Trials / Completed
CompletedNCT00492752
A Randomized, Double-Blinded, Placebo-Controlled Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma
A Randomized, Double-blinded, Placebo-controlled Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 226 (actual)
- Sponsor
- Bayer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sorafenib (Nexavar, BAY43-9006) | multikinase inhibitor; Sorafenib 400 mg (orally) twice daily |
| DRUG | Placebo | Matching placebo (orally) twice daily |
Timeline
- Start date
- 2005-10-01
- Primary completion
- 2007-03-01
- Completion
- 2009-07-01
- First posted
- 2007-06-27
- Last updated
- 2014-04-16
- Results posted
- 2011-01-13
Locations
23 sites across 3 countries: China, South Korea, Taiwan
Source: ClinicalTrials.gov record NCT00492752. Inclusion in this directory is not an endorsement.