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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)


Phase 3
18 Years
N/A
Not Enrolling
Both
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

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Trial Information

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)


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

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Time Frame:

From randomization until patient death; assessed monthly

Safety Issue:

No

Principal Investigator

Justin Ricker, MD

Investigator Role:

Study Director

Investigator Affiliation:

Abbott

Authority:

Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Study ID:

M10-963

NCT ID:

NCT01009593

Start Date:

January 2010

Completion Date:

July 2012

Related Keywords:

  • 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
  • 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
  • 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

Name

Location

Site Reference ID/Investigator# 23247Beverly Hills, California  90211-1850
Site Reference ID/Investigator# 23608LaVerne, California  91750
Site Reference ID/Investigator# 23852Orange, California  92868
Site Reference ID/Investigator# 40162Orange, California  92868
Site Reference ID/Investigator# 23254Newark, Delaware  19713
Site Reference ID/Investigator# 23253Gainesville, Georgia  30505
Site Reference ID/Investigator# 24848Honolulu, Hawaii  96819
Site Reference ID/Investigator# 23609Honolulu, Hawaii  96813
Site Reference ID/Investigator# 23250Louisville, Kentucky  40202
Site Reference ID/Investigator# 23257St. Louis, Missouri  63104
Site Reference ID/Investigator# 23603Las Vegas, Nevada  89135
Site Reference ID/Investigator# 23244Durham, North Carolina  27710
Site Reference ID/Investigator# 23252Portland, Oregon  97213