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)
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| ClinicalTrials.gov Identifier: NCT01108705 |
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Recruitment Status :
Terminated
First Posted : April 22, 2010
Last Update Posted : October 12, 2015
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Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Carcinoma, Hepatocellular | Drug: Brivanib Drug: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 87 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | 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 Start Date : | May 2010 |
| Actual Primary Completion Date : | October 2013 |
| Actual Study Completion Date : | October 2013 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Brivanib |
Drug: Brivanib
Tablets, Oral, 800 mg, once daily, until disease progression or toxicity
Other Name: BMS-582664 |
| Placebo Comparator: Placebo |
Drug: Placebo
Tablets, Oral, 0mg, once daily, until disease progression or toxicity |
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 [ Time Frame: Every 6 weeks for an average of 6 months ]
Secondary Outcome Measures :
- Compare time to progression (TTP) using modified RECIST for HCC [ Time Frame: Every 6 weeks ]
- Compare objective response rate (ORR) and disease control rate (DCR) using modified RECIST for HCC [ Time Frame: Every 6 weeks ]
- Assess duration of response, duration of disease control and time to response [ Time Frame: Every 6 weeks ]
- Assess serious and nonserious adverse events, laboratory evaluations, significant physical examination findings and ECG results [ Time Frame: Every 6 weeks ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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)
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01108705
Locations
| China, Anhui | |
| Local Institution | |
| Hefei, Anhui, China, 230022 | |
| China, Beijing | |
| Local Institution | |
| Beijing, Beijing, China, 100021 | |
| Local Institution | |
| Beijing, Beijing, China, 100071 | |
| Local Institution | |
| Beijing, Beijing, China, 100853 | |
| China, Chongqing | |
| Local Institution | |
| Chongqing, Chongqing, China, 400038 | |
| China, Fujian | |
| Local Institution | |
| Fu Zhou, Fujian, China, 350014 | |
| Local Institution | |
| Fuzhou, Fujian, China, 350025 | |
| China, Guangdong | |
| Local Institution | |
| Guangzhou, Guangdong, China, 510060 | |
| Local Institution | |
| Guangzhou, Guangdong, China, 510515 | |
| Local Institution | |
| Guanzhou, Guangdong, China, 610080 | |
| China, Heilongjiang | |
| Local Institution | |
| Ha Erbin, Heilongjiang, China, 150040 | |
| China, Hubei | |
| Local Institution | |
| Hankou, Hubei, China, 430023 | |
| Local Institution | |
| Wuhan, Hubei, China, 430030 | |
| China, Jiangsu | |
| Local Institution | |
| Nanjing, Jiangsu, China, 210002 | |
| Local Institution | |
| Nanjing, Jiangsu, China, 210029 | |
| Local Institution | |
| Suzhou, Jiangsu, China, 215006 | |
| China, Jilin | |
| Local Institution | |
| Chang Chun, Jilin, China, 130012 | |
| Local Institution | |
| Changchun, Jilin, China, 130021 | |
| China, Liaoning | |
| Local Institution | |
| Shenyang, Liaoning, China, 110001 | |
| China, Shanghai | |
| Local Institution | |
| Shanghai, Shanghai, China, 200032 | |
| Local Institution | |
| Shanghai, Shanghai, China, 200080 | |
| China, Sichuan | |
| Local Institution | |
| Chengdu, Sichuan, China, 610041 | |
| China, Tianjin | |
| Local Institution | |
| Tianjing, Tianjin, China, 300060 | |
| China, Zhejiang | |
| Local Institution | |
| Hangzhou, Zhejiang, China, 310022 | |
| China | |
| Local Institution | |
| Xi An, China, 710000 | |
| Local Institution | |
| Xi'an, China, 710038 | |
| Korea, Republic of | |
| Local Institution | |
| Gyeonggi-do, Korea, Republic of, 410-769 | |
| Local Institution | |
| Seoul, Korea, Republic of, 135-710 | |
| Singapore | |
| Local Institution | |
| Singapore, Singapore, 308433 | |
| Taiwan | |
| Local Institution | |
| Kaohsiung County, Taiwan, 833 | |
| Local Institution | |
| Taipei, Taiwan, 11217 | |
| Local Institution | |
| Taoyuan, Taiwan, 333 | |
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT01108705 |
| Other Study ID Numbers: |
CA182-047 |
| First Posted: | April 22, 2010 Key Record Dates |
| Last Update Posted: | October 12, 2015 |
| Last Verified: | September 2015 |
Additional relevant MeSH terms:
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Carcinoma Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma |
Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases |