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| ID | Type | Description | Link |
|---|---|---|---|
| EUDRACT #: 2008-005084-34 |
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The purpose of this study is to determine if Brivanib is an effective treatment for liver cancer in patients who have failed or could not take Sorafenib
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brivanib | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brivanib | Drug | Tablets, Oral, 800 mg, once daily, until disease progression or toxicity |
|
| Measure | Description | Time Frame |
|---|---|---|
| To compare overall survival of subjects with advanced HCC who have progressed on/after or are intolerant to Sorafenib and receive Brivanib plus best supportive care (BSC) to those receiving placebo plus BSC | computerized tomography (CT)/ magnetic resonance imaging (MRI) every six weeks until progression or death |
| Measure | Description | Time Frame |
|---|---|---|
| To compare time to progression (TTP) (Investigator assessed using modified Response Evaluation Criteria In Solid Tumors (RECIST) for HCC criteria) | 35 months | |
| To compare the Independent Radiological Review Committee (IRRC) assessed objective response rate (ORR) and disease control rate (DCR) using modified RECIST for HCC criteria |
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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 |
|---|---|---|---|
| 28131794 | Derived | Lencioni R, Montal R, Torres F, Park JW, Decaens T, Raoul JL, Kudo M, Chang C, Rios J, Boige V, Assenat E, Kang YK, Lim HY, Walters I, Llovet JM. Objective response by mRECIST as a predictor and potential surrogate end-point of overall survival in advanced HCC. J Hepatol. 2017 Jun;66(6):1166-1172. doi: 10.1016/j.jhep.2017.01.012. Epub 2017 Jan 26. | |
| 23980090 |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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| Placebo | Other | Tablets, Oral, 0 mg, once daily, until disease progression or toxicity |
|
| Best Supportive Care | Procedure | Trans-Arterial Chemo-Embolization (TACE) Therapy |
|
| 35 months |
| To assess duration of response, duration of disease control and time to response | 6 weeks |
| To assess safety profile of brivanib. Safety will be assessed by the number of adverse events (AEs), serious adverse events (SAEs), periodic data monitoring committee (DMC) review | 35 months |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| Loma Linda University Cancer Center | Loma Linda | California | 92350 | United States |
| Richard Finn, M.D. | Los Angeles | California | 90095-7077 | United States |
| Sharp Clinical Oncology Research | San Diego | California | 92123 | United States |
| Pacific Hematology Oncology Associates | San Francisco | California | 94115 | United States |
| UF Health Clinical Research Center | Gainesville | Florida | 32610 | United States |
| James Graham Brown Cancer Center | Louisville | Kentucky | 40202 | United States |
| 3912 Taubman Center | Ann Arbor | Michigan | 48109 | United States |
| Henry Ford Health System Irb | Detroit | Michigan | 48202 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Mount Sinai School Of Medicine | New York | New York | 10029 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| Oregon Health & Sci Univ | Portland | Oregon | 97239 | United States |
| University Of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| University Of Texas | Houston | Texas | 77030 | United States |
| The University Of Texas Health Science Center | San Antonio | Texas | 78229 | United States |
| Mcguire Dvamc | Richmond | Virginia | 23249 | United States |
| Local Institution | Capital Federal | Buenos Aires | C1264AAA | Argentina |
| Local Institution | Rosario | Santa Fe Province | 2000 | Argentina |
| Local Institution | Brussels | 1000 | Belgium |
| Local Institution | Salvador | Estado de Bahia | 41825-010 | Brazil |
| Local Institution | Salvador - Ba | Estado de Bahia | 40050-410 | Brazil |
| Local Institution | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Local Institution | São Paulo | 05403-010 | Brazil |
| Local Institution | Calgary | Alberta | T2N 4Z6 | Canada |
| Local Institution | Vancouver | British Columbia | V5Z 1M9 | Canada |
| Local Institution | Toronto | Ontario | M5G 2N2 | Canada |
| Local Institution | Beijing | Beijing Municipality | 100071 | China |
| Local Institution | Guangzhou | Guangdong | 510060 | China |
| Local Institution | Guanzhou | Guangdong | 610080 | China |
| Local Institution | Nanning | Guangxi | 530021 | China |
| Local Institution | Wuhan | Hubei | 430030 | China |
| Local Institution | Nanjing | Jiangsu | 210002 | China |
| Local Institution | Tianjin | Tianjin Municipality | 30060 | China |
| Local Institution | Hangzhou | Zhejiang | 130016 | China |
| Local Institution | Bordeaux | 33075 | France |
| Local Institution | Créteil | 94010 | France |
| Local Institution | Grenoble | 38043 | France |
| Local Institution | Lille | 59037 | France |
| Local Institution | Lyon | 69317 | France |
| Local Institution | Montpellier | 34295 | France |
| Local Institution | Montpellier | 34298 | France |
| Local Institution | Paris | 75013 | France |
| Local Institution | Paris | 75020 | France |
| Local Institution | Paris | 75571 | France |
| Local Institution | Rennes | 35042 | France |
| Local Institution | Toulouse | 31059 | France |
| Local Institution | Vandœuvre-lès-Nancy | 54511 | France |
| Local Institution | Villejuif | 94805 | France |
| Local Institution | Berlin | 13353 | Germany |
| Local Institution | Frankfurt | 60590 | Germany |
| Local Institution | Freiburg im Breisgau | 79106 | Germany |
| Local Institution | Halle | 06120 | Germany |
| Local Institution | Hanover | 30625 | Germany |
| Local Institution | Mainz | 55131 | Germany |
| Local Institution | Ulm | 89081 | Germany |
| Local Institution | Würzburg | 97080 | Germany |
| Local Institution | Kifissia | 14564 | Greece |
| Local Institution | Thessaloniki | 54642 | Greece |
| Local Institution | Hong Kong | 8525 | Hong Kong |
| Local Institution | Kochi | Kerala | 682304 | India |
| Local Institution | Chennai | 600035 | India |
| Local Institution | Kolkata | 700 053 | India |
| Local Institution | New Delhi | 110 070 | India |
| Local Institution | Ancona | 60126 | Italy |
| Local Institution | Meldola (fc) | 47014 | Italy |
| Local Institution | Milan | 20122 | Italy |
| Local Institution | Milan | 20133 | Italy |
| Local Institution | Naples | 80131 | Italy |
| Local Institution | Padova | 35128 | Italy |
| Local Institution | Pisa | 56124 | Italy |
| Local Institution | Chiba | Chiba | 2608677 | Japan |
| Local Institution | Kashiwa-shi | Chiba | 2778577 | Japan |
| Local Institution | Ogaki-shi | Gifu | 5038502 | Japan |
| Local Institution | Yokohama | Kanagawa | 232-0024 | Japan |
| Local Institution | Kochi | Kochi | 7818555 | Japan |
| Local Institution | Kyoto | Kyoto | 6028566 | Japan |
| Local Institution | Tsu | Mie-ken | 5148507 | Japan |
| Local Institution | Higashinari-ku | Osaka | 5378511 | Japan |
| Local Institution | Osaka | Osaka | 5438555 | Japan |
| Local Institution | Osaka | Osaka | 5458586 | Japan |
| Local Institution | Osaka-sayama-shi | Osaka | 5898511 | Japan |
| Local Institution | Sunto-gun | Shizuoka | 4118777 | Japan |
| Local Institution | Bunkyo-ku | Tokyo | 1138655 | Japan |
| Local Institution | Chuo-ku | Tokyo | 104-0045 | Japan |
| Local Institution | Musashino-shi | Tokyo | 1808610 | Japan |
| Local Institution | Toyama | Toyama | 9308550 | Japan |
| Local Institution | Shimonoseki-shi | Yamaguchi | 7500061 | Japan |
| Local Institution | Nishinomiya-shi | 6638501 | Japan |
| Local Institution | D.f. | Mexico City | 14140 | Mexico |
| Local Institution | Cuernavaca | Morelos | 62290 | Mexico |
| Local Institution | Toluca | State of Mexico | 05440 | Mexico |
| Local Institution | San Juan | 00910 | Puerto Rico |
| Local Institution | Moscow | 115478 | Russia |
| Local Institution | Moscow | 119992 | Russia |
| Local Institution | Moscow | 125367 | Russia |
| Local Institution | Busan | 609735 | South Korea |
| Local Institution | Daegu | 700-721 | South Korea |
| Local Institution | Gyeonggi-do | 410-769 | South Korea |
| Local Institution | Seoul | 120-752 | South Korea |
| Local Institution | Seoul | 135-710 | South Korea |
| Local Institution | Seoul | 136-701 | South Korea |
| Local Institution | Seoul | 138-736 | South Korea |
| Local Institution | Barcelona | 08036 | Spain |
| Local Institution | Madrid | 28034 | Spain |
| Local Institution | Oviedo | 33006 | Spain |
| Local Institution | Taichung | 404 | Taiwan |
| Local Institution | Tainan | 704 | Taiwan |
| Local Institution | Taipei | 100 | Taiwan |
| Local Institution | Taipei | 112 | Taiwan |
| Local Institution | Taoyuan Hsien | 333 | Taiwan |
| Llovet JM, Decaens T, Raoul JL, Boucher E, Kudo M, Chang C, Kang YK, Assenat E, Lim HY, Boige V, Mathurin P, Fartoux L, Lin DY, Bruix J, Poon RT, Sherman M, Blanc JF, Finn RS, Tak WY, Chao Y, Ezzeddine R, Liu D, Walters I, Park JW. Brivanib in patients with advanced hepatocellular carcinoma who were intolerant to sorafenib or for whom sorafenib failed: results from the randomized phase III BRISK-PS study. J Clin Oncol. 2013 Oct 1;31(28):3509-16. doi: 10.1200/JCO.2012.47.3009. Epub 2013 Aug 26. |
| BMS Clinical Trial Patient Recruiting | View source |
| Investigator Inquiry Form | View source |
| FDA Safety Alerts and Recalls | View source |
| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| C509922 | brivanib |
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