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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)

Primary Purpose

Carcinoma, Hepatocellular

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Brivanib
Placebo
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Hepatocellular

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Brivanib

Placebo

Arm Description

Outcomes

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

Secondary Outcome Measures

Compare time to progression (TTP) using modified RECIST for HCC
Compare objective response rate (ORR) and disease control rate (DCR) using modified RECIST for HCC
Assess duration of response, duration of disease control and time to response
Assess serious and nonserious adverse events, laboratory evaluations, significant physical examination findings and ECG results

Full Information

First Posted
April 15, 2010
Last Updated
September 23, 2015
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT01108705
Brief Title
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
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Terminated
Study Start Date
May 2010 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Hepatocellular

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
87 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brivanib
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Brivanib
Other Intervention Name(s)
BMS-582664
Intervention Description
Tablets, Oral, 800 mg, once daily, until disease progression or toxicity
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablets, Oral, 0mg, once daily, until disease progression or toxicity
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Compare time to progression (TTP) using modified RECIST for HCC
Time Frame
Every 6 weeks
Title
Compare objective response rate (ORR) and disease control rate (DCR) using modified RECIST for HCC
Time Frame
Every 6 weeks
Title
Assess duration of response, duration of disease control and time to response
Time Frame
Every 6 weeks
Title
Assess serious and nonserious adverse events, laboratory evaluations, significant physical examination findings and ECG results
Time Frame
Every 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230022
Country
China
Facility Name
Local Institution
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Facility Name
Local Institution
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100071
Country
China
Facility Name
Local Institution
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Facility Name
Local Institution
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400038
Country
China
Facility Name
Local Institution
City
Fu Zhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
Facility Name
Local Institution
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350025
Country
China
Facility Name
Local Institution
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Facility Name
Local Institution
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Facility Name
Local Institution
City
Guanzhou
State/Province
Guangdong
ZIP/Postal Code
610080
Country
China
Facility Name
Local Institution
City
Ha Erbin
State/Province
Heilongjiang
ZIP/Postal Code
150040
Country
China
Facility Name
Local Institution
City
Hankou
State/Province
Hubei
ZIP/Postal Code
430023
Country
China
Facility Name
Local Institution
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Name
Local Institution
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
Facility Name
Local Institution
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
Local Institution
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Facility Name
Local Institution
City
Chang Chun
State/Province
Jilin
ZIP/Postal Code
130012
Country
China
Facility Name
Local Institution
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
Local Institution
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110001
Country
China
Facility Name
Local Institution
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Local Institution
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200080
Country
China
Facility Name
Local Institution
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Local Institution
City
Tianjing
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Facility Name
Local Institution
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Facility Name
Local Institution
City
Xi An
ZIP/Postal Code
710000
Country
China
Facility Name
Local Institution
City
Xi'an
ZIP/Postal Code
710038
Country
China
Facility Name
Local Institution
City
Gyeonggi-do
ZIP/Postal Code
410-769
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Local Institution
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Facility Name
Local Institution
City
Kaohsiung County
ZIP/Postal Code
833
Country
Taiwan
Facility Name
Local Institution
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Local Institution
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan

12. IPD Sharing Statement

Links:
URL
http://www.bms.com/studyconnect/Pages/home.aspx
Description
BMS clinical trial educational resource

Learn more about this trial

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

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