Comparison of Brivanib and Best Supportive Care to Placebo for Treatment of Liver Cancer for Asian Subjects 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: May 15, 2014
Last verified: May 2014

April 15, 2010
May 15, 2014
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • Compare objective response rate (ORR) and disease control rate (DCR) using modified RECIST for HCC [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
  • Assess duration of response, duration of disease control and time to response [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
  • Assess serious and nonserious adverse events, laboratory evaluations, significant physical examination findings and ECG results [ Time Frame: Every 6 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Comparison of Brivanib and Best Supportive Care to Placebo for Treatment of Liver Cancer for Asian Subjects 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 if brivanib is an effective treatment for liver cancer in Asian patients who have failed or could not take sorafenib.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

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

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
  • 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:

  • 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
  • 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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China,   Korea, Republic of,   Singapore,   Taiwan
 
NCT01108705
CA182-047
Yes
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
May 2014

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