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Hepato Cellular Carcinoma (HCC)Phase 3BRISK FLNCT00858871

First Line Hepato Cellular Carcinoma (HCC)

A Phase 3 study testing Brivanib and Sorafenib in people with Hepato Cellular Carcinoma (HCC), run by Bristol-Myers Squibb at 173 sites in 26 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepato Cellular Carcinoma (HCC)
What is being tested?
Brivanib and Sorafenib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,714 participants
Where
173 sitesin 26 countries
Study dates
May 2009to Sep 2013
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

173 sites in 26 countries.

173 sites in 26 countries

China19 sites

  • Local Institution

    Beijing, Beijing Municipality, 100021

  • Local Institution

    Beijing, Beijing Municipality, 100034

  • Local Institution

    Beijing, Beijing Municipality, 100071

  • Local Institution

    Changsha, Hunan, 410008

  • Local Institution

    Changzhou, Jiangsu, 213003

  • Local Institution

    Chengdu, Sichuan, 610041

  • Local Institution

    Chongqing, Chongqing Municipality, 400038

  • Local Institution

    Dalian, Liaoning, 116011

  • Local Institution

    Guangzhou, Guangdong, 510515

  • Local Institution

    Guanzhou, Guangdong, 510010

  • Local Institution

    Hangzhou, Zhejiang, 130016

  • Local Institution

    Nanjing, Jiangsu, 210000

  • Local Institution

    Nanjing, Jiangsu, 210002

  • Local Institution

    Nanjing, Jiangsu, 210008

  • Local Institution

    Nanning, Guangxi, 530021

  • Local Institution

    Shanghai, Shanghai Municipality, 200080

  • Local Institution

    Suzhou, Jiangsu, 215006

  • Local Institution

    Wuhan, Hubei, 430030

  • Local Institution

    Xi'an, Shaanxi, 710032

Other trials in China

Japan18 sites

  • Local Institution

    Chuo-Ku, Tokyo, 104-0045

  • Local Institution

    Higashinari-ku, Osaka, 5378511

  • Local Institution

    Kanazawa, Ishikawa-ken, 9208641

  • Local Institution

    Kashiwa-shi, Chiba, 277-0882

  • Local Institution

    Kawasaki-shi, Kanagawa, 2138587

  • Local Institution

    Minato-ku, Tokyo, 105-0001

  • Local Institution

    Musashino-shi, Tokyo, 180-0023

  • Local Institution

    Nishinomiya-shi, 6638501

  • Local Institution

    Okayama, Okayama-ken, 7000082

  • Local Institution

    Osaka, Osaka, 534-0021

  • Local Institution

    Osaka, Osaka, 5438555

  • Local Institution

    Osaka, Osaka, 5458586

  • Local Institution

    Ōsaka-sayama, Osaka, 5890014

  • Local Institution

    Sapporo, Hokkaido, 060-0033

  • Local Institution

    Shimonoseki-shi, Yamaguchi, 7500061

  • Local Institution

    Sunto-gun, Shizuoka, 411-8777

  • Local Institution

    Tsu, Mie-ken, 5148507

  • Local Institution

    Yokohama, Kanagawa, 232-0024

Other trials in Japan

France13 sites

  • Local Institution

    Bordeaux, 33075

  • Local Institution

    Clichy, 92118

  • Local Institution

    Créteil, 94010

  • Local Institution

    Grenoble, 38043

  • Local Institution

    Lille, 59037

  • Local Institution

    Lyon, 69317

  • Local Institution

    Marseille, 13009

  • Local Institution

    Marseille, 13385

  • Local Institution

    Paris, 75012

  • Local Institution

    Paris, 75013

  • Local Institution

    Paris, 75020

  • Local Institution

    Rennes, 35042

  • Local Institution

    Vandœuvre-lès-Nancy, 54511

Other trials in France

India13 sites

  • Local Institution

    Ahmedabad, 380009

  • Local Institution

    Chennai, 600006

  • Local Institution

    Coimbatore, 641037

  • Local Institution

    Hyderabad, Andhra Pradesh, 500082

  • Local Institution

    Hyderabad, 500024

  • Local Institution

    Kochi, Kerala, 682304

  • Local Institution

    Kolkata, 700 053

  • Local Institution

    Kolkata, 700054

  • Local Institution

    Mumbai, 400012

  • Local Institution

    Mumbai, 400036

  • Local Institution

    New Delhi, 110 070

  • Local Institution

    Pune, Maharashtra, 411001

  • Local Institution

    Trivandrum, Kerala, 695011

Other trials in India

United States12 sites

  • 3912 Taubman Center

    Ann Arbor, Michigan, 48109

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Agajanian Institute Of Hematology And Oncology

    Downey, California, 90241

  • Medical Specialists Of Palm Beaches

    Lake Worth, Florida, 33467

  • Univ Of Ark For Med Sci

    Little Rock, Arkansas, 72205

  • James Graham Brown Cancer Center

    Louisville, Kentucky, 40202

  • University Of Wisconsin

    Madison, Wisconsin, 53792

  • Thomas Jefferson Univ.

    Philadelphia, Pennsylvania, 19107

  • Mcguire Dvamc

    Richmond, Virginia, 23249

  • Sharp Clinical Oncology Research

    San Diego, California, 92123

  • Mayo Clinic Arizona

    Scottsdale, Arizona, 85259

  • Va Ct Healthcare System

    West Haven, Connecticut, 06516

Other trials in United States

Brazil12 sites

  • Local Institution

    Barretos, São Paulo, 14784-400

  • Local Institution

    Curitiba, Paraná, 81520-060

  • Local Institution

    Divinópolis, Minas Gerais, 35500-249

  • Local Institution

    Fortaleza, Ceará, 60430-230

  • Local Institution

    Goiânia, Goiás, 74075-040

  • Local Institution

    Jaú, São Paulo, 17210-080

  • Local Institution

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Local Institution

    Porto Alegre, Rio Grande do Sul, 90050-170

  • Local Institution

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Local Institution

    Salvador, Estado de Bahia, 41950-610

  • Local Institution

    Salvador - Ba, Estado de Bahia, 40050-410

  • Local Institution

    São Paulo, São Paulo, 01323-010

Other trials in Brazil

South Korea9 sites

  • Local Institution

    Busan, 609-735

  • Local Institution

    Daegu, 700-721

  • Local Institution

    Gyeonggi-do, 410-769

  • Local Institution

    Kyunggi-do, 463-707

  • Local Institution

    Seoul, 110-744

  • Local Institution

    Seoul, 120-752

  • Local Institution

    Seoul, 135-710

  • Local Institution

    Seoul, 137-040

  • Local Institution

    Seoul, 138-736

Other trials in South Korea

Mexico7 sites

  • Local Institution

    Aguascalientes, Aguascalientes, 20234

  • Local Institution

    D.f., Mexico City, 06720

  • Local Institution

    D.f., Mexico City, 14140

  • Local Institution

    Distrito Federal, Mexico City, 06760

  • Local Institution

    Mexico City, Mexico City, 06726

  • Local Institution

    Monterrey, Nuevo León, 64710

  • Local Institution

    Tlalpan, Mexico City, 14000

Other trials in Mexico

Taiwan7 sites

  • Local Institution

    Changhua, 500

  • Local Institution

    Kaohsiung City, 833

  • Local Institution

    Taichung, 404

  • Local Institution

    Tainan R.o.c., 70403

  • Local Institution

    Taipei, 100

  • Local Institution

    Taipei, 112

  • Local Institution

    Taoyuan, 333

Other trials in Taiwan

United Kingdom7 sites

  • Local Institution

    Birmingham, West Midlands, B15 2TT

  • Local Institution

    Bristol, Avon, BS2 8ED

  • Local Institution

    Leeds, Yorkshire, LS9 7TF

  • Local Institution

    London, Greater London, NW3 2QG

  • Local Institution

    London, Greater London, SE5 9RS

  • Local Institution

    London, Greater London, W12 0HS

  • Local Institution

    Manchester, Greater Manchester, M20 4BX

Other trials in United Kingdom

Italy6 sites

  • Local Institution

    Milan, 20122

  • Local Institution

    Milan, 20141

  • Local Institution

    Naples, 80131

  • Local Institution

    Pisa, 56124

  • Local Institution

    Roma, 00168

  • Local Institution

    Torrette -Ancona, 60020

Other trials in Italy

Australia5 sites

  • Local Institution

    Camperdown, New South Wales, 2050

  • Local Institution

    Concord, New South Wales, 2139

  • Local Institution

    Parkville, Victoria, 3050

  • Local Institution

    Prahan, Victoria, 3004

  • Local Institution

    Westmead Nsw, New South Wales, 2145

Other trials in Australia

Germany5 sites

  • Local Institution

    Berlin, 13353

  • Local Institution

    Halle, 06120

  • Local Institution

    Hamburg, 20246

  • Local Institution

    Magdeburg, 39120

  • Local Institution

    Ulm, 89081

Other trials in Germany

South Africa5 sites

  • Local Institution

    Cape Town, Western Cape, 7570

  • Local Institution

    Durban, KwaZulu-Natal, 4091

  • Local Institution

    Observatory, Cape Town, Western Cape, 7925

  • Local Institution

    Pretoria, Gauteng, 0002

  • Local Institution

    Rondebosch, Western Cape, 7700

Other trials in South Africa

Turkey (Türkiye)5 sites

  • Local Institution

    Ankara, 06460

  • Local Institution

    Antalya, 07070

  • Local Institution

    Istanbul

  • Local Institution

    Izmir, 35100

  • Local Institution

    Kayseri, 38039

Other trials in Turkey (Türkiye)

Argentina4 sites

  • Local Institution

    Buenos Aires, Buenos Aires, C1181ACH

  • Local Institution

    Caba, Buenos Aires, 1221

  • Local Institution

    Capital Federal, Buenos Aires, C1264AAA

  • Local Institution

    Rosario, Santa Fe Province, 2000

Other trials in Argentina

Canada4 sites

  • Local Institution

    Calgary, Alberta, T2N 2T9

  • Local Institution

    London, Ontario, N6A A5

  • Local Institution

    Montreal, Quebec, H2X 3J4

  • Local Institution

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

Poland4 sites

  • Local Institution

    Gdansk, 80952

  • Local Institution

    Gliwice, 44-101

  • Local Institution

    Krakow, 31-501

  • Local Institution

    Warsaw, 02-781

Other trials in Poland

Russia4 sites

  • Local Institution

    Moscow, 115 478

  • Local Institution

    Moscow, 115998

  • Local Institution

    Moscow, 119992

  • Local Institution

    Moscow, 125367

Other trials in Russia

Czechia3 sites

  • Local Institution

    Brno, 656 53

  • Local Institution

    Prague, 128 08

  • Local Institution

    Prague, 150 06

Other trials in Czechia

Spain3 sites

  • Local Institution

    Alicante, 03010

  • Local Institution

    Barcelona, 08208

  • Local Institution

    Santiago de Compostela, A Coruna, 15706

Other trials in Spain

Hong Kong2 sites

  • Local Institution

    Hong Kong, 8525

  • Local Institution

    Shatin, 8520

Other trials in Hong Kong

Sweden2 sites

  • Local Institution

    Stockholm, 141 86

  • Local Institution

    Uppsala, 751 85

Other trials in Sweden

Thailand2 sites

  • Local Institution

    Bangkok, 10400

  • Local Institution

    Bangkok, 10700

Other trials in Thailand

Belgium1 site

  • Local Institution

    Liège, 4000

Other trials in Belgium

Puerto Rico1 site

  • Local Institution

    San Juan, Pr, 00910

Other trials in Puerto Rico

About this study

Official title: A Randomized, Double-blind, Multi-center Phase III Study of Brivanib Versus Sorafenib as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma

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.

Being tested
Brivanib, Placebo, Sorafenib

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BrivanibDrug

    Also called BMS-582664

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

  • PlaceboDrug

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

  • SorafenibDrug

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

  • PlaceboDrug

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

Study groups in NCT00858871
Study groupRoleWhat they receive
BrivanibActive comparatorNot described
Receives: Drug: Brivanib; Drug: Placebo
SorafenibActive comparatorNot described
Receives: Drug: Sorafenib; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Survival will be assessed continuously

Secondary outcomes (7)

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

    Measured: Every 6 weeks

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

    Measured: Every 6 weeks

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

    Measured: Every 6 weeks

  4. To assess the safety profile of brivanib and sorafenib

    Measured: Every 6 weeks

  5. To explore PK and exposure-response in the study population

    Measured: Every 6 weeks

  6. To compare time to symptomatic progression

    Measured: Every 6 weeks

  7. To compare health-related quality of life

    Measured: Every 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2009 (estimated)
  2. Study startMay 2009
  3. Primary completionJun 2012
  4. Study completionSep 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,714 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00858871
Sponsor's protocol ID
CA182-033
Other IDs
EUDRACT # 2008-003533-24
Acronym
BRISK FL
Status last verified
Oct 2016
First submitted
9 Mar 2009
Last updated
17 Oct 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 34052255

  • 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.

    PubMed 23980084

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Brivanib and Sorafenib in people with Hepato Cellular Carcinoma (HCC), run by Bristol-Myers Squibb at 173 sites in 26 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 173 sites in China, Japan, France, India, United States and 21 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To compare the overall survival of brivanib versus sorafenib in subjects with advanced HCC who have not received prior systemic treatment (time frame: Survival will be assessed continuously). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00858871, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2016; AzTrials last refreshed its copy on 30 Oct 2026.

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