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

Carcinoma, Hepatocellular Clinical Trial

— BRISK-APS  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01108705
• Other study ID #: CA182-047
• Status: Terminated
• Phase: Phase 3
• First received: April 15, 2010
• Last updated: September 23, 2015
• Start date: May 2010
• Est. completion date: October 2013

Study information

• Verified date: September 2015
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug AdministrationKorea: Food and Drug AdministrationSingapore: Health Sciences Authority
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 87
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular

Intervention

Drug:
• Brivanib
Tablets, Oral, 800 mg, once daily, until disease progression or toxicity
• Placebo
Tablets, Oral, 0mg, once daily, until disease progression or toxicity

Locations

Country	Name	City	State
China	Local Institution	Beijing	Beijing
China	Local Institution	Beijing	Beijing
China	Local Institution	Beijing	Beijing
China	Local Institution	Chang Chun	Jilin
China	Local Institution	Changchun	Jilin
China	Local Institution	Chengdu	Sichuan
China	Local Institution	Chongqing	Chongqing
China	Local Institution	Fu Zhou	Fujian
China	Local Institution	Fuzhou	Fujian
China	Local Institution	Guangzhou	Guangdong
China	Local Institution	Guangzhou	Guangdong
China	Local Institution	Guanzhou	Guangdong
China	Local Institution	Ha Erbin	Heilongjiang
China	Local Institution	Hangzhou	Zhejiang
China	Local Institution	Hankou	Hubei
China	Local Institution	Hefei	Anhui
China	Local Institution	Nanjing	Jiangsu
China	Local Institution	Nanjing	Jiangsu
China	Local Institution	Shanghai	Shanghai
China	Local Institution	Shanghai	Shanghai
China	Local Institution	Shenyang	Liaoning
China	Local Institution	Suzhou	Jiangsu
China	Local Institution	Tianjing	Tianjin
China	Local Institution	Wuhan	Hubei
China	Local Institution	Xi An
China	Local Institution	Xi'an
Korea, Republic of	Local Institution	Gyeonggi-do
Korea, Republic of	Local Institution	Seoul
Singapore	Local Institution	Singapore
Taiwan	Local Institution	Kaohsiung County
Taiwan	Local Institution	Taipei
Taiwan	Local Institution	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

China,  Korea, Republic of,  Singapore,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Every 6 weeks for an average of 6 months	No
Secondary	Compare time to progression (TTP) using modified RECIST for HCC		Every 6 weeks	No
Secondary	Compare objective response rate (ORR) and disease control rate (DCR) using modified RECIST for HCC		Every 6 weeks	No
Secondary	Assess duration of response, duration of disease control and time to response		Every 6 weeks	No
Secondary	Assess serious and nonserious adverse events, laboratory evaluations, significant physical examination findings and ECG results		Every 6 weeks	Yes

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry form