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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Terminated
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
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United States of America
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California
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Delaware
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Graz
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Vienna
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Brussels
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Belgium
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Edegem
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Ghent
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Gilly
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Taiwan
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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/ct2/show/NCT01009593
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01009593