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

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:

MedlinePlus related topics: Cancer Digestive Diseases Liver Cancer Liver Diseases

Drug Information available for: Sorafenib Sorafenib tosylate

U.S. FDA Resources

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

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 Publica 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:

Adenocarcinoma
Adenocarcinoma, Mucinous
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
Carcinoma, Hepatocellular

Neoplasms, Cystic, Mucinous, and Serous
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 May 16, 2013