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| Sponsor: | Bayer |
|---|---|
| Information provided by: | Bayer |
| ClinicalTrials.gov Identifier: | NCT00692770 |
Purpose
To evaluate efficacy and safety of sorafenib versus placebo in the adjuvant treatment of Hepatocellular Carcinoma (HCC) after potentially curative treatment (surgical resection or local ablation).
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoma, Hepatocellular |
Drug: Nexavar (Sorafenib, BAY43-9006) Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Phase III Randomized, Double-blind, Placebo-controlled Study of Sorafenib as Adjuvant Treatment for Hepatocellular Carcinoma After Surgical Resection or Local Ablation. |
| Estimated Enrollment: | 1100 |
| Study Start Date: | August 2008 |
| Estimated Study Completion Date: | November 2011 |
| Estimated Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Arm 1: Experimental |
Drug: Nexavar (Sorafenib, BAY43-9006)
400mg (2 x 200mg tablets) orally, twice a day, continuously , until disease recurrence or unacceptable toxicity or other criteria for withdrawal are met.
|
| Arm 2: Placebo Comparator |
Drug: Placebo
400mg (2 x 200mg tablets) orally, twice a day, continuously , until disease recurrence or unacceptable toxicity or other criteria for withdrawal are met.
|
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| Contact: Bayer Clinical Trials Contact | clinical-trials-contact@bayerhealthcare.com | |
| Contact: For trial location information (Phone Menu Options '3' or '4') | (+)1-888-84 22937 |
Hide Study Locations| United States, Alabama | |
| Recruiting | |
| Birmingham, Alabama, United States, 35294 | |
| United States, Arizona | |
| Recruiting | |
| Phoenix, Arizona, United States, 85054-4502 | |
| United States, California | |
| Terminated | |
| La Jolla, California, United States, 92093 | |
| Recruiting | |
| Los Angeles, California, United States, 90095 | |
| Recruiting | |
| Los Angeles, California, United States, 90089 | |
| Recruiting | |
| San Francisco, California, United States, 94115 | |
| United States, District of Columbia | |
| Recruiting | |
| Washington, District of Columbia, United States, 20007-2197 | |
| United States, Florida | |
| Recruiting | |
| Miami, Florida, United States, 33136 | |
| United States, Georgia | |
| Recruiting | |
| Atlanta, Georgia, United States, 30322 | |
| Not yet recruiting | |
| Atlanta, Georgia, United States, 30309-1231 | |
| United States, Illinois | |
| Not yet recruiting | |
| Maywood, Illinois, United States, 60153 | |
| Not yet recruiting | |
| Chicago, Illinois, United States, 60612-7236 | |
| United States, Indiana | |
| Recruiting | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Kansas | |
| Not yet recruiting | |
| Kansas City, Kansas, United States, 66160 | |
| United States, Kentucky | |
| Recruiting | |
| Louisville, Kentucky, United States, 40202 | |
| United States, Louisiana | |
| Recruiting | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Maryland | |
| Recruiting | |
| Baltimore, Maryland, United States, 21287 | |
| United States, Massachusetts | |
| Recruiting | |
| Boston, Massachusetts, United States, 02114-2696 | |
| Recruiting | |
| Burlington, Massachusetts, United States, 01805 | |
| United States, Michigan | |
| Recruiting | |
| Ann Arbor, Michigan, United States, 48109-0330 | |
| United States, Minnesota | |
| Recruiting | |
| Minneapolis, Minnesota, United States, 55455 | |
| Recruiting | |
| Minneapolis, Minnesota, United States, 55407 | |
| United States, New York | |
| Recruiting | |
| New York, New York, United States, 10029 | |
| United States, Ohio | |
| Recruiting | |
| Columbus, Ohio, United States, 43210-1240 | |
| Recruiting | |
| Cleveland, Ohio, United States, 44195 | |
| Not yet recruiting | |
| Cleveland, Ohio, United States, 44106-2602 | |
| United States, Oregon | |
| Recruiting | |
| Portland, Oregon, United States, 97239 | |
| Recruiting | |
| Portland, Oregon, United States, 97213-2967 | |
| United States, Pennsylvania | |
| Recruiting | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, Texas | |
| Not yet recruiting | |
| Houston, Texas, United States, 77030 | |
| United States, Virginia | |
| Recruiting | |
| Richmond, Virginia, United States, 23249-0002 | |
| United States, Washington | |
| Recruiting | |
| Seattle, Washington, United States, 98109-1023 | |
| Recruiting | |
| Seattle, Washington, United States, 98101 | |
| United States, Wisconsin | |
| Not yet recruiting | |
| Madison, Wisconsin, United States, 53792 | |
| Argentina, Buenos Aires | |
| Not yet recruiting | |
| Pilar, Buenos Aires, Argentina, B1629AHJ | |
| Argentina, Capital Federal | |
| Not yet recruiting | |
| Buenos Aires, Capital Federal, Argentina, C1280AEB | |
| Not yet recruiting | |
| Buenos Aires, Capital Federal, Argentina, C1181ACH | |
| Not yet recruiting | |
| Buenos Aires, Capital Federal, Argentina, 1078 | |
| Not yet recruiting | |
| Buenos Aires, Capital Federal, Argentina, C1118AAT | |
| Argentina, Mendoza | |
| Not yet recruiting | |
| Guaymallen, Mendoza, Argentina, 5519 | |
| Argentina, Santa Fe | |
| Not yet recruiting | |
| Rosario, Santa Fe, Argentina, 2000 | |
| Australia, New South Wales | |
| Recruiting | |
| Camperdown, New South Wales, Australia, 2050 | |
| Recruiting | |
| Randwick, New South Wales, Australia, 2031 | |
| Not yet recruiting | |
| St Leonards, New South Wales, Australia, 2065 | |
| Australia, Queensland | |
| Not yet recruiting | |
| Greenslopes, Queensland, Australia, 4120 | |
| Australia, Victoria | |
| Not yet recruiting | |
| Heidelberg, Victoria, Australia, 3084 | |
| Not yet recruiting | |
| Prahran, Victoria, Australia, 3181 | |
| Austria | |
| Not yet recruiting | |
| Salzburg, Austria, 5020 | |
| Recruiting | |
| Wien, Austria, 1090 | |
| Austria, Oberösterreich | |
| Recruiting | |
| Linz, Oberösterreich, Austria, 4010 | |
| Austria, Tirol | |
| Recruiting | |
| Innsbruck, Tirol, Austria, 6020 | |
| Belgium | |
| Recruiting | |
| Bruxelles, Belgium, 1200 | |
| Recruiting | |
| Liege, Belgium, 4000 | |
| Recruiting | |
| Gent, Belgium, 9000 | |
| Recruiting | |
| Leuven, Belgium, 3000 | |
| Brazil | |
| Not yet recruiting | |
