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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-013435-38 | EudraCT Number |
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See termination reason in detailed description
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The primary objective of this study is to assess the overall survival (OS) of oral linifanib given as monotherapy once daily (QD) compared to sorafenib given twice daily (BID) per standard of care in subjects with advanced or metastatic HCC.
The IDMC recommended discontinuation of the study, and, the protocol was amended to end study treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABT-869 | Experimental |
| |
| Sorafenib | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-869 | Drug | Tablets, Oral, 17.5 mg, Once Daily, Until disease progression or unacceptable toxicity |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | From randomization until patient death; assessed monthly |
| Measure | Description | Time Frame |
|---|---|---|
| Time To Progression (TTP) | From randomization until patient progression; assessed every 6 weeks | |
| Overall Response Rate (ORR) | Assessed Every 6 weeks |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Justin Ricker, MD | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 23247 | Beverly Hills | California | 90211-1850 | United States | ||
| Site Reference ID/Investigator# 23608 |
| 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. | |
| 25488963 | Derived |
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| Sorafenib | Drug | Tablets, Oral, 400 mg, Twice Daily, Until disease progression or unacceptable toxicity. |
|
| LaVerne |
| California |
| 91750 |
| United States |
| Site Reference ID/Investigator# 23852 | Orange | California | 92868 | United States |
| Site Reference ID/Investigator# 40162 | Orange | California | 92868 | United States |
| Site Reference ID/Investigator# 23254 | Newark | Delaware | 19713 | United States |
| Site Reference ID/Investigator# 23253 | Gainesville | Georgia | 30505 | United States |
| Site Reference ID/Investigator# 23609 | Honolulu | Hawaii | 96813 | United States |
| Site Reference ID/Investigator# 24848 | Honolulu | Hawaii | 96819 | United States |
| Site Reference ID/Investigator# 23250 | Louisville | Kentucky | 40202 | United States |
| Site Reference ID/Investigator# 23257 | St Louis | Missouri | 63104 | United States |
| Site Reference ID/Investigator# 23603 | Las Vegas | Nevada | 89135 | United States |
| Site Reference ID/Investigator# 23244 | Durham | North Carolina | 27710 | United States |
| Site Reference ID/Investigator# 23252 | Portland | Oregon | 97213 | United States |
| Site Reference ID/Investigator# 35705 | Buenos Aires | B1629ODT | Argentina |
| Site Reference ID/Investigator# 35702 | Rosario, Santa Fe | S2002KDS | Argentina |
| Site Reference ID/Investigator# 23152 | Camperdown | 2050 | Australia |
| Site Reference ID/Investigator# 23150 | Concord | 2139 | Australia |
| Site Reference ID/Investigator# 27122 | Kingswood | 2747 | Australia |
| Site Reference ID/Investigator# 23153 | Kogarah | 2217 | Australia |
| Site Reference ID/Investigator# 24103 | Southport | 4215 | Australia |
| Site Reference ID/Investigator# 27968 | Graz | 8036 | Austria |
| Site Reference ID/Investigator# 27969 | Innsbruck | A-6020 | Austria |
| Site Reference ID/Investigator# 27970 | Linz | 4020 | Austria |
| Site Reference ID/Investigator# 27967 | Vienna | 1090 | Austria |
| Site Reference ID/Investigator# 38902 | Brussels | 1070 | Belgium |
| Site Reference ID/Investigator# 23162 | Brussels | 1200 | Belgium |
| Site Reference ID/Investigator# 23843 | Edegem | 2650 | Belgium |
| Site Reference ID/Investigator# 23161 | Ghent | 9000 | Belgium |
| Site Reference ID/Investigator# 23842 | Gilly | 6060 | Belgium |
| Site Reference ID/Investigator# 23163 | Leuven | 3000 | Belgium |
| Site Reference ID/Investigator# 26702 | Edmonton | T6G 2X8 | Canada |
| Site Reference ID/Investigator# 25482 | Halifax | B3H 2Y9 | Canada |
| Site Reference ID/Investigator# 39614 | Montreal | H2X 3J4 | Canada |
| Site Reference ID/Investigator# 23184 | Ottawa | K1H 8L6 | Canada |
| Site Reference ID/Investigator# 23183 | Sherbrooke | J1G 2E8 | Canada |
| Site Reference ID/Investigator# 24522 | Toronto | M4C 3E7 | Canada |
| Site Reference ID/Investigator# 36967 | Temuco | 01745 | Chile |
| Site Reference ID/Investigator# 36964 | Viña del Mar | Chile |
| Site Reference ID/Investigator# 23186 | Beijing | 100071 | China |
| Site Reference ID/Investigator# 43443 | Changchun | 130012 | China |
| Site Reference ID/Investigator# 23194 | Chengdu | 610041 | China |
| Site Reference ID/Investigator# 43442 | Chongqing | 400038 | China |
| Site Reference ID/Investigator# 44444 | Dalian | 116011 | China |
| Site Reference ID/Investigator# 43444 | Fuzhou | 350025 | China |
| Site Reference ID/Investigator# 43482 | Guangzhou | 510515 | China |
| Site Reference ID/Investigator# 42563 | Hangzhou | 310016 | China |
| Site Reference ID/Investigator# 44443 | Harbin | 150081 | China |
| Site Reference ID/Investigator# 44062 | Jinan | 250031 | China |
| Site Reference ID/Investigator# 23191 | Nanjing | 210002 | China |
| Site Reference ID/Investigator# 44063 | Nanning | 530021 | China |
| Site Reference ID/Investigator# 42817 | Qingdao | 266003 | China |
| Site Reference ID/Investigator# 40624 | Shanghai | 200032 | China |
| Site Reference ID/Investigator# 23189 | Shanghai | 200080 | China |
| Site Reference ID/Investigator# 40448 | Suzhou | 215006 | China |
| Site Reference ID/Investigator# 23190 | Xi'an | 710032 | China |
| Site Reference ID/Investigator# 23167 | Brno | 625 00 | Czechia |
| Site Reference ID/Investigator# 23166 | Olomouc | 775 20 | Czechia |
| Site Reference ID/Investigator# 24523 | Prague | 12808 | Czechia |
| Site Reference ID/Investigator# 23844 | Prague | 14021 | Czechia |
| Site Reference ID/Investigator# 40930 | Prague | 18081 | Czechia |
| Site Reference ID/Investigator# 23197 | ĂšstĂ nad Labem | 401 13 | Czechia |
| Site Reference ID/Investigator# 23442 | Aarhus C | 8000 | Denmark |
| Site Reference ID/Investigator# 23198 | Alexandria | 21131 | Egypt |
| Site Reference ID/Investigator# 23199 | Cairo | 11796 | Egypt |
| Site Reference ID/Investigator# 43302 | Amiens | 80054 | France |
| Site Reference ID/Investigator# 23201 | Clichy | 92118 | France |
| Site Reference ID/Investigator# 43144 | Créteil | 94010 | France |
| Site Reference ID/Investigator# 23200 | Lille | 59037 | France |
| Site Reference ID/Investigator# 23168 | Paris | 75571 | France |
| Site Reference ID/Investigator# 40623 | Paris | 75651 | France |
| Site Reference ID/Investigator# 28345 | Rouen | 76031 | France |
| Site Reference ID/Investigator# 23165 | Strasbourg | 67091 | France |
| Site Reference ID/Investigator# 28347 | Vandœuvre-lès-Nancy | 54511 | France |
| Site Reference ID/Investigator# 23267 | Berlin | 13353 | Germany |
| Site Reference ID/Investigator# 23845 | Bochum | 44789 | Germany |
| Site Reference ID/Investigator# 23266 | Frankfurt am Main | 60590 | Germany |
| Site Reference ID/Investigator# 23268 | Freiburg im Breisgau | 79106 | Germany |
| Site Reference ID/Investigator# 23269 | Mainz | 55131 | Germany |
| Site Reference ID/Investigator# 24525 | Athens | 115 27 | Greece |
| Site Reference ID/Investigator# 24980 | Hong Kong | Hong Kong |
| Site Reference ID/Investigator# 27998 | Benevento | 82100 | Italy |
| Site Reference ID/Investigator# 23424 | Milan | 20122 | Italy |
| Site Reference ID/Investigator# 41488 | Milan | 20132 | Italy |
| Site Reference ID/Investigator# 23425 | Palermo | 90127 | Italy |
| Site Reference ID/Investigator# 41542 | Pavia | 27100 | Italy |
| Site Reference ID/Investigator# 23428 | Rome | 00144 | Italy |
| Site Reference ID/Investigator# 24042 | Rome | 00168 | Italy |
| Site Reference ID/Investigator# 26506 | Aichi | Japan |
| Site Reference ID/Investigator# 36308 | Chiba | Japan |
| Site Reference ID/Investigator# 37602 | Chiba | Japan |
| Site Reference ID/Investigator# 29758 | Fukuoka | Japan |
| Site Reference ID/Investigator# 37603 | Hokkaido | Japan |
| Site Reference ID/Investigator# 28189 | Ibaraki-ken | Japan |
| Site Reference ID/Investigator# 26505 | Kanazawa | Japan |
| Site Reference ID/Investigator# 29757 | Kumamoto | Japan |
| Site Reference ID/Investigator# 27343 | Kurume | Japan |
| Site Reference ID/Investigator# 29759 | Matsuyama | Japan |
| Site Reference ID/Investigator# 26507 | Osaka | Japan |
| Site Reference ID/Investigator# 27959 | Osaka | Japan |
| Site Reference ID/Investigator# 26508 | Sayama | Japan |
| Site Reference ID/Investigator# 29756 | Shimotsuke | Japan |
| Site Reference ID/Investigator# 36782 | Shizuoka | Japan |
| Site Reference ID/Investigator# 28187 | Tochigi-ken | Japan |
| Site Reference ID/Investigator# 26503 | Tokyo | Japan |
| Site Reference ID/Investigator# 27242 | Tokyo | Japan |
| Site Reference ID/Investigator# 26504 | Yokohama | Japan |
| Site Reference ID/Investigator# 26509 | Yufu | Japan |
| Site Reference ID/Investigator# 23461 | George Town | 11200 | Malaysia |
| Site Reference ID/Investigator# 23460 | Kuala Lumpur | 50603 | Malaysia |
| Site Reference ID/Investigator# 23459 | Petaling Jaya, Selangor | 46050 | Malaysia |
| Site Reference ID/Investigator# 23155 | Durango, DGO. | CP 34000 | Mexico |
| Site Reference ID/Investigator# 43102 | Monterrey, NL | CP 64000 | Mexico |
| Site Reference ID/Investigator# 43145 | Monterrey, NL | CP 64020 | Mexico |
| Site Reference ID/Investigator# 23272 | Amsterdam | 1081 HV | Netherlands |
| Site Reference ID/Investigator# 23270 | Amsterdam | 1105 AZ | Netherlands |
| Site Reference ID/Investigator# 24782 | Rotterdam | 3015 CE | Netherlands |
| Site Reference ID/Investigator# 23160 | Auckland | 1142 | New Zealand |
| Site Reference ID/Investigator# 23846 | Oslo | 0407 | Norway |
| Site Reference ID/Investigator# 42706 | Ponce | 00716 | Puerto Rico |
| Site Reference ID/Investigator# 42705 | San Juan | 00936-5067 | Puerto Rico |
| Site Reference ID/Investigator# 33979 | Baia Mare | 430031 | Romania |
| Site Reference ID/Investigator# 33344 | Bucharest | 022328 | Romania |
| Site Reference ID/Investigator# 33343 | Cluj-Napoca | 400015 | Romania |
| Site Reference ID/Investigator# 33977 | Craiova | 200385 | Romania |
| Site Reference ID/Investigator# 33345 | Iași | 700106 | Romania |
| Site Reference ID/Investigator# 33346 | Oradea | 410469 | Romania |
| Site Reference ID/Investigator# 43202 | Chelyabinsk | 454087 | Russia |
| Site Reference ID/Investigator# 43203 | Kazan' | 420029 | Russia |
| Site Reference ID/Investigator# 23462 | Moscow | 115478 | Russia |
| Site Reference ID/Investigator# 23849 | Moscow | 115478 | Russia |
| Site Reference ID/Investigator# 23159 | Singapore | 119228 | Singapore |
| Site Reference ID/Investigator# 23158 | Singapore | 169610 | Singapore |
| Site Reference ID/Investigator# 23447 | Busan | 602-715 | South Korea |
| Site Reference ID/Investigator# 39003 | Busan | 614-735 | South Korea |
| Site Reference ID/Investigator# 23445 | Busan | 626-770 | South Korea |
| Site Reference ID/Investigator# 23444 | Daegu | 700-721 | South Korea |
| Site Reference ID/Investigator# 26543 | Gyeonggi-do | 410-769 | South Korea |
| Site Reference ID/Investigator# 23457 | Jeollanam-do | 519-809 | South Korea |
| Site Reference ID/Investigator# 39002 | Jeonju | 561-712 | South Korea |
| Site Reference ID/Investigator# 23454 | Seoul | 120-752 | South Korea |
| Site Reference ID/Investigator# 25562 | Seoul | 138-701 | South Korea |
| Site Reference ID/Investigator# 23449 | Seoul | 138-736 | South Korea |
| Site Reference ID/Investigator# 23456 | Seoul | 152-703 | South Korea |
| Site Reference ID/Investigator# 23450 | Suwon | 443-721 | South Korea |
| Site Reference ID/Investigator# 23466 | A Coruña | 15006 | Spain |
| Site Reference ID/Investigator# 26063 | Madrid | 28007 | Spain |
| Site Reference ID/Investigator# 40931 | Madrid | 28033 | Spain |
| Site Reference ID/Investigator# 23465 | Madrid | 28034 | Spain |
| Site Reference ID/Investigator# 23463 | Madrid | 28050 | Spain |
| Site Reference ID/Investigator# 23467 | Santander | 39008 | Spain |
| Site Reference ID/Investigator# 23468 | Zaragoza | 50009 | Spain |
| Site Reference ID/Investigator# 23475 | Changhua | 500 | Taiwan |
| Site Reference ID/Investigator# 23472 | Kaohsiung County | 833 | Taiwan |
| Site Reference ID/Investigator# 25262 | Taichung | 404 | Taiwan |
| Site Reference ID/Investigator# 23474 | Taichung | 40705 | Taiwan |
| Site Reference ID/Investigator# 23476 | Tainan | 704 | Taiwan |
| Site Reference ID/Investigator# 23478 | Tainan | 710 | Taiwan |
| Site Reference ID/Investigator# 23477 | Tainan | 736 | Taiwan |
| Site Reference ID/Investigator# 23470 | Taipei | 10449 | Taiwan |
| Site Reference ID/Investigator# 43237 | Taipei | 110 | Taiwan |
| Site Reference ID/Investigator# 23473 | Taipei | 112 | Taiwan |
| Site Reference ID/Investigator# 23469 | Taipei | Taiwan |
| Site Reference ID/Investigator# 23471 | Taoyuan | 333 | Taiwan |
| Cainap C, Qin S, Huang WT, Chung IJ, Pan H, Cheng Y, Kudo M, Kang YK, Chen PJ, Toh HC, Gorbunova V, Eskens FA, Qian J, McKee MD, Ricker JL, Carlson DM, El-Nowiem S. Linifanib versus Sorafenib in patients with advanced hepatocellular carcinoma: results of a randomized phase III trial. J Clin Oncol. 2015 Jan 10;33(2):172-9. doi: 10.1200/JCO.2013.54.3298. Epub 2014 Dec 8. |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D008107 | Liver Diseases |
| D009370 | Neoplasms by Histologic Type |
| D004067 | Digestive System Neoplasms |
| D002277 | Carcinoma |
| D008113 | Liver Neoplasms |
| D009369 | Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D000230 | Adenocarcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
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| ID | Term |
|---|---|
| C513486 | linifanib |
| 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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