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A Phase III Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma

NCT00105443 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 602

Last updated 2014-10-31

Study results available
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Summary

The purpose of the study is: Find out if patients receiving sorafenib will live longer. Find out if sorafenib has any effect on patient reported outcomes. Find out if sorafenib prevents the growth of or shrinks liver tumors and/or their metastases. Determine the pharmacokinetics (PK) in patients with liver cancer.

Conditions

  • Carcinoma, Hepatocellular

Interventions

DRUG

Sorafenib (Nexavar, BAY43-9006)

Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid); 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment.

DRUG

Placebo

Sorafenib-matching placebo tablets were orally administered twice daily (bid).

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-03-31
Primary Completion
2008-11-30
Completion
2008-11-30

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • Chile
  • Croatia
  • France
  • Germany
  • Greece
  • Israel
  • Italy
  • Mexico
  • New Zealand
  • Peru
  • Poland
  • Romania
  • Russia
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT00105443 on ClinicalTrials.gov