Trials / Completed
CompletedNCT00105443
A Phase III Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma
A Phase III Randomized, Placebo-controlled Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 602 (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 of or shrinks liver tumors and/or their metastases. Determine the pharmacokinetics (PK) in patients with liver cancer.
Detailed description
The following abbreviations were used in the Adverse Event section: * international normalized ratio (inr) * Common Terminology Criteria for Adverse Events (ctcae) * Not Otherwise Specified (nos) * Gastrointestinal (gi) * Central nervous system (cns) * Absolute Neutrophil Count (anc) * Alanine aminotransferase (ALT) * Aspartate aminotransferase (AST) * Creatine phosphokinase (cpk) * Gammaglutamyltransferase (ggt) * Genitourinary (gu) * Atrioventricular (av)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sorafenib (Nexavar, BAY43-9006) | Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid); 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. |
| DRUG | Placebo | Sorafenib-matching placebo tablets were orally administered twice daily (bid). |
Timeline
- Start date
- 2005-03-01
- Primary completion
- 2008-11-01
- Completion
- 2008-11-01
- First posted
- 2005-03-15
- Last updated
- 2014-10-31
- Results posted
- 2010-09-27
Locations
178 sites across 23 countries: United States, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, Croatia, France, Germany, Greece, Israel, Italy, Mexico, New Zealand, Peru, Poland, Romania, Russia, Spain, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT00105443. Inclusion in this directory is not an endorsement.