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

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ClinicalTrials.gov Identifier: NCT00825955
Recruitment Status : Completed
First Posted : January 21, 2009
Last Update Posted : October 9, 2019
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment Phase
Liver Cancer Drug: Brivanib Other: Placebo Procedure: Best Supportive Care Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 587 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 Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Subjects With Advanced Hepatocellular Carcinoma (HCC) Who Have Failed or Are Intolerant to Sorafenib: The BRISK PS Study (Brivanib Study in HCC Patients at Risk Post Sorafenib)
Actual Study Start Date : February 17, 2009
Actual Primary Completion Date : November 15, 2011
Actual Study Completion Date : August 25, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

Arm Intervention/treatment
Experimental: Brivanib Drug: Brivanib
Tablets, Oral, 800 mg, once daily, until disease progression or toxicity
Other Name: BMS-582664

Procedure: Best Supportive Care
Trans-Arterial Chemo-Embolization (TACE) Therapy

Placebo Comparator: Placebo Other: Placebo
Tablets, Oral, 0 mg, once daily, until disease progression or toxicity

Procedure: Best Supportive Care
Trans-Arterial Chemo-Embolization (TACE) Therapy

Primary Outcome Measures :
  1. 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: computerized tomography (CT)/ magnetic resonance imaging (MRI) every six weeks until progression or death ]

Secondary Outcome Measures :
  1. To compare time to progression (TTP) (Investigator assessed using modified Response Evaluation Criteria In Solid Tumors (RECIST) for HCC criteria) [ Time Frame: 35 months ]
  2. To compare the Independent Radiological Review Committee (IRRC) assessed objective response rate (ORR) and disease control rate (DCR) using modified RECIST for HCC criteria [ Time Frame: 35 months ]
  3. To assess duration of response, duration of disease control and time to response [ Time Frame: 6 weeks ]
  4. To assess safety profile of brivanib. Safety will be assessed by the number of adverse events (AEs), serious adverse events (SAEs), periodic data monitoring committee (DMC) review [ Time Frame: 35 months ]

Information from the National Library of Medicine

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

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

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
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2
  • Subjects who have a life expectancy of at least 8 weeks
  • Adequate hematologic, hepatic, and renal function

Exclusion Criteria:

  • women of childbearing potential (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 > Common Terminology Criteria for Adverse Events (CTCAE) 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)

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): NCT00825955

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Sponsors and Collaborators
Bristol-Myers Squibb
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
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: NCT00825955    
Other Study ID Numbers: CA182-034
EUDRACT #: 2008-005084-34
First Posted: January 21, 2009    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases