Trial record 1 of 891 for:    "Carcinoma, Hepatocellular"
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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:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01009593
First received: October 14, 2009
Last updated: September 7, 2012
Last verified: June 2012
  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: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time To Progression (TTP) [ Time Frame: From randomization until patient progression; assessed every 6 weeks ] [ Designated as safety issue: No ]
  • Overall Response Rate (ORR) [ Time Frame: Assessed Every 6 weeks ] [ Designated as safety issue: No ]

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
Other Name: ABT-869
Active Comparator: Sorafenib Drug: Sorafenib
Tablets, Oral, 400 mg, Twice Daily, Until disease progression or unacceptable toxicity.
Other Name: Sorafenib

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01009593

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

No publications provided

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01009593     History of Changes
Other Study ID Numbers: M10-963, 2009-013435-38
Study First Received: October 14, 2009
Last Updated: September 7, 2012
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Federal Office for Safety in Health Care
Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Health Canada
Chile: Instituto de Salud Pública de Chile
China: Food and Drug Administration
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Egypt: Ministry of Health, Drug Policy and Planning Center
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organization of Medicines
Hong Kong: Department of Health
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Japan: Pharmaceuticals and Medical Devices Agency
Korea: Food and Drug Administration
Malaysia: Ministry of Health
Mexico: Federal Commission for Protection Against Health Risks
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
New Zealand: Medsafe
Norway: Norwegian Medicines Agency
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
Singapore: Health Sciences Authority
Spain: Agencia Española de Medicamentos y Productos Sanitarios
United States: Food and Drug Administration
Taiwan : Food and Drug Administration

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, Hepatocellular
Adenocarcinoma
Neoplasms
Carcinoma
Digestive System Diseases
Gastrointestinal Diseases
Digestive System Neoplasms
Gastrointestinal Neoplasms
Liver Diseases
Liver Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Sorafenib
Antineoplastic Agents
Angiogenesis Inhibitors
Protein Kinase Inhibitors
Angiogenesis Modulating Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Therapeutic Uses
Pharmacologic Actions
Growth Substances
Growth Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 01, 2014