Trial Condition(s):

Carcinoma, Hepatocellular

A Phase III study of sorafenib in patients with advanced hepatocellular carcinoma (SHARP)

Bayer Identifier:

100554

ClinicalTrials.gov Identifier:

NCT00105443

EudraCT Number:

2004-001773-26

Study Completed

Trial 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.

Inclusion Criteria
- Ages eligible for study: 18 years and above, Genders eligible for study: both 
- Patients who have a life expectancy of at least 12 weeks 
- Patients with histologically or cytologically documented Hepatocellular Carcinoma (HCC) 
- Patients must have at least one tumor lesion that meets both of the following criteria: (1) Accurately measured in at least one dimension according to RECIST (Response Evaluation Criteria in Solid Tumors) (2) Not previously treated with local therapy 
- Patients who have an ECOG (Eastern Cooperative Oncology Group) PS (Performance Status) of 0, 1, or 2
Exclusion Criteria
- Previous or concurrent cancer that is distinct in primary site or histology from HCC, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta [Noninvasive papillary carcinoma], Tis [Carcinoma in situ: "flat tumor"] & T1 [Tumor invades subepithelial connective tissue]). Any cancer curatively treated > 3 years prior to entry is permitted
- Renal failure requiring hemo- or peritoneal dialysis 
- History of cardiac disease
- Active clinically serious infections 
- Known history of human immunodeficiency virus (HIV) infection
- Known central nervous system tumors including metastatic brain disease 
- Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry

Trial Summary

Enrollment Goal
602
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
Yes
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Frankfurt, Germany, 60590

Status
Completed
 
Locations

Investigative Site

Regensburg, Germany, 93042

Status
Completed
 
Locations

Investigative Site

Essen, Germany, 45147

Status
Completed
 
Locations

Investigative Site

Tübingen, Germany, 72076

Status
Completed
 
Locations

Investigative Site

Hannover, Germany, 30625

Status
Completed
 
Locations

Investigative Site

Berlin, Germany, 12200

Status
Completed
 
Locations

Investigative Site

München, Germany, 81675

Status
Completed
 
Locations

Investigative Site

London, United Kingdom, SE1 9RT

Status
Completed
 
Locations

Investigative Site

Canton, United States, 44718

Status
Completed
 
Locations

Investigative Site

Seattle, United States, 98104

Status
Completed
 
Locations

Investigative Site

Ann Arbor, United States, 48109-0362

Status
Completed
 
Locations

Investigative Site

Freiburg, Germany, 79106

Status
Completed
 
Locations

Investigative Site

Hamburg, Germany, 20246

Status
Completed
 
Locations

Investigative Site

Halle/Saale, Germany, 06120

Status
Completed
 
Locations

Investigative Site

München, Germany, 81377

Status
Completed
 
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Investigative Site

Düsseldorf, Germany, 40225

Status
Completed
 
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Investigative Site

Mainz, Germany, 55131

Status
Completed
 
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Investigative Site

Bonn, Germany, 53105

Status
Completed
 
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Magdeburg, Germany, 39120

Status
Completed
 
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Homburg, Germany, 66421

Status
Completed
 
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Investigative Site

London, United Kingdom, NW3 2QG

Status
Completed
 
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Glasgow, United Kingdom, G11 6NT

Status
Completed
 
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Investigative Site

Bristol, United Kingdom, BS2 8ED

Status
Completed
 
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Newcastle upon-Tyne, United Kingdom, NE2 4HH

Status
Completed
 
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Investigative Site

St. Louis, United States, 63104

Status
Completed
 
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New York, United States, 10016

Status
Completed
 
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Investigative Site

NANTES, France, 44805

Status
Completed
 
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Investigative Site

VANDOEUVRE-LES-NANCY, France, 54500

Status
Completed
 
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Investigative Site

Los Angeles, United States, 90095-7077

Status
Completed
 
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Investigative Site

Los Angeles, United States, 90057

Status
Completed
 
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Investigative Site

Richmond, United States, 23249

Status
Completed
 
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Stanford, United States, 94305

Status
Completed
 
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New York, United States, 10029

Status
Completed
 
Locations

Investigative Site

New York, United States, 10021

Status
Completed
 
Locations

Investigative Site

Houston, United States, 77030-1502

Status
Completed
 
Locations

Investigative Site

PARIS, France, 75020

Status
Completed
 
Locations

Investigative Site

DIJON, France, 21000

Status
Completed
 
Locations

Investigative Site

RENNES, France, 35000

Status
Completed
 
Locations

Investigative Site

Forlì, Italy, 47100

Status
Completed
 
Locations

Investigative Site

Palermo, Italy, 90127

Status
Completed
 
Locations

Investigative Site

Padova, Italy, 35128

Status
Completed
 
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Investigative Site

Avellino, Italy, 83100

Status
Completed
 
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Bologna, Italy, 40138

Status
Completed
 
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Investigative Site

Milano, Italy, 20122

Status
Completed
 
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Investigative Site

Milano, Italy, 20133

Status
Completed
 
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Barcelona, Spain, 08036

Status
Completed
 
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Investigative Site

Cruces/Barakaldo, Spain, 48903

Status
Completed
 
Locations

Investigative Site

Madrid, Spain, 28041

Status
Completed
 
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Investigative Site

Phoenix, United States, 85054-4502

Status
Completed
 
Locations

Investigative Site

Detroit, United States, 48202-2689

Status
Completed
 
Locations

Investigative Site

Portland, United States, 97239

Status
Completed
 
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Investigative Site

Pittsburgh, United States, 15213

Status
Completed
 
Locations

Investigative Site

BONDY, France, 93143

Status
Completed
 
Locations

Investigative Site

CLICHY, France, 92110

Status
Completed
 
Locations

Investigative Site

LILLE CEDEX, France, 59020

Status
Completed
 
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Investigative Site

MARSEILLE, France, 13005

Status
Completed
 
Locations

Investigative Site

BORDEAUX, France, 33000

Status
Completed
 
Locations

Investigative Site

Gdansk, Poland, 80-952

Status
Completed
 
Locations

Investigative Site

Warszawa, Poland, 02-507

Status
Completed
 
Locations

Investigative Site

Warszawa, Poland, 02-781

Status
Completed
 
Locations

Investigative Site

Poznan, Poland, 61-878

Status
Completed
 
Locations

Investigative Site

Roma, Italy, 00144

Status
Completed
 
Locations

Investigative Site

Pavia, Italy, 27100

Status
Completed
 
Locations

Investigative Site

Madrid, Spain, 28034

Status
Completed
 
Locations

Investigative Site

Barcelona, Spain, 08035

Status
Completed
 
Locations

Investigative Site

Winnipeg, Canada, R2H 2A6

Status
Completed
 
Locations

Investigative Site

Calgary, Canada, T2N 4N1

Status
Completed
 
Locations

Investigative Site

Ottawa, Canada, K1H 1C4

Status
Completed
 
Locations

Investigative Site

Edmonton, Canada, T6G 2C8

Status
Completed
 
Locations

Investigative Site

BRUXELLES - BRUSSEL, Belgium, 1200

Status
Completed
 
Locations

Investigative Site

BRUXELLES - BRUSSEL, Belgium, 1070

Status
Completed
 
Locations

Investigative Site

GENT, Belgium, 9000

Status
Completed
 
Locations

Investigative Site

Ciudad de México, Mexico, 06729

Status
Completed
 
Locations

Rabin Medical Center - Beilinson Campus

Petach Tikva, Israel, 49100

Status
Completed
 
Locations

Investigative Site

Westmead, Australia, 2145

Status
Completed
 
Locations

Investigative Site

Heidelberg, Australia, 3084

Status
Completed
 
Locations

Investigative Site

East Bentleigh, Australia, 3165

Status
Completed
 
Locations

Investigative Site

Milano, Italy, 20089

Status
Completed
 
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Investigative Site

Pisa, Italy, 56126

Status
Completed
 
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Investigative Site

Córdoba, Spain, 14004

Status
Completed
 
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Investigative Site

Valencia, Spain, 46014

Status
Completed
 
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Investigative Site

Pamplona, Spain, 31008

Status
Completed
 
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Investigative Site

Barcelona, Spain, 08003

Status
Completed
 
Locations

Investigative Site

Alicante, Spain, 03010

Status
Completed
 
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Investigative Site

Toronto, Canada, M5G 2N2

Status
Completed
 
Locations

Investigative Site

Montreal, Canada, H3A 1A1

Status
Completed
 
Locations

Investigative Site

BRUXELLES - BRUSSEL, Belgium, 1090

Status
Completed
 
Locations

Investigative Site

LEUVEN, Belgium, 3000

Status
Completed
 
Locations

Investigative Site

Monterrey, Mexico, 64000

Status
Completed
 
Locations

Investigative Site

Sofia, Bulgaria, 1431

Status
Completed
 
Locations

Investigative Site

Buenos Aires, Argentina, C1181ACH

Status
Completed
 
Locations

Investigative Site

Pilar, Argentina, B1629AHJ

Status
Completed
 
Locations

Investigative Site

Thessaloniki, Greece, 56403

Status
Completed
 
Locations

Investigative Site

Thessaloniki, Greece, 540 07

Status
Completed
 
Locations

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel, 64239

Status
Completed
 
Locations

Investigative Site

Haifa, Israel, 3109601

Status
Completed
 
Locations

Investigative Site

Camperdown, Australia, 2050

Status
Completed
 
Locations

Investigative Site

Melbourne, Australia, 3052

Status
Completed
 
Locations

Investigative Site

Randwick, Australia, 2031

Status
Completed
 
Locations

Investigative Site

Varna, Bulgaria, 9010

Status
Completed
 
Locations

Investigative Site

San Miguel de Tucumán, Argentina, T4000HXU

Status
Completed
 
Locations

Investigative Site

Santiago de Chile, Chile

Status
Completed
 
Locations

Investigative Site

Santiago de Chile, Chile, 833-0024

Status
Completed
 
Locations

Investigative Site

Thessaloniki, Greece, 54639

Status
Completed
 
Locations

Investigative Site

Sao Paulo, Brazil, 01246-903

Status
Completed
 
Locations

Investigative Site

St. Petersburg, Russia, 195067

Status
Completed
 
Locations

Investigative Site

Moscow, Russia, 111 020

Status
Completed
 
Locations

Investigative Site

Moscow, Russia, 113 811

Status
Completed
 
Locations

Investigative Site

Moscow, Russia, 129 010

Status
Completed
 
Locations

Investigative Site

Moscow, Russia, 129110

Status
Completed
 
Locations

Investigative Site

Genève, Switzerland, 1211

Status
Completed
 
Locations

Investigative Site

Auckland, New Zealand, 1023

Status
Completed
 
Locations

Investigative Site

Zürich, Switzerland, 8091

Status
Completed
 
Locations

Investigative Site

Wellington South, New Zealand, 6001

Status
Completed
 
Locations

Investigative Site

Timisoara, Romania, 300223

Status
Completed
 
Locations

Investigative Site

Iasi, Romania, 700111

Status
Completed
 
Locations

Investigative Site

Craiova Dolj, Romania, 200642

Status
Completed
 

Trial Design