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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.
Information provided by (Responsible Party):
Bristol-Myers Squibb Identifier:
First received: April 15, 2010
Last updated: September 23, 2015
Last verified: September 2015
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.

Condition Intervention Phase
Carcinoma, Hepatocellular
Drug: Brivanib
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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 Asian Subjects With Advanced Hepatocellular Carcinoma (HCC) Who Have Failed or Are Intolerant to Sorafenib

Resource links provided by NLM:

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 87
Study Start Date: May 2010
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Brivanib Drug: Brivanib
Tablets, Oral, 800 mg, once daily, until disease progression or toxicity
Other Name: BMS-582664
Placebo Comparator: Placebo Drug: Placebo
Tablets, Oral, 0mg, once daily, until disease progression or toxicity


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

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)
  Contacts and Locations
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Please refer to this study by its identifier: NCT01108705

  Hide Study Locations
China, Anhui
Local Institution
Hefei, Anhui, China, 230022
China, Beijing
Local Institution
Beijing, Beijing, China, 100021
Local Institution
Beijing, Beijing, China, 100071
Local Institution
Beijing, Beijing, China, 100853
China, Chongqing
Local Institution
Chongqing, Chongqing, China, 400038
China, Fujian
Local Institution
Fu Zhou, Fujian, China, 350014
Local Institution
Fuzhou, Fujian, China, 350025
China, Guangdong
Local Institution
Guangzhou, Guangdong, China, 510060
Local Institution
Guangzhou, Guangdong, China, 510515
Local Institution
Guanzhou, Guangdong, China, 610080
China, Heilongjiang
Local Institution
Ha Erbin, Heilongjiang, China, 150040
China, Hubei
Local Institution
Hankou, Hubei, China, 430023
Local Institution
Wuhan, Hubei, China, 430030
China, Jiangsu
Local Institution
Nanjing, Jiangsu, China, 210002
Local Institution
Nanjing, Jiangsu, China, 210029
Local Institution
Suzhou, Jiangsu, China, 215006
China, Jilin
Local Institution
Chang Chun, Jilin, China, 130012
Local Institution
Changchun, Jilin, China, 130021
China, Liaoning
Local Institution
Shenyang, Liaoning, China, 110001
China, Shanghai
Local Institution
Shanghai, Shanghai, China, 200032
Local Institution
Shanghai, Shanghai, China, 200080
China, Sichuan
Local Institution
Chengdu, Sichuan, China, 610041
China, Tianjin
Local Institution
Tianjing, Tianjin, China, 300060
China, Zhejiang
Local Institution
Hangzhou, Zhejiang, China, 310022
Local Institution
Xi An, China, 710000
Local Institution
Xi'an, China, 710038
Korea, Republic of
Local Institution
Gyeonggi-do, Korea, Republic of, 410-769
Local Institution
Seoul, Korea, Republic of, 135-710
Local Institution
Singapore, Singapore, 308433
Local Institution
Kaohsiung County, Taiwan, 833
Local Institution
Taipei, Taiwan, 11217
Local Institution
Taoyuan, Taiwan, 333
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb Identifier: NCT01108705     History of Changes
Other Study ID Numbers: CA182-047
Study First Received: April 15, 2010
Last Updated: September 23, 2015

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on April 28, 2017