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| Sponsor: | Bayer |
|---|---|
| Information provided by: | Bayer |
| ClinicalTrials.gov Identifier: | NCT00105443 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoma, Hepatocellular |
Drug: Nexavar (Sorafenib, BAY43-9006) Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Phase III Randomized, Placebo-Controlled Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma |
| Enrollment: | 602 |
| Study Start Date: | March 2005 |
| Study Completion Date: | November 2008 |
| Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Arm 1: Active Comparator |
Drug: Nexavar (Sorafenib, BAY43-9006)
400 mg BID BAY 43-9006
|
| Arm 2: Placebo Comparator |
Drug: Placebo
400 mg BID Placebo
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| Tucson, Arizona, United States, 85724 | |
| Phoenix, Arizona, United States, 85054-4502 | |
| United States, California | |
| Los Angeles, California, United States, 90095 | |
| Orange, California, United States, 92868-3201 | |
| Los Angeles, California, United States, 90057 | |
| Stanford, California, United States, 94305-5118 | |
| San Francisco, California, United States, 94121 | |
| United States, Connecticut | |
| Farmington, Connecticut, United States, 06030 | |
| New Haven, Connecticut, United States, 06520-8064 | |
| United States, Florida | |
| Gainesville, Florida, United States, 32610 | |
| Tampa, Florida, United States, 33612 | |
| Miami, Florida, United States, 33136 | |
| United States, Georgia | |
| Atlanta, Georgia, United States, 30365 | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Illinois | |
| Chicago, Illinois, United States, 60612 | |
| Chicago, Illinois, United States, 60611 | |
| United States, Kentucky | |
| Lexington, Kentucky, United States, 40536 | |
| United States, Michigan | |
| Ann Arbor, Michigan, United States, 48109-0330 | |
| Detroit, Michigan, United States, 48202 | |
| United States, Missouri | |
| St. Louis, Missouri, United States, 63110 | |
| United States, Nebraska | |
| Omaha, Nebraska, United States, 68198 | |
| United States, New York | |
| Manhasset, New York, United States, 11030-3876 | |
| New York, New York, United States, 10032 | |
| New York, New York, United States, 10029 | |
| New York, New York, United States, 10032 | |
| New York, New York, United States, 10016 | |
| United States, Ohio | |
| Canton, Ohio, United States, 44718 | |
| United States, Oregon | |
| Portland, Oregon, United States, 97239 | |
| United States, Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Philadelphia, Pennsylvania, United States, 19140 | |
| Pittsburgh, Pennsylvania, United States, 15213-2592 | |
| United States, Texas | |
| Houston, Texas, United States, 77030-2707 | |
| United States, Virginia | |
| Richmond, Virginia, United States, 23249-0002 | |
| United States, Washington | |
| Seattle, Washington, United States, 98122-4307 | |
| Seattle, Washington, United States, 98104 | |
| Argentina, Buenos Aires | |
| Mar del Plata, Buenos Aires, Argentina, 7600 | |
| Pilar, Buenos Aires, Argentina, B1629AHJ | |
| Argentina, Capital Federal | |
| Bueno Aires, Capital Federal, Argentina, C1417DTB | |
| Buenos Aires, Capital Federal, Argentina, C1120AAF | |
| Buenos Aires, Capital Federal, Argentina, C1181ACH | |
| Buenos Aires, Capital Federal, Argentina, C1145ADP | |
| Argentina, Tucumán | |
| San Miguel de Tucumán, Tucumán, Argentina, T4000GTB | |
| San Miguel de Tucumán, Tucumán, Argentina, T4000HXU | |
| Australia, New South Wales | |
| Sydney, New South Wales, Australia, 2050 | |
| Sydney, New South Wales, Australia, 2145 | |
| Sydney, New South Wales, Australia, 2031 | |
| Australia, Victoria | |
| Melbourne, Victoria, Australia, 3052 | |
| Melbourne, Victoria, Australia, 3084 | |
| Melbourne, Victoria, Australia, 3168 | |
| Belgium | |
| BRUXELLES, Belgium, 1200 | |
| BRUGGE, Belgium, 8000 | |
| BRUXELLES, Belgium, 1070 | |
| GENT, Belgium, 9000 | |
| BRUXELLES, Belgium, 1090 | |
| LEUVEN, Belgium, 3000 | |
| Brazil | |
| Belo Horizonte, Brazil, 30380490 | |
| Belo Horizonte, Brazil, 30180090 | |
| Sao Paulo, Brazil, 01246-903 | |
| Brazil, Rio Grande do Sul | |
| Porto Alegre, Rio Grande do Sul, Brazil, 90619900 | |
| Brazil, RS | |
| Porto Alegre, RS, Brazil | |
| Bulgaria | |
| Stara Zagora, Bulgaria, 6000 | |
| Sofia, Bulgaria, 1527 | |
| Varna, Bulgaria, 9010 | |
| Sofia, Bulgaria, 1431 | |
| Sofia, Bulgaria, 1233 | |
| Sofia, Bulgaria, 1431 | |
| Canada, Alberta | |
| Calgary, Alberta, Canada, T2N 4N1 | |
| Edmonton, Alberta, Canada, T6G 2C8 | |
| Canada, British Columbia | |
| Vancouver, British Columbia, Canada, V5Z 1M9 | |
| Canada, Manitoba | |
| Winnipeg, Manitoba, Canada, R2H 2A6 | |
| Canada, Ontario | |
| London, Ontario, Canada, N6A 5A5 | |
| Toronto, Ontario, Canada, M5G 2C4 | |
| Ottawa, Ontario, Canada, K1H 8L6 | |
| Canada, Quebec | |
| Montreal, Quebec, Canada, H3A 1A1 | |
| Chile | |
| Santiago, Chile | |
| Chile, Región Metropolitana | |
| Santiago de Chile, Región Metropolitana, Chile, 833-0024 | |
| Chile, RM | |
| Santiago de Chile, RM, Chile | |
| Croatia | |
| Zagreb, Croatia, 10000 | |
| France | |
| LILLE CEDEX, France, 59020 | |
| BONDY, France, 93143 | |
| SAINT HERBLAIN, France, 44805 | |
| VANDOEUVRE-LES-NANCY, France, 54500 | |
| CLICHY, France, 92110 | |
| LILLE CEDEX, France, 59020 | |
| PARIS, France, 75020 | |
| DIJON, France, 21000 | |
| RENNES CEDEX, France, 35062 | |
| MARSEILLE, France, 13005 | |
| BORDEAUX, France, 33000 | |
| RENNES CEDEX, France, 35062 | |
| Germany | |
| Berlin, Germany, 12200 | |
| Hamburg, Germany, 20251 | |
| Germany, Baden-Württemberg | |
| Freiburg, Baden-Württemberg, Germany, 79106 | |
| Tübingen, Baden-Württemberg, Germany, 72076 | |
| Germany, Bayern | |
| Regensburg, Bayern, Germany, 93053 | |
| München, Bayern, Germany, 81377 | |
| München, Bayern, Germany, 81675 | |
| Germany, Hessen | |
| Frankfurt, Hessen, Germany, 60596 | |
| Germany, Niedersachsen | |
| Hannover, Niedersachsen, Germany, 30625 | |
| Germany, Nordrhein-Westfalen | |
| Essen, Nordrhein-Westfalen, Germany, 45147 | |
| Düsseldorf, Nordrhein-Westfalen, Germany, 40225 | |
| Bonn, Nordrhein-Westfalen, Germany, 53105 | |
| Germany, Rheinland-Pfalz | |
| Mainz, Rheinland-Pfalz, Germany, 55131 | |
| Germany, Saarland | |
| Homburg, Saarland, Germany, 66421 | |
| Germany, Sachsen-Anhalt | |
| Halle, Sachsen-Anhalt, Germany, 06097 | |
| Magdeburg, Sachsen-Anhalt, Germany, 39112 | |
| Greece | |
| Thessaloniki, Greece, 540 07 | |
| Thessaloniki, Greece, 54639 | |
| Thessaloniki, Greece, 56403 | |
| Greece, Attica | |
| Haidari, Attica, Greece, 12462 | |
| Athens, Attica, Greece, 115 27 | |
| Greece, Ioannina | |
| Dourouti-Ioannina, Ioannina, Greece, 45500 | |
| Israel | |
| Zerifin, Israel, 70300 | |
| Petach Tikva, Israel, 49100 | |
| Tel Aviv, Israel, 64239 | |
| Haifa, Israel, 31096 | |
| Italy | |
| Forlì, Italy, 47100 | |
| Roma, Italy, 00128 | |
| Palermo, Italy, 90129 | |
