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

NCT ID: NCT01108705

Last Updated: 2015-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2013-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Carcinoma, Hepatocellular

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Brivanib

Group Type EXPERIMENTAL

Brivanib

Intervention Type DRUG

Tablets, Oral, 800 mg, once daily, until disease progression or toxicity

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Tablets, Oral, 0mg, once daily, until disease progression or toxicity

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Brivanib

Tablets, Oral, 800 mg, once daily, until disease progression or toxicity

Intervention Type DRUG

Placebo

Tablets, Oral, 0mg, once daily, until disease progression or toxicity

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

BMS-582664

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Local Institution

Hefei, Anhui, China

Site Status

Local Institution

Beijing, Beijing Municipality, China

Site Status

Local Institution

Beijing, Beijing Municipality, China

Site Status

Local Institution

Beijing, Beijing Municipality, China

Site Status

Local Institution

Chongqing, Chongqing Municipality, China

Site Status

Local Institution

Fuzhou, Fujian, China

Site Status

Local Institution

Fuzhou, Fujian, China

Site Status

Local Institution

Guangzhou, Guangdong, China

Site Status

Local Institution

Guangzhou, Guangdong, China

Site Status

Local Institution

Guanzhou, Guangdong, China

Site Status

Local Institution

Harbin, Heilongjiang, China

Site Status

Local Institution

Hankou, Hubei, China

Site Status

Local Institution

Wuhan, Hubei, China

Site Status

Local Institution

Nanjing, Jiangsu, China

Site Status

Local Institution

Nanjing, Jiangsu, China

Site Status

Local Institution

Suzhou, Jiangsu, China

Site Status

Local Institution

Changchun, Jilin, China

Site Status

Local Institution

Changchun, Jilin, China

Site Status

Local Institution

Shenyang, Liaoning, China

Site Status

Local Institution

Shanghai, Shanghai Municipality, China

Site Status

Local Institution

Shanghai, Shanghai Municipality, China

Site Status

Local Institution

Chengdu, Sichuan, China

Site Status

Local Institution

Tianjin, Tianjin Municipality, China

Site Status

Local Institution

Hangzhou, Zhejiang, China

Site Status

Local Institution

Xi'an, , China

Site Status

Local Institution

Xi'an, , China

Site Status

Local Institution

Singapore, , Singapore

Site Status

Local Institution

Gyeonggi-do, , South Korea

Site Status

Local Institution

Seoul, , South Korea

Site Status

Local Institution

Kaohsiung County, , Taiwan

Site Status

Local Institution

Taipei, , Taiwan

Site Status

Local Institution

Taoyuan District, , Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China Singapore South Korea Taiwan

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CA182-047

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.