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| ID | Type | Description | Link |
|---|---|---|---|
| EUDRACT # 2008-008715-26 |
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The purpose of this study is to compare the Overall Survival (OS) of HCC patients who receive brivanib as adjuvant treatments to TACE therapy, with the OS of HCC patients who receive matched placebo with TACE therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brivanib | Active Comparator | Adjuvant treatment with TACE Therapy |
|
| Brivanib Placebo | Placebo Comparator | Placebo adjuvant treatment with TACE Therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brivanib | Drug | Tablets, Oral, 200 mg, once daily, until disease progression or toxicity |
|
| Measure | Description | Time Frame |
|---|---|---|
| To compare the Overall Survival (OS) of HCC patients who receive brivanib as adjuvant treatments to TACE therapy, with the OS of HCC patients who receive matched placebo with TACE therapy | Survival will be assessed continuously |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the Time-To-Disease Progression (TTDP) of patients receiving brivanib with TACE therapy to that of patients receiving placebo with TACE therapy | Every 8 weeks | |
| To compare the time to extrahepatic spread or vascular invasion in the brivanib and placebo arms |
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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 |
|---|---|---|---|---|---|---|
| Richard Finn, M.D. | Los Angeles | California | 90095 | United States | ||
| Sharp Clinical Oncology Research |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
| Investigator Inquiry Form |
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| Brivanib Placebo | Other | Tablets, Oral, 0 mg, once daily, until disease progression or toxicity |
|
| TACE Therapy | Procedure | Trans-Arterial Chemo-Embolization Therapy |
|
| Every 8 weeks |
| To determine the total number of TACE sessions in the brivanib and placebo arms and to compare the rate of TACE sessions in the brivanib and placebo arms | End of Study |
| To evaluate the safety of brivanib in combination with TACE | Every 8 weeks |
| San Diego |
| California |
| 92123 |
| United States |
| Montefiore Medical Center | The Bronx | New York | 10467-2401 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| The University Of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| University Of Virginia Health System | Charlottesville | Virginia | 22908 | United States |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109-1023 | United States |
| Local Institution | Capital Federal | Buenos Aires | C1405BCK | Argentina |
| Local Institution | Buenos Aires | C1181ACH | Argentina |
| Local Institution | Parkville | Victoria | 3050 | Australia |
| Local Institution | Vancouver | British Columbia | V5Z 1M9 | Canada |
| Local Institution | Montreal | Quebec | H2X 3J4 | Canada |
| Local Institution | Beijing | Beijing Municipality | 100071 | China |
| Local Institution | Guanzhou | Guangdong | 610080 | China |
| Local Institution | Nanning | Guangxi | 530021 | China |
| Local Institution | Harbin | Heilongjiang | 150081 | China |
| Local Institution | Changsha | Hunan | 410013 | China |
| Local Institution | Changzhou | Jiangsu | 213003 | China |
| Local Institution | Nanjing | Jiangsu | 210000 | China |
| Local Institution | Nanjing | Jiangsu | 210002 | China |
| Local Institution | Nanjing | Jiangsu | 210009 | China |
| Local Institution | Suzhou | Jiangsu | 215006 | China |
| Local Institution | Changchun | Jilin | 130021 | China |
| Local Institution | Xi'an | Shan3xi | 710032 | China |
| Local Institution | Shanghai | Shanghai Municipality | 200032 | China |
| Local Institution | Shanghai | Shanghai Municipality | 200433 | China |
| Local Institution | Chengdu | Sichuan | 610041 | China |
| Local Institution | Tianjin | Tianjin Municipality | 30060 | China |
| Local Institution | Hangzhou | Zhejiang | 310022 | China |
| Local Institution | Angers | 49933 | France |
| Local Institution | Bondy | 93143 | France |
| 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 | 13385 | France |
| Local Institution | Paris | 75012 | France |
| Local Institution | Paris | 75013 | France |
| Local Institution | Toulouse | 31059 | France |
| Local Institution | Hong Kong | 8525 | Hong Kong |
| Local Institution | New Territories | 8520 | Hong Kong |
| Local Institution | Genova | 16132 | Italy |
| Local Institution | Padova | 35128 | Italy |
| Local Institution | Pisa | 56124 | Italy |
| Local Institution | Roma | 00168 | Italy |
| Local Institution | Toyoake | Aichi-ken | 470-1101 | Japan |
| Local Institution | Chiba | Chiba | 2608677 | Japan |
| Local Institution | Kashiwa-shi | Chiba | 277-0882 | Japan |
| Local Institution | Ogaki-shi | Gifu | 5038502 | Japan |
| Local Institution | Hiroshima | Hiroshima | 734-0037 | Japan |
| Local Institution | Kure-shi | Hiroshima | 7370023 | 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 | Kochi | Kochi | 7818555 | Japan |
| Local Institution | Kumamoto | Kumamoto | 8608556 | Japan |
| Local Institution | Kyoto | Kyoto | 6028566 | Japan |
| Local Institution | Tsu | Mie-ken | 5148507 | Japan |
| Local Institution | Okayama | Okayama-ken | 700-0082 | 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 | 545-8586 | 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 | Toyama | Toyama | 9308550 | Japan |
| Local Institution | Nishinomiya-shi | 6638501 | Japan |
| Local Institution | Busan | 609735 | 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 | 137-701 | South Korea |
| Local Institution | Seoul | 138-736 | South Korea |
| Local Institution | Suwon | 443-721 | South Korea |
| Local Institution | Taegu | 700721 | South Korea |
| Local Institution | Madrid | 28007 | Spain |
| Local Institution | Madrid | 28222 | Spain |
| Local Institution | Valencia | 46010 | Spain |
| Local Institution | Valencia | 46014 | Spain |
| Local Institution | Kaohsiung City | 80756 | Taiwan |
| Local Institution | Taichung | 404 | Taiwan |
| Local Institution | Tainan | 704 | 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 |
| FDA Safety Alerts and Recalls | View source |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| C509922 | brivanib |
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