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A Randomized, Double-Blinded, Placebo-Controlled Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma

NCT00492752 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 226

Last updated 2014-04-16

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 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)

multikinase inhibitor; Sorafenib 400 mg (orally) twice daily

DRUG

Placebo

Matching placebo (orally) twice daily

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2007-03-31
Completion
2009-07-31

Countries

  • China
  • South Korea
  • Taiwan

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 NCT00492752 on ClinicalTrials.gov