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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00858871
Recruitment Status : Completed
First Posted : March 10, 2009
Last Update Posted : October 17, 2016
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hepato Cellular Carcinoma (HCC) Drug: Brivanib Drug: Placebo Drug: Sorafenib Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1714 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Multi-center Phase III Study of Brivanib Versus Sorafenib as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma
Study Start Date : May 2009
Actual Primary Completion Date : June 2012
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Sorafenib

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Brivanib 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
Active Comparator: Sorafenib 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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. To compare the time to progression (TTP) (investigator assessed using modified RECIST criteria for HCC [ Time Frame: Every 6 weeks ]
  2. 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 ]
  3. To determine duration of response, duration of disease control, and time to response (TTR) [ Time Frame: Every 6 weeks ]
  4. To assess the safety profile of brivanib and sorafenib [ Time Frame: Every 6 weeks ]
  5. To explore PK and exposure-response in the study population [ Time Frame: Every 6 weeks ]
  6. To compare time to symptomatic progression [ Time Frame: Every 6 weeks ]
  7. To compare health-related quality of life [ Time Frame: Every 6 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00858871


Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00858871    
Other Study ID Numbers: CA182-033
EUDRACT # 2008-003533-24
First Posted: March 10, 2009    Key Record Dates
Last Update Posted: October 17, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
 Neoplasms by Site
Digestive System Diseases
Liver Diseases
Sorafenib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action