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| ID | Type | Description | Link |
|---|---|---|---|
| EUDRACT # 2008-003533-24 |
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The purpose of this study is to compare the overall survival of brivanib versus sorafenib in subjects with advanced HCC who have not received prior systemic therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brivanib | Active Comparator |
| |
| Sorafenib | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brivanib | Drug | Tablets, Oral, 800 mg, Once Daily, Until disease progression or unacceptable toxicity |
|
| Measure | Description | Time Frame |
|---|---|---|
| To compare the overall survival of brivanib versus sorafenib in subjects with advanced HCC who have not received prior systemic treatment | Survival will be assessed continuously |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the time to progression (TTP) (investigator assessed using modified RECIST criteria for HCC | Every 6 weeks | |
| To compare the investigator assessed objective response rate (ORR) and disease control rate (DCR) using modified RECIST criteria for HCC |
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Arizona | Scottsdale | Arizona | 85259 | United States | ||
| Univ Of Ark For Med Sci |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34052255 | Derived | Kolamunnage-Dona R, Berhane S, Potts H, Williams EH, Tanner J, Janowitz T, Hoare M, Johnson P. Sorafenib is associated with a reduced rate of tumour growth and liver function deterioration in HCV-induced hepatocellular carcinoma. J Hepatol. 2021 Oct;75(4):879-887. doi: 10.1016/j.jhep.2021.05.015. Epub 2021 May 27. | |
| 23980084 | Derived |
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| Placebo | Drug | Capsules, Oral, twice Daily, Until disease progression or unacceptable toxicity |
|
| Sorafenib | Drug | Capsules, Oral, 800 mg, twice daily, Until disease progression or unacceptable toxicity |
|
| Placebo | Drug | Tablets, Oral, Once Daily, Until disease progression or unacceptable toxicity |
|
| Every 6 weeks |
| To determine duration of response, duration of disease control, and time to response (TTR) | Every 6 weeks |
| To assess the safety profile of brivanib and sorafenib | Every 6 weeks |
| To explore PK and exposure-response in the study population | Every 6 weeks |
| To compare time to symptomatic progression | Every 6 weeks |
| To compare health-related quality of life | Every 6 weeks |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| Agajanian Institute Of Hematology And Oncology | Downey | California | 90241 | United States |
| Sharp Clinical Oncology Research | San Diego | California | 92123 | United States |
| Va Ct Healthcare System | West Haven | Connecticut | 06516 | United States |
| Medical Specialists Of Palm Beaches | Lake Worth | Florida | 33467 | United States |
| James Graham Brown Cancer Center | Louisville | Kentucky | 40202 | United States |
| 3912 Taubman Center | Ann Arbor | Michigan | 48109 | United States |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Thomas Jefferson Univ. | Philadelphia | Pennsylvania | 19107 | United States |
| Mcguire Dvamc | Richmond | Virginia | 23249 | United States |
| University Of Wisconsin | Madison | Wisconsin | 53792 | United States |
| Local Institution | Buenos Aires | Buenos Aires | C1181ACH | Argentina |
| Local Institution | Caba | Buenos Aires | 1221 | Argentina |
| Local Institution | Capital Federal | Buenos Aires | C1264AAA | Argentina |
| Local Institution | Rosario | Santa Fe Province | 2000 | Argentina |
| Local Institution | Camperdown | New South Wales | 2050 | Australia |
| Local Institution | Concord | New South Wales | 2139 | Australia |
| Local Institution | Westmead Nsw | New South Wales | 2145 | Australia |
| Local Institution | Parkville | Victoria | 3050 | Australia |
| Local Institution | Prahan | Victoria | 3004 | Australia |
| Local Institution | Liège | 4000 | Belgium |
| Local Institution | Fortaleza | Ceará | 60430-230 | Brazil |
| Local Institution | Salvador | Estado de Bahia | 41950-610 | Brazil |
| Local Institution | Salvador - Ba | Estado de Bahia | 40050-410 | Brazil |
| Local Institution | Goiânia | Goiás | 74075-040 | Brazil |
| Local Institution | Divinópolis | Minas Gerais | 35500-249 | Brazil |
| Local Institution | Curitiba | Paraná | 81520-060 | Brazil |
| Local Institution | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| Local Institution | Porto Alegre | Rio Grande do Sul | 90050-170 | Brazil |
| Local Institution | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Local Institution | Barretos | São Paulo | 14784-400 | Brazil |
| Local Institution | Jaú | São Paulo | 17210-080 | Brazil |
| Local Institution | São Paulo | São Paulo | 01323-010 | Brazil |
| Local Institution | Calgary | Alberta | T2N 2T9 | Canada |
| Local Institution | Vancouver | British Columbia | V5Z 1M9 | Canada |
| Local Institution | London | Ontario | N6A A5 | Canada |
| Local Institution | Montreal | Quebec | H2X 3J4 | Canada |
| Local Institution | Beijing | Beijing Municipality | 100021 | China |
| Local Institution | Beijing | Beijing Municipality | 100034 | China |
| Local Institution | Beijing | Beijing Municipality | 100071 | China |
| Local Institution | Chongqing | Chongqing Municipality | 400038 | China |
| Local Institution | Guangzhou | Guangdong | 510515 | China |
| Local Institution | Guanzhou | Guangdong | 510010 | China |
| Local Institution | Nanning | Guangxi | 530021 | China |
| Local Institution | Wuhan | Hubei | 430030 | China |
| Local Institution | Changsha | Hunan | 410008 | China |
| Local Institution | Changzhou | Jiangsu | 213003 | China |
| Local Institution | Nanjing | Jiangsu | 210000 | China |
| Local Institution | Nanjing | Jiangsu | 210002 | China |
| Local Institution | Nanjing | Jiangsu | 210008 | China |
| Local Institution | Suzhou | Jiangsu | 215006 | China |
| Local Institution | Dalian | Liaoning | 116011 | China |
| Local Institution | Xi'an | Shaanxi | 710032 | China |
| Local Institution | Shanghai | Shanghai Municipality | 200080 | China |
| Local Institution | Chengdu | Sichuan | 610041 | China |
| Local Institution | Hangzhou | Zhejiang | 130016 | China |
| Local Institution | Brno | 656 53 | Czechia |
| Local Institution | Prague | 128 08 | Czechia |
| Local Institution | Prague | 150 06 | Czechia |
| Local Institution | Bordeaux | 33075 | France |
| Local Institution | Clichy | 92118 | France |
| Local Institution | Créteil | 94010 | France |
| Local Institution | Grenoble | 38043 | France |
| Local Institution | Lille | 59037 | France |
| Local Institution | Lyon | 69317 | France |
| Local Institution | Marseille | 13009 | France |
| Local Institution | Marseille | 13385 | France |
| Local Institution | Paris | 75012 | France |
| Local Institution | Paris | 75013 | France |
| Local Institution | Paris | 75020 | France |
| Local Institution | Rennes | 35042 | France |
| Local Institution | Vandœuvre-lès-Nancy | 54511 | France |
| Local Institution | Berlin | 13353 | Germany |
| Local Institution | Halle | 06120 | Germany |
| Local Institution | Hamburg | 20246 | Germany |
| Local Institution | Magdeburg | 39120 | Germany |
| Local Institution | Ulm | 89081 | Germany |
| Local Institution | Hong Kong | 8525 | Hong Kong |
| Local Institution | Shatin | 8520 | Hong Kong |
| Local Institution | Hyderabad | Andhra Pradesh | 500082 | India |
| Local Institution | Kochi | Kerala | 682304 | India |
| Local Institution | Trivandrum | Kerala | 695011 | India |
| Local Institution | Pune | Maharashtra | 411001 | India |
| Local Institution | Ahmedabad | 380009 | India |
| Local Institution | Chennai | 600006 | India |
| Local Institution | Coimbatore | 641037 | India |
| Local Institution | Hyderabad | 500024 | India |
| Local Institution | Kolkata | 700 053 | India |
| Local Institution | Kolkata | 700054 | India |
| Local Institution | Mumbai | 400012 | India |
| Local Institution | Mumbai | 400036 | India |
| Local Institution | New Delhi | 110 070 | India |
| Local Institution | Milan | 20122 | Italy |
| Local Institution | Milan | 20141 | Italy |
| Local Institution | Naples | 80131 | Italy |
| Local Institution | Pisa | 56124 | Italy |
| Local Institution | Roma | 00168 | Italy |
| Local Institution | Torrette -Ancona | 60020 | Italy |
| Local Institution | Kashiwa-shi | Chiba | 277-0882 | Japan |
| Local Institution | Sapporo | Hokkaido | 060-0033 | Japan |
| Local Institution | Kanazawa | Ishikawa-ken | 9208641 | Japan |
| Local Institution | Kawasaki-shi | Kanagawa | 2138587 | Japan |
| Local Institution | Yokohama | Kanagawa | 232-0024 | Japan |
| Local Institution | Tsu | Mie-ken | 5148507 | Japan |
| Local Institution | Okayama | Okayama-ken | 7000082 | Japan |
| Local Institution | Higashinari-ku | Osaka | 5378511 | Japan |
| Local Institution | Osaka | Osaka | 534-0021 | Japan |
| Local Institution | Osaka | Osaka | 5438555 | Japan |
