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

November 13, 2023 updated by: Sumitomo Pharma America, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

714

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Bankstown, New South Wales, Australia, 2200
        • Bankstown-Lidcombe
      • Camperdown, New South Wales, Australia, 2050
        • Chris O'Brien Lifehouse
      • Darlinghurst, New South Wales, Australia, 2010
        • St Vincent's hospital
      • Gosford, New South Wales, Australia, 2250
        • Central coast area health (public)
      • Port Macquarie, New South Wales, Australia, 2444
        • Port Macquaries Base Hospital
      • St Leonards, New South Wales, Australia, 2065
        • Royal North Shore Hospital
      • Wagga Wagga, New South Wales, Australia, 2650
        • Riverina Cancer Care Centre
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Royal Brisbane & Women's Hospital
      • Nambour, Queensland, Australia, 4560
        • Sunshine Coast Hospital and Health Service
      • Southport, Queensland, Australia, 4215
        • Gold Coast University Hospital
      • Townsville, Queensland, Australia, 4814
        • Townsville Hospital
      • Woolloongabba, Queensland, Australia, 4102
        • Princess Alexandra Hospital
    • South Australia
      • Bedford Park, South Australia, Australia, 5042
        • Flinders Medical Centre
      • Kurralta Park, South Australia, Australia, 5037
        • Ashford Cancer Centre Research
      • Woodville, South Australia, Australia, 5011
        • The Queen Elizabeth Hospital
    • Victoria
      • Bendigo, Victoria, Australia, 3550
        • Bendigo Hospital
      • East Bentleigh, Victoria, Australia, 3165
        • Monash Health
      • East Bentleigh, Victoria, Australia, 3165
        • Peninsula & South Eastern Haematology and Oncology Group
      • Fitzroy, Victoria, Australia, 3065
        • St Vincent's hospital
      • Heidelberg, Victoria, Australia, 3084
        • Austin Hospital
      • Heidelberg, Victoria, Australia, 3084
        • Ballarat Base Hospital
      • Parkville, Victoria, Australia, 3050
        • Royal Melbourne Hospital
      • St Albans, Victoria, Australia, 3021
        • Sunshine Hospital
      • Wendouree, Victoria, Australia, 3355
        • Ballarat Oncology And Haematology Services
    • Western Australia
      • Subiaco, Western Australia, Australia, 6008
        • Fiona Stanley Hospital
  • Belgium
      • Brugge (Assebroek), Belgium, 8310
        • AZ Sint-Lucas - Campus Sint-Lucas
      • Liège, Belgium, 4000
        • CHU de Liège - Domaine Universitaire du Sart Tilman
    • Antwerpen
      • Bonheiden, Antwerpen, Belgium, 2820
        • Imelda Ziekenhuis
      • Edegem, Antwerpen, Belgium, 2650
        • UZ Antwerpen
    • Brussels Capital Region
      • Brussel, Brussels Capital Region, Belgium, 1090
        • UZ Brussel - Campus Jette
      • Bruxelles, Brussels Capital Region, Belgium, 1000
        • Institut Jules Bordet
      • Bruxelles, Brussels Capital Region, Belgium, B-1200
        • Cliniques Universitaires Saint-Luc
    • Hainaut
      • Mons, Hainaut, Belgium, 7000
        • CHU Ambroise Pare
    • Vlaams Brabant
      • Leuven, Vlaams Brabant, Belgium, 3000
        • UZ Leuven - Campus Gasthuisberg
  • Brazil
      • Rio de Janeiro, Brazil, 20231-050
        • Inca-RJ
      • São Paulo, Brazil, 08270-070
        • Casa de Saude Santa Marcelina
      • São Paulo, Brazil, 01236030
        • IEP São Lucas
    • Bahia
      • Salvador, Bahia, Brazil, 41820021
        • Oncovida - Centro de Oncologia da Bahia
    • Ceará
      • Fortaleza, Ceará, Brazil, 60430-230
        • Instituto do Câncer do Ceará - Instituto do Câncer do Cear
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30150-270
        • Cetus Hospital Dia Oncologia
    • Paraná
      • Curitiba, Paraná, Brazil, 81520-060
        • Hospital Erasto Gaertner
    • Rio Grande Do Sul
      • Lajeado, Rio Grande Do Sul, Brazil, 95900000
        • Hospital Bruno Born
      • Passo Fundo, Rio Grande Do Sul, Brazil, 99010-260
        • Hospital da cidade de Passo Fundo
      • Pelotas, Rio Grande Do Sul, Brazil, 96015-280
        • UPCO - Unidade de Pesquisa Clinica em Oncologia LTDA
    • Santa Catarina
      • Itajai, Santa Catarina, Brazil, 88301-220
        • Clinica de Neoplasias Litoral
    • São Paulo
      • Jaú, São Paulo, Brazil, 17210-080
        • Fundacao Dr Amaral Carvalho
      • São José do Rio Preto, São Paulo, Brazil, 15090-000
        • Hospital de Base de Sao Jose do Rio Preto
  • Bulgaria
      • Pleven, Bulgaria, 5800
        • UMHAT ""Dr. Georgi Stranski"" Dept. Medical Oncology
      • Sofia, Bulgaria, 1233
        • District Dispensery with Stationary - Sofia District
      • Sofia, Bulgaria, 1233
        • Multiprofile Hospital for active treatment
      • Sofia, Bulgaria, 1606
        • UMHAT"Sv.Ivan Rilski"
      • Varna, Bulgaria, 9010
        • Uni. Multiprofile Hospital for Active treatment Sveta Marina
      • Vratsa, Bulgaria, 3000
        • COC - Vratsa Dept. of Palliative Care
    • Sofia-Grad
      • Sofia, Sofia-Grad, Bulgaria, 1756
        • Specialised Hospital for Active Treatment in Oncology
  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • The Ottawa Hospital Cancer Centre
      • Toronto, Ontario, Canada, M5G 1X5
        • Mount Sinai Hospital
      • Toronto, Ontario, Canada, M5B 1W8
        • Saint Michael's Hospital Li Ka Shing Knowledge Institute
      • Toronto, Ontario, Canada, M5G 2C4
        • Princess Margaret Hospital
    • Quebec
      • Montreal, Quebec, Canada, H3G 1A4
        • McGill University Health Centre - Montreal General Hospital
      • Montreal, Quebec, Canada, H2L 2W5
        • Hopital Notre-Dame du CHUM
  • China
      • Wuhan, China, 430030
        • Tongji Hospital
    • Beijing
      • Beijing, Beijing, China, 100142
        • Beijing Cancer Hospital
      • Beijing, Beijing, China, 100853
        • Chinese PLA General Hospital
      • Beijing, Beijing, China, 100021
        • Cancer Hospital Chinese Academy of Medical Sciences
      • Beijing, Beijing, China, 100071
        • The 307th hospital of chinese People's liberation army
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Fujian Medical University Union Hospital
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Sun Yat-sen University Cancer Center
      • Guangzhou, Guangdong, China, 510515
        • Southern Medical University, Nanfang Hospital
    • Heilongjiang
      • Heilongjiang, Heilongjiang, China, 150081
        • Harbin medical university cancer hospital
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Henan Cancer Hospital
      • Zhengzhou, Henan, China, 450003
        • The First Affiliated Hospital of Zhengzhou University
    • Hunan
      • Changsha, Hunan, China, 410006
        • Hunan Cancer hospital
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Jiangsu Province Hospital
      • Nanjing, Jiangsu, China, 210002
        • The 81 Hospital of the Chinese People's Liberation Army
      • Nanjing, Jiangsu, China, 210009
        • Jiang Su Cancer Hospital
    • Jilin
      • Changchun, Jilin, China, 130021
        • The First Bethune Hospital of Jilin University
      • Jilin, Jilin, China, 130021
        • Jilin Cancer Hospital
    • Liaoning
      • Shenyang, Liaoning, China, 110002
        • The First Hospital of China Medical University
    • Ningxia
      • Yinchuan, Ningxia, China, 750004
        • General Hospital of Ningxia Medical University
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Fudan University Shanghai Cancer Center
      • Shanghai, Shanghai, China, 200032
        • Zhongshan Hospital
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital, Sichuan University
    • Tianjin
      • Tianjin, Tianjin, China, 300202
        • Tianjin Medical University Cancer Institute & Hospital
    • Xinjiang
      • Urumqi, Xinjiang, China, 830000
        • Xin Jiang Tumor Hospital, Xin Jiang Medical University
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Zhejiang Cancer Hospital
      • Hangzhou, Zhejiang, China, 310016
        • Sir Run Run Shaw Hospital School of Medicine, Zhejiang University
  • Czechia
      • Brno, Czechia, 656 53
        • Masarykuv onkologicky ustav
      • Praha 2, Czechia, 128 08
        • Všeobecná fakultní nemocnice v Praze
      • Praha 8, Czechia, 180 81
        • Nemocnice Na Bulovce
    • Královéhradecký Kraj
      • Hradec Kralove, Královéhradecký Kraj, Czechia, 500 05
        • FN Hradec Králové
    • Olomoucký Kraj
      • Olomouc, Olomoucký Kraj, Czechia, 775 20
        • Fakultni Nemocnice Olomouc
  • Estonia
    • Harjumaa
      • Tallinn, Harjumaa, Estonia, 10138
        • East Tallinn Central Hospital Oncology Center
    • Tartumaa
      • Tartu, Tartumaa, Estonia, 51014
        • Tartu University Hospital Clinic of Hematology and Oncology
  • France
      • Brest Cedex, France, 29609
        • Hôpital Morvan - CHRU de Brest
      • Clermont-Ferrand, France, 63003
        • CHU Estaing
      • Marseille, France, 13385
        • CHU - Hôpital De La Timone
      • Mont de Marsan Cedex, France, 40024
        • Centre Hospitalier de Mont de Marsan - Hopital Layne
      • Rennes, France, 35042
        • Centre Eugene Marquis
      • Saint Etienne, France, 42270
        • CHU Saint Etienne
      • Toulouse cedex, France, 31052
        • Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital
      • Villejuif, France, 94800
        • Institut Gustave Roussy
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, France, 06189 Cedex 2
        • Centre Antoine Lacassagne
    • Bouches-du-Rhône
      • Marseille, Bouches-du-Rhône, France, 13008
        • Hopital Saint Joseph - Marseille
    • Loire-Atlantique
      • St Herblain Cedex, Loire-Atlantique, France, 44805
        • Centre Paul Papin
      • St Herblain Cedex, Loire-Atlantique, France, 44805
        • Centre René Gauducheau
    • Rhône
      • Lyon, Rhône, France, 69008
        • Hôpital Privé Jean Mermoz
    • Vendée
      • La Roche sur Yon Cedex 9, Vendée, France, 85925
        • CHD Vendée La Roche sur Yon
    • Vienne
      • Poitiers, Vienne, France, 86021
        • Hospital of Poitiers
  • Germany
      • Berlin, Germany, 13353
        • Charité
      • Berlin, Germany, 12200
        • Charite - Campus Benjamin Franklin (Cbf)
      • Esslingen, Germany, 73730
        • Klinikum Esslingen
      • Hamburg, Germany, 22081
        • OncoResearch Lerchenfeld GmbH
      • Hamburg, Germany, 20249
        • Facharztzentrum Eppendorf
    • Bayern
      • München, Bayern, Germany, 81925
        • Klinikum Bogenhausen
    • Hessen
      • Frankfurt/Main, Hessen, Germany, 60596
        • Klinikum der Johann Wolfgang Goethe-Universität
    • Nordrhein-Westfalen
      • Bielefeld, Nordrhein-Westfalen, Germany, 33611
        • Ev. Krankenhaus Bielefeld
      • Essen, Nordrhein-Westfalen, Germany, 45136
        • Kliniken Essen-Mitte Evang. Huyssens-Stiftung
    • Rheinland-Pfalz
      • Maintz, Rheinland-Pfalz, Germany, 55101
        • Johannes Gutenberg-Universitaet
    • Sachsen
      • Dresden, Sachsen, Germany, 1307
        • Universitätsklinik Carl-Gustav-Carus Dresden
      • Leipzig, Sachsen, Germany, 4103
        • Universitätsklinikum Leipzig
  • Hungary
      • Budapest, Hungary, 1122
        • Orszagos Onkologiai Intezet
      • Budapest, Hungary, 1083
        • Semmelweis Egyetem
      • Budapest, Hungary, 1125
        • Semmelweis Egyetem
      • Budapest, Hungary, 1097
        • Egyesített Szent István és Szent László Kórház-Rendelőintéze
      • Kaposvár, Hungary, 7400
        • Somogy Megyei Kaposi Mor Oktato Korhaz
    • Baranya
      • Pécs, Baranya, Hungary, 7624
        • Pecsi Tudomanyegyetem Klinikai Kozpont
    • Békés
      • Gyula, Békés, Hungary, 5700
        • Békés Megyei Pándy Kálmán Kórház
    • Gyor-Moson-Sopron
      • Gyor, Gyor-Moson-Sopron, Hungary, 9024
        • Petz Aladar Megyei Oktato Korhaz
    • Hajdú-Bihar
      • Debrecen, Hajdú-Bihar, Hungary, H-4032
        • Debreceni Egyetem Klinikai Kozpont
    • Jász-Nagykun-Szolnok
      • Szolnok, Jász-Nagykun-Szolnok, Hungary, 5004
        • Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház- Rendelőinté
    • Szabolcs-Szatmár-Bereg
      • Nyiregyhaza, Szabolcs-Szatmár-Bereg, Hungary, 4400
        • Josa Andras Oktato Korhaza
  • Israel
      • Haifa, Israel, 31096
        • Rambam Health Care Campus
    • HaDarom
      • Beer Sheva, HaDarom, Israel, 84101
        • Soroka Medical Center [Oncology]
    • HaMerkaz
      • Holon, HaMerkaz, Israel, 58100
        • The E. Wolfson Medical Center [Oncology]
      • Kfar Saba, HaMerkaz, Israel, 44281
        • Meir Medical Center
      • Petah Tikva, HaMerkaz, Israel, 49100
        • Rabin Medical Center - Beilinson Hospital
    • Tel-Aviv
      • Tel Aviv, Tel-Aviv, Israel, 64239
        • Tel Aviv Sourasky Medical Center
    • Yerushalayim
      • Jerusalem, Yerushalayim, Israel, 91120
        • Hadassah Medical Organisation
  • Italy
      • Ancona, Italy, 60126
        • Ospedale Umberto I, AOU Ospedali Riuniti Umberto I - GM.Lanc
      • Bari, Italy, 701264
        • IRCCS Ospedale Oncologico "Giovanni Paolo II"
      • Bergamo, Italy, 24125
        • Humanitas Gavazzeni
      • Bologna, Italy, 40138
        • Policlinico S.Orsola Malpighi, AOU di Bologna
      • Catania, Italy, 95100
        • PO Garibaldi-Nesima, ARNAS Garibaldi
      • Cremona, Italy, 26100
        • Azienda Ospedaliera "Istituti Ospitalieri" di Cremona
      • Genova, Italy, 16132
        • AOU S.Martino, IRCCS, IST-Istituto Nazionale Ricerca Sul Can
      • Milano, Italy, 20121
        • Azienda Ospedaliera Fatebenefratelli e Oftalmico
      • Padova, Italy, 35128
        • Istituto Oncologico Veneto IOV-IRCCS
      • Piacenza, Italy, 29100
        • Ospedale Guglielmo da Saliceto, AUSL Piacenza
      • Ravenna, Italy, 48100
        • Unità di Biostatistica e Sperimentazioni Cliniche IRST
      • Torino, Italy, 10126
        • Ospedale Molinette, AO Città della Salute e della Scienza di
    • Forli
      • Meldola, Forli, Italy, 47014
        • Irccs Irst
    • Ravenna
      • Faenza, Ravenna, Italy, 48018
        • AUSL della Romagna, Osp. degli Infermi
  • Japan
      • Chiba, Japan
        • Chiba Cancer Center
      • Gifu, Japan
        • Gifu University Hospital
      • Osaka, Japan
        • Osaka Medical Center for Cancer and Cardiovascular Diseases
    • Aichi
      • Nagoya, Aichi, Japan
        • Aichi Cancer Center Hospital
    • Chiba
      • Kashiwa, Chiba, Japan
        • National Cancer Center Hospital East
    • Ehime
      • Matsuyama, Ehime, Japan
        • National Hospital Organization Shikoku Cancer Center
    • Hokkaido
      • Sapporo, Hokkaido, Japan
        • Hokkaido University Hospital
    • Hyogo
      • Kobe, Hyogo, Japan
        • Kobe City Medical Center General Hospital
    • Nagano
      • Saku, Nagano, Japan
        • Saku Central Hospital Advanced Care Center
    • Osaka
      • Suita, Osaka, Japan
        • Osaka University Hospital
    • Saitama
      • Kita-Adachi, Saitama, Japan
        • Saitama Cancer Center
    • Shizuoka
      • Sunto, Shizuoka, Japan
        • Shizuoka Cancer Center
    • Tochigi
      • Utsunomiya, Tochigi, Japan
        • Tochigi Cancer Center
    • Tokyo
      • Chuo, Tokyo, Japan
        • National Cancer Center Hospital
      • Mitaka, Tokyo, Japan
        • Kyorin University Hospial
  • Korea, Republic of
    • Gyeonggido
      • SeongNam, Gyeonggido, Korea, Republic of, 463-707
        • Seoul National University Bundang Hospital
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 138-736
        • Asan Medical Center
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 135-710
        • Samsung Medical Center
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 138-736
        • Seoul National University Hospital
  • Lithuania
      • Klaipeda, Lithuania, LT-92288
        • Klaipeda University Hospital
      • Vilnius, Lithuania, LT-08661
        • Vilniaus Universiteto ligonines Santariskiu Klinikos
    • Kauno Apskritis
      • Kaunas, Kauno Apskritis, Lithuania, LT-45434
        • Hospital of Lithuanian University of Health Sciences
      • Kaunas, Kauno Apskritis, Lithuania, LT-50009
        • Hospital of Lithuanian University of Health Sciences
    • Panevežio Apskritis
      • Panevezys, Panevežio Apskritis, Lithuania, LT-35144
        • Respublikine Panevezio ligonine
    • Vilniaus Apskritis
      • Vilnius, Vilniaus Apskritis, Lithuania, LT-08860
        • National Cancer Institute
    • Šiauliu Apskritis
      • Siauliai, Šiauliu Apskritis, Lithuania, LT-76231
        • Siauliai County Hospital
  • Poland
    • Kujawsko-pomorskie
      • Bydgoszcz, Kujawsko-pomorskie, Poland, 85-796
        • Centrum Onkologii im. F.Lukaszczyka
    • Malopolskie
      • Krakow, Malopolskie, Poland, 31-108
        • Szpital Specjalistyczny im. L. Rydygiera w Krakowie
    • Mazowieckie
      • Otwock, Mazowieckie, Poland, 05-400
        • Europejskie Centrum Zdrowia Otwock, Szpital im. F. Chopina
      • Warszawa, Mazowieckie, Poland, 02-781
        • Centrum Onkologii Instytut im. M. Sklodowskiej-Curie
      • Warszawa, Mazowieckie, Poland, 03-291
        • Magodent sp. z o.o. Szpital Onkologiczny
    • Podkarpackie
      • Brzozow, Podkarpackie, Poland, 36-20
        • Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onko
    • Pomorskie
      • Gdansk, Pomorskie, Poland, 80-210
        • Wojewodzkie Centrum Onkologii w Gdansku
    • Wielkopolskie
      • Poznan, Wielkopolskie, Poland, 61-485
        • NZOZ Centrum Medyczne HCP Lecznictwo Stacjonarne
    • Zachodniopomorskie
      • Szczecin, Zachodniopomorskie, Poland, 71-730
        • Zachodniopomorskie Centrum Onkologii
    • Łódzkie
      • Lodz, Łódzkie, Poland, 93-510
        • Wojewodzki Szpital Specjalistyczny im. M.Kopernika
  • Romania
      • Bucuresti, Romania, 022328
        • Institutul Clinic Fundeni
      • Bucuresti, Romania, 010719
        • Med Life
      • Bucuresti, Romania, 011464
        • Spitalul Clinic CF 2
      • Iasi, Romania, 700106
        • Centrul de Oncologie Euroclinic
      • Lasi, Romania, 700483
        • Institutul Regional de Oncologie Iasi
      • Sibiu, Romania, 550245
        • Spitalul Clinic Judetean de Urgenta Sibiu
    • Cluj
      • Floresti, Cluj, Romania, 407280
        • Radiotherapy Center CJ radioterapie si chimioterapie adulti
    • Dolj
      • Craiova, Dolj, Romania, 200347
        • Centrul de Oncologie Sf. Nectarie
      • Craiova, Dolj, Romania, 200385
        • Oncolab
    • Maramures
      • Baia-Mare, Maramures, Romania, 430031
        • Sp. Jud. de Urg. "Dr. Constantin Opris" Baia Mare
    • Timis
      • Timisoara, Timis, Romania, 300239
        • OncoMed
      • Timisoara, Timis, Romania, 300239
        • Spitalul Clinic Municipal de Urgenta Timisoara
  • Russian Federation
      • Krasnodar, Russian Federation, 350040
        • Guz Clinical Oncology Dispensary #1
    • Bahkortostan, Respublika
      • Ufa, Bahkortostan, Respublika, Russian Federation, 450054
        • Republican Clinical Oncology Dispensary
    • Leningradskaya Oblast'
      • Saint Petersburg, Leningradskaya Oblast', Russian Federation, 190121
        • Military Medical Academy n.a. S.M. Kirov
    • Moskva
      • Moscow, Moskva, Russian Federation, 115478
        • Russian Oncological Research Center n.a. N.N. Blokhin RAMS
      • Moscow, Moskva, Russian Federation, 129301
        • City Clinical Hospital #40
    • Permskiy Kray
      • Perm, Permskiy Kray, Russian Federation, 614066
        • GUZ Perm Regional Oncology Dispensary
    • Sankt-Peterburg
      • Saint Petersburg, Sankt-Peterburg, Russian Federation, 195067
        • Northwestern State Medical University n.a. Mechnikov
      • Saint Petersburg, Sankt-Peterburg, Russian Federation, 197022
        • First Pavlov State Medical University of Saint-Petersburg
      • Saint Petersburg, Sankt-Peterburg, Russian Federation, 197758
        • GBUZ Saint Petersburg clinical scientific and practical cent
    • Sankt-Petersburg
      • Saint Petersburg, Sankt-Petersburg, Russian Federation, 198255
        • SPb State Budget Institution Oncology Dispansery
    • Stavropol'skiy Kray
      • Pyatigorsk, Stavropol'skiy Kray, Russian Federation, 357502
        • GBUZ of Stavropol Territory Pyatigorsk Oncology Dispensary
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitario Vall d'Hebron
      • Barcelona, Spain, 08003
        • H.del Mar
      • Barcelona, Spain, 08041
        • H.Sta.Creu i St.Pau
      • Burgos, Spain, 09006
        • H.U. de Burgos
      • Hospitalet de Llobregat, Spain, 08907
        • Institut Catalá d´Oncología (I.C.O.)
      • Madrid, Spain, 28007
        • H.G.U. G. Marañón
      • Madrid, Spain, 28040
        • H.C. S.Carlos
      • Madrid, Spain, 28033
        • M.D. Anderson Cancer Center Madrid
      • Madrid, Spain, 28034
        • H.U. R. y Cajal
      • Murcia, Spain, 30120
        • H.U.V.Arrixaca
      • Sevilla, Spain, 41013
        • H.U.V. del Rocio
      • Valencia, Spain, 46014
        • C.H.G.U.de Valencia
      • Zaragoza, Spain, 50009
        • H.U. Miguel Servet
    • Andalucía
      • Sevilla, Andalucía, Spain, 41009
        • H.U.V. Macarena
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Institut català d'oncologia-hospital germans trias i pujol
    • Castilla Y León
      • Avila, Castilla Y León, Spain, 05004
        • C.A.AV-H.Ntra.Sra.de Sonsoles
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • H.U.P Hierro-Majadahonda
  • United Kingdom
      • Belfast, United Kingdom, BT9 7AB
        • Belfast City Hospital
      • London, United Kingdom, SE1 2PR
        • St. Georges Hospital
      • Manchester, United Kingdom, M20 4BX
        • Christie Hospital NHS Foundation Trust
      • Southampton, United Kingdom, SO16 6YD
        • Southampton University Hospital
    • Aberdeen City
      • Aberdeen, Aberdeen City, United Kingdom, AB25 2ZN
        • Aberdeen Royal Infirmary
    • Glasgow City
      • Glasgow, Glasgow City, United Kingdom, G12 0YH
        • The Beatson West of Scotland Cancer Centre
    • Surrey
      • Guildford, Surrey, United Kingdom, GU2 7XX
        • Royal Surrey County Hospital
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • The Royal Marsden Hospital
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic - Arizona
    • Colorado
      • Denver, Colorado, United States, 80222
        • Colorado Cancer Research Program
    • Indiana
      • Goshen, Indiana, United States, 46526
        • Indiana University Health Goshen Center for Cancer Care
      • South Bend, Indiana, United States, 46628
        • Northern Indiana Cancer Research Consortium
    • Iowa
      • Sioux City, Iowa, United States, 51101
        • Siouxland Regional Cancer Center
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Cancer Center of Kansas
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner NCI CORP
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Spectrum Health Butterworth
      • Traverse City, Michigan, United States, 49684
        • Munson Medical Center
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic - Rochester
      • Saint Louis Park, Minnesota, United States, 55416
        • Metro-Minnesota NCI CORP
    • Missouri
      • Saint Louis, Missouri, United States, 63131
        • Heartland NCORP
    • New Hampshire
      • Concord, New Hampshire, United States, 03106
        • New Hampshire Oncology Hematology - Concord
      • Laconia, New Hampshire, United States, 03246
        • New Hampshire Oncology Hematology - Laconia
    • New York
      • New York, New York, United States, 10065
        • Weill Medical College of Cornell University
      • Syracuse, New York, United States, 13210
        • State University of New York Upstate Medical University
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27516
        • Indiana University Health University Hospital
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • The University of Oklahoma Health Sciences Center (OUHSC)
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Medical Center
    • Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center
      • Seattle, Washington, United States, 98104
        • Swedish Cancer Institute/ Swedish Health Services
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54301
        • Saint Vincent Hospital CCOP
      • Green Bay, Wisconsin, United States, 54307
        • St. Mary's Hospital
      • La Crosse, Wisconsin, United States, 54601
        • Gundersen Lutheran Medical Center
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield CCOP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BBI608 plus Paclitaxel
Drug: BBI608
BBI608 480