Trials / Completed
CompletedNCT00044512
A Study to Estimate Safety and Efficacy of Sorafenib (BAY43-9006) in the Treatment of Hepatocellular Carcinoma
A Phase II Multicenter Uncontrolled Trial of Sorafenib (BAY43-9006) in Patients With Advanced Hepatocellular Carcinoma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 137 (actual)
- Sponsor
- Bayer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Evaluate anti-cancer activity (e.g. proportion of patients with confirmed complete response or partial response) in patients with advanced, inoperable biopsy-proven hepatocellular carcinoma.
Detailed description
In addition to the key secondary outcome parameters the following exploratory parameters were evaluated in subpopulations: * Pharmacokinetics (PK) profile of Sorafenib * Plasma and tissue tumor biomarkers
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sorafenib (Nexavar, BAY43-9006) | Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day) |
Timeline
- Start date
- 2002-08-01
- Primary completion
- 2008-02-01
- Completion
- 2008-02-01
- First posted
- 2002-09-04
- Last updated
- 2014-04-16
- Results posted
- 2009-08-06
Locations
23 sites across 5 countries: United States, Belgium, France, Israel, Italy
Source: ClinicalTrials.gov record NCT00044512. Inclusion in this directory is not an endorsement.