| Padova, Italy, 35128 | |
| Pisa, Italy, 56126 | |
| Bologna, Italy, 40138 | |
| Milano, Italy, 20122 | |
| Pavia, Italy, 27100 | |
| Milano, Italy, 20133 | |
| Avellino, Italy, 83100 | |
| Italy, Milano | |
| Rozzano, Milano, Italy, 20089 | |
| Mexico | |
| Monterrey, Mexico, 64000 | |
| México, D.F., Mexico, 06720 | |
| México, D.F., Mexico, 14050 | |
| México, D.F., Mexico, 06720 | |
| Mexico, DF | |
| México, DF, Mexico, 14080 | |
| New Zealand | |
| Auckland, New Zealand, 1023 | |
| Wellington South, New Zealand, 6021 | |
| Peru | |
| Lima, Peru, 44 | |
| Comas Lima, Peru | |
| Lima Cercado, Peru, LIMA 1 | |
| Poland | |
| Gdansk, Poland, 80-952 | |
| Warszawa, Poland, 02-507 | |
| Warszawa, Poland, 02-781 | |
| Poznan, Poland, 61-701 | |
| Romania | |
| Craiova Dolj, Romania, 200642 | |
| Romania, Iasi county | |
| Iasi, Iasi county, Romania, 700111 | |
| Romania, Timis county | |
| Timisoara, Timis county, Romania, 300223 | |
| Russian Federation | |
| Kazan, Russian Federation, 420012 | |
| Krasnodar, Russian Federation, 350040 | |
| Ekaterinburg, Russian Federation, 620036 | |
| St. Petersburg, Russian Federation, 197758 | |
| Ekaterinburg, Russian Federation, 620102 | |
| Tolgliatti, Russian Federation | |
| St. Petersburg, Russian Federation, 195 067 | |
| Moscow, Russian Federation, 105229 | |
| St. Petersburg, Russian Federation, 188663 | |
| Kirov, Russian Federation, 610002 | |
| Moscow, Russian Federation, 129 010 | |
| Moscow, Russian Federation, 111 020 | |
| Moscow, Russian Federation, 129110 | |
| Moscow, Russian Federation, 113 811 | |
| Moscow, Russian Federation, 105 203 | |
| Moscow, Russian Federation, 115478 | |
| Spain | |
| Alicante, Spain, 03010 | |
| Barcelona, Spain, 08036 | |
| Barcelona, Spain, 08035 | |
| Barcelona, Spain, 08003 | |
| Barcelona, Spain, 08035 | |
| Córdoba, Spain, 14004 | |
| Madrid, Spain, 28006 | |
| Madrid, Spain, 28041 | |
| Madrid, Spain, 28034 | |
| Pamplona, Spain, 31008 | |
| Valencia, Spain, 46014 | |
| Spain, Barcelona | |
| Badalona, Barcelona, Spain, 08916 | |
| Spain, Bizkaia | |
| Barakaldo, Bizkaia, Spain, 48903 | |
| Switzerland | |
| Bern, Switzerland, 3010 | |
| Genève, Switzerland, 1211 | |
| St. Gallen, Switzerland, 9007 | |
| Zürich, Switzerland, 8091 | |
| United Kingdom | |
| Newcastle-upon-Tyne, United Kingdom, NE2 4HH | |
| United Kingdom, Avon | |
| Bristol, Avon, United Kingdom, BS2 8ED | |
| United Kingdom, Greater London | |
| London, Greater London, United Kingdom, NW3 2QG | |
| London, Greater London, United Kingdom, SE1 9RT | |
| United Kingdom, Oxfordshire | |
| Oxford, Oxfordshire, United Kingdom, OX1 2JD | |
| United Kingdom, Strathclyde | |
| Glasgow, Strathclyde, United Kingdom, G11 6NT | |
| Study Director: | Bayer Study Director | Bayer |
More Information
| Responsible Party: | Bayer HealthCare AG ( Therapeutic Area Head ) |
| Study ID Numbers: | 100554, EudraCT No: 2004-001773-26, SHARP |
| Study First Received: | March 14, 2005 |
| Last Updated: | June 4, 2009 |
| ClinicalTrials.gov Identifier: | NCT00105443 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Liver Cancer Cancer |
|
Liver Diseases Neoplasms by Histologic Type Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Carcinoma, Hepatocellular Antineoplastic Agents Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |
Carcinoma Liver Neoplasms Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Adenocarcinoma Sorafenib Neoplasms, Glandular and Epithelial |
