Clinical Trials Directory

Trials / Completed

CompletedNCT00079612

Study of Nexavar (Sorafenib, BAY 43-9006) in Patients With Advanced Refractory Cancer

Randomized Discontinuation Study of BAY 43-9006 in Patients With Advanced Refractory Cancer.

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
501 (actual)
Sponsor
Bayer · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The purpose of the study is to: * Find out if BAY 43-9006 prevents the growth of tumors * For patients who have stable cancer status after 3 months of treatment if it is safer and/or more effective to continue to give BAY 43-9006 or to stop giving BAY 43-9006 at that time. * Find out how long the effect of BAY 43-9006 is on tumors. To assess the safety of BAY 43-9006 (sorafenib) in the treatment of advanced refractory cancers. * Measure the amount of BAY 43-9006 and some of its targets in the blood stream in some patients.

Conditions

Interventions

TypeNameDescription
DRUGSorafenib (Nexavar, BAY43-9006)800mg daily (2x 400mg tabs)
DRUGPlacebo2x 400mg tabs daily

Timeline

Start date
2002-09-01
Completion
2007-01-01
First posted
2004-03-11
Last updated
2014-12-19

Locations

7 sites across 2 countries: United States, United Kingdom

Source: ClinicalTrials.gov record NCT00079612. Inclusion in this directory is not an endorsement.