| Belo Horizonte, Brazil, 30380490 | |
| Brazil, Rio Grande do Sul | |
| Recruiting | |
| Porto Alegre, Rio Grande do Sul, Brazil, 90619900 | |
| Brazil, RS | |
| Not yet recruiting | |
| Porto Alegre, RS, Brazil | |
| Recruiting | |
| Porto Alegre, RS, Brazil, 90470 340 | |
| Brazil, SP | |
| Not yet recruiting | |
| São Paulo, SP, Brazil, 01323-001 | |
| Recruiting | |
| Sao Paulo, SP, Brazil, 05403-900 | |
| Bulgaria | |
| Not yet recruiting | |
| Sofia, Bulgaria, 01784 | |
| Not yet recruiting | |
| Sofia, Bulgaria, 1431 | |
| Recruiting | |
| Varna, Bulgaria, 9010 | |
| Not yet recruiting | |
| Plovdiv, Bulgaria, 4004 | |
| Canada, Alberta | |
| Recruiting | |
| Calgary, Alberta, Canada, T2N 4N1 | |
| Recruiting | |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| Canada, British Columbia | |
| Recruiting | |
| Vancouver, British Columbia, Canada, V5Z 4E6 | |
| Canada, Manitoba | |
| Not yet recruiting | |
| Winnipeg, Manitoba, Canada, R2H 2A6 | |
| Canada, Nova Scotia | |
| Not yet recruiting | |
| Halifax, Nova Scotia, Canada, B3H 3A7 | |
| Canada, Ontario | |
| Recruiting | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Not yet recruiting | |
| Ottawa, Ontario, Canada, K1H 8L6 | |
| Terminated | |
| London, Ontario, Canada, N6A 5A5 | |
| Canada, Quebec | |
| Not yet recruiting | |
| Montreal, Quebec, Canada, H3A 1A1 | |
| Chile | |
| Not yet recruiting | |
| Valparaiso, Chile, 236-3058 | |
| Not yet recruiting | |
| Santiago, Chile, 838-0456 | |
| Not yet recruiting | |
| Viña Del Mar, Chile | |
| Chile, Región Metropolitana | |
| Not yet recruiting | |
| Santiago de Chile, Región Metropolitana, Chile, 833-0024 | |
| China | |
| Recruiting | |
| Beijing, China, 100071 | |
| Recruiting | |
| Beijing, China, 100036 | |
| Recruiting | |
| Shanghai, China, 200438 | |
| Recruiting | |
| Beijing, China, 100021 | |
| Not yet recruiting | |
| Shanghai, China, 200032 | |
| Recruiting | |
| Tianjin, China | |
| Recruiting | |
| Beijing, China, 100853 | |
| Not yet recruiting | |
| Chongqing, China, 400038 | |
| Not yet recruiting | |
| Shanghai, China, 200001 | |
| China, Anhuii | |
| Recruiting | |
| Hefei, Anhuii, China, 230022 | |
| China, Guangdong | |
| Recruiting | |
| Guangzhou, Guangdong, China, 510060 | |
| Not yet recruiting | |
| Guangzhou, Guangdong, China, 510515 | |
| Recruiting | |
| Guangzhou, Guangdong, China, 510080 | |
| Recruiting | |
| Guangzhou, Guangdong, China, 510000 | |
| China, Guangxi | |
| Recruiting | |
| Nanning, Guangxi, China, 530021 | |
| China, Hubei | |
| Not yet recruiting | |
| Wuhan, Hubei, China, 430030 | |
| China, Hubei province | |
| Recruiting | |
| Wuhan, Hubei province, China, 430032 | |
| China, Hunan | |
| Not yet recruiting | |
| Changsha, Hunan, China, 410013 | |
| Recruiting | |
| Changsha, Hunan, China, 410013 | |
| Not yet recruiting | |
| Changsha, Hunan, China, 410008 | |
| China, Jiangsu | |
| Recruiting | |
| Nanjing, Jiangsu, China, 210002 | |
| China, Liaoning | |
| Recruiting | |
| Dalian, Liaoning, China, 116027 | |
| China, Shan'xi | |
| Recruiting | |
| Xi'an, Shan'xi, China, 710068 | |
| Recruiting | |
| Xi'an, Shan'xi, China, 710038 | |
| China, Shanxi | |
| Recruiting | |
| Xi'an, Shanxi, China, 710061 | |
| China, Sichuan | |
| Not yet recruiting | |
| Chengdu, Sichuan, China, 610041 | |
| China, Zhejiang | |
| Not yet recruiting | |
| Hangzhou, Zhejiang, China, (310022), | |
| France | |
| Recruiting | |
| Bondy, France, 93143 | |
| Recruiting | |
| Bordeaux, France, 33000 | |
| Recruiting | |
| Vandoeuvre-les-nancy, France, 54500 | |
| Recruiting | |
| Paris, France, 75020 | |
| Recruiting | |
| Lille, France, 59037 | |
| Recruiting | |
| Paris, France, 75012 | |
| Recruiting | |
| Lyon Cedex, France, 69288 | |
| Recruiting | |
| Angers Cedex 01, France, 49033 | |
| Recruiting | |
| Creteil, France, 94010 | |
| Recruiting | |
| Toulouse, France, 31059 | |
| Recruiting | |
| Rennes Cedex, France, 35062 | |
| Recruiting | |
| Villejuif, France, 94800 | |
| Recruiting | |
| Marseille, France, 13005 | |
| Not yet recruiting | |
| Nice, France, 06002 | |
| Germany | |
| Recruiting | |
| Berlin, Germany, 12200 | |
| Recruiting | |
| Hamburg, Germany, 20251 | |
| Germany, Baden-Württemberg | |
| Not yet recruiting | |
| Freiburg, Baden-Württemberg, Germany, 79106 | |
| Germany, Bayern | |
| Not yet recruiting | |
| München, Bayern, Germany, 81675 | |
| Recruiting | |
| Regensburg, Bayern, Germany, 93053 | |
| Not yet recruiting | |
| München, Bayern, Germany, 81377 | |
| Germany, Niedersachsen | |
| Recruiting | |
| Hannover, Niedersachsen, Germany, 30625 | |
| Not yet recruiting | |
| Göttingen, Niedersachsen, Germany, 37075 | |
| Germany, Nordrhein-Westfalen | |
| Recruiting | |
| Düsseldorf, Nordrhein-Westfalen, Germany, 40225 | |
| Recruiting | |
| Essen, Nordrhein-Westfalen, Germany, 45147 | |
| Recruiting | |
| Aachen, Nordrhein-Westfalen, Germany, 52074 | |
| Recruiting | |
| Köln, Nordrhein-Westfalen, Germany, 50931 | |
| Germany, Rheinland-Pfalz | |
| Recruiting | |
| Mainz, Rheinland-Pfalz, Germany, 55131 | |
| Germany, Saarland | |
| Not yet recruiting | |
| Homburg, Saarland, Germany, 66421 | |
| Germany, Sachsen-Anhalt | |
| Recruiting | |
| Halle, Sachsen-Anhalt, Germany, 06097 | |
| Recruiting | |
| Magdeburg, Sachsen-Anhalt, Germany, 39112 | |
| Greece | |
| Not yet recruiting | |
| Thessaloniki, Greece, 54642 | |
| Not yet recruiting | |
| Larissa, Greece, 41111 | |
| Not yet recruiting | |
| Thessaloniki, Greece, 540 07 | |
| Hong Kong | |
| Recruiting | |
| Hong Kong, Hong Kong | |
| Not yet recruiting | |
| Hong Kong, Hong Kong | |
| Italy | |
| Not yet recruiting | |
| Palermo, Italy, 90127 | |
| Recruiting | |
| Milano, Italy, 20133 | |
| Recruiting | |
| Bologna, Italy, 40138 | |
| Recruiting | |
| Milano, Italy, 20121 | |
| Recruiting | |
| Palermo, Italy, 90127 | |
| Recruiting | |
| Benevento, Italy, 82100 | |
| Recruiting | |
| Roma, Italy, 00168 | |
| Recruiting | |
| Roma, Italy, 00189 | |
| Recruiting | |
| Catania, Italy, 95124 | |
| Recruiting | |
| Torino, Italy, 10126 | |
| Recruiting | |
| Bari, Italy, 70124 | |
| Recruiting | |
| Modena, Italy, 41124 | |
| Recruiting | |
| Napoli, Italy, 80131 | |
| Not yet recruiting | |
| Padova, Italy, 35128 | |
| Italy, Cagliari | |
| Recruiting | |
| Selargius, Cagliari, Italy, 09047 | |
| Italy, Foggia | |
| Not yet recruiting | |
| San Giovanni Rotondo, Foggia, Italy, 71013 | |
| Japan | |
| Recruiting | |
| Fukuoka, Japan, 812-8582 | |
| Recruiting | |
| Kumamoto, Japan, 860-8556 | |
| Recruiting | |
| Kyoto, Japan, 606-8507 | |
| Recruiting | |
| Okayama, Japan, 700-8558 | |
| Recruiting | |
| Osaka, Japan, 537-8511 | |
| Recruiting | |
| Tokushima, Japan, 770-8503 | |
| Japan, Chiba | |
| Recruiting | |
| Kashiwa, Chiba, Japan, 277-8577 | |
| Japan, Ishikawa | |
| Recruiting | |
| Kanazawa, Ishikawa, Japan, 920-8641 | |
| Japan, Kanagawa | |
| Terminated | |
| Kawasaki, Kanagawa, Japan, 213-8587 | |
| Recruiting | |
| Yokohama, Kanagawa, Japan, 232¿0024 | |
| Japan, Osaka | |
| Recruiting | |
| Osakasayama, Osaka, Japan, 589-8511 | |
| Recruiting | |
| Suita, Osaka, Japan, 565-0871 | |
| Japan, Tokyo | |
| Recruiting | |
| Chuo-ku, Tokyo, Japan, 104-0045 | |
| Recruiting | |
| Shibuya-ku, Tokyo, Japan, 150-8935 | |
| Recruiting | |
| Itabashi-ku, Tokyo, Japan, 173-8610 | |
| Recruiting | |
| Shinjuku-ku, Tokyo, Japan, 162-8666 | |
| Recruiting | |
| Bunkyo-ku, Tokyo, Japan, 113-8655 | |
| Recruiting | |
| Minato-ku, Tokyo, Japan, 105-8470 | |
| Korea, Republic of | |
| Recruiting | |
| Seoul, Korea, Republic of, 110-744 | |
| Recruiting | |
| Seoul, Korea, Republic of, 138-736 | |
| Recruiting | |
| Seoul, Korea, Republic of, 120-752 | |
| Recruiting | |
| Seoul, Korea, Republic of, 135-710 | |
| Recruiting | |
| Gyeonggi-do, Korea, Republic of, 410-769 | |
| Recruiting | |
| Seoul, Korea, Republic of | |
| Recruiting | |
| Pusan, Korea, Republic of, 602 739 | |
| Not yet recruiting | |
| Ask Contact, Korea, Republic of, 561-712 | |
| Recruiting | |
| Daegu, Korea, Republic of, 702-701 | |
| Korea, Republic of, South Korea | |
| Recruiting | |
| Goyang-si, South Korea, Korea, Republic of, 411-706 | |
| Mexico | |
| Recruiting | |
| México, D.f., Mexico, 14050 | |
| Recruiting | |
| México, D.f., Mexico, 14080 | |
| Mexico, Nueva León | |
| Not yet recruiting | |
| Monterrey, Nueva León, Mexico, 64710 | |
| New Zealand | |
| Not yet recruiting | |
| Christchurch, New Zealand, 8011 | |
| Recruiting | |
| Auckland, New Zealand, 1023 | |
| Peru | |
| Not yet recruiting | |
| Lima, Peru, LIMA 11 | |
| Not yet recruiting | |
| San Borja, Peru | |
| Not yet recruiting | |
| Chiclayo, Peru, CIX | |
| Portugal | |
| Not yet recruiting | |
| Coimbra, Portugal, 3000-076 | |
| Not yet recruiting | |
| Lisboa, Portugal, 1069-166 | |
| Romania | |
| Not yet recruiting | |
| Bucharest, Romania, 11172 | |
| Not yet recruiting | |
| Cluj-Napoca, Romania, 400015 | |
| Recruiting | |
| Bucharest, Romania | |
| Recruiting | |
| Iasi, Romania | |
| Romania, Iasi county | |
| Not yet recruiting | |
| Iasi, Iasi county, Romania, 700111 | |
| Russian Federation | |
| Not yet recruiting | |
| Voronezh, Russian Federation, 394000 | |
| Not yet recruiting | |
| Moscow, Russian Federation, 115478 | |
| Recruiting | |
| Moscow, Russian Federation, 119992 | |
| Recruiting | |
| Moscow, Russian Federation, 115478 | |
| Recruiting | |
| St. Petersburg, Russian Federation, 197758 | |
| Russian Federation, Kaluga region | |
| Not yet recruiting | |
| Obninsk, Kaluga region, Russian Federation, 249036 | |
| Singapore | |
| Recruiting | |
| Singapore, Singapore, 169608 | |
| Recruiting | |
| Singapore, Singapore, 119074 | |
| Spain | |
| Not yet recruiting | |
| A Coruña, Spain, 15006 | |
| Recruiting | |
| Badajoz, Spain, 06080 | |
| Recruiting | |
| Barcelona, Spain, 08036 | |
| Recruiting | |
| Barcelona, Spain, 08035 | |
| Recruiting | |
| Valladolid, Spain, 47010 | |
| Recruiting | |
| Madrid, Spain, 28040 | |
| Recruiting | |
| Madrid, Spain, 28007 | |
| Recruiting | |
| Córdoba, Spain, 14004 | |
| Spain, Asturias | |
| Recruiting | |
| Oviedo, Asturias, Spain, 33006 | |
| Spain, Barcelona | |
| Recruiting | |
| Sabadell, Barcelona, Spain, 08208 | |
| Spain, Bizkaia | |
| Recruiting | |
| Barakaldo, Bizkaia, Spain, 48903 | |
| Spain, Madrid | |
| Not yet recruiting | |
| Majadahonda, Madrid, Spain, 28222 | |
| Sweden | |
| Recruiting | |
| Stockholm, Sweden, 171 76 | |
| Recruiting | |
| Göteborg, Sweden, 413 45 | |
| Switzerland | |
| Recruiting | |
| Bern, Switzerland, 3010 | |
| Recruiting | |
| Zürich, Switzerland, 8091 | |
| Taiwan | |
| Not yet recruiting | |
| Changhua, Taiwan, 500 | |
| Recruiting | |
| Taipei, Taiwan, 100 | |
| Recruiting | |
| Taipei, Taiwan, 112 | |
| Not yet recruiting | |
| Kaohsiung, Taiwan, 833 | |
| Not yet recruiting | |
| Kaohsiung, Taiwan, 80756 | |
| United Kingdom, Greater London | |
| Recruiting | |
| London, Greater London, United Kingdom, NW3 2QG | |
| Recruiting | |
| London, Greater London, United Kingdom, SE5 9RS | |
| Not yet recruiting | |
| London, Greater London, United Kingdom, EC1A 7BE | |
| United Kingdom, Greater Manchester | |
| Not yet recruiting | |
| Manchester, Greater Manchester, United Kingdom, M20 4BX | |
| United Kingdom, Hampshire | |
| Not yet recruiting | |
| Southampton, Hampshire, United Kingdom, SO16 6YD | |
| United Kingdom, Tyne and Wear | |
| Not yet recruiting | |
| Newcastle Upon Tyne, Tyne and Wear, United Kingdom, NE7 7DN | |
| United Kingdom, West Midlands | |
| Not yet recruiting | |
| Birmingham, West Midlands, United Kingdom, B15 2TT | |
| United Kingdom, West Yorkshire | |
| Not yet recruiting | |
| Leeds, West Yorkshire, United Kingdom, LS9 7TF | |
| Study Director: | Bayer Study Director | Bayer |
More Information
| Responsible Party: | Bayer HealthCare AG ( Therapeutic Area Head ) |
| Study ID Numbers: | 12414, 2008-001087-36, STORM |
| Study First Received: | June 5, 2008 |
| Last Updated: | November 23, 2009 |
| ClinicalTrials.gov Identifier: | NCT00692770 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Hepatocellular, Sorafenib, Adjuvant, Surgical resection, Ablation |
|
Liver Diseases Neoplasms by Histologic Type Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Carcinoma, Hepatocellular Physiological Effects of Drugs Adjuvants, Immunologic 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 |