Trial Condition(s):
Carcinoma, Hepatocellular
A Phase III study of sorafenib in patients with advanced hepatocellular carcinoma (SHARP)
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | ||
|---|---|---|---|
Locations Investigative Site Frankfurt, Germany, 60590 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Regensburg, Germany, 93042 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Essen, Germany, 45147 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Tübingen, Germany, 72076 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Hannover, Germany, 30625 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Berlin, Germany, 12200 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site München, Germany, 81675 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site London, United Kingdom, SE1 9RT | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Canton, United States, 44718 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Seattle, United States, 98104 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Ann Arbor, United States, 48109-0362 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Freiburg, Germany, 79106 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Hamburg, Germany, 20246 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Halle/Saale, Germany, 06120 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site München, Germany, 81377 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Düsseldorf, Germany, 40225 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Mainz, Germany, 55131 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Bonn, Germany, 53105 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Magdeburg, Germany, 39120 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Homburg, Germany, 66421 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site London, United Kingdom, NW3 2QG | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Glasgow, United Kingdom, G11 6NT | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Bristol, United Kingdom, BS2 8ED | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Newcastle upon-Tyne, United Kingdom, NE2 4HH | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site St. Louis, United States, 63104 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site New York, United States, 10016 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site NANTES, France, 44805 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site VANDOEUVRE-LES-NANCY, France, 54500 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Los Angeles, United States, 90095-7077 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Los Angeles, United States, 90057 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Richmond, United States, 23249 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Stanford, United States, 94305 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site New York, United States, 10029 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site New York, United States, 10021 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Houston, United States, 77030-1502 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site PARIS, France, 75020 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site DIJON, France, 21000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site RENNES, France, 35000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Forlì, Italy, 47100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Palermo, Italy, 90127 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Padova, Italy, 35128 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Avellino, Italy, 83100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Bologna, Italy, 40138 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Milano, Italy, 20122 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Milano, Italy, 20133 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Barcelona, Spain, 08036 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Cruces/Barakaldo, Spain, 48903 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Madrid, Spain, 28041 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Phoenix, United States, 85054-4502 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Detroit, United States, 48202-2689 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Portland, United States, 97239 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Pittsburgh, United States, 15213 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site BONDY, France, 93143 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site CLICHY, France, 92110 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site LILLE CEDEX, France, 59020 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site MARSEILLE, France, 13005 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site BORDEAUX, France, 33000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Gdansk, Poland, 80-952 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Warszawa, Poland, 02-507 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Warszawa, Poland, 02-781 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Poznan, Poland, 61-878 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Roma, Italy, 00144 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Pavia, Italy, 27100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Madrid, Spain, 28034 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Barcelona, Spain, 08035 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Winnipeg, Canada, R2H 2A6 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Calgary, Canada, T2N 4N1 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Ottawa, Canada, K1H 1C4 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Edmonton, Canada, T6G 2C8 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site BRUXELLES - BRUSSEL, Belgium, 1200 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site BRUXELLES - BRUSSEL, Belgium, 1070 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site GENT, Belgium, 9000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Ciudad de México, Mexico, 06729 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Rabin Medical Center - Beilinson Campus Petach Tikva, Israel, 49100 | Status Completed | Contact Us: E-mail: clini[email protected] Phone: Not Available | |
Locations Investigative Site Westmead, Australia, 2145 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Heidelberg, Australia, 3084 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site East Bentleigh, Australia, 3165 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Milano, Italy, 20089 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Pisa, Italy, 56126 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Córdoba, Spain, 14004 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Valencia, Spain, 46014 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Pamplona, Spain, 31008 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Barcelona, Spain, 08003 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Alicante, Spain, 03010 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Toronto, Canada, M5G 2N2 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Montreal, Canada, H3A 1A1 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site BRUXELLES - BRUSSEL, Belgium, 1090 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site LEUVEN, Belgium, 3000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Monterrey, Mexico, 64000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Sofia, Bulgaria, 1431 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Buenos Aires, Argentina, C1181ACH | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Pilar, Argentina, B1629AHJ | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Thessaloniki, Greece, 56403 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Thessaloniki, Greece, 540 07 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Tel Aviv Sourasky Medical Center Tel Aviv, Israel, 64239 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Haifa, Israel, 3109601 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Camperdown, Australia, 2050 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Melbourne, Australia, 3052 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Randwick, Australia, 2031 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Varna, Bulgaria, 9010 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site San Miguel de Tucumán, Argentina, T4000HXU | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Santiago de Chile, Chile | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Santiago de Chile, Chile, 833-0024 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Thessaloniki, Greece, 54639 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Sao Paulo, Brazil, 01246-903 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site St. Petersburg, Russia, 195067 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Moscow, Russia, 111 020 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Moscow, Russia, 113 811 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Moscow, Russia, 129 010 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Moscow, Russia, 129110 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Genève, Switzerland, 1211 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Auckland, New Zealand, 1023 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Zürich, Switzerland, 8091 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Wellington South, New Zealand, 6001 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Timisoara, Romania, 300223 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Iasi, Romania, 700111 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Craiova Dolj, Romania, 200642 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Primary Outcome
- Overall Survival (OS)Timeframe: 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
- Time to Symptomatic Progression (TTSP)Timeframe: 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
Secondary Outcome
- Time to Progression (TTP)Timeframe: 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
- Disease Control (DC)Timeframe: time from randomization to end of treatment up to the data cutoff date approximately 19 months after start of enrollment
- Patients Reported Outcome (PRO) by Use of the FACT-Hep QuestionnaireTimeframe: from randomization to end of treatment up to the data cutoff date approximately 19 months after start of enrollment
Additional Information
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