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Sponsored by: |
Istituto Clinico Humanitas |
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Information provided by: | Istituto Clinico Humanitas |
ClinicalTrials.gov Identifier: | NCT00490685 |
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 | Intervention | Phase |
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Carcinoma, Hepatocellular |
Drug: Sorafenib (BAY-43-9006) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized Continuation, Dose Escalation Trial of Sorafenib in Patients With Advanced HCC With Radiological Progression on Prior Sorafenib Treatment (Phase II Study) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients with advanced/inoperable HCC not eligible for radical or loco-regional therapies Male or female patients ≥ 18 years of age Life expectancy of at least 12 weeks at screening Histologically or cytologically documented HCC
At least one tumor lesion that meets both of the following criteria:
The following laboratory parameters:
Written informed consent prior to any study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
Exclusion Criteria:
Responsible Party: | Istituto Clinico Humanitas ( Armando Santoro, MD ) |
Study ID Numbers: | ONC-2006-004, EUDRACT 2007-000758-30 |
Study First Received: | June 22, 2007 |
Last Updated: | September 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00490685 |
Health Authority: | Italy: Ministry of Health |
Liver Diseases Digestive System Neoplasms Carcinoma, Hepatocellular Disease Progression Liver neoplasms Carcinoma Liver Neoplasms |
Digestive System Diseases Gastrointestinal Neoplasms Adenocarcinoma Sorafenib Neoplasms, Glandular and Epithelial Hepatocellular carcinoma |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |