check_circleStudy Completed

Carcinoma, Hepatocellular

Bayer Identifier:

100554

ClinicalTrials.gov Identifier:

NCT00105443

EudraCT Number:

2004-001773-26

EU CT Number:

Not Available
A Phase III study of sorafenib in patients with advanced hepatocellular carcinoma

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.

Key Participants Requirements

Sex

Both

Age

18 Years
  • - 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
  • - 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
March 2005 - November 2008
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Frankfurt, 60590, Germany
Completed
Regensburg, 93042, Germany
Completed
Essen, 45147, Germany
Completed
Tübingen, 72076, Germany
Completed
Hannover, 30625, Germany
Completed
Berlin, 12200, Germany
Completed
München, 81675, Germany
Completed
Essen, 45147, Germany
Withdrawn
Oxford, OX1 2JD, United Kingdom
Completed
London, SE1 9RT, United Kingdom
Completed
Canton, 44718, United States
Completed
Seattle, 98104, United States
Withdrawn
Orange, 92668-3298, United States
Completed
Ann Arbor, 48109-0362, United States
Completed
Freiburg, 79106, Germany
Completed
Hamburg, 20246, Germany
Completed
Halle/Saale, 06120, Germany
Completed
München, 81377, Germany
Completed
Düsseldorf, 40225, Germany
Completed
Mainz, 55131, Germany
Completed
Bonn, 53105, Germany
Completed
Magdeburg, 39120, Germany
Completed
Homburg, 66421, Germany
Completed
London, NW3 2QG, United Kingdom
Completed
Glasgow, G11 6NT, United Kingdom
Completed
Bristol, BS2 8ED, United Kingdom
Completed
Newcastle upon-Tyne, NE2 4HH, United Kingdom
Withdrawn
Omaha, 68198-2000, United States
Completed
St. Louis, 63104, United States
Withdrawn
New York, 10032, United States
Withdrawn
Tampa, 33612, United States
Withdrawn
Atlanta, 30308, United States
Withdrawn
Seattle, 98195-6174, United States
Withdrawn
Philadelphia, 19104, United States
Withdrawn
Tucson, 85724, United States
Withdrawn
Miami, 33136, United States
Withdrawn
Chicago, 60612, United States
Withdrawn
San Francisco, 94121, United States
Completed
New York, 10016, United States
Withdrawn
LILLE CEDEX, 59020, France
Completed
NANTES, 44805, France
Completed
VANDOEUVRE-LES-NANCY, 54500, France
Completed
Los Angeles, 90095-7077, United States
Withdrawn
Chicago, 60612, United States
Completed
Los Angeles, 90057, United States
Withdrawn
Chicago, 60611, United States
Withdrawn
Manhasset, 11030-3876, United States
Withdrawn
Gainesville, 32610, United States
Completed
Richmond, 23249, United States
Completed
Stanford, 94305, United States
Withdrawn
Philadelphia, 19140, United States
Completed
New York, 10029, United States
Withdrawn
Atlanta, 30322, United States
Withdrawn
Lexington, 40536, United States
Completed
New York, 10021, United States
Completed
Houston, 77030-1502, United States
Withdrawn
Farmington, 06030, United States
Completed
PARIS, 75020, France
Completed
DIJON, 21000, France
Completed
RENNES, 35000, France
Withdrawn
RENNES, 35000, France
Completed
Forlì, 47100, Italy
Completed
Palermo, 90127, Italy
Completed
Padova, 35128, Italy
Completed
Avellino, 83100, Italy
Completed
Bologna, 40138, Italy
Completed
Milano, 20122, Italy
Completed
Bologna, 40138, Italy
Completed
Milano, 20133, Italy
Completed
Barcelona, 08036, Spain
Completed
Cruces/Barakaldo, 48903, Spain
Completed
Madrid, 28041, Spain
Withdrawn
Badalona, 08916, Spain
Completed
Phoenix, 85054-4502, United States
Completed
Detroit, 48202-2689, United States
Completed
Portland, 97239, United States
Completed
Pittsburgh, 15213, United States
Withdrawn
New Haven, 06510-8019, United States
Completed
BONDY, 93143, France
Completed
CLICHY, 92110, France
Completed
LILLE CEDEX, 59020, France
Completed
MARSEILLE, 13005, France
Completed
BORDEAUX, 33000, France
Completed
Gdansk, 80-952, Poland
Completed
Warszawa, 02-507, Poland
Completed
Warszawa, 02-781, Poland
Completed
Poznan, 61-878, Poland
Completed
Roma, 00144, Italy
Completed
Pavia, 27100, Italy
Completed
Madrid, 28034, Spain
Completed
Barcelona, 08035, Spain
Completed
Winnipeg, R2H 2A6, Canada
Completed
Calgary, T2N 4N1, Canada
Completed
Ottawa, K1H 1C4, Canada
Completed
Edmonton, T6G 2C8, Canada
Withdrawn
Vancouver, V5Z 1H8, Canada
Completed
BRUXELLES - BRUSSEL, 1200, Belgium
Withdrawn
BRUGGE, 8000, Belgium
Completed
BRUXELLES - BRUSSEL, 1070, Belgium
Completed
GENT, 9000, Belgium
Completed
Ciudad de México, 06729, Mexico
Withdrawn
Zrifin, 6093000, Israel
Completed
Rabin Medical Center - Beilinson CampusPetach Tikva, 49100, Israel
Completed
Westmead, 2145, Australia
Completed
Heidelberg, 3084, Australia
Completed
East Bentleigh, 3165, Australia
Completed
Milano, 20089, Italy
Completed
Bologna, 40138, Italy
Completed
Pisa, 56126, Italy
Withdrawn
Barcelona, 08035, Spain
Completed
Córdoba, 14004, Spain
Completed
Valencia, 46014, Spain
Withdrawn
Madrid, 28006, Spain
Completed
Pamplona, 31008, Spain
Completed
Barcelona, 08003, Spain
Completed
Alicante, 03010, Spain
Withdrawn
London, N6A 5A5, Canada
Completed
Toronto, M5G 2N2, Canada
Completed
Montreal, H3A 1A1, Canada
Completed
BRUXELLES - BRUSSEL, 1090, Belgium
Completed
LEUVEN, 3000, Belgium
Completed
Monterrey, 64000, Mexico
Withdrawn
Stara Zagora, 6000, Bulgaria
Withdrawn
Sofia, 1527, Bulgaria
Withdrawn
Sofia, 1233, Bulgaria
Completed
Sofia, 1431, Bulgaria
Withdrawn
Mar del Plata, 7600, Argentina
Withdrawn
Bueno Aires, C1417DTB, Argentina
Withdrawn
Buenos Aires, C1120AAF, Argentina
Completed
Buenos Aires, C1181ACH, Argentina
Withdrawn
Buenos Aires, C1145ADP, Argentina
Withdrawn
San Miguel de Tucumán, T4000GTB, Argentina
Completed
Pilar, B1629AHJ, Argentina
Withdrawn
Santiago Región Metropolitana, Chile
Completed
Thessaloniki, 56403, Greece
Completed
Thessaloniki, 540 07, Greece
Withdrawn
México, 14080, Mexico
Withdrawn
México, D.F., 14050, Mexico
Withdrawn
México, D.F., 06720, Mexico
Completed
Tel Aviv Sourasky Medical CenterTel Aviv, 64239, Israel
Completed
Haifa, 3109601, Israel
Completed
Camperdown, 2050, Australia
Completed
Melbourne, 3052, Australia
Completed
Randwick, 2031, Australia
Completed
Varna, 9010, Bulgaria
Completed
Sofia, 1431, Bulgaria
Completed
San Miguel de Tucumán, T4000HXU, Argentina
Completed
Santiago de Chile, Chile
Completed
Santiago de Chile, 833-0024, Chile
Completed
Thessaloniki, 54639, Greece
Withdrawn
Chaidari, 12462, Greece
Withdrawn
Ioannina, 45500, Greece
Completed
Sao Paulo, 01246-903, Brazil
Withdrawn
Belo Horizonte, 30380490, Brazil
Withdrawn
Belo Horizonte, 30180090, Brazil
Withdrawn
Porto Alegre, 90035-003, Brazil
Withdrawn
Kazan, 420012, Russia
Withdrawn
Yekaterinburg, 620036, Russia
Withdrawn
Yekaterinburg, 620102, Russia
Withdrawn
Moscow, 115478, Russia
Completed
St. Petersburg, 195067, Russia
Completed
Moscow, 111 020, Russia
Completed
Moscow, 113 811, Russia
Withdrawn
Moscow, 105 203, Russia
Withdrawn
Tolgliatti, Russia
Withdrawn
Bern, 3010, Switzerland
Withdrawn
Athens, 115 27, Greece
Withdrawn
Porto Alegre, 90619900, Brazil
Withdrawn
Krasnodar, 350040, Russia
Withdrawn
St. Petersburg, 197758, Russia
Withdrawn
Moscow, 105229, Russia
Withdrawn
St. Petersburg, 188663, Russia
Withdrawn
Kirov, 610027, Russia
Completed
Moscow, 129 010, Russia
Completed
Moscow, 129110, Russia
Withdrawn
St. Gallen, 9007, Switzerland
Completed
Genève, 1211, Switzerland
Withdrawn
Comas Lima, Peru
Withdrawn
Lima Cercado, LIMA 1, Peru
Completed
Auckland, 1023, New Zealand
Completed
Zürich, 8091, Switzerland
Withdrawn
Lima, LIMA 34, Peru
Completed
Wellington South, 6001, New Zealand
Withdrawn
Zagreb, 10000, Croatia
Completed
Timisoara, 300223, Romania
Completed
Iasi, 700111, Romania
Completed
Craiova Dolj, 200642, Romania

Primary Outcome

  • Overall Survival (OS)
    date_rangeTime Frame:
    from randomization to death due to any cause until an average 7.2 months later up to the data cut-off date approximately 19 months after start of enrollment
    enhanced_encryption
    Safety Issue:
    No
  • Time to Symptomatic Progression (TTSP)
    date_rangeTime Frame:
    from randomization to the first documented symptomatic progression until an average 4.8 months later up to the data cut-off date approximately 19 months after start of enrollment
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Time to Progression (TTP)
    date_rangeTime Frame:
    from randomization to disease progression based on radiological assessment until an average 2.8 months later up to the data cut-off date approximately 19 months after start of enrollment
    enhanced_encryption
    Safety Issue:
    No
  • Disease Control (DC)
    date_rangeTime Frame:
    time from randomization to end of treatment up to the data cutoff date approximately 19 months after start of enrollment
    enhanced_encryption
    Safety Issue:
    No
  • Patients Reported Outcome (PRO) by Use of the FACT-Hep Questionnaire
    date_rangeTime Frame:
    from randomization to end of treatment up to the data cutoff date approximately 19 months after start of enrollment
    enhanced_encryption
    Safety Issue:
    No

Trial design

A Phase III randomized, placebo-controlled study of sorafenib in patients with advanced hepatocellular carcinoma
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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