Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01009593




Registration number
NCT01009593
Ethics application status
Date submitted
14/10/2009
Date registered
6/11/2009
Date last updated
10/09/2012

Titles & IDs
Public title
Efficacy and Tolerability of ABT-869 Versus Sorafenib in Advanced Hepatocellular Carcinoma (HCC)
Scientific 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)
Secondary ID [1] 0 0
2009-013435-38
Secondary ID [2] 0 0
M10-963
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatocellular Carcinoma Non-resectable 0 0
Hepatocellular Carcinoma Recurrent 0 0
Carcinoma, Hepatocellular 0 0
Liver Diseases 0 0
Neoplasms by Histologic Type 0 0
Digestive System Neoplasms 0 0
Carcinoma 0 0
Liver Neoplasms 0 0
Neoplasms 0 0
Neoplasms by Site 0 0
Digestive System Diseases 0 0
Adenocarcinoma 0 0
Neoplasms, Glandular and Epithelial 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Liver
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 0 0 0 0
Any cancer
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 0 0 0 0
Oesophageal (gullet)
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ABT-869
Treatment: Drugs - Sorafenib

Experimental: ABT-869 -

Active comparator: Sorafenib -


Treatment: Drugs: ABT-869
Tablets, Oral, 17.5 mg, Once Daily, Until disease progression or unacceptable toxicity

Treatment: Drugs: Sorafenib
Tablets, Oral, 400 mg, Twice Daily, Until disease progression or unacceptable toxicity.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
From randomization until patient death; assessed monthly
Secondary outcome [1] 0 0
Time To Progression (TTP)
Timepoint [1] 0 0
From randomization until patient progression; assessed every 6 weeks
Secondary outcome [2] 0 0
Overall Response Rate (ORR)
Timepoint [2] 0 0
Assessed Every 6 weeks

Eligibility
Key inclusion criteria
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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2012
Sample size
Target
Accrual to date
Final
1035
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Site Reference ID/Investigator# 23152 - Camperdown
Recruitment hospital [2] 0 0
Site Reference ID/Investigator# 23150 - Concord
Recruitment hospital [3] 0 0
Site Reference ID/Investigator# 27122 - Kingswood
Recruitment hospital [4] 0 0
Site Reference ID/Investigator# 23153 - Kogarah
Recruitment hospital [5] 0 0
Site Reference ID/Investigator# 24103 - Southport
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2139 - Concord
Recruitment postcode(s) [3] 0 0
2747 - Kingswood
Recruitment postcode(s) [4] 0 0
2217 - Kogarah
Recruitment postcode(s) [5] 0 0
4215 - Southport
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Delaware
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Hawaii
Country [5] 0 0
United States of America
State/province [5] 0 0
Kentucky
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
Nevada
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Oregon
Country [10] 0 0
Argentina
State/province [10] 0 0
Buenos Aires
Country [11] 0 0
Argentina
State/province [11] 0 0
Rosario, Santa Fe
Country [12] 0 0
Austria
State/province [12] 0 0
Graz
Country [13] 0 0
Austria
State/province [13] 0 0
Innsbruck
Country [14] 0 0
Austria
State/province [14] 0 0
Linz
Country [15] 0 0
Austria
State/province [15] 0 0
Vienna
Country [16] 0 0
Belgium
State/province [16] 0 0
Brussels
Country [17] 0 0
Belgium
State/province [17] 0 0
Edegem
Country [18] 0 0
Belgium
State/province [18] 0 0
Ghent
Country [19] 0 0
Belgium
State/province [19] 0 0
Gilly
Country [20] 0 0
Belgium
State/province [20] 0 0
Leuven
Country [21] 0 0
Canada
State/province [21] 0 0
Edmonton
Country [22] 0 0
Canada
State/province [22] 0 0
Halifax
Country [23] 0 0
Canada
State/province [23] 0 0
Montreal
Country [24] 0 0
Canada
State/province [24] 0 0
Ottawa
Country [25] 0 0
Canada
State/province [25] 0 0
Sherbrooke
Country [26] 0 0
Canada
State/province [26] 0 0
Toronto
Country [27] 0 0
Chile
State/province [27] 0 0
Temuco
Country [28] 0 0
Chile
State/province [28] 0 0
Vina del Mar
Country [29] 0 0
China
State/province [29] 0 0
Beijing
Country [30] 0 0
China
State/province [30] 0 0
Changchun
Country [31] 0 0
China
State/province [31] 0 0
Chengdu
Country [32] 0 0
China
State/province [32] 0 0
Chongqing
Country [33] 0 0
China
State/province [33] 0 0
Dalian
Country [34] 0 0
China
State/province [34] 0 0
Fuzhou
Country [35] 0 0
China
State/province [35] 0 0
Guangzhou City
Country [36] 0 0
China
State/province [36] 0 0
Hangzhou
Country [37] 0 0
China
State/province [37] 0 0
Harbin
Country [38] 0 0
China
State/province [38] 0 0
Jinan
Country [39] 0 0
China
State/province [39] 0 0
Nanjing City
Country [40] 0 0
China
State/province [40] 0 0
Nanning City
Country [41] 0 0
China
State/province [41] 0 0
Qingdao
Country [42] 0 0
China
State/province [42] 0 0
Shanghai
Country [43] 0 0
China
State/province [43] 0 0
Suzhou
Country [44] 0 0
China
State/province [44] 0 0
Xian
Country [45] 0 0
Czech Republic
State/province [45] 0 0
Brno
Country [46] 0 0
Czech Republic
State/province [46] 0 0
Olomouc
Country [47] 0 0
Czech Republic
State/province [47] 0 0
Prague 2
Country [48] 0 0
Czech Republic
State/province [48] 0 0
Prague 4
Country [49] 0 0
Czech Republic
State/province [49] 0 0
Prague 8
Country [50] 0 0
Czech Republic
State/province [50] 0 0
Usti nad Labem
Country [51] 0 0
Denmark
State/province [51] 0 0
Aarhus C
Country [52] 0 0
Egypt
State/province [52] 0 0
Alexandria
Country [53] 0 0
Egypt
State/province [53] 0 0
Cairo
Country [54] 0 0
France
State/province [54] 0 0
Amiens
Country [55] 0 0
France
State/province [55] 0 0
Clichy
Country [56] 0 0
France
State/province [56] 0 0
Creteil
Country [57] 0 0
France
State/province [57] 0 0
Lille Cedex
Country [58] 0 0
France
State/province [58] 0 0
Paris Cedex 12
Country [59] 0 0
France
State/province [59] 0 0
Paris Cedex 13
Country [60] 0 0
France
State/province [60] 0 0
Rouen Cedex
Country [61] 0 0
France
State/province [61] 0 0
Strasbourg Cedex
Country [62] 0 0
France
State/province [62] 0 0
Vandoeuvre Les Nancy
Country [63] 0 0
Germany
State/province [63] 0 0
Berlin
Country [64] 0 0
Germany
State/province [64] 0 0
Bochum
Country [65] 0 0
Germany
State/province [65] 0 0
Frankfurt am Main
Country [66] 0 0
Germany
State/province [66] 0 0
Freiburg
Country [67] 0 0
Germany
State/province [67] 0 0
Mainz
Country [68] 0 0
Greece
State/province [68] 0 0
Athens
Country [69] 0 0
Hong Kong
State/province [69] 0 0
Hong Kong
Country [70] 0 0
Italy
State/province [70] 0 0
Benevento
Country [71] 0 0
Italy
State/province [71] 0 0
Milan
Country [72] 0 0
Italy
State/province [72] 0 0
Palermo
Country [73] 0 0
Italy
State/province [73] 0 0
Pavia
Country [74] 0 0
Italy
State/province [74] 0 0
Rome
Country [75] 0 0
Japan
State/province [75] 0 0
Aichi
Country [76] 0 0
Japan
State/province [76] 0 0
Chiba
Country [77] 0 0
Japan
State/province [77] 0 0
Fukuoka
Country [78] 0 0
Japan
State/province [78] 0 0
Hokkaido
Country [79] 0 0
Japan
State/province [79] 0 0
Ibaraki-ken
Country [80] 0 0
Japan
State/province [80] 0 0
Kanazawa
Country [81] 0 0
Japan
State/province [81] 0 0
Kumamoto
Country [82] 0 0
Japan
State/province [82] 0 0
Kurume
Country [83] 0 0
Japan
State/province [83] 0 0
Matsuyama-city
Country [84] 0 0
Japan
State/province [84] 0 0
Osakasayama
Country [85] 0 0
Japan
State/province [85] 0 0
Osaka
Country [86] 0 0
Japan
State/province [86] 0 0
Shimotsuke
Country [87] 0 0
Japan
State/province [87] 0 0
Shizuoka
Country [88] 0 0
Japan
State/province [88] 0 0
Tochigi-ken
Country [89] 0 0
Japan
State/province [89] 0 0
Tokyo
Country [90] 0 0
Japan
State/province [90] 0 0
Yokohama City
Country [91] 0 0
Japan
State/province [91] 0 0
Yufu
Country [92] 0 0
Korea, Republic of
State/province [92] 0 0
Busan
Country [93] 0 0
Korea, Republic of
State/province [93] 0 0
Daegu
Country [94] 0 0
Korea, Republic of
State/province [94] 0 0
Gyeonggi-do
Country [95] 0 0
Korea, Republic of
State/province [95] 0 0
Jeollanam-do
Country [96] 0 0
Korea, Republic of
State/province [96] 0 0
Jeonju-si
Country [97] 0 0
Korea, Republic of
State/province [97] 0 0
Seoul
Country [98] 0 0
Korea, Republic of
State/province [98] 0 0
Suwon-si
Country [99] 0 0
Malaysia
State/province [99] 0 0
Kuala Lumpur
Country [100] 0 0
Malaysia
State/province [100] 0 0
Penang
Country [101] 0 0
Malaysia
State/province [101] 0 0
Petaling Jaya, Selangor
Country [102] 0 0
Mexico
State/province [102] 0 0
Durango, DGO.
Country [103] 0 0
Mexico
State/province [103] 0 0
Monterrey, NL
Country [104] 0 0
Netherlands
State/province [104] 0 0
Amsterdam
Country [105] 0 0
Netherlands
State/province [105] 0 0
Rotterdam
Country [106] 0 0
New Zealand
State/province [106] 0 0
Auckland
Country [107] 0 0
Norway
State/province [107] 0 0
Oslo
Country [108] 0 0
Puerto Rico
State/province [108] 0 0
Ponce
Country [109] 0 0
Puerto Rico
State/province [109] 0 0
San Juan
Country [110] 0 0
Romania
State/province [110] 0 0
Baia Mare
Country [111] 0 0
Romania
State/province [111] 0 0
Bucharest
Country [112] 0 0
Romania
State/province [112] 0 0
Cluj Napoca
Country [113] 0 0
Romania
State/province [113] 0 0
Craiova
Country [114] 0 0
Romania
State/province [114] 0 0
Iasi
Country [115] 0 0
Romania
State/province [115] 0 0
Oradea
Country [116] 0 0
Russian Federation
State/province [116] 0 0
Chelyabinsk
Country [117] 0 0
Russian Federation
State/province [117] 0 0
Kazan
Country [118] 0 0
Russian Federation
State/province [118] 0 0
Moscow
Country [119] 0 0
Singapore
State/province [119] 0 0
Singapore
Country [120] 0 0
Spain
State/province [120] 0 0
A Coruna
Country [121] 0 0
Spain
State/province [121] 0 0
Madrid
Country [122] 0 0
Spain
State/province [122] 0 0
Santander
Country [123] 0 0
Spain
State/province [123] 0 0
Zaragoza
Country [124] 0 0
Taiwan
State/province [124] 0 0
Changhua City
Country [125] 0 0
Taiwan
State/province [125] 0 0
Kaohsiung County
Country [126] 0 0
Taiwan
State/province [126] 0 0
Taichung City
Country [127] 0 0
Taiwan
State/province [127] 0 0
Taichung
Country [128] 0 0
Taiwan
State/province [128] 0 0
Tainan
Country [129] 0 0
Taiwan
State/province [129] 0 0
Taipei City
Country [130] 0 0
Taiwan
State/province [130] 0 0
Taipei
Country [131] 0 0
Taiwan
State/province [131] 0 0
Taoyuan

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Abbott
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01009593
Trial related presentations / publications
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.
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. Erratum In: J Clin Oncol. 2017 Aug 1;35(22):2590. doi: 10.1200/JCO.2017.74.5729.
Public notes

Contacts
Principal investigator
Name 0 0
Justin Ricker, MD
Address 0 0
Abbott
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01009593