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

NCT01108705 | Terminated Phase 3 DMC

• 1 other identifier: CA182-047
• Study Type: interventional
• Target: 87
• Locations: 4 countries
• Sites: 32

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.

Conditions

Carcinoma, Hepatocellular

Outcome Measures

Primary Outcomes (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

  Every 6 weeks for an average of 6 months

Secondary Outcomes (4)

• Compare time to progression (TTP) using modified RECIST for HCC

  Every 6 weeks

• Compare objective response rate (ORR) and disease control rate (DCR) using modified RECIST for HCC

  Every 6 weeks

• Assess duration of response, duration of disease control and time to response

  Every 6 weeks

• Assess serious and nonserious adverse events, laboratory evaluations, significant physical examination findings and ECG results

  Every 6 weeks

Study Arms (2)

Brivanib

EXPERIMENTAL

Drug: Brivanib

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Brivanib DRUG

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

Also known as: BMS-582664

Brivanib

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (32)

Local Institution

Hefei, Anhui, 230022, China

Location

Local Institution

Beijing, Beijing Municipality, 100021, China

Location

Local Institution

Beijing, Beijing Municipality, 100071, China

Location

Local Institution

Beijing, Beijing Municipality, 100853, China

Location

Local Institution

Chongqing, Chongqing Municipality, 400038, China

Location

Local Institution

Fuzhou, Fujian, 350014, China

Location

Local Institution

Fuzhou, Fujian, 350025, China

Location

Local Institution

Guangzhou, Guangdong, 510060, China

Location

Local Institution

Guangzhou, Guangdong, 510515, China

Location

Local Institution

Guanzhou, Guangdong, 610080, China

Location

Local Institution

Harbin, Heilongjiang, 150040, China

Location

Local Institution

Hankou, Hubei, 430023, China

Location

Local Institution

Wuhan, Hubei, 430030, China

Location

Local Institution

Nanjing, Jiangsu, 210002, China

Location

Local Institution

Nanjing, Jiangsu, 210029, China

Location

Local Institution

Suzhou, Jiangsu, 215006, China

Location

Local Institution

Changchun, Jilin, 130012, China

Location

Local Institution

Changchun, Jilin, 130021, China

Location

Local Institution

Shenyang, Liaoning, 110001, China

Location

Local Institution

Shanghai, Shanghai Municipality, 200032, China

Location

Local Institution

Shanghai, Shanghai Municipality, 200080, China

Location

Local Institution

Chengdu, Sichuan, 610041, China

Location

Local Institution

Tianjin, Tianjin Municipality, 300060, China

Location

Local Institution

Hangzhou, Zhejiang, 310022, China

Location

Local Institution

Xi'an, 710000, China

Location

Local Institution

Xi'an, 710038, China

Location

Local Institution

Singapore, 308433, Singapore

Location

Local Institution

Gyeonggi-do, 410-769, South Korea

Location

Local Institution

Seoul, 135-710, South Korea

Location

Local Institution

Kaohsiung County, 833, Taiwan

Location

Local Institution

Taipei, 11217, Taiwan

Location

Local Institution

Taoyuan District, 333, Taiwan

Location

Related Links

• BMS clinical trial educational resource
• Investigator Inquiry form

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

brivanib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2010
• First Posted: April 22, 2010
• Study Start: May 1, 2010
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: October 12, 2015

Record last verified: 2015-09

Locations

SG (1); TW (3); KR (2); CN (26)