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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)

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. Identifier: NCT01108705
Recruitment Status : Terminated
First Posted : April 22, 2010
Last Update Posted : October 12, 2015
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
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 or disease Intervention/treatment Phase
Carcinoma, Hepatocellular Drug: Brivanib Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 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 Asian Subjects With Advanced Hepatocellular Carcinoma (HCC) Who Have Failed or Are Intolerant to Sorafenib
Study Start Date : May 2010
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. Compare time to progression (TTP) using modified RECIST for HCC [ Time Frame: Every 6 weeks ]
  2. Compare objective response rate (ORR) and disease control rate (DCR) using modified RECIST for HCC [ Time Frame: Every 6 weeks ]
  3. Assess duration of response, duration of disease control and time to response [ Time Frame: Every 6 weeks ]
  4. Assess serious and nonserious adverse events, laboratory evaluations, significant physical examination findings and ECG results [ Time Frame: Every 6 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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)

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 identifier (NCT number): NCT01108705

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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
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb Identifier: NCT01108705    
Other Study ID Numbers: CA182-047
First Posted: April 22, 2010    Key Record Dates
Last Update Posted: October 12, 2015
Last Verified: September 2015
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases