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

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Carcinoma, Hepatocellular

Intervention: Sorafenib (Nexavar, BAY43-9006) (Drug); Sorafenib (Nexavar, BAY43-9006) + Erlotinib, Tarceva (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Overall Survival

Secondary outcome:

Time to Radiological Tumor Progression (TTP)

Disease Control

Health-related Quality of Life and Utility Values as Measured by EQ-5D - Index

Health-related Quality of Life and Utility Values as Measured by EQ-5D - VAS

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients > 18 years of age

- Patients who have a life expectancy of at least 12 weeks

- Patients with histological or cytologically documented HCC

- Patients must have at least one tumor lesion that meets both of the following

criteria:

- The lesion can be accurately measured in at least one dimension according to

response evaluation criteria in solid tumors (RECIST)

- The lesion has not been previously treated with local therapy

- Patients who have an ECOG PS (Eastern Cooperative Oncology Group Performance Status)

of 0 or 1

- Cirrhotic status of Child-Pugh class A.

- Patients who give 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. Exclusion Criteria:

- History of cardiac disease: congestive heart failure > New York Heart Association

(NYHA) class 2; active coronary artery disease (CAD); cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin), or uncontrolled hypertension. Myocardial infarction more than 6 months prior to study entry is permitted.

- Abnormalities of the cornea based on history (e. g. dry eye syndrome, Sogren's

syndrome) including congenital abnormality (e. g. Fuch's dystrophy), abnormal slit-lamp examination using a vital dye (e. g. fluorescein, Bengal-Rose), and/or an abnormal corneal sensitivity test (Schirmer test or similar tear production test).

- History of interstitial lung disease (ILD).

- Patients with clinically significant gastrointestinal bleeding within 30 days prior

to study entry.

- Previous treatment with yttrium-90 spheres

- Any condition that is unstable or which could jeopardize the safety of the patient

and his/her compliance in the study.

- Uncontrolled ascites (defined as not easily controlled with diuretic treatment)

Locations and Contacts

Wien 1090, Austria

Bruxelles - Brussel 1200, Belgium

Edegem 2650, Belgium

Gent 9000, Belgium

Kortrijk 8500, Belgium

La Louviere 7100, Belgium

Leuven 3000, Belgium

Liege 4000, Belgium

Rio de Janeiro 21941-913, Brazil

Sao Paulo 01509-900, Brazil

Sao Paulo 05403-000, Brazil

Plovdiv 4002, Bulgaria

Sofia 1784, Bulgaria

Varna 9002, Bulgaria

Varna 9010, Bulgaria

Santiago 7601003, Chile

Santiago 838-0455, Chile

Beijing 100021, China

Beijing 100071, China

Bogotá, Colombia

Bucaramanga, Colombia

Cali, Colombia

Floridablanca, Colombia

Medellín, Colombia

Bordeaux 33000, France

Clichy 92110, France

Creteil 94010, France

La Roche Sur Yon 85925, France

Lille 59037, France

Lyon Cedex 04 69317, France

Marseille 13005, France

Paris 75012, France

Pessac 33604, France

Vandoeuvre-les-nancy 54500, France

Villejuif 94800, France

Berlin 12200, Germany

Athens 115 27, Greece

Athens 11528, Greece

Heraklion 711 10, Greece

Larissa 41111, Greece

Thessaloniki 546 36, Greece

Thessaloniki 54642, Greece

Hong Kong, Hong Kong

Beer Sheva 8410101, Israel

Haifa 3109601, Israel

Petach Tikva 4941492, Israel

Rehovot 7610001, Israel

Tel Hashomer 5262000, Israel

Zrifin 6093000, Israel

Bergamo 24128, Italy

Reggio Emilia 42100, Italy

Seoul 110-744, Korea, Republic of

Seoul 135-710, Korea, Republic of

Seoul 138-736, Korea, Republic of

Seoul 152-703, Korea, Republic of

Auckland 1023, New Zealand

Christchurch 8011, New Zealand

Wellington South 6021, New Zealand

Lima Cercado LIMA 1, Peru

Lima 01, Peru

Lima LIMA 1, Peru

Lima LIMA 27, Peru

Lima LIMA 34, Peru

Bydgoszcz 85-796, Poland

Gdansk 80-952, Poland

Gliwice 44-101, Poland

Warszawa 02-781, Poland

Barnaul 656049, Russian Federation

Kazan 420029, Russian Federation

Kemerovo 650000, Russian Federation

Moscow 115478, Russian Federation

Nizhny Novgorod 603001, Russian Federation

St.Petersburg, Russian Federation

Yaroslavl 150054, Russian Federation

Singapore 169610, Singapore

Singapore 308433, Singapore

Barcelona 08036, Spain

Lugo 27003, Spain

Madrid 28040, Spain

Madrid 28041, Spain

Málaga 29010, Spain

Santander 39008, Spain

Valencia 46026, Spain

Valencia 46010, Spain

Tainan 736, Taiwan

Taipei 112, Taiwan

Taoyuan 333, Taiwan

Glasgow G12 0YN, United Kingdom

London SE5 9RS, United Kingdom

Newcastle Upon Tyne NE7 7DN, United Kingdom

Edmonton, Alberta T6G 1Z2, Canada

Temuco, Araucanía, Chile

Athens, Attica 11527, Greece

Freiburg, Baden-Württemberg 79106, Germany

Heidelberg, Baden-Württemberg 69120, Germany

Tübingen, Baden-Württemberg 72076, Germany

Hospitalet de Llobregat, Barcelona 08907, Spain

München, Bayern 81675, Germany

Regensburg, Bayern 93042, Germany

La Jolla, California 92037, United States

San Francisco, California 94115, United States

Washington, District of Columbia 20007, United States

Port Elizabeth, Eastern Cape 6045, South Africa

Gainesville, Florida 32610, United States

Miami, Florida 33136, United States

Johannesburg, Gauteng 2193, South Africa

Atlanta, Georgia 30318, United States

Guangzhou, Guangdong 510060, China

Goyang-si, Gyeonggido 410-769, Korea, Republic of

Honolulu, Hawaii 96817, United States

Frankfurt, Hessen 60590, Germany

Maywood, Illinois 60153-5585, United States

Nanjing, Jiangsu 210002, China

Westwood, Kansas 66205, United States

Louisville, Kentucky 40202, United States

Durban, Kwazulu-Natal 2091, South Africa

New Orleans, Louisiana 70112, United States

Shreveport, Louisiana 71103, United States

San Sebastián de los Reyes, Madrid 28702, Spain

Baltimore, Maryland 21202, United States

Boston, Massachusetts 02114, United States

Boston, Massachusetts 02215-5450, United States

Boston, Massachusetts 02215, United States

Worcester, Massachusetts 01655, United States

Detroit, Michigan 48201, United States

Detroit, Michigan 48202, United States

Rozzano, Milano 20089, Italy

Belo Horizonte, Minas Gerais 30110-090, Brazil

Minneapolis, Minnesota 55455, United States

St. Louis, Missouri 63110, United States

Albuquerque, New Mexico 87106, United States

Randwick, New South Wales 2031, Australia

Shatin, New Territories, Hong Kong

Buffalo, New York 14263, United States

New York, New York 10029, United States

Rochester, New York 14642, United States

Valhalla, New York 10595, United States

Hannover, Niedersachsen 30625, Germany

Essen, Nordrhein-Westfalen 45147, Germany

Köln, Nordrhein-Westfalen 50937, Germany

Charlotte, North Carolina 28203, United States

Columbus, Ohio 43210, United States

Toronto, Ontario M5G 2M9, Canada

Philadelpahia, Pennsylvania 19107, United States

Philadelphia, Pennsylvania 19141, United States

Montreal, Quebec H3A 1A1, Canada

Brisbane, Queensland 4120, Australia

Herston, Queensland 4029, Australia

Mainz, Rheinland-Pfalz 55131, Germany

Porto Alegre, Rio Grande do Sul 90020-090, Brazil

Homburg, Saarland 66421, Germany

Dresden, Sachsen 01127, Germany

São Paulo, Sao Paulo 05651-900, Brazil

Sheffield, South Yorkshire S10 2SJ, United Kingdom

Houston, Texas 77030, United States

Viña del Mar, V Region, Chile

Clayton, Victoria 3168, Australia

Melbourne, Victoria 3004, Australia

Charlottesville, Virginia 22908, United States

Seattle, Washington 98109-1023, United States

Nedlands, Western Australia 6009, Australia

Cape Town, Western Cape 7500, South Africa

Hangzhou, Zhejiang 310016, China

Additional Information

Click here and search for drug information provided by the FDA.

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.

Starting date: May 2009
Last updated: July 21, 2015

Page last updated: August 23, 2015

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