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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
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United States of America
State/province [2] 0 0
Delaware
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United States of America
State/province [3] 0 0
Georgia
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United States of America
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Hawaii
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United States of America
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Kentucky
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United States of America
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Missouri
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United States of America
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Nevada
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United States of America
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North Carolina
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United States of America
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Oregon
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Argentina
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Buenos Aires
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Argentina
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Rosario, Santa Fe
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Austria
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Graz
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Austria
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Innsbruck
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Austria
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Linz
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Austria
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Vienna
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Belgium
State/province [16] 0 0
Brussels
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Belgium
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Edegem
Country [18] 0 0
Belgium
State/province [18] 0 0
Ghent
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Belgium
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Gilly
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Belgium
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Leuven
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Canada
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Edmonton
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Canada
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Halifax
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Canada
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Montreal
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Canada
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Ottawa
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Canada
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Sherbrooke
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Canada
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Toronto
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Chile
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Temuco
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Chile
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Vina del Mar
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China
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Beijing
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China
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Changchun
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China
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Chengdu
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China
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Chongqing
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China
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Dalian
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China
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Fuzhou
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China
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Guangzhou City
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China
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Hangzhou
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China
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Harbin
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China
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Jinan
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China
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Nanjing City
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China
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Nanning City
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China
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Qingdao
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China
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Shanghai
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China
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Suzhou
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China
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Xian
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Czech Republic
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Brno
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Czech Republic
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Olomouc
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Czech Republic
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Prague 2
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Czech Republic
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Prague 4
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Czech Republic
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Prague 8
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Czech Republic
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Usti nad Labem
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Denmark
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Aarhus C
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Egypt
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Alexandria
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Egypt
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Cairo
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France
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Amiens
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France
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Clichy
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France
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Creteil
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France
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Lille Cedex
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France
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Paris Cedex 12
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France
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Paris Cedex 13
Country [60] 0 0
France
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Rouen Cedex
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France
State/province [61] 0 0
Strasbourg Cedex
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France
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Vandoeuvre Les Nancy
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Germany
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Berlin
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Germany
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Bochum
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Germany
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Frankfurt am Main
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Germany
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Freiburg
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Germany
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Mainz
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Greece
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Athens
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Hong Kong
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Hong Kong
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Italy
State/province [70] 0 0
Benevento
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Italy
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Milan
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Italy
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Palermo
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Italy
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Pavia
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Italy
State/province [74] 0 0
Rome
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Japan
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Aichi
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Japan
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Chiba
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Japan
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Fukuoka
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Japan
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Hokkaido
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Japan
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Ibaraki-ken
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Japan
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Kanazawa
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Japan
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Kumamoto
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Japan
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Kurume
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Japan
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Matsuyama-city
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Japan
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Osakasayama
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Japan
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Osaka
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Japan
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Shimotsuke
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Japan
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Shizuoka
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Japan
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Tochigi-ken
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Japan
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Tokyo
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Japan
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Yokohama City
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Japan
State/province [91] 0 0
Yufu
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Korea, Republic of
State/province [92] 0 0
Busan
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Korea, Republic of
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Daegu
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Jeollanam-do
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Korea, Republic of
State/province [96] 0 0
Jeonju-si
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Korea, Republic of
State/province [97] 0 0
Seoul
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Korea, Republic of
State/province [98] 0 0
Suwon-si
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Malaysia
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Kuala Lumpur
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Malaysia
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Penang
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Malaysia
State/province [101] 0 0
Petaling Jaya, Selangor
Country [102] 0 0
Mexico
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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
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Netherlands
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Rotterdam
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New Zealand
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Auckland
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Norway
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Oslo
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Puerto Rico
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Ponce
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Puerto Rico
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San Juan
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Romania
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Baia Mare
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Romania
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Bucharest
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Romania
State/province [112] 0 0
Cluj Napoca
Country [113] 0 0
Romania
State/province [113] 0 0
Craiova
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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
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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
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Spain
State/province [120] 0 0
A Coruna
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Spain
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Madrid
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Spain
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Santander
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Spain
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Zaragoza
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Taiwan
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Changhua City
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Taiwan
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Kaohsiung County
Country [126] 0 0
Taiwan
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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
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01009593