First Line Hepato Cellular Carcinoma (HCC) (BRISK FL)


Tracking Information

Start Date  ICMJEMay 2009
Estimated Primary Completion DateFebruary 2013   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: March 9, 2009)
To compare the overall survival of brivanib versus sorafenib in subjects with advanced HCC who have not received prior systemic treatment [ Time Frame: Survival will be assessed continuously ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00858871 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: November 18, 2009)
  • To compare the time to progression (TTP) (investigator assessed using modified RECIST criteria for HCC [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
  • To compare the investigator assessed objective response rate (ORR) and disease control rate (DCR) using modified RECIST criteria for HCC [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
  • To determine duration of response, duration of disease control, and time to response (TTR) [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
  • To assess the safety profile of brivanib and sorafenib [ Time Frame: Every 6 weeks ] [ Designated as safety issue: Yes ]
  • To explore PK and exposure-response in the study population [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
  • To compare time to symptomatic progression [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
  • To compare health-related quality of life [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures  ICMJE 
 (submitted: March 9, 2009)
  • To compare the time to progression (TTP) (investigator assessed using modified RECIST criteria [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
  • To compare the investigator assessed objective response rate (ORR) and disease control rate (DCR) using modified RECIST criteria [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
  • To determine duration of response, duration of disease control, and time to response (TTR) [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
  • To assess the safety profile of brivanib and sorafenib [ Time Frame: Every 6 weeks ] [ Designated as safety issue: Yes ]
  • To explore PK and exposure-response in the study population [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
  • To compare time to symptomatic progression [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
  • To compare health-related quality of life [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]

Descriptive Information

Brief Title  ICMJEFirst Line Hepato Cellular Carcinoma (HCC)
Official Title  ICMJEA Randomized, Double-blind, Multi-center Phase III Study of Brivanib Versus Sorafenib as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma
Brief 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.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Condition  ICMJEHepato Cellular Carcinoma (HCC)
Intervention  ICMJE
  • Drug: Brivanib
    Tablets, Oral, 800 mg, Once Daily, Until disease progression or unacceptable toxicity
    Other Name: BMS-582664
  • 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
Study Arms / Comparison Groups
  • Brivanib: Active Comparator
    Interventions:
    • Drug: Brivanib
    • Drug: Placebo
  • Sorafenib: Active Comparator
    Interventions:
    • Drug: Sorafenib
    • Drug: Placebo

Recruitment Information

Estimated Enrollment  ICMJE1050
Estimated Completion DateFebruary 2013
Estimated Primary Completion DateFebruary 2013   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologic or cytologic confirmed diagnosis of HCC.
  • Advanced HCC: disease not eligible for surgical and/or locoregional therapies OR progressive disease after surgical and/or locoregional therapies
  • Child-Pugh Class A
  • ECOG performance status 0-1
  • Adequate hematologic, hepatic, and renal function

Exclusion Criteria:

  • Prior use of any systemic anti-cancer chemotherapy, immunotherapy or molecular targeted agents for HCC
  • History of active cardiac disease
  • Thrombotic or embolic events within the past 6 months (except HCC tumor thrombus)
  • Any other hemorrhage/bleeding event >= CTCAE Grade 3 within 8 weeks except for esophageal or gastric varices
  • Inability to swallow tablets or untreated malabsorption syndrome
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,   Australia,   Belgium,   Brazil,   Canada,   China,   Czech Republic,   France,   Germany,   Hong Kong,   India,   Italy,   Japan,   Korea, Republic of,   Mexico,   Poland,   Russian Federation,   South Africa,   Spain,   Sweden,   Taiwan,   Thailand,   Turkey,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00858871
Responsible PartyStudy Director, Bristol-Myers Squibb
Study ID Numbers  ICMJECA182-033, EUDRACT # 2008-003533-24
Study Sponsor  ICMJEBristol-Myers Squibb
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Bristol-Myers SquibbBristol-Myers Squibb
Information Provided ByBristol-Myers Squibb