Phase III Trans-Arterial Chemo-Embolization (TACE) Adjuvant HCC
BRISK TA
A Randomized, Double-blind, Multicenter Phase III Study of Brivanib Versus Placebo as Adjuvant Therapy to Trans-Arterial Chemo-Embolization (TACE) in Patients With Unresectable Hepatocellular Carcinoma (The BRISK TA Study)
2 other identifiers
interventional
734
13 countries
94
Brief Summary
The purpose of this study is to compare the Overall Survival (OS) of HCC patients who receive brivanib as adjuvant treatments to TACE therapy, with the OS of HCC patients who receive matched placebo with TACE therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 hepatocellular-carcinoma
Started Jul 2009
Longer than P75 for phase_3 hepatocellular-carcinoma
94 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 22, 2009
CompletedFirst Posted
Study publicly available on registry
May 27, 2009
CompletedStudy Start
First participant enrolled
July 20, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 28, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 26, 2018
CompletedDecember 2, 2019
November 1, 2019
3.2 years
May 22, 2009
November 26, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To compare the Overall Survival (OS) of HCC patients who receive brivanib as adjuvant treatments to TACE therapy, with the OS of HCC patients who receive matched placebo with TACE therapy
Survival will be assessed continuously
Secondary Outcomes (4)
To compare the Time-To-Disease Progression (TTDP) of patients receiving brivanib with TACE therapy to that of patients receiving placebo with TACE therapy
Every 8 weeks
To compare the time to extrahepatic spread or vascular invasion in the brivanib and placebo arms
Every 8 weeks
To determine the total number of TACE sessions in the brivanib and placebo arms and to compare the rate of TACE sessions in the brivanib and placebo arms
End of Study
To evaluate the safety of brivanib in combination with TACE
Every 8 weeks
Study Arms (2)
Brivanib
ACTIVE COMPARATORAdjuvant treatment with TACE Therapy
Brivanib Placebo
PLACEBO COMPARATORPlacebo adjuvant treatment with TACE Therapy
Interventions
Tablets, Oral, 200 mg, once daily, until disease progression or toxicity
Tablets, Oral, 0 mg, once daily, until disease progression or toxicity
Eligibility Criteria
You may qualify if:
- Patients with diagnosis of hepatocellular carcinoma
- Cirrhotic status of Child-Pugh Class A or B with a score of 7
- ECOG performance status of 0 or 1
- Adequate hematologic, hepatic, and renal function
You may not qualify if:
- Prior use of any systemic anticancer chemotherapy, immunotherapy, investigational or molecular targeted agents for HCC
- History of cardiac disease
- Active and untreated hepatitis B
- Inability to swallow tablets or untreated malabsorption syndrome
- History of human immunodeficiency virus (HIV) infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (94)
Richard Finn, M.D.
Los Angeles, California, 90095, United States
Sharp Clinical Oncology Research
San Diego, California, 92123, United States
Montefiore Medical Center
The Bronx, New York, 10467-2401, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
The University Of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
University Of Virginia Health System
Charlottesville, Virginia, 22908, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109-1023, United States
Local Institution
Capital Federal, Buenos Aires, C1405BCK, Argentina
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Buenos Aires, C1181ACH, Argentina
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Parkville, Victoria, 3050, Australia
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Vancouver, British Columbia, V5Z 1M9, Canada
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Montreal, Quebec, H2X 3J4, Canada
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Beijing, Beijing Municipality, 100071, China
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Guanzhou, Guangdong, 610080, China
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Nanning, Guangxi, 530021, China
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Harbin, Heilongjiang, 150081, China
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Changsha, Hunan, 410013, China
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Changzhou, Jiangsu, 213003, China
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Nanjing, Jiangsu, 210000, China
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Nanjing, Jiangsu, 210002, China
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Nanjing, Jiangsu, 210009, China
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Suzhou, Jiangsu, 215006, China
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Changchun, Jilin, 130021, China
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Xi'an, Shan3xi, 710032, China
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Shanghai, Shanghai Municipality, 200032, China
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Shanghai, Shanghai Municipality, 200433, China
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Chengdu, Sichuan, 610041, China
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Tianjin, Tianjin Municipality, 30060, China
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Hangzhou, Zhejiang, 310022, China
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Angers, 49933, France
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Bondy, 93143, France
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Bordeaux, 33075, France
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Clichy, 92118, France
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Créteil, 94010, France
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Grenoble, 38043, France
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Lille, 59037, France
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Lyon, 69317, France
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Marseille, 13385, France
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Paris, 75012, France
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Paris, 75013, France
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Toulouse, 31059, France
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Hong Kong, 8525, Hong Kong
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New Territories, 8520, Hong Kong
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Genova, 16132, Italy
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Padua, 35128, Italy
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Pisa, 56124, Italy
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Roma, 00168, Italy
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Toyoake, Aichi-ken, 470-1101, Japan
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Chiba, Chiba, 2608677, Japan
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Kashiwa-shi, Chiba, 277-0882, Japan
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Ogaki-shi, Gifu, 5038502, Japan
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Hiroshima, Hiroshima, 734-0037, Japan
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Kure-shi, Hiroshima, 7370023, Japan
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Sapporo, Hokkaido, 060-0033, Japan
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Kanazawa, Ishikawa-ken, 9208641, Japan
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Kawasaki-shi, Kanagawa, 2138587, Japan
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Yokohama, Kanagawa, 232-0024, Japan
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Kochi, Kochi, 7818555, Japan
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Kumamoto, Kumamoto, 8608556, Japan
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Kyoto, Kyoto, 6028566, Japan
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Tsu, Mie-ken, 5148507, Japan
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Okayama, Okayama-ken, 700-0082, Japan
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Higashinari-ku, Osaka, 5378511, Japan
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Osaka, Osaka, 534-0021, Japan
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Osaka, Osaka, 5438555, Japan
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Osaka, Osaka, 545-8586, Japan
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Ōsaka-sayama, Osaka, 5890014, Japan
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Sunto-gun, Shizuoka, 411-8777, Japan
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Chuo-ku, Tokyo, 104-0045, Japan
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Minato-ku, Tokyo, 105-0001, Japan
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Musashino-shi, Tokyo, 180-0023, Japan
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Toyama, Toyama, 9308550, Japan
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Nishinomiya-shi, 6638501, Japan
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Busan, 609735, South Korea
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Kyunggi-do, 463-707, South Korea
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Seoul, 110-744, South Korea
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Seoul, 120-752, South Korea
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Seoul, 135-710, South Korea
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Seoul, 137-701, South Korea
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Seoul, 138-736, South Korea
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Suwon, 443-721, South Korea
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Taegu, 700721, South Korea
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Madrid, 28007, Spain
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Madrid, 28222, Spain
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Valencia, 46010, Spain
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Valencia, 46014, Spain
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Kaohsiung City, 80756, Taiwan
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Taichung, 404, Taiwan
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Tainan, 704, Taiwan
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Taipei, 100, Taiwan
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Taipei, 112, Taiwan
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Taoyuan District, 333, Taiwan
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Bangkok, 10400, Thailand
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Bangkok, 10700, Thailand
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
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
May 22, 2009
First Posted
May 27, 2009
Study Start
July 20, 2009
Primary Completion
September 28, 2012
Study Completion
January 26, 2018
Last Updated
December 2, 2019
Record last verified: 2019-11