Clinical trial NCT01108705: 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
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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Carcinoma, Hepatocellular
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2010-04-22
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
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
timeFrame: Every 6 weeks for an average of 6 months
Secondary outcomes:
measure: Compare time to progression (TTP) using modified RECIST for HCC
timeFrame: Every 6 weeks
measure: Compare objective response rate (ORR) and disease control rate (DCR) using modified RECIST for HCC
timeFrame: Every 6 weeks
measure: Assess duration of response, duration of disease control and time to response
timeFrame: Every 6 weeks
measure: Assess serious and nonserious adverse events, laboratory evaluations, significant physical examination findings and ECG results
timeFrame: Every 6 weeks
Other outcomes:
Locations:
city: Hefei
country: China
facility: Local Institution
state: Anhui
city: Beijing
country: China
facility: Local Institution
state: Beijing
city: Beijing
country: China
facility: Local Institution
state: Beijing
city: Beijing
country: China
facility: Local Institution
state: Beijing
city: Chongqing
country: China
facility: Local Institution
state: Chongqing
city: Fu Zhou
country: China
facility: Local Institution
state: Fujian
city: Fuzhou
country: China
facility: Local Institution
state: Fujian
city: Guangzhou
country: China
facility: Local Institution
state: Guangdong
city: Guangzhou
country: China
facility: Local Institution
state: Guangdong
city: Guanzhou
country: China
facility: Local Institution
state: Guangdong
city: Ha Erbin
country: China
facility: Local Institution
state: Heilongjiang
city: Hankou
country: China
facility: Local Institution
state: Hubei
city: Wuhan
country: China
facility: Local Institution
state: Hubei
city: Nanjing
country: China
facility: Local Institution
state: Jiangsu
city: Nanjing
country: China
facility: Local Institution
state: Jiangsu
city: Suzhou
country: China
facility: Local Institution
state: Jiangsu
city: Chang Chun
country: China
facility: Local Institution
state: Jilin
city: Changchun
country: China
facility: Local Institution
state: Jilin
city: Shenyang
country: China
facility: Local Institution
state: Liaoning
city: Shanghai
country: China
facility: Local Institution
state: Shanghai
city: Shanghai
country: China
facility: Local Institution
state: Shanghai
city: Chengdu
country: China
facility: Local Institution
state: Sichuan
city: Tianjing
country: China
facility: Local Institution
state: Tianjin
city: Hangzhou
country: China
facility: Local Institution
state: Zhejiang
city: Xi An
country: China
facility: Local Institution
city: Xi'an
country: China
facility: Local Institution
city: Gyeonggi-do
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Singapore
country: Singapore
facility: Local Institution
city: Kaohsiung County
country: Taiwan
facility: Local Institution
city: Taipei
country: Taiwan
facility: Local Institution
city: Taoyuan
country: Taiwan
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: