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Efficacy and Tolerability of ABT-869 Versus Sorafenib in Advanced Hepatocellular Carcinoma (HCC)

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 evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01009593
Recruitment Status : Terminated (See termination reason in detailed description)
First Posted : November 6, 2009
Last Update Posted : September 10, 2012
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Non-resectable Hepatocellular Carcinoma Recurrent Carcinoma, Hepatocellular Liver Diseases Neoplasms by Histologic Type Digestive System Neoplasms Carcinoma Liver Neoplasms Neoplasms Neoplasms by Site Digestive System Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial Drug: ABT-869 Drug: Sorafenib Phase 3

Detailed Description:
The IDMC recommended discontinuation of the study, and, the protocol was amended to end study treatment.

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Study Type : Interventional  (Clinical Trial)
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 : January 2010
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Sorafenib

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.

Primary Outcome Measures :
  1. Overall Survival [ Time Frame: From randomization until patient death; assessed monthly ]

Secondary Outcome Measures :
  1. Time To Progression (TTP) [ Time Frame: From randomization until patient progression; assessed every 6 weeks ]
  2. Overall Response Rate (ORR) [ Time Frame: Assessed Every 6 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01009593

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Sponsors and Collaborators
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Study Director: Justin Ricker, MD Abbott
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Abbott Identifier: NCT01009593    
Other Study ID Numbers: M10-963
2009-013435-38 ( EudraCT Number )
First Posted: November 6, 2009    Key Record Dates
Last Update Posted: September 10, 2012
Last Verified: June 2012
Keywords provided by Abbott:
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors
Angiogenesis Inhibitors
Inhibitors, Angiogenesis
Protein Kinase Inhibitors
Pharmacologic Actions
Growth Inhibitors
Angiogenesis Modulating Agents
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Liver Neoplasms
Neoplasms by Site
Digestive System Neoplasms
Gastrointestinal Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Liver Diseases
Digestive System Diseases
Gastrointestinal Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action