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Sorafenib Tosylate With or Without Pravastatin in Treating Patients With Liver Cancer and Cirrhosis

NCT01075555 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 323

Last updated 2020-03-30

No results posted yet for this study

Summary

RATIONALE: Sorafenib tosylate and pravastatin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib tosylate may also stop the growth of liver cancer by blocking blood flow to the tumor. It is not yet known whether sorafenib tosylate is more effective when given alone or together with pravastatin in treating patients with liver cancer and cirrhosis.

PURPOSE: This randomized phase III trial is studying sorafenib tosylate given together with pravastatin to see how well it works compared with giving sorafenib tosylate alone in treating patients with liver cancer and cirrhosis.

Conditions

Interventions

DRUG

pravastatin sodium

DRUG

sorafenib tosylate

Sponsors & Collaborators

  • Centre Hospitalier Universitaire Dijon

    collaborator OTHER

  • Federation Francophone de Cancerologie Digestive

    lead OTHER

Principal Investigators

  • Jean-Louis Jouve · Hopital Du Bocage

  • Jacques Denis, MD · Hopital Louise Michel

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

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 NCT01075555 on ClinicalTrials.gov