Trials / Completed
CompletedNCT00073307
Study of BAY43-9006 in Patients With Unresectable and/or Metastatic Renal Cell Cancer
A Phase III Randomized Study of BAY43-9006 in Patients With Unresectable and/or Metastatic Renal Cell Cancer.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 903 (actual)
- Sponsor
- Bayer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate safety, efficacy (including quality of life), and pharmacokinetics of BAY43-9006 when added to Best Supportive Care in patients with unresectable and/or metastatic renal cell cancer, who have received one prior systemic regimen for advanced disease.
Detailed description
Overall Survival (OS), Patient-reported outcome (PRO)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sorafenib (Nexavar, BAY43-9006) | Multi Kinase Inhibitor |
| DRUG | Placebo | Placebo |
Timeline
- Start date
- 2003-11-01
- Primary completion
- 2006-09-01
- Completion
- 2010-04-01
- First posted
- 2003-11-21
- Last updated
- 2014-02-06
- Results posted
- 2011-12-14
Locations
121 sites across 19 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, France, Germany, Hungary, Israel, Italy, Netherlands, Poland, Russia, South Africa, Spain, Ukraine, United Kingdom
Source: ClinicalTrials.gov record NCT00073307. Inclusion in this directory is not an endorsement.