Comparison of Brivanib and Best Supportive Care to Placebo for Treatment of Liver Cancer for Those Subjects Who Have Failed Sorafenib Treatment


Tracking Information

Start Date  ICMJEFebruary 2009
Estimated Primary Completion DateJanuary 2011   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 24, 2009)		To compare overall survival of subjects with advanced HCC who have progressed on/after or are intolerant to sorafenib and receive brivanib plus best supportive care (BSC) to those receiving placebo plus BSC [ Time Frame: CT/MRI every six weeks until progression or death ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ICMJE 
 (submitted: January 20, 2009)		Compare overall survival of subjects with advanced HCC who have progressed on/after or are intolerant to sorafenib and receive brivanib plus best supportive care (BSC) to those receiving placebo plus BSC [ Time Frame: CT/MRI every six weeks until progression or death ] [ Designated as safety issue: No ]
Change HistoryComplete list of historical versions of study NCT00825955 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: November 24, 2009)
  • To compare time to progression (TTP) (Investigator assessed using modified RECIST for HCC criteria) [ Time Frame: 23 months ] [ Designated as safety issue: No ]
  • To compare investigator assessed objective response rate (ORR) and disease control rate (DCR) using modified RECIST for HCC criteria [ Time Frame: 23 months ] [ Designated as safety issue: No ]
  • To assess duration of response, duration of disease control and time to response [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • To assess safety profile of brivanib [ Time Frame: 23 months ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ICMJE 
 (submitted: January 20, 2009)
  • Compare time to progression (TTP) (Investigator assessed using modified WHO criteria) [ Time Frame: 23 months ] [ Designated as safety issue: No ]
  • Compare investigator assessed objective response rate (ORR) and disease control rate (DCR) using modified WHO criteria [ Time Frame: 23 months ] [ Designated as safety issue: No ]
  • Assess duration of response, duration of disease control and time to response [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Assess safety profile of brivanib [ Time Frame: 23 months ] [ Designated as safety issue: Yes ]

Descriptive Information

Brief Title  ICMJEComparison of Brivanib and Best Supportive Care to Placebo for Treatment of Liver Cancer for Those Subjects Who Have Failed Sorafenib Treatment
Official Title  ICMJEA Randomized, Double-blind, Multi-center Phase III Study of Brivanib Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Subjects With Advanced Hepatocellular Carcinoma (HCC) Who Have Failed or Are Intolerant to Sorafenib
Brief Summary

The purpose of this study is to determine if brivanib is an effective treatment for liver cancer in patients who have failed or could not take sorafenib

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Condition  ICMJELiver Cancer
Intervention  ICMJE
  • Drug: Brivanib
    Tablets, Oral, 800 mg, once daily, until disease progression or toxicity
    Other Name: BMS-582664
  • Drug: Placebo
    Tablets, Oral, once daily, until disease progression or toxicity
Study Arms / Comparison Groups
  • Brivanib: Experimental
    Intervention: Drug: Brivanib
  • Placebo: Placebo Comparator
    Intervention: Drug: Placebo

Recruitment Information

Estimated Enrollment  ICMJE340
Estimated Completion DateJanuary 2011
Estimated Primary Completion DateJanuary 2011   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologic or cytologic confirmed diagnosis of HCC
  • Advanced disease defined as (i) disease not eligible for surgical or loco-regional therapy or (ii) disease progressive after surgical or loco-regional therapy
  • Patient has failed >= 14 days of sorafenib treatment
  • Cirrhotic status of Child-Pugh Class A or B with a score of 7
  • EDOG performance status 0, 1, 2
  • Subjects who have a life expectancy of at least 8 weeks
  • Adequate hematologic, hepatic, and renal function

Exclusion Criteria:

  • WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy
  • Previous or concurrent cancer that is distinct in primary site
  • History of active cardiac disease
  • Thrombotic or embolic events within the past 6 months
  • Any other hemorrhage/bleeding event > CTC AE Grade 3 within 4 weeks
  • Inability to swallow tablets or untreated malabsorption syndrome
  • History of human immunodeficiency virus (HIV) infection
  • Prior use of systemic investigational agents for HCC (except for Sorafenib)
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.
Location Countries  ICMJEUnited States,   Argentina,   Belgium,   Brazil,   Canada,   China,   France,   Germany,   Greece,   Hong Kong,   India,   Italy,   Japan,   Korea, Republic of,   Mexico,   Russian Federation,   Spain,   Sweden,   Taiwan

Administrative Information

NCT ID  ICMJENCT00825955
Responsible PartyStudy Director, Bristol-Myers Squibb
Study ID Numbers  ICMJECA182-034, EUDRACT #: 2008-005084-34
Study Sponsor  ICMJEBristol-Myers Squibb
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Bristol-Myers SquibbBristol-Myers Squibb
Information Provided ByBristol-Myers Squibb