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First Line Hepato Cellular Carcinoma (HCC)

NCT00858871 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1714

Last updated 2016-10-17

No results posted yet for this study

Summary

The purpose of this study is to compare the overall survival of brivanib versus sorafenib in subjects with advanced HCC who have not received prior systemic therapy.

Conditions

  • Hepato Cellular Carcinoma (HCC)

Interventions

DRUG

Brivanib

Tablets, Oral, 800 mg, Once Daily, Until disease progression or unacceptable toxicity

DRUG

Placebo

Capsules, Oral, twice Daily, Until disease progression or unacceptable toxicity

DRUG

Sorafenib

Capsules, Oral, 800 mg, twice daily, Until disease progression or unacceptable toxicity

DRUG

Placebo

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

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2012-06-30
Completion
2013-09-30

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Canada
  • China
  • Czechia
  • France
  • Germany
  • Hong Kong
  • India
  • Italy
  • Japan
  • Mexico
  • Poland
  • Puerto Rico
  • Russia
  • South Africa
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT00858871 on ClinicalTrials.gov