symptomatic progression (TTSP).


Enrollment: 216
Study Start Date: September 2011
Study Completion Date: June 2017
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sorafenib plus Pravastatin
The treatment received will be sorafenib 400 mg/12 h + pravastatin 40 mg/24 h.
Drug: Pravastatin

Treatment:

Patients will be randomized in two groups, A and B:

  • Control Group (A ≡ 1): Patients will receive treatment with sorafenib 400 mg/12 h + placebo/24 h.
  • Experimental Group (B ≡ 2): The treatment received will be sorafenib 400 mg/12 h + pravastatin 40 mg/24 h.
Placebo Comparator: Sorafenib plus Placebo
The treatment received will be sorafenib 400 mg/12 h + placebo/24 h.
Drug: Pravastatin

Treatment:

Patients will be randomized in two groups, A and B:

  • Control Group (A ≡ 1): Patients will receive treatment with sorafenib 400 mg/12 h + placebo/24 h.
  • Experimental Group (B ≡ 2): The treatment received will be sorafenib 400 mg/12 h + pravastatin 40 mg/24 h.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01418729


Locations
Spain
Hospital Donostia, Instituto Biodonostia
San Sebastian, Gipuzkoa, Spain, 20014
Sponsors and Collaborators
Hospital Donostia
INSTITUTO BIODONOSTIA
Investigators
Study Chair: Juan I Arenas, MD,PHD Hospital Donostia
Principal Investigator: Javier Bustamante Scheneider, MD Hospital de Cruces
Principal Investigator: Trinidad Serrano Aullo, MD, PHD Hospital Clínico Universitario Lozano Blesa
Principal Investigator: Mercedes Iñarrairaegui Bastarrica, MD Clínica Universitaria de Navarra
Principal Investigator: Sonia Blanco Sampascual, MD Hospital de Basurto
Principal Investigator: Maria Varela, MD, PHD Hospital Central de Asturias
Principal Investigator: Oscar Nuñez, MD Hospital Infanta Sofia
  More Information

Additional Information:
Responsible Party: Juan I. Arenas Ruiz-Tapiador, MD. PHD, Hospital Donostia
ClinicalTrials.gov Identifier: NCT01418729     History of Changes
Other Study ID Numbers: ESTAHEP-2010
2010-024421-21 ( EudraCT Number )
First Submitted: August 15, 2011
First Posted: August 17, 2011
Last Update Posted: September 20, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Sorafenib
Pravastatin
Niacinamide
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors