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

Study Overview
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Brief Summary
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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.

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

Official Title
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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)

Conditions
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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

Intervention / Treatment
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* Drug: ABT-869
* Drug: Sorafenib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABT-869<br> | Drug: ABT-869<br>* Tablets, Oral, 17.5 mg, Once Daily, Until disease progression or unacceptable toxicity<br>|
| Active Comparator: Sorafenib<br> | Drug: Sorafenib<br>* Tablets, Oral, 400 mg, Twice Daily, Until disease progression or unacceptable toxicity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | From randomization until patient death; assessed monthly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time To Progression (TTP) |  | From randomization until patient progression; assessed every 6 weeks | 
| Overall Response Rate (ORR) |  | Assessed Every 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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, Sorafenib