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Spots Global Cancer Trial Database for Nexavar-Tarceva Combination Therapy for First Line Treatment of Patients Diagnosed With Hepatocellular Carcinoma

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Trial Identification

Brief Title: Nexavar-Tarceva Combination Therapy for First Line Treatment of Patients Diagnosed With Hepatocellular Carcinoma

Official Title: A Phase III Randomized, Placebo Controlled, Double Blind Trial of Sorafenib Plus Erlotinib vs. Sorafenib Plus Placebo as First Line Systemic Treatment for Hepatocellular Carcinoma (HCC)

Study ID: NCT00901901

Study Description

Brief Summary: This is a randomized trial to evaluate the clinical benefit of sorafenib 400 mg twice daily and erlotinib 150 mg once a day versus sorafenib 400 mg twice daily and placebo erlotinib once daily in subjects with unresectable advanced or metastatic Child-Pugh A HCC. Patients who are candidates for potentially curative intervention (i.e. surgical resection or local ablation) are not eligible for this study.

Detailed Description: European quality of life scale (5 dimensions) (EQ-5D)

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

, San Francisco, California, United States

, Washington, District of Columbia, United States

, Gainesville, Florida, United States

, Miami, Florida, United States

, Atlanta, Georgia, United States

, Honolulu, Hawaii, United States

, Maywood, Illinois, United States

, Westwood, Kansas, United States

, Louisville, Kentucky, United States

, New Orleans, Louisiana, United States

, Baltimore, Maryland, United States

, Boston, Massachusetts, United States

, Boston, Massachusetts, United States

, Worcester, Massachusetts, United States

, Detroit, Michigan, United States

, Minneapolis, Minnesota, United States

, New York, New York, United States

, Rochester, New York, United States

, Valhalla, New York, United States

, Charlotte, North Carolina, United States

, Philadelphia, Pennsylvania, United States

, Houston, Texas, United States

, Seattle, Washington, United States

, Randwick, New South Wales, Australia

, Brisbane, Queensland, Australia

, Herston, Queensland, Australia

, Clayton, Victoria, Australia

, Melbourne, Victoria, Australia

, Nedlands, Western Australia, Australia

, Wien, , Austria

, Bruxelles - Brussel, , Belgium

, Edegem, , Belgium

, Gent, , Belgium

, Kortrijk, , Belgium

, La Louviere, , Belgium

, Leuven, , Belgium

, Liege, , Belgium

, Belo Horizonte, Minas Gerais, Brazil

, Porto Alegre, Rio Grande Do Sul, Brazil

, São Paulo, Sao Paulo, Brazil

, Rio de Janeiro, , Brazil

, Sao Paulo, , Brazil

, Sao Paulo, , Brazil

, Plovdiv, , Bulgaria

, Sofia, , Bulgaria

, Varna, , Bulgaria

, Varna, , Bulgaria

, Edmonton, Alberta, Canada

, Montreal, Quebec, Canada

, Santiago, , Chile

, Santiago, , Chile

, Guangzhou, Guangdong, China

, Nanjing, Jiangsu, China

, Hangzhou, Zhejiang, China

, Beijing, , China

, Beijing, , China

, Floridablanca, , Colombia

, Medellín, , Colombia

, Bordeaux, , France

, Clichy, , France

, Creteil, , France

, La Roche Sur Yon, , France

, Lille, , France

, Lyon, , France

, Marseille, , France

, Paris, , France

, Pessac, , France

, Vandoeuvre-les-nancy, , France

, Villejuif, , France

, Freiburg, Baden-Württemberg, Germany

, Tübingen, Baden-Württemberg, Germany

, München, Bayern, Germany

, Regensburg, Bayern, Germany

, Frankfurt, Hessen, Germany

, Hannover, Niedersachsen, Germany

, Essen, Nordrhein-Westfalen, Germany

, Köln, Nordrhein-Westfalen, Germany

, Mainz, Rheinland-Pfalz, Germany

, Homburg, Saarland, Germany

, Berlin, , Germany

, Athens, , Greece

, Larissa, , Greece

, Thessaloniki, , Greece

, Thessaloniki, , Greece

, Hong Kong, , Hong Kong

, Shatin, , Hong Kong

, Beer Sheva, , Israel

, Haifa, , Israel

, Petah Tikva, , Israel

, Rehovot, , Israel

, Zrifin, , Israel

, Milano, Lombardia, Italy

, Goyang-si, Gyeonggido, Korea, Republic of

, Seoul, , Korea, Republic of

, Seoul, , Korea, Republic of

, Seoul, , Korea, Republic of

, Seoul, , Korea, Republic of

, Auckland, , New Zealand

, Christchurch, , New Zealand

, Wellington South, , New Zealand

, Lima, , Peru

, Lima, , Peru

, Bydgoszcz, , Poland

, Gdansk, , Poland

, Gliwice, , Poland

, Warszawa, , Poland

, Barnaul, , Russian Federation

, Moscow, , Russian Federation

, Nizhny Novgorod, , Russian Federation

, Singapore, , Singapore

, Singapore, , Singapore

, Johannesburg, Gauteng, South Africa

, Cape Town, Western Cape, South Africa

, Hospitalet de Llobregat, Barcelona, Spain

, Barcelona, , Spain

, Lugo, , Spain

, Madrid, , Spain

, Santander, , Spain

, Valencia, , Spain

, Valencia, , Spain

, Tainan, , Taiwan

, Taipei, , Taiwan

, Taoyuan, , Taiwan

, Sheffield, South Yorkshire, United Kingdom

, Glasgow, , United Kingdom

, London, , United Kingdom

, Newcastle Upon Tyne, , United Kingdom

Contact Details

Name: Bayer Study Director

Affiliation: Bayer

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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