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

This study is currently recruiting participants.
Verified January 2012 by Hospital Donostia
Sponsor:
Collaborator:
INSTITUTO BIODONOSTIA
Information provided by (Responsible Party):
Juan I. Arenas Ruiz-Tapiador, Hospital Donostia
ClinicalTrials.gov Identifier:
NCT01418729
First received: August 15, 2011
Last updated: January 25, 2012
Last verified: January 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by Hospital Donostia:

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

  • time to symptomatic progression (TTSP). [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    To evaluate the time to symptomatic progression (TTSP).


Estimated Enrollment: 216
Study Start Date: September 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2013 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01418729

Contacts
Contact: Juan I Arenas, MD, PHD +34 943007000 ext 3662 juan.arenasruiz@osakidetza.net
Contact: Ioana Riaño +34 943006255 ioana.rianofernandez@osakidetza.net

Locations
Spain
Hospital Donostia, Instituto Biodonostia Recruiting
San Sebastian, Gipuzkoa, Spain, 20014
Contact: Juan I Arenas Ruiz-Tapiador, MD, PHD     +34 943007000 ext 3662     juan.arenasruiz@osakidetza.net    
Contact: Ioana Riaño Fernandez     *34 943006255     ioana.rianofernandez@osakidetza.net    
Principal Investigator: Juan I Arenas Ruiz-Tapiador, MD, PHD            
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:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

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
Study First Received: August 15, 2011
Last Updated: January 25, 2012
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

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
Pravastatin
 Sorafenib
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Antineoplastic Agents
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013