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

NCT01009593 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1035

Last updated 2012-09-10

No results posted yet for this study

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.

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
  • Digestive System Diseases
  • Adenocarcinoma
  • Neoplasms, Glandular and Epithelial

Interventions

DRUG

ABT-869

Tablets, Oral, 17.5 mg, Once Daily, Until disease progression or unacceptable toxicity

DRUG

Sorafenib

Tablets, Oral, 400 mg, Twice Daily, Until disease progression or unacceptable toxicity.

Sponsors & Collaborators

Principal Investigators

  • Justin Ricker, MD · Abbott

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Canada
  • Chile
  • China
  • Czechia
  • Denmark
  • Egypt
  • France
  • Germany
  • Greece
  • Hong Kong
  • Italy
  • Japan
  • Malaysia
  • Mexico
  • Netherlands
  • New Zealand
  • Norway
  • Puerto Rico
  • Romania
  • Russia
  • Singapore
  • South Korea
  • Spain
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01009593 on ClinicalTrials.gov