| Local Institution | Osaka | Osaka | 5458586 | Japan |
| Local Institution | Ōsaka-sayama | Osaka | 5890014 | Japan |
| Local Institution | Sunto-gun | Shizuoka | 411-8777 | Japan |
| Local Institution | Chuo-Ku | Tokyo | 104-0045 | Japan |
| Local Institution | Minato-ku | Tokyo | 105-0001 | Japan |
| Local Institution | Musashino-shi | Tokyo | 180-0023 | Japan |
| Local Institution | Shimonoseki-shi | Yamaguchi | 7500061 | Japan |
| Local Institution | Nishinomiya-shi | 6638501 | Japan |
| Local Institution | Aguascalientes | Aguascalientes | 20234 | Mexico |
| Local Institution | D.f. | Mexico City | 06720 | Mexico |
| Local Institution | D.f. | Mexico City | 14140 | Mexico |
| Local Institution | Distrito Federal | Mexico City | 06760 | Mexico |
| Local Institution | Mexico City | Mexico City | 06726 | Mexico |
| Local Institution | Tlalpan | Mexico City | 14000 | Mexico |
| Local Institution | Monterrey | Nuevo León | 64710 | Mexico |
| Local Institution | Gdansk | 80952 | Poland |
| Local Institution | Gliwice | 44-101 | Poland |
| Local Institution | Krakow | 31-501 | Poland |
| Local Institution | Warsaw | 02-781 | Poland |
| Local Institution | San Juan | Pr | 00910 | Puerto Rico |
| Local Institution | Moscow | 115 478 | Russia |
| Local Institution | Moscow | 115998 | Russia |
| Local Institution | Moscow | 119992 | Russia |
| Local Institution | Moscow | 125367 | Russia |
| Local Institution | Pretoria | Gauteng | 0002 | South Africa |
| Local Institution | Durban | KwaZulu-Natal | 4091 | South Africa |
| Local Institution | Cape Town | Western Cape | 7570 | South Africa |
| Local Institution | Observatory, Cape Town | Western Cape | 7925 | South Africa |
| Local Institution | Rondebosch | Western Cape | 7700 | South Africa |
| Local Institution | Busan | 609-735 | South Korea |
| Local Institution | Daegu | 700-721 | South Korea |
| Local Institution | Gyeonggi-do | 410-769 | South Korea |
| Local Institution | Kyunggi-do | 463-707 | South Korea |
| Local Institution | Seoul | 110-744 | South Korea |
| Local Institution | Seoul | 120-752 | South Korea |
| Local Institution | Seoul | 135-710 | South Korea |
| Local Institution | Seoul | 137-040 | South Korea |
| Local Institution | Seoul | 138-736 | South Korea |
| Local Institution | Santiago de Compostela | A Coruna | 15706 | Spain |
| Local Institution | Alicante | 03010 | Spain |
| Local Institution | Barcelona | 08208 | Spain |
| Local Institution | Stockholm | 141 86 | Sweden |
| Local Institution | Uppsala | 751 85 | Sweden |
| Local Institution | Changhua | 500 | Taiwan |
| Local Institution | Kaohsiung City | 833 | Taiwan |
| Local Institution | Taichung | 404 | Taiwan |
| Local Institution | Tainan R.o.c. | 70403 | Taiwan |
| Local Institution | Taipei | 100 | Taiwan |
| Local Institution | Taipei | 112 | Taiwan |
| Local Institution | Taoyuan | 333 | Taiwan |
| Local Institution | Bangkok | 10400 | Thailand |
| Local Institution | Bangkok | 10700 | Thailand |
| Local Institution | Ankara | 06460 | Turkey (Türkiye) |
| Local Institution | Antalya | 07070 | Turkey (Türkiye) |
| Local Institution | Istanbul | Turkey (Türkiye) |
| Local Institution | Izmir | 35100 | Turkey (Türkiye) |
| Local Institution | Kayseri | 38039 | Turkey (Türkiye) |
| Local Institution | Bristol | Avon | BS2 8ED | United Kingdom |
| Local Institution | London | Greater London | NW3 2QG | United Kingdom |
| Local Institution | London | Greater London | SE5 9RS | United Kingdom |
| Local Institution | London | Greater London | W12 0HS | United Kingdom |
| Local Institution | Manchester | Greater Manchester | M20 4BX | United Kingdom |
| Local Institution | Birmingham | West Midlands | B15 2TT | United Kingdom |
| Local Institution | Leeds | Yorkshire | LS9 7TF | United Kingdom |
| Johnson PJ, Qin S, Park JW, Poon RT, Raoul JL, Philip PA, Hsu CH, Hu TH, Heo J, Xu J, Lu L, Chao Y, Boucher E, Han KH, Paik SW, Robles-Avina J, Kudo M, Yan L, Sobhonslidsuk A, Komov D, Decaens T, Tak WY, Jeng LB, Liu D, Ezzeddine R, Walters I, Cheng AL. Brivanib versus sorafenib as first-line therapy in patients with unresectable, advanced hepatocellular carcinoma: results from the randomized phase III BRISK-FL study. J Clin Oncol. 2013 Oct 1;31(28):3517-24. doi: 10.1200/JCO.2012.48.4410. Epub 2013 Aug 26. |
| ID | Term |
|---|---|
| C509922 | brivanib |
| D000077157 | Sorafenib |
| ID | Term |
|---|---|
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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