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

NCT01418729 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2017-09-20

No results posted yet for this study

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.

Conditions

  • Advanced Hepatocarcinoma

Interventions

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.

Sponsors & Collaborators

  • INSTITUTO BIODONOSTIA

    collaborator UNKNOWN

  • Hospital Donostia

    lead OTHER

Principal Investigators

  • Juan I Arenas, MD,PHD · Hospital Donostia

  • Javier Bustamante Scheneider, MD · Hospital de Cruces

  • Trinidad Serrano Aullo, MD, PHD · Hospital Clínico Universitario Lozano Blesa

  • Mercedes Iñarrairaegui Bastarrica, MD · Clínica Universitaria de Navarra

  • Sonia Blanco Sampascual, MD · Hospital de Basurto

  • Maria Varela, MD, PHD · Hospital Central de Asturias

  • Oscar Nuñez, MD · Hospital Infanta Sofia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2015-12-31
Completion
2017-06-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01418729 on ClinicalTrials.gov