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

Phase 3

Terminated

• Conditions: 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
• Interventions: Drug: ABT-869; Drug: Sorafenib

• Registration Number: NCT01009593
• Lead Sponsor: Abbott

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2009-10-14
• Study First Submitted QC: 2009-11-05
• Study First Posted: 2009-11-06
• Study Start: 2010-01
• Status Verified: 2012-06
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Last Update Submitted: 2012-09-07
• Last Update Posted: 2012-09-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1035

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ABT-869	ABT-869	-
Sorafenib	Sorafenib	-

Primary Outcome Measures

Name	Time	Method
Overall Survival	From randomization until patient death; assessed monthly

Secondary Outcome Measures

Name	Time	Method
Time To Progression (TTP)	From randomization until patient progression; assessed every 6 weeks
Overall Response Rate (ORR)	Assessed Every 6 weeks

Trial Locations

Locations (163)

Site Reference ID/Investigator# 23247; 🇺🇸 Beverly Hills, California, United States

Site Reference ID/Investigator# 23608; 🇺🇸 LaVerne, California, United States

Site Reference ID/Investigator# 23852; 🇺🇸 Orange, California, United States

Site Reference ID/Investigator# 40162; 🇺🇸 Orange, California, United States

Site Reference ID/Investigator# 23254; 🇺🇸 Newark, Delaware, United States

Site Reference ID/Investigator# 23253; 🇺🇸 Gainesville, Georgia, United States

Site Reference ID/Investigator# 23609; 🇺🇸 Honolulu, Hawaii, United States

Site Reference ID/Investigator# 24848; 🇺🇸 Honolulu, Hawaii, United States

Site Reference ID/Investigator# 23250; 🇺🇸 Louisville, Kentucky, United States

Site Reference ID/Investigator# 23257; 🇺🇸 St. Louis, Missouri, United States

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