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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)
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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)
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Secondary ID [1]
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0
2009-013435-38
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Secondary ID [2]
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0
M10-963
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hepatocellular Carcinoma Non-resectable
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0
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Hepatocellular Carcinoma Recurrent
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0
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Carcinoma, Hepatocellular
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0
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Liver Diseases
0
0
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Neoplasms by Histologic Type
0
0
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Digestive System Neoplasms
0
0
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Carcinoma
0
0
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Liver Neoplasms
0
0
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Neoplasms
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0
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Neoplasms by Site
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0
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Digestive System Diseases
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0
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Adenocarcinoma
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0
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Neoplasms, Glandular and Epithelial
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0
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Condition category
Condition code
Cancer
0
0
0
0
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Non melanoma skin cancer
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Cancer
0
0
0
0
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Kidney
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Cancer
0
0
0
0
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Liver
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Oral and Gastrointestinal
0
0
0
0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Cancer
0
0
0
0
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Any cancer
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Cancer
0
0
0
0
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Bowel - Back passage (rectum) or large bowel (colon)
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Cancer
0
0
0
0
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Oesophageal (gullet)
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Cancer
0
0
0
0
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Other cancer types
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
0
0
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Survival
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Assessment method [1]
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Timepoint [1]
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From randomization until patient death; assessed monthly
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Secondary outcome [1]
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Time To Progression (TTP)
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Assessment method [1]
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Timepoint [1]
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From randomization until patient progression; assessed every 6 weeks
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Secondary outcome [2]
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Overall Response Rate (ORR)
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Assessment method [2]
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Timepoint [2]
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Assessed Every 6 weeks
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/07/2012
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Sample size
Target
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Accrual to date
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Final
1035
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Site Reference ID/Investigator# 23152 - Camperdown
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Recruitment hospital [2]
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Site Reference ID/Investigator# 23150 - Concord
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Recruitment hospital [3]
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Site Reference ID/Investigator# 27122 - Kingswood
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Recruitment hospital [4]
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Site Reference ID/Investigator# 23153 - Kogarah
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Recruitment hospital [5]
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Site Reference ID/Investigator# 24103 - Southport
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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2139 - Concord
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Recruitment postcode(s) [3]
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2747 - Kingswood
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Recruitment postcode(s) [4]
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2217 - Kogarah
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Recruitment postcode(s) [5]
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4215 - Southport
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Recruitment outside Australia
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California
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Rosario, Santa Fe
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Yufu
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Abbott
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Address
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01009593
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Contacts
Principal investigator
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Justin Ricker, MD
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Abbott
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01009593
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