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Comparison of Brivanib and Best Supportive Care (BSC) With Placebo and BSC for Treatment of Liver Cancer in Asian Patients Who Have Failed Sorafenib Treatment (BRISK-APS)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01108705
First received: April 15, 2010
Last updated: September 23, 2015
Last verified: September 2015

April 15, 2010
September 23, 2015
May 2010
October 2013   (Final data collection date for primary outcome measure)
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: Every 6 weeks for an average of 6 months ]
Same as current
Complete list of historical versions of study NCT01108705 on ClinicalTrials.gov Archive Site
  • Compare time to progression (TTP) using modified RECIST for HCC [ Time Frame: Every 6 weeks ]
  • Compare objective response rate (ORR) and disease control rate (DCR) using modified RECIST for HCC [ Time Frame: Every 6 weeks ]
  • Assess duration of response, duration of disease control and time to response [ Time Frame: Every 6 weeks ]
  • Assess serious and nonserious adverse events, laboratory evaluations, significant physical examination findings and ECG results [ Time Frame: Every 6 weeks ]
Same as current
Not Provided
Not Provided
 
Comparison of Brivanib and Best Supportive Care (BSC) With Placebo and BSC for Treatment of Liver Cancer in Asian Patients Who Have Failed Sorafenib Treatment
A Randomized, Double-blind, Multi-center Phase III Study of Brivanib Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Asian Subjects With Advanced Hepatocellular Carcinoma (HCC) Who Have Failed or Are Intolerant to Sorafenib
The purpose of this study is to determine whether brivanib is an effective treatment for liver cancer in Asian patients who have failed or could not tolerate sorafenib therapy.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Carcinoma, Hepatocellular
  • Drug: Brivanib
    Tablets, Oral, 800 mg, once daily, until disease progression or toxicity
    Other Name: BMS-582664
  • Drug: Placebo
    Tablets, Oral, 0mg, once daily, until disease progression or toxicity
  • Experimental: Brivanib
    Intervention: Drug: Brivanib
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
87
October 2013
October 2013   (Final data collection date for primary outcome measure)

Key Inclusion Criteria:

  • Diagnosis of advanced hepatocellular carcinoma
  • Asian ethnicity
  • 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 performance status of 0, 1, or 2
  • Life expectancy of at least 8 weeks
  • Adequate hematologic, hepatic, and renal function

Key Exclusion Criteria:

  • Women of childbearing potential 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
  • Inability to swallow tablets or untreated malabsorption syndrome
  • History of HIV infection
  • Prior use of systemic investigational agents for hepatocellular carcinoma (except sorafenib)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China,   Korea, Republic of,   Singapore,   Taiwan
 
 
NCT01108705
CA182-047
Yes
Not Provided
Not Provided
Not Provided
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP