AzTrials
AzTrials

Gastric CancerPhase 3BRIGHTERNCT02178956

A Study of BBI608 Plus Weekly Paclitaxel to Treat Gastric and Gastro-Esophageal Junction Cancer

A Phase 3 study testing BBI608 and Paclitaxel in people with Gastric Cancer and Gastroesophageal Junction Cancer, run by Sumitomo Pharma America, Inc. at 263 sites in 22 countries.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this study is to find out whether it is better to receive a new drug, BBI608, in addition to paclitaxel chemotherapy or better to receive paclitaxel chemotherapy alone as second line treatment for gastric and gastroesophageal junction cancer after prior first line platinum and fluoropyrimidine based… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
BBI608 and Paclitaxel
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
714 participants
Where
263 sitesin 22 countries
Study dates
Oct 2014to 20 Sep 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Cytologically or histologically confirmed advanced gastric or GEJ adenocarcinoma that is metastatic or locally advanced and unresectable.
  • Failed treatment with one regimen containing at least a platinum/fluoropyrimidine doublet for unresectable or metastatic disease.Treatment failure is defined as progression of disease (clinical or radiologic) during first line treatment for unresectable or metastatic disease or ≤ 6 months after last dose of first line treatment.
  • Paclitaxel therapy is appropriate for the patient and is recommended by the Investigator.
  • Imaging investigations including CT/MRI of chest/abdomen/pelvis or other scans as necessary to document all sites of disease done within 21 days prior to randomization. Patients with either measurable disease OR non-measurable evaluable disease will be eligible.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • ･≥ 18 years of age.
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  • For male or female patient of child producing potential: Must agree to use contraception or take measures to avoid pregnancy during the study and for 6 months after the final dose of Paclitaxel or for 30 days for female patients and for 90 days for male patients, of the final BBI608/Placebo dose if Paclitaxel was not administered.
  • Women of child bearing potential (WOCBP) must have a negative serum or urine pregnancy test within 5 days prior to randomization.
  • Alanine transaminase (ALT) ≤ 3 × institutional upper limit of normal (ULN) [≤ 5 × ULN in presence of liver metastases] within 14 days prior to randomization.
  • Hemoglobin (Hgb) ≥ 9.0 g/dL within 14 days prior to randomization. Must not have required transfusion within 1 week of baseline Hgb assessment.
  • Total bilirubin ≤ 1.5 × institutional ULN [≤ 2.0 x ULN in presence of liver metastases] within 14 days prior to randomization.
  • Creatinine ≤ 1.5 × institutional ULN or Creatinine Clearance > 50 ml/min (as calculated by the Cockroft-Gault equation) within 14 days prior to randomization.
  • Absolute neutrophil count ≥ 1.5 x 10^9/L within 14 days prior to randomization.
  • Platelet count ≥ 100 x 10^9/L within 14 days prior to randomization. Must not have required transfusion within 1 week of baseline platelet assessment.
  • Other baseline laboratory evaluations must be done within 14 days prior to randomization.
  • Patient must consent to provision of a representative formalin fixed paraffin block of tumor tissue, if available, in order that the specific correlative marker assays may be conducted.
  • Patient must consent to provision of a sample of blood in order that the specific correlative marker assays may be conducted.
  • Patients must be accessible for treatment and follow up.
  • Protocol treatment is to begin within 2 working days of patient randomization.
  • The patient is not receiving therapy in a concurrent clinical study and the patient agrees not to participate in other interventional clinical studies during their participation in this trial while on study treatment. Patients participating in surveys or observational studies are eligible to participate in this study.

Who cannot join

  • Anti-cancer chemotherapy or biologic therapy if administered prior to the first planned dose of BBI608/placebo within period of time equivalent to the usual cycle length of the regimen. An exception is made for oral fluoropyrimidines (e.g. capecitabine, S-1), where a minimum of 10 days since last dose must be observed prior to the first planned dose of BBI608/placebo.Radiotherapy, immunotherapy, or investigational agents within four weeks of first planned dose of BBI608/placebo, with the exception of a single dose of radiation up to 8 Gray (equal to 800 RAD) with palliative intent for pain control up to 14 days before randomization.
  • Prior taxanes in the neoadjuvant or adjuvant setting with progression occurring within 6 months of completion of taxane therapy; or any taxanes in the metastatic setting.
  • More than one prior chemotherapy regimen administered in the metastatic setting.
  • Major surgery within 4 weeks prior to randomization.
  • Any known symptomatic brain metastases requiring steroids.
  • Women who are pregnant or breastfeeding.
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  • Gastrointestinal disorder(s) which, in the opinion of the Qualified/Principal Investigator, would significantly impede the absorption of an oral agent.
  • Unable or unwilling to swallow BBI608/placebo capsules daily.
  • Uncontrolled intercurrent illness.
  • Peripheral neuropathy ≥ CTCAE Grade 2 at baseline.
  • History of other malignancies except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥ 3 years.
  • Prior treatment with BBI608.
  • Any active disease condition which would render the protocol treatment dangerous or impair the ability of the patient to receive protocol therapy.
  • Any condition (e.g. psychological, geographical, etc.) that does not permit compliance with the protocol.

Trial locations and contacts

263 sites in 22 countries.

263 sites in 22 countries

United States26 sites

  • Indiana University Health University Hospital

    Chapel Hill, North Carolina, 27516

  • Ohio State University Medical Center

    Columbus, Ohio, 43210

  • New Hampshire Oncology Hematology - Concord

    Concord, New Hampshire, 03106

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Colorado Cancer Research Program

    Denver, Colorado, 80222

  • Indiana University Health Goshen Center For Cancer Care

    Goshen, Indiana, 46526

  • Spectrum Health Butterworth

    Grand Rapids, Michigan, 49503

  • Saint Vincent Hospital CCOP

    Green Bay, Wisconsin, 54301

  • St. Mary's Hospital

    Green Bay, Wisconsin, 54307

  • Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • New Hampshire Oncology Hematology - Laconia

    Laconia, New Hampshire, 03246

  • Marshfield CCOP

    Marshfield, Wisconsin, 54449

  • Ochsner NCI CORP

    New Orleans, Louisiana, 70121

  • Weill Medical College of Cornell University

    New York, New York, 10065

  • The University of Oklahoma Health Sciences Center (OUHSC)

    Oklahoma City, Oklahoma, 73104

  • Mayo Clinic - Rochester

    Rochester, Minnesota, 55905

  • Metro-Minnesota NCI CORP

    Saint Louis Park, Minnesota, 55416

  • Mayo Clinic - Arizona

    Scottsdale, Arizona, 85259

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Swedish Cancer Institute/ Swedish Health Services

    Seattle, Washington, 98104

  • Siouxland Regional Cancer Center

    Sioux City, Iowa, 51101

  • Northern Indiana Cancer Research Consortium

    South Bend, Indiana, 46628

  • Heartland NCORP

    St Louis, Missouri, 63131

  • State University of New York Upstate Medical University

    Syracuse, New York, 13210

  • Munson Medical Center

    Traverse City, Michigan, 49684

  • Cancer Center of Kansas

    Wichita, Kansas, 67214

Other trials in United States

China26 sites

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

  • The 307th Hospital of Chinese People's Liberation Army

    Beijing, Beijing Municipality, 100071

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100853

  • The First Bethune Hospital of Jilin University

    Changchun, Jilin, 130021

  • Hunan Cancer Hospital

    Changsha, Hunan, 410006

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001

  • Sun Yat-Sen University Cancer Center

    Guangzhou, Guangdong, 510060

  • Southern Medical University, Nanfang Hospital

    Guangzhou, Guangdong, 510515

  • Sir Run Run Shaw Hospital School of Medicine, Zhejiang University

    Hangzhou, Zhejiang, 310016

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

  • Harbin Medical University Cancer Hospital

    Heilongjiang, Heilongjiang, 150081

  • Jilin Cancer Hospital

    Jilin City, Jilin, 130021

  • The 81 Hospital of the Chinese People's Liberation Army

    Nanjing, Jiangsu, 210002

  • Jiang Su Cancer Hospital

    Nanjing, Jiangsu, 210009

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

  • Zhongshan Hospital

    Shanghai, Shanghai Municipality, 200032

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110002

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality, 300202

  • Xin Jiang Tumor Hospital, Xin Jiang Medical University

    Ürümqi, Xinjiang, 830000

  • Tongji Hospital

    Wuhan, 430030

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia, 750004

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450003

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450008

Other trials in China

Australia25 sites

  • Bankstown-Lidcombe

    Bankstown, New South Wales, 2200

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042

  • Bendigo Hospital

    Bendigo, Victoria, 3550

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales, 2050

  • St Vincent's Hospital

    Darlinghurst, New South Wales, 2010

  • Monash Health

    East Bentleigh, Victoria, 3165

  • Peninsula & South Eastern Haematology and Oncology Group

    East Bentleigh, Victoria, 3165

  • St Vincent's Hospital

    Fitzroy, Victoria, 3065

  • Central coast area health (public)

    Gosford, New South Wales, 2250

  • Austin Hospital

    Heidelberg, Victoria, 3084

  • Ballarat base hospital

    Heidelberg, Victoria, 3084

  • Royal Brisbane & Women's Hospital

    Herston, Queensland, 4029

  • Ashford Cancer Centre Research

    Kurralta Park, South Australia, 5037

  • Sunshine Coast Hospital and Health Service

    Nambour, Queensland, 4560

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Port Macquaries Base Hospital

    Port Macquarie, New South Wales, 2444

  • Gold Coast University Hospital

    Southport, Queensland, 4215

  • Sunshine Hospital

    St Albans, Victoria, 3021

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065

  • Fiona Stanley Hospital

    Subiaco, Western Australia, 6008

  • Townsville Hospital

    Townsville, Queensland, 4814

  • Riverina Cancer Care Centre

    Wagga Wagga, New South Wales, 2650

  • Ballarat Oncology and Haematology Services

    Wendouree, Victoria, 3355

  • The Queen Elizabeth Hospital

    Woodville, South Australia, 5011

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

Spain17 sites

  • C.A.AV-H.Ntra.Sra.de Sonsoles

    Ávila, Castille and León, 05004

  • Institut Català d'Oncologia-Hospital Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • H.del Mar

    Barcelona, 08003

  • Hospital Universitario Vall d'Hebrón

    Barcelona, 08035

  • H.Sta.Creu i St.Pau

    Barcelona, 08041

  • H.U. de Burgos

    Burgos, 09006

  • Institut Catalá d´Oncología (I.C.O.)

    L'Hospitalet de Llobregat, 08907

  • H.G.U. G. Marañón

    Madrid, 28007

  • M.D. Anderson Cancer Center Madrid

    Madrid, 28033

  • H.U. R. y Cajal

    Madrid, 28034

  • H.C. S.Carlos

    Madrid, 28040

  • H.U.P Hierro-Majadahonda

    Majadahonda, Madrid, 28222

  • H.U.V.Arrixaca

    Murcia, 30120

  • H.U.V. Macarena

    Seville, Andalusia, 41009

  • H.U.V. del Rocío

    Seville, 41013

  • C.H.G.U.de Valencia

    Valencia, 46014

  • H.U. Miguel Servet

    Zaragoza, 50009

Other trials in Spain

France15 sites

  • Hôpital Morvan - CHRU de Brest

    Brest, 29609

  • CHU Estaing

    Clermont-Ferrand, 63003

  • Chd Vendee La Roche Sur Yon

    La Roche-sur-Yon, Vendée, 85925

  • Hopital Privé Jean Mermoz

    Lyon, Rhône, 69008

  • Hopital Saint Joseph - Marseille

    Marseille, Bouches-du-Rhône, 13008

  • CHU - Hôpital De La Timone

    Marseille, 13385

  • Centre Hospitalier De Mont De Marsan - Hopital Layné

    Mont-de-Marsan, 40024

  • Centre Antoine Lacassagne

    Nice, Alpes-Maritimes, 06189 Cedex 2

  • Hospital of Poitiers

    Poitiers, Vienne, 86021

  • Centre eugène marquis

    Rennes, 35042

  • CHU Saint Etienne

    Saint-Etienne, 42270

  • Centre Paul Papin

    Saint-Herblain, Loire-Atlantique, 44805

  • Centre Rene Gauducheau

    Saint-Herblain, Loire-Atlantique, 44805

  • Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital

    Toulouse, 31052

  • Institut Gustave Roussy

    Villejuif, 94800

Other trials in France

Japan15 sites

  • Chiba Cancer Center

    Chiba

  • National Cancer Center Hospital

    Chūō, Tokyo

  • Gifu University Hospital

    Gifu

  • National Cancer Center Hospital East

    Kashiwa, Chiba

  • Saitama Cancer Center

    Kita-Adachi, Saitama

  • Kobe City Medical Center General Hospital

    Kobe, Hyōgo

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama, Ehime

  • Kyorin University Hospial

    Mitaka, Tokyo

  • Aichi Cancer Center Hospital

    Nagoya, Aichi-ken

  • Osaka Medical Center for Cancer and Cardiovascular Diseases

    Osaka

  • Saku Central Hospital Advanced Care Center

    Saku, Nagano

  • Hokkaido University Hospital

    Sapporo, Hokkaido

  • Osaka University Hospital

    Suita, Osaka

  • Shizuoka Cancer Center

    Sunto, Shizuoka

  • Tochigi Cancer Center

    Utsunomiya, Tochigi

Other trials in Japan

Italy14 sites

  • Ospedale Umberto I, AOU Ospedali Riuniti Umberto I - GM.Lanc

    Ancona, 60126

  • IRCCS Ospedale Oncologico "Giovanni Paolo II"

    Bari, 701264

  • Humanitas Gavazzeni

    Bergamo, 24125

  • Policlinico S.Orsola Malpighi, AOU di Bologna

    Bologna, 40138

  • PO Garibaldi-Nesima, ARNAS Garibaldi

    Catania, 95100

  • Azienda Ospedaliera "Istituti Ospitalieri" di Cremona

    Cremona, 26100

  • AUSL della Romagna, Osp. degli Infermi

    Faenza, Ravenna, 48018

  • AOU S.Martino, IRCCS, IST-Istituto Nazionale Ricerca Sul Can

    Genova, 16132

  • Irccs Irst

    Meldola, Forli, 47014

  • Azienda Ospedaliera Fatebenefratelli e Oftalmico

    Milan, 20121

  • Istituto Oncologico Veneto IOV-IRCCS

    Padova, 35128

  • Ospedale Guglielmo da Saliceto, AUSL Piacenza

    Piacenza, 29100

  • Unità di Biostatistica e Sperimentazioni Cliniche IRST

    Ravenna, 48100

  • Ospedale Molinette, AO Città della Salute e della Scienza di

    Torino, 10126

Other trials in Italy

Brazil13 sites

  • Cetus Hospital Dia Oncologia

    Belo Horizonte, Minas Gerais, 30150-270

  • Hospital Erasto Gaertner

    Curitiba, Paraná, 81520-060

  • Instituto do Câncer do Ceará - Instituto do Câncer do Cear

    Fortaleza, Ceará, 60430-230

  • Clinica de Neoplasias Litoral

    Itajaí, Santa Catarina, 88301-220

  • Fundaçao dr Amaral Carvalho

    Jaú, São Paulo, 17210-080

  • Hospital Bruno Born

    Lajeado, Rio Grande do Sul, 95900000

  • Hospital da Cidade de Passo Fundo

    Passo Fundo, Rio Grande do Sul, 99010-260

  • UPCO - Unidade de Pesquisa Clinica em Oncologia LTDA

    Pelotas, Rio Grande do Sul, 96015-280

  • Inca-RJ

    Rio de Janeiro, 20231-050

  • Oncovida - Centro de Oncologia da Bahia

    Salvador, Estado de Bahia, 41820021

  • Hospital de Base de São José do Rio Preto

    São José do Rio Preto, São Paulo, 15090-000

  • IEP São Lucas

    São Paulo, 01236030

  • Casa de Saúde Santa Marcelina

    São Paulo, 08270-070

Other trials in Brazil

Germany12 sites

  • Charite - Campus Benjamin Franklin (Cbf)

    Berlin, 12200

  • Charite

    Berlin, 13353

  • Ev. Krankenhaus Bielefeld

    Bielefeld, North Rhine-Westphalia, 33611

  • Universitätsklinik Carl-Gustav-Carus Dresden

    Dresden, Saxony, 1307

  • Kliniken Essen-Mitte Evang. Huyssens-Stiftung

    Essen, North Rhine-Westphalia, 45136

  • Klinikum Esslingen

    Esslingen am Neckar, 73730

  • Klinikum der Johann Wolfgang Goethe-Universität

    Frankfurt am Main, Hesse, 60596

  • Facharztzentrum Eppendorf

    Hamburg, 20249

  • OncoResearch Lerchenfeld GmbH

    Hamburg, 22081

  • Universitätsklinikum Leipzig

    Leipzig, Saxony, 4103

  • Johannes Gutenberg-Universitaet

    Maintz, Rhineland-Palatinate, 55101

  • Klinikum Bogenhausen

    München, Bavaria, 81925

Other trials in Germany

Romania12 sites

  • Sp. Jud. de Urg. "Dr. Constantin Opris" Baia Mare

    Baia Mare, Maramureş, 430031

  • Med Life

    Bucharest, 010719

  • Spitalul Clinic CF 2

    Bucharest, 011464

  • Institutul Clinic Fundeni

    Bucharest, 022328

  • Centrul de Oncologie Sf. Nectarie

    Craiova, Dolj, 200347

  • Oncolab

    Craiova, Dolj, 200385

  • Radiotherapy Center CJ radioterapie si chimioterapie adulti

    Floreşti, Cluj, 407280

  • Centrul de Oncologie Euroclinic

    Iași, 700106

  • Institutul Regional de Oncologie Iasi

    Lasi, Lasi, 700483

  • Spitalul Clinic Judetean de Urgenta Sibiu

    Sibiu, 550245

  • Oncomed

    Timișoara, Timiș County, 300239

  • Spitalul Clinic Municipal de Urgenta Timisoara

    Timișoara, Timiș County, 300239

Other trials in Romania

Hungary11 sites

  • Semmelweis Egyetem

    Budapest, 1083

  • Egyesített Szent István és Szent László Kórház-Rendelőintéze

    Budapest, 1097

  • Országos Onkológiai Intézet

    Budapest, 1122

  • Semmelweis Egyetem

    Budapest, 1125

  • Debreceni Egyetem Klinikai Központ

    Debrecen, Hajdú-Bihar, H-4032

  • Petz Aladár Megyei Oktató Kórház

    Győr, Győr-Moson-Sopron, 9024

  • Békés Megyei Pándy Kálmán Kórház

    Gyula, Bekes County, 5700

  • Somogy Megyei Kaposi Mór Oktató Kórház

    Kaposvár, 7400

  • Josa Andras Oktato Korhaza

    Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400

  • Pécsi Tudományegyetem Klinikai Központ

    Pécs, Baranya, 7624

  • Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház- Rendelőinté

    Szolnok, Jász-Nagykun-Szolnok, 5004

Other trials in Hungary

Russia11 sites

  • Guz Clinical Oncology Dispensary #1

    Krasnodar, 350040

  • Russian Oncological Research Center n.a. N.N. Blokhin RAMS

    Moscow, Moscow, 115478

  • City Clinical Hospital #40

    Moscow, Moscow, 129301

  • GUZ Perm Regional Oncology Dispensary

    Perm, Permskiy Kray, 614066

  • GBUZ of Stavropol Territory Pyatigorsk Oncology Dispensary

    Pyatigorsk, Stavropol Kray, 357502

  • Military Medical Academy n.a. S.M. Kirov

    Saint Petersburg, Leningradskaya Oblast', 190121

  • Northwestern State Medical University n.a. Mechnikov

    Saint Petersburg, Sankt-Peterburg, 195067

  • First Pavlov State Medical University of Saint-Petersburg

    Saint Petersburg, Sankt-Peterburg, 197022

  • GBUZ Saint Petersburg clinical scientific and practical cent

    Saint Petersburg, Sankt-Peterburg, 197758

  • SPb State Budget Institution Oncology Dispansery

    Saint Petersburg, Sankt-Peterburg, 198255

  • Republican Clinical Oncology Dispensary

    Ufa, Bahkortostan, Respublika, 450054

Other trials in Russia

Poland10 sites

  • Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onko

    Brzozów, Podkarpackie Voivodeship, 36-20

  • Centrum Onkologii im. F.Lukaszczyka

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796

  • Wojewodzkie Centrum Onkologii w Gdansku

    Gdansk, Pomeranian Voivodeship, 80-210

  • Szpital Specjalistyczny im. L. Rydygiera w Krakowie

    Krakow, Lesser Poland Voivodeship, 31-108

  • Wojewodzki Szpital Specjalistyczny im. M.Kopernika

    Lodz, Łódź Voivodeship, 93-510

  • Europejskie Centrum Zdrowia Otwock, Szpital im. F. Chopina

    Otwock, Masovian Voivodeship, 05-400

  • NZOZ Centrum Medyczne HCP Lecznictwo Stacjonarne

    Poznan, Greater Poland Voivodeship, 61-485

  • Zachodniopomorskie Centrum Onkologii

    Szczecin, West Pomeranian Voivodeship, 71-730

  • Centrum Onkologii Instytut im. M. Sklodowskiej-Curie

    Warsaw, Masovian Voivodeship, 02-781

  • Magodent sp. z o.o. Szpital Onkologiczny

    Warsaw, Masovian Voivodeship, 03-291

Other trials in Poland

Belgium9 sites

  • Imelda Ziekenhuis

    Bonheiden, Antwerpen, 2820

  • AZ Sint-Lucas - Campus Sint-Lucas

    Brugge (Assebroek), 8310

  • Institut Jules Bordet

    Brussels, Brussels Capital, 1000

  • UZ Brussel - Campus Jette

    Brussels, Brussels Capital, 1090

  • Cliniques Universitaires Saint-Luc

    Brussels, Brussels Capital, B-1200

  • UZ Antwerpen

    Edegem, Antwerpen, 2650

  • UZ Leuven - Campus Gasthuisberg

    Leuven, Vlaams Brabant, 3000

  • CHU de Liège - Domaine Universitaire du Sart Tilman

    Liège, 4000

  • CHU Ambroise Paré

    Mons, Hainaut, 7000

Other trials in Belgium

United Kingdom9 sites

  • Aberdeen Royal Infirmary

    Aberdeen, Aberdeen City, AB25 2ZN

  • Belfast City Hospital

    Belfast, BT9 7AB

  • The Beatson West Of Scotland Cancer Centre

    Glasgow, Glasgow City, G12 0YH

  • Royal Surrey County Hospital

    Guildford, Surrey, GU2 7XX

  • St. Georges Hospital

    London, SE1 2PR

  • Christie Hospital NHS Foundation Trust

    Manchester, M20 4BX

  • Southampton University Hospital

    Southampton, SO16 6YD

  • The Royal Marsden Hospital

    Sutton, Surrey, SM2 5PT

  • The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital

    Sutton, Surrey, SM2 5PT

Other trials in United Kingdom

Bulgaria7 sites

  • UMHAT ""Dr. Georgi Stranski"" Dept. Medical Oncology

    Pleven, 5800

  • Specialised Hospital for Active Treatment in Oncology

    Sofia, Sofia-Grad, 1756

  • District Dispensery with Stationary - Sofia District

    Sofia, 1233

  • Multiprofile hospital for active treatment

    Sofia, 1233

  • UMHAT"Sv.Ivan Rilski"

    Sofia, 1606

  • Uni. Multiprofile Hospital for Active treatment Sveta Marina

    Varna, 9010

  • COC - Vratsa Dept. of Palliative Care

    Vratsa, 3000

Other trials in Bulgaria

Israel7 sites

  • Soroka Medical Center [Oncology]

    Beersheba, Southern District, 84101

  • Rambam Health Care Campus

    Haifa, 31096

  • The E. Wolfson Medical Center [Oncology]

    Holon, Central District, 58100

  • Hadassah Medical Organisation

    Jerusalem, Jerusalem, 91120

  • Meir Medical Center

    Kfar Saba, Central District, 44281

  • Rabin Medical Center - Beilinson Hospital

    Petah Tikva, Central District, 49100

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, Tel Aviv, 64239

Other trials in Israel

Lithuania7 sites

  • Hospital of Lithuanian University of Health sciences

    Kaunas, Kaunas County, LT-45434

  • Hospital of Lithuanian University of Health Sciences

    Kaunas, Kaunas County, LT-50009

  • Klaipeda University Hospital

    Klaipėda, LT-92288

  • Respublikine Panevezio ligonine

    Panevezys, Panevežio Apskritis, LT-35144

  • Siauliai County Hospital

    Šiauliai, Šiauliu Apskritis, LT-76231

  • National Cancer Institute

    Vilnius, Vilnius County, LT-08860

  • Vilniaus Universiteto ligonines Santariskiu Klinikos

    Vilnius, LT-08661

Other trials in Lithuania

Canada6 sites

  • Hopital Notre-Dame du CHUM

    Montreal, Quebec, H2L 2W5

  • McGill University Health Centre - Montreal General Hospital

    Montreal, Quebec, H3G 1A4

  • The Ottawa Hospital Cancer Centre

    Ottawa, Ontario, K1H 8L6

  • Saint Michael's Hospital Li Ka Shing Knowledge Institute

    Toronto, Ontario, M5B 1W8

  • Mount Sinai Hospital

    Toronto, Ontario, M5G 1X5

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2C4

Other trials in Canada

Czechia5 sites

  • Masarykuv onkologicky ustav

    Brno, 656 53

  • FN Hradec Kralove

    Hradec Králové, Hradec Králové Region, 500 05

  • Fakultni nemocnice Olomouc

    Olomouc, Olomouc Region, 775 20

  • Vseobecna fakultni nemocnice v Praze

    Prague, 128 08

  • Nemocnice Na Bulovce

    Prague, 180 81

Other trials in Czechia

South Korea4 sites

  • Seoul National University Bundang Hospital

    Seongnam, Gyeonggido, 463-707

  • Samsung Medical Center

    Seoul, Seoul Teugbyeolsi, 135-710

  • Asan medical Center

    Seoul, Seoul Teugbyeolsi, 138-736

  • Seoul National University Hospital

    Seoul, Seoul Teugbyeolsi, 138-736

Other trials in South Korea

Estonia2 sites

  • East Tallinn Central Hospital Oncology Center

    Tallinn, Harju, 10138

  • Tartu University Hospital Clinic of Hematology and Oncology

    Tartu, Tartu, 51014

Other trials in Estonia

About this study

Official title: A Phase III Clinical Trial of BBI608 Plus Weekly Paclitaxel vs. Placebo Plus Weekly Paclitaxel in Adult Patients With Advanced, Previously Treated Gastric and Gastro-Esophageal Junction Adenocarcinoma

The purpose of this study is to find out whether it is better to receive a new drug, BBI608, in addition to paclitaxel chemotherapy or better to receive paclitaxel chemotherapy alone as second line treatment for gastric and gastroesophageal junction cancer after prior first line platinum and fluoropyrimidine based chemotherapy.

Read the detailed description

The goal of this study is to determine if paclitaxel given together with BBI608 as second line therapy will prolong overall survival compared to paclitaxel alone.

Approximately 700 patients will be randomized with histologically or cytologically confirmed metastatic gastric or gastroesophageal junction adenocarcinoma.

Patients must have failed first line therapy with any platinum/fluoropyrimidine doublet.

BBI608/placebo will be administered daily, paclitaxel will be administered i.v. on days 1, 8 and 15 of a 4 weekly cycle.

Being tested
BBI608, Paclitaxel, Placebo
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • BBI608Drug

    Also called Napabucasin, BB608, BBI-608

    BBI608 480 mg orally two times daily (960 mg total daily dose)

  • PaclitaxelDrug

    Paclitaxel 80 mg/m2 I.V. infusion on Days 1, 8, and 15 of every 4-week cycle

  • PlaceboOther

    Orally two times daily

Study groups in NCT02178956
Study groupRoleWhat they receive
BBI608 plus PaclitaxelExperimentalNot described
Receives: Drug: BBI608; Drug: Paclitaxel
Placebo plus PaclitaxelPlacebo comparatorNot described
Receives: Drug: Paclitaxel; Other: Placebo

What is being measured

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

  1. Overall Survival

    The primary objective of this study is to assess the effect of orally administered BBI608 plus weekly paclitaxel, in comparison to placebo plus weekly paclitaxel on the Overall Survival of patients with advanced histopathologically confirmed gastric or gastroesophageal junction adenocarcinoma who failed treatment with one platinum/fluoropyrimidine containing regimen for unresectable or metastatic disease.

    Measured: 36 months

Secondary outcomes (4)

  1. Progression Free Survival

    Defined as the time from randomization to the first objective documentation of disease progression or death due to any cause which comes first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria(RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in anon-target lesion, or the appearance of new lesions.

    Measured: 36 months

  2. Objective Response Rate

    Objective Response Rate is defined as the percentage of patients with a documented complete response or partial response (CR + PR) based on RECIST 1.1.

    Measured: 36 months

  3. Disease Control Rate

    Disease control Rate is defined as the percentage of patients with a documented complete response or partial response (CR + PR+SD) based on RECIST 1.1.

    Measured: 36 months

  4. Number of Patients With Adverse Events

    All patients who have received at least one dose of BBI608/Placebo will be included in the safety analysis. The number of patients who experienced at least one adverse event is reported.

    Measured: 36 months

Timeline

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

  1. First posted1 Jul 2014 (estimated)
  2. Study startOct 2014
  3. Primary completion20 Sep 2017
  4. Study completion20 Sep 2017

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
714 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02178956
Sponsor's protocol ID
BBI608-336
Other IDs
2014-000774-18, 2014
Acronym
BRIGHTER
Status last verified
Nov 2023
First submitted
27 Jun 2014
Last updated
15 Nov 2023
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BBI608 and Paclitaxel in people with Gastric Cancer and Gastroesophageal Junction Cancer, run by Sumitomo Pharma America, Inc. at 263 sites in 22 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 20 inclusion and 14 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 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 263 sites in United States, China, Australia, Spain, France and 17 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 10 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Overall Survival (time frame: 36 months). 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 NCT02178956.

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 15 Nov 2023.

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