Dose Escalation of Sorafenib in Patients With Advanced Hepatocellular Carcinoma (HCC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00490685|
Recruitment Status : Completed
First Posted : June 25, 2007
Last Update Posted : September 2, 2010
The aim of the study is to evaluate, after radiological progression, efficacy in patients treated with Sorafenib at a dose of 600 mg bid compared to that in patients treated with best supportive care.
Primary efficacy objective is progression free survival from randomization.
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Hepatocellular||Drug: Sorafenib (BAY-43-9006)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||142 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Continuation, Dose Escalation Trial of Sorafenib in Patients With Advanced HCC With Radiological Progression on Prior Sorafenib Treatment (Phase II Study)|
|Study Start Date :||April 2007|
|Actual Primary Completion Date :||June 2008|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00490685
|Istituto Clinico Humanitas|
|Rozzano, Milan, Italy, 20089|
|Principal Investigator:||Armando Santoro, MD||Istituto Clinico Humanitas|