First Line Hepato Cellular Carcinoma (HCC)

NCT00858871 | Completed Phase 3 DMC

• 2 other identifiers: CA182-033EUDRACT # 2008-003533-24
• Study Type: interventional
• Target: 1,714
• Locations: 26 countries
• Sites: 173

Brief Summary

The purpose of this study is to compare the overall survival of brivanib versus sorafenib in subjects with advanced HCC who have not received prior systemic therapy.

Conditions

Hepato Cellular Carcinoma (HCC)

Outcome Measures

Primary Outcomes (1)

• To compare the overall survival of brivanib versus sorafenib in subjects with advanced HCC who have not received prior systemic treatment

  Survival will be assessed continuously

Secondary Outcomes (7)

• To compare the time to progression (TTP) (investigator assessed using modified RECIST criteria for HCC

  Every 6 weeks

• To compare the investigator assessed objective response rate (ORR) and disease control rate (DCR) using modified RECIST criteria for HCC

  Every 6 weeks

• To determine duration of response, duration of disease control, and time to response (TTR)

  Every 6 weeks

• To assess the safety profile of brivanib and sorafenib

  Every 6 weeks

• To explore PK and exposure-response in the study population

  Every 6 weeks

Study Arms (2)

Brivanib

ACTIVE COMPARATOR

Drug: Brivanib; Drug: Placebo

Sorafenib

ACTIVE COMPARATOR

Drug: Sorafenib; Drug: Placebo

Interventions

Brivanib DRUG

Tablets, Oral, 800 mg, Once Daily, Until disease progression or unacceptable toxicity

Also known as: BMS-582664

Brivanib

Placebo DRUG

Capsules, Oral, twice Daily, Until disease progression or unacceptable toxicity

Brivanib

Sorafenib DRUG

Capsules, Oral, 800 mg, twice daily, Until disease progression or unacceptable toxicity

Sorafenib

Eligibility Criteria

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

You may qualify if:

• Histologic or cytologic confirmed diagnosis of HCC.
• Advanced HCC: disease not eligible for surgical and/or locoregional therapies OR progressive disease after surgical and/or locoregional therapies
• Child-Pugh Class A
• ECOG performance status 0-1
• Adequate hematologic, hepatic, and renal function

You may not qualify if:

• Prior use of any systemic anti-cancer chemotherapy, immunotherapy or molecular targeted agents for HCC
• History of active cardiac disease
• Thrombotic or embolic events within the past 6 months (except HCC tumor thrombus)
• Any other hemorrhage/bleeding event \>= CTCAE Grade 3 within 8 weeks except for esophageal or gastric varices
• Inability to swallow tablets or untreated malabsorption syndrome

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (173)

Mayo Clinic Arizona

Scottsdale, Arizona, 85259, United States

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Univ Of Ark For Med Sci

Little Rock, Arkansas, 72205, United States

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Agajanian Institute Of Hematology And Oncology

Downey, California, 90241, United States

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Sharp Clinical Oncology Research

San Diego, California, 92123, United States

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Va Ct Healthcare System

West Haven, Connecticut, 06516, United States

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Medical Specialists Of Palm Beaches

Lake Worth, Florida, 33467, United States

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James Graham Brown Cancer Center

Louisville, Kentucky, 40202, United States

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3912 Taubman Center

Ann Arbor, Michigan, 48109, United States

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Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

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Thomas Jefferson Univ.

Philadelphia, Pennsylvania, 19107, United States

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Mcguire Dvamc

Richmond, Virginia, 23249, United States

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University Of Wisconsin

Madison, Wisconsin, 53792, United States

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Buenos Aires, Buenos Aires, C1181ACH, Argentina

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Caba, Buenos Aires, 1221, Argentina

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Capital Federal, Buenos Aires, C1264AAA, Argentina

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Rosario, Santa Fe Province, 2000, Argentina

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Camperdown, New South Wales, 2050, Australia

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Concord, New South Wales, 2139, Australia

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Westmead Nsw, New South Wales, 2145, Australia

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Parkville, Victoria, 3050, Australia

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Prahan, Victoria, 3004, Australia

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Liège, 4000, Belgium

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Fortaleza, Ceará, 60430-230, Brazil

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Salvador, Estado de Bahia, 41950-610, Brazil

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Salvador - Ba, Estado de Bahia, 40050-410, Brazil

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Goiânia, Goiás, 74075-040, Brazil

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Divinópolis, Minas Gerais, 35500-249, Brazil

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Curitiba, Paraná, 81520-060, Brazil

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Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

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Porto Alegre, Rio Grande do Sul, 90050-170, Brazil

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Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

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Barretos, São Paulo, 14784-400, Brazil

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Jaú, São Paulo, 17210-080, Brazil

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São Paulo, São Paulo, 01323-010, Brazil

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Calgary, Alberta, T2N 2T9, Canada

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Vancouver, British Columbia, V5Z 1M9, Canada

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London, Ontario, N6A A5, Canada

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Montreal, Quebec, H2X 3J4, Canada

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Beijing, Beijing Municipality, 100021, China

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Beijing, Beijing Municipality, 100034, China

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Beijing, Beijing Municipality, 100071, China

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Chongqing, Chongqing Municipality, 400038, China

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Guangzhou, Guangdong, 510515, China

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Guanzhou, Guangdong, 510010, China

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Nanning, Guangxi, 530021, China

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Wuhan, Hubei, 430030, China

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Changsha, Hunan, 410008, 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, 210008, China

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Suzhou, Jiangsu, 215006, China

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Dalian, Liaoning, 116011, China

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Xi'an, Shaanxi, 710032, China

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Shanghai, Shanghai Municipality, 200080, China

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Chengdu, Sichuan, 610041, China

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Hangzhou, Zhejiang, 130016, China

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Brno, 656 53, Czechia

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Prague, 128 08, Czechia

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Prague, 150 06, Czechia

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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, 13009, 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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Paris, 75020, France

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Rennes, 35042, France

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Vandœuvre-lès-Nancy, 54511, France

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Berlin, 13353, Germany

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Halle, 06120, Germany

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Hamburg, 20246, Germany

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Magdeburg, 39120, Germany

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Ulm, 89081, Germany

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Hong Kong, 8525, Hong Kong

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Shatin, 8520, Hong Kong

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Hyderabad, Andhra Pradesh, 500082, India

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Kochi, Kerala, 682304, India

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Trivandrum, Kerala, 695011, India

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Pune, Maharashtra, 411001, India

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Ahmedabad, 380009, India

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Chennai, 600006, India

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Coimbatore, 641037, India

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Hyderabad, 500024, India

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Kolkata, 700 053, India

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Kolkata, 700054, India

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Mumbai, 400012, India

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Mumbai, 400036, India

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New Delhi, 110 070, India

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Milan, 20122, Italy

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Milan, 20141, Italy

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Napoli, 80131, Italy

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Pisa, 56124, Italy

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Roma, 00168, Italy

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Torrette -Ancona, 60020, Italy

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Kashiwa-shi, Chiba, 277-0882, 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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Tsu, Mie-ken, 5148507, Japan

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Okayama, Okayama-ken, 7000082, 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, 5458586, 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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Shimonoseki-shi, Yamaguchi, 7500061, Japan

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Nishinomiya-shi, 6638501, Japan

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Aguascalientes, Aguascalientes, 20234, Mexico

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D.f., Mexico City, 06720, Mexico

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D.f., Mexico City, 14140, Mexico

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Distrito Federal, Mexico City, 06760, Mexico

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Mexico City, Mexico City, 06726, Mexico

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Tlalpan, Mexico City, 14000, Mexico

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Monterrey, Nuevo León, 64710, Mexico

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Gdansk, 80952, Poland

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Gliwice, 44-101, Poland

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Krakow, 31-501, Poland

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Warsaw, 02-781, Poland

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San Juan, Pr, 00910, Puerto Rico

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Moscow, 115 478, Russia

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Moscow, 115998, Russia

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Moscow, 119992, Russia

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Moscow, 125367, Russia

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Pretoria, Gauteng, 0002, South Africa

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Durban, KwaZulu-Natal, 4091, South Africa

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Cape Town, Western Cape, 7570, South Africa

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Observatory, Cape Town, Western Cape, 7925, South Africa

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Rondebosch, Western Cape, 7700, South Africa

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Busan, 609-735, South Korea

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Daegu, 700-721, South Korea

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Gyeonggi-do, 410-769, 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, 137-040, South Korea

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Seoul, 138-736, South Korea

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Santiago de Compostela, A Coruna, 15706, Spain

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Alicante, 03010, Spain

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Barcelona, 08208, Spain

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Stockholm, 141 86, Sweden

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Uppsala, 751 85, Sweden

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Changhua, 500, Taiwan

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Kaohsiung City, 833, Taiwan

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Taichung, 404, Taiwan

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Tainan R.o.c., 70403, 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

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Ankara, 06460, Turkey (Türkiye)

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Antalya, 07070, Turkey (Türkiye)

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Istanbul, Turkey (Türkiye)

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Izmir, 35100, Turkey (Türkiye)

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Kayseri, 38039, Turkey (Türkiye)

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Bristol, Avon, BS2 8ED, United Kingdom

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London, Greater London, NW3 2QG, United Kingdom

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London, Greater London, SE5 9RS, United Kingdom

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London, Greater London, W12 0HS, United Kingdom

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Manchester, Greater Manchester, M20 4BX, United Kingdom

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Birmingham, West Midlands, B15 2TT, United Kingdom

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Leeds, Yorkshire, LS9 7TF, United Kingdom

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Related Publications (2)

• Kolamunnage-Dona R, Berhane S, Potts H, Williams EH, Tanner J, Janowitz T, Hoare M, Johnson P. Sorafenib is associated with a reduced rate of tumour growth and liver function deterioration in HCV-induced hepatocellular carcinoma. J Hepatol. 2021 Oct;75(4):879-887. doi: 10.1016/j.jhep.2021.05.015. Epub 2021 May 27.

  PMID: 34052255 DERIVED

• Johnson PJ, Qin S, Park JW, Poon RT, Raoul JL, Philip PA, Hsu CH, Hu TH, Heo J, Xu J, Lu L, Chao Y, Boucher E, Han KH, Paik SW, Robles-Avina J, Kudo M, Yan L, Sobhonslidsuk A, Komov D, Decaens T, Tak WY, Jeng LB, Liu D, Ezzeddine R, Walters I, Cheng AL. Brivanib versus sorafenib as first-line therapy in patients with unresectable, advanced hepatocellular carcinoma: results from the randomized phase III BRISK-FL study. J Clin Oncol. 2013 Oct 1;31(28):3517-24. doi: 10.1200/JCO.2012.48.4410. Epub 2013 Aug 26.

  PMID: 23980084 DERIVED

Related Links

• BMS clinical trial educational resource
• Investigator Inquiry form

MeSH Terms

Interventions

brivanib; Sorafenib

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

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: March 9, 2009
• First Posted: March 10, 2009
• Study Start: May 1, 2009
• Primary Completion: June 1, 2012
• Study Completion: September 1, 2013
• Last Updated: October 17, 2016

Record last verified: 2016-10

Locations

BR (12); DE (5); JP (18); PR (1); RU (4); GB (7); HK (2); CN (19); ZA (5); US (12); AR (4); ME (7); ES (3); PL (4); TU (5); SE (2); AU (5); TW (7); BE (1); CA (4); CZ (3); FR (13); IT (6); KR (9); TH (2); IN (13)