Trial Condition(s):
Carcinoma, Hepatocellular
A Study to Estimate Safety and Efficacy of Sorafenib (BAY43-9006) in the Treatment of Hepatocellular Carcinoma
Bayer Identifier:
10874
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
Inclusion Criteria
- Histologically or cytologically confirmed primary hepatocellular carcinoma (HCC) - Inoperable disease (T2-T4, any N, M0 or M1) or refused surgery - Measurable disease - At least 1 bidimensionally measurable lesion of at least 2 cm by computed tomography (CT) scan or magnetic resonance imaging (MRI) - Presence of at least 1 of the following: - Alpha-fetoprotein greater than the upper limit of normal (ULN) - Hepatitis C antibody positive - Hepatitis B surface antigen positive - Child's Pugh class A or B - Candidate for systemic therapy
Exclusion Criteria
- Fibrolamellar disease mixed histology - Metastatic brain or meningeal tumors
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Hôpital de la Timone - Marseille MARSEILLE, France, 13005 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Pisana Pisa, Italy, 56126 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hadassah University Hospital Ein Kerem Jerusalem, Israel, 91120 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre Eugène Marquis - Rennes Cedex RENNES CEDEX, France, 35062 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ospedale Borgo Trento Verona, Italy, 37126 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre Oscar Lambret - Lille LILLE CEDEX, France, 59020 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS Osp Maggiore Policlinico Milano, Italy, 20122 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Institut Jules Bordet/Jules Bordet Instituut BRUXELLES - BRUSSEL, Belgium, 1000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre René Gauducheau - Nantes SAINT HERBLAIN, France, 44805 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tel Aviv Sourasky Medical Center Tel Aviv, Israel, 64239 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations AUSL Forlì - Emilia Romagna Forlì, Italy, 47100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Memorial Sloan-Kettering Cancer Center New York, United States, 10021-6007 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations UZ Gent GENT, Belgium, 9000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kaplan Medical Center Rehovot, Israel, 76100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Metropolitan Hematology Oncology Medical Group Los Angeles, United States, 90057 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital Erasme/Erasmus Ziekenhuis BRUXELLES - BRUSSEL, Belgium, 1070 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations UZ Brussel BRUXELLES - BRUSSEL, Belgium, 1090 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Chaim Sheba Medical Center Tel Hashomer, Israel, 52621 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations UZ Leuven Gasthuisberg LEUVEN, Belgium, 3000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital Tenon - Paris PARIS, France, 75020 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Rabin Medical Center - Beilinson Campus Petach Tikva, Israel, 49100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS Ist Clinico Humanitas Rozzano, Italy, 20089 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Rambam Medical Center Haifa, Israel, 31096 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A phase II multicenter uncontrolled trial of Sorafenib (BAY43-9006) in patients with advanced Hepatocellular Carcinoma
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- Percentage of Participants for Each Type of ResponseTimeframe: Until 30 days after termination of active therapy
Secondary Outcome
- Duration of ResponseTimeframe: up to 3 years later
- Time to ResponseTimeframe: up to 3 years later
- Time to ProgressionTimeframe: up to 3 years later
- Duration of Stable DiseaseTimeframe: up to 3 years later
- Time to Minor ResponseTimeframe: up to 3 years later
- Duration of Minor ResponseTimeframe: Time from MR to PD
- Overall SurvivalTimeframe: Start of treatment to death
Additional Information
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