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

This study has been terminated.
(See termination reason in detailed description)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01009593
First Posted: November 6, 2009
Last Update Posted: September 10, 2012
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.
Information provided by (Responsible Party):
Abbott
  Purpose
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 Intervention 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

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Abbott:

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

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

Enrollment: 1035
Study Start Date: January 2010
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01009593


  Show 163 Study Locations
Sponsors and Collaborators
Abbott
Investigators
Study Director: Justin Ricker, MD Abbott
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01009593     History of Changes
Other Study ID Numbers: M10-963
2009-013435-38 ( EudraCT Number )
First Submitted: October 14, 2009
First Posted: November 6, 2009
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
Sorafenib

Additional relevant MeSH terms:
Carcinoma
Neoplasms
Adenocarcinoma
Carcinoma, Hepatocellular
Liver Diseases
Liver Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Neoplasms by Site
Digestive System Neoplasms
Gastrointestinal Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Sorafenib
Niacinamide
Molecular Mechanisms of Pharmacological Action
Angiogenesis Modulating Agents
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs