Efficacy and Tolerability of ABT-869 Versus Sorafenib in Advanced Hepatocellular Carcinoma (HCC)
Sponsor
Abbott (Industry)
Overall Status
Terminated
CT.gov ID
NCT01009593
Collaborator
(none)
1,035
163
2
30
6.3
0.2
Study Details
Study Description
Brief Summary
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.
Detailed Description
The IDMC recommended discontinuation of the study, and, the protocol was amended to end study treatment.
Study Design
Study Type:
Interventional
Actual Enrollment
:
1035 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-label, Randomized Phase 3 Study of the Efficacy and Tolerability of Linifanib (ABT-869) Versus Sorafenib in Subjects With Advanced Hepatocellular Carcinoma (HCC)
Study Start Date
:
Jan 1, 2010
Actual Primary Completion Date
:
Jul 1, 2012
Actual Study Completion Date
:
Jul 1, 2012
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ABT-869
|
Drug: ABT-869
Tablets, Oral, 17.5 mg, Once Daily, Until disease progression or unacceptable toxicity
|
| Active Comparator: Sorafenib
|
Drug: Sorafenib
Tablets, Oral, 400 mg, Twice Daily, Until disease progression or unacceptable toxicity.
|
Outcome Measures
Primary Outcome Measures
- Overall Survival [From randomization until patient death; assessed monthly]
Secondary Outcome Measures
- Time To Progression (TTP) [From randomization until patient progression; assessed every 6 weeks]
- Overall Response Rate (ORR) [Assessed Every 6 weeks]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria
-
Histologic or cytologic diagnosis with unresectable or metastatic HCC
-
Child Pugh Class A
-
ECOG performance status 0-1
-
Adequate hematologic, hepatic, and renal function
Exclusion Criteria
-
Prior systemic (administered intravenously or orally rather than locoregionally) treatment for HCC
-
Prior local therapy (including liver-directed therapy) within 4 weeks from entry
-
Untreated brain or meningeal metastases
-
Current treatment on another clinical trial
-
Pregnancy or breastfeeding
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Site Reference ID/Investigator# 23247 | Beverly Hills | California | United States | 90211-1850 |
| 2 | Site Reference ID/Investigator# 23608 | LaVerne | California | United States | 91750 |
| 3 | Site Reference ID/Investigator# 23852 | Orange | California | United States | 92868 |
| 4 | Site Reference ID/Investigator# 40162 | Orange | California | United States | 92868 |
| 5 | Site Reference ID/Investigator# 23254 | Newark | Delaware | United States | 19713 |
| 6 | Site Reference ID/Investigator# 23253 | Gainesville | Georgia | United States | 30505 |
| 7 | Site Reference ID/Investigator# 23609 | Honolulu | Hawaii | United States | 96813 |
| 8 | Site Reference ID/Investigator# 24848 | Honolulu | Hawaii | United States | 96819 |
| 9 | Site Reference ID/Investigator# 23250 | Louisville | Kentucky | United States | 40202 |
| 10 | Site Reference ID/Investigator# 23257 | St. Louis | Missouri | United States | 63104 |
| 11 | Site Reference ID/Investigator# 23603 | Las Vegas | Nevada | United States | 89135 |
| 12 | Site Reference ID/Investigator# 23244 | Durham | North Carolina | United States | 27710 |
| 13 | Site Reference ID/Investigator# 23252 | Portland | Oregon | United States | 97213 |
| 14 | Site Reference ID/Investigator# 35705 | Buenos Aires | Argentina | B1629ODT | |
| 15 | Site Reference ID/Investigator# 35702 | Rosario, Santa Fe | Argentina | S2002KDS | |
| 16 | Site Reference ID/Investigator# 23152 | Camperdown | Australia | 2050 | |
| 17 | Site Reference ID/Investigator# 23150 | Concord | Australia | 2139 | |
| 18 | Site Reference ID/Investigator# 27122 | Kingswood | Australia | 2747 | |
| 19 | Site Reference ID/Investigator# 23153 | Kogarah | Australia | 2217 | |
| 20 | Site Reference ID/Investigator# 24103 | Southport | Australia | 4215 | |
| 21 | Site Reference ID/Investigator# 27968 | Graz | Austria | 8036 | |
| 22 | Site Reference ID/Investigator# 27969 | Innsbruck | Austria | A-6020 | |
| 23 | Site Reference ID/Investigator# 27970 | Linz | Austria | 4020 | |
| 24 | Site Reference ID/Investigator# 27967 | Vienna | Austria | 1090 | |
| 25 | Site Reference ID/Investigator# 38902 | Brussels | Belgium | 1070 | |
| 26 | Site Reference ID/Investigator# 23162 | Brussels | Belgium | 1200 | |
| 27 | Site Reference ID/Investigator# 23843 | Edegem | Belgium | 2650 | |
| 28 | Site Reference ID/Investigator# 23161 | Ghent | Belgium | 9000 | |
| 29 | Site Reference ID/Investigator# 23842 | Gilly | Belgium | 6060 | |
| 30 | Site Reference ID/Investigator# 23163 | Leuven | Belgium | 3000 | |
| 31 | Site Reference ID/Investigator# 26702 | Edmonton | Canada | T6G 2X8 | |
| 32 | Site Reference ID/Investigator# 25482 | Halifax | Canada | B3H 2Y9 | |
| 33 | Site Reference ID/Investigator# 39614 | Montreal | Canada | H2X 3J4 | |
| 34 | Site Reference ID/Investigator# 23184 | Ottawa | Canada | K1H 8L6 | |
| 35 | Site Reference ID/Investigator# 23183 | Sherbrooke | Canada | J1G 2E8 | |
| 36 | Site Reference ID/Investigator# 24522 | Toronto | Canada | M4C 3E7 | |
| 37 | Site Reference ID/Investigator# 36967 | Temuco | Chile | 01745 | |
| 38 | Site Reference ID/Investigator# 36964 | Vina del Mar | Chile | ||
| 39 | Site Reference ID/Investigator# 23186 | Beijing | China | 100071 | |
| 40 | Site Reference ID/Investigator# 43443 | Changchun | China | 130012 | |
| 41 | Site Reference ID/Investigator# 23194 | Chengdu | China | 610041 | |
| 42 | Site Reference ID/Investigator# 43442 | Chongqing | China | 400038 | |
| 43 | Site Reference ID/Investigator# 44444 | Dalian | China | 116011 | |
| 44 | Site Reference ID/Investigator# 43444 | Fuzhou | China | 350025 | |
| 45 | Site Reference ID/Investigator# 43482 | Guangzhou City | China | 510515 | |
| 46 | Site Reference ID/Investigator# 42563 | Hangzhou | China | 310016 | |
| 47 | Site Reference ID/Investigator# 44443 | Harbin | China | 150081 | |
| 48 | Site Reference ID/Investigator# 44062 | Jinan | China | 250031 | |
| 49 | Site Reference ID/Investigator# 23191 | Nanjing City | China | 210002 | |
| 50 | Site Reference ID/Investigator# 44063 | Nanning City | China | 530021 | |
| 51 | Site Reference ID/Investigator# 42817 | Qingdao | China | 266003 | |
| 52 | Site Reference ID/Investigator# 40624 | Shanghai | China | 200032 | |
| 53 | Site Reference ID/Investigator# 23189 | Shanghai | China | 200080 | |
| 54 | Site Reference ID/Investigator# 40448 | Suzhou | China | 215006 | |
| 55 | Site Reference ID/Investigator# 23190 | Xian | China | 710032 | |
| 56 | Site Reference ID/Investigator# 23167 | Brno | Czech Republic | 625 00 | |
| 57 | Site Reference ID/Investigator# 23166 | Olomouc | Czech Republic | 775 20 | |
| 58 | Site Reference ID/Investigator# 24523 | Prague 2 | Czech Republic | 12808 | |
| 59 | Site Reference ID/Investigator# 23844 | Prague 4 | Czech Republic | 14021 | |
| 60 | Site Reference ID/Investigator# 40930 | Prague 8 | Czech Republic | 18081 | |
| 61 | Site Reference ID/Investigator# 23197 | Usti nad Labem | Czech Republic | 401 13 | |
| 62 | Site Reference ID/Investigator# 23442 | Aarhus C | Denmark | 8000 | |
| 63 | Site Reference ID/Investigator# 23198 | Alexandria | Egypt | 21131 | |
| 64 | Site Reference ID/Investigator# 23199 | Cairo | Egypt | 11796 | |
| 65 | Site Reference ID/Investigator# 43302 | Amiens | France | 80054 | |
| 66 | Site Reference ID/Investigator# 23201 | Clichy | France | 92118 | |
| 67 | Site Reference ID/Investigator# 43144 | Creteil | France | 94010 | |
| 68 | Site Reference ID/Investigator# 23200 | Lille Cedex | France | 59037 | |
| 69 | Site Reference ID/Investigator# 23168 | Paris Cedex 12 | France | 75571 | |
| 70 | Site Reference ID/Investigator# 40623 | Paris Cedex 13 | France | 75651 | |
| 71 | Site Reference ID/Investigator# 28345 | Rouen Cedex | France | 76031 | |
| 72 | Site Reference ID/Investigator# 23165 | Strasbourg Cedex | France | 67091 | |
| 73 | Site Reference ID/Investigator# 28347 | Vandoeuvre Les Nancy | France | 54511 | |
| 74 | Site Reference ID/Investigator# 23267 | Berlin | Germany | 13353 | |
| 75 | Site Reference ID/Investigator# 23845 | Bochum | Germany | 44789 | |
| 76 | Site Reference ID/Investigator# 23266 | Frankfurt am Main | Germany | 60590 | |
| 77 | Site Reference ID/Investigator# 23268 | Freiburg | Germany | 79106 | |
| 78 | Site Reference ID/Investigator# 23269 | Mainz | Germany | 55131 | |
| 79 | Site Reference ID/Investigator# 24525 | Athens | Greece | 115 27 | |
| 80 | Site Reference ID/Investigator# 24980 | Hong Kong | Hong Kong | ||
| 81 | Site Reference ID/Investigator# 27998 | Benevento | Italy | 82100 | |
| 82 | Site Reference ID/Investigator# 23424 | Milan | Italy | 20122 | |
| 83 | Site Reference ID/Investigator# 41488 | Milan | Italy | 20132 | |
| 84 | Site Reference ID/Investigator# 23425 | Palermo | Italy | 90127 | |
| 85 | Site Reference ID/Investigator# 41542 | Pavia | Italy | 27100 | |
| 86 | Site Reference ID/Investigator# 23428 | Rome | Italy | 00144 | |
| 87 | Site Reference ID/Investigator# 24042 | Rome | Italy | 00168 | |
| 88 | Site Reference ID/Investigator# 26506 | Aichi | Japan | ||
| 89 | Site Reference ID/Investigator# 36308 | Chiba | Japan | ||
| 90 | Site Reference ID/Investigator# 37602 | Chiba | Japan | ||
| 91 | Site Reference ID/Investigator# 29758 | Fukuoka | Japan | ||
| 92 | Site Reference ID/Investigator# 37603 | Hokkaido | Japan | ||
| 93 | Site Reference ID/Investigator# 28189 | Ibaraki-ken | Japan | ||
| 94 | Site Reference ID/Investigator# 26505 | Kanazawa | Japan | ||
| 95 | Site Reference ID/Investigator# 29757 | Kumamoto | Japan | ||
| 96 | Site Reference ID/Investigator# 27343 | Kurume | Japan | ||
| 97 | Site Reference ID/Investigator# 29759 | Matsuyama-city | Japan | ||
| 98 | Site Reference ID/Investigator# 26508 | Osakasayama | Japan | ||
| 99 | Site Reference ID/Investigator# 26507 | Osaka | Japan | ||
| 100 | Site Reference ID/Investigator# 27959 | Osaka | Japan | ||
| 101 | Site Reference ID/Investigator# 29756 | Shimotsuke | Japan | ||
| 102 | Site Reference ID/Investigator# 36782 | Shizuoka | Japan | ||
| 103 | Site Reference ID/Investigator# 28187 | Tochigi-ken | Japan | ||
| 104 | Site Reference ID/Investigator# 26503 | Tokyo | Japan | ||
| 105 | Site Reference ID/Investigator# 27242 | Tokyo | Japan | ||
| 106 | Site Reference ID/Investigator# 26504 | Yokohama City | Japan | ||
| 107 | Site Reference ID/Investigator# 26509 | Yufu | Japan | ||
| 108 | Site Reference ID/Investigator# 23447 | Busan | Korea, Republic of | 602-715 | |
| 109 | Site Reference ID/Investigator# 39003 | Busan | Korea, Republic of | 614-735 | |
| 110 | Site Reference ID/Investigator# 23445 | Busan | Korea, Republic of | 626-770 | |
| 111 | Site Reference ID/Investigator# 23444 | Daegu | Korea, Republic of | 700-721 | |
| 112 | Site Reference ID/Investigator# 26543 | Gyeonggi-do | Korea, Republic of | 410-769 | |
| 113 | Site Reference ID/Investigator# 23457 | Jeollanam-do | Korea, Republic of | 519-809 | |
| 114 | Site Reference ID/Investigator# 39002 | Jeonju-si | Korea, Republic of | 561-712 | |
| 115 | Site Reference ID/Investigator# 23454 | Seoul | Korea, Republic of | 120-752 | |
| 116 | Site Reference ID/Investigator# 25562 | Seoul | Korea, Republic of | 138-701 | |
| 117 | Site Reference ID/Investigator# 23449 | Seoul | Korea, Republic of | 138-736 | |
| 118 | Site Reference ID/Investigator# 23456 | Seoul | Korea, Republic of | 152-703 | |
| 119 | Site Reference ID/Investigator# 23450 | Suwon-si | Korea, Republic of | 443-721 | |
| 120 | Site Reference ID/Investigator# 23460 | Kuala Lumpur | Malaysia | 50603 | |
| 121 | Site Reference ID/Investigator# 23461 | Penang | Malaysia | 11200 | |
| 122 | Site Reference ID/Investigator# 23459 | Petaling Jaya, Selangor | Malaysia | 46050 | |
| 123 | Site Reference ID/Investigator# 23155 | Durango, DGO. | Mexico | CP 34000 | |
| 124 | Site Reference ID/Investigator# 43102 | Monterrey, NL | Mexico | CP 64000 | |
| 125 | Site Reference ID/Investigator# 43145 | Monterrey, NL | Mexico | CP 64020 | |
| 126 | Site Reference ID/Investigator# 23272 | Amsterdam | Netherlands | 1081 HV | |
| 127 | Site Reference ID/Investigator# 23270 | Amsterdam | Netherlands | 1105 AZ | |
| 128 | Site Reference ID/Investigator# 24782 | Rotterdam | Netherlands | 3015 CE | |
| 129 | Site Reference ID/Investigator# 23160 | Auckland | New Zealand | 1142 | |
| 130 | Site Reference ID/Investigator# 23846 | Oslo | Norway | 0407 | |
| 131 | Site Reference ID/Investigator# 42706 | Ponce | Puerto Rico | 00716 | |
| 132 | Site Reference ID/Investigator# 42705 | San Juan | Puerto Rico | 00936-5067 | |
| 133 | Site Reference ID/Investigator# 33979 | Baia Mare | Romania | 430031 | |
| 134 | Site Reference ID/Investigator# 33344 | Bucharest | Romania | 022328 | |
| 135 | Site Reference ID/Investigator# 33343 | Cluj Napoca | Romania | 400015 | |
| 136 | Site Reference ID/Investigator# 33977 | Craiova | Romania | 200385 | |
| 137 | Site Reference ID/Investigator# 33345 | Iasi | Romania | 700106 | |
| 138 | Site Reference ID/Investigator# 33346 | Oradea | Romania | 410469 | |
| 139 | Site Reference ID/Investigator# 43202 | Chelyabinsk | Russian Federation | 454087 | |
| 140 | Site Reference ID/Investigator# 43203 | Kazan | Russian Federation | 420029 | |
| 141 | Site Reference ID/Investigator# 23462 | Moscow | Russian Federation | 115478 | |
| 142 | Site Reference ID/Investigator# 23849 | Moscow | Russian Federation | 115478 | |
| 143 | Site Reference ID/Investigator# 23159 | Singapore | Singapore | 119228 | |
| 144 | Site Reference ID/Investigator# 23158 | Singapore | Singapore | 169610 | |
| 145 | Site Reference ID/Investigator# 23466 | A Coruna | Spain | 15006 | |
| 146 | Site Reference ID/Investigator# 26063 | Madrid | Spain | 28007 | |
| 147 | Site Reference ID/Investigator# 40931 | Madrid | Spain | 28033 | |
| 148 | Site Reference ID/Investigator# 23465 | Madrid | Spain | 28034 | |
| 149 | Site Reference ID/Investigator# 23463 | Madrid | Spain | 28050 | |
| 150 | Site Reference ID/Investigator# 23467 | Santander | Spain | 39008 | |
| 151 | Site Reference ID/Investigator# 23468 | Zaragoza | Spain | 50009 | |
| 152 | Site Reference ID/Investigator# 23475 | Changhua City | Taiwan | 500 | |
| 153 | Site Reference ID/Investigator# 23472 | Kaohsiung County | Taiwan | 833 | |
| 154 | Site Reference ID/Investigator# 25262 | Taichung City | Taiwan | 404 | |
| 155 | Site Reference ID/Investigator# 23474 | Taichung | Taiwan | 40705 | |
| 156 | Site Reference ID/Investigator# 23476 | Tainan | Taiwan | 704 | |
| 157 | Site Reference ID/Investigator# 23478 | Tainan | Taiwan | 710 | |
| 158 | Site Reference ID/Investigator# 23477 | Tainan | Taiwan | 736 | |
| 159 | Site Reference ID/Investigator# 23470 | Taipei City | Taiwan | 10449 | |
| 160 | Site Reference ID/Investigator# 43237 | Taipei | Taiwan | 110 | |
| 161 | Site Reference ID/Investigator# 23473 | Taipei | Taiwan | 112 | |
| 162 | Site Reference ID/Investigator# 23469 | Taipei | Taiwan | ||
| 163 | Site Reference ID/Investigator# 23471 | Taoyuan | Taiwan | 333 |
Sponsors and Collaborators
- Abbott
Investigators
- Study Director: Justin Ricker, MD, Abbott
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Abbott
ClinicalTrials.gov Identifier:
NCT01009593
Other Study ID Numbers:
- M10-963
- 2009-013435-38
First Posted:
Nov 6, 2009
Last Update Posted:
Sep 10, 2012
Last Verified:
Jun 1, 2012
Keywords provided by Abbott
Additional relevant MeSH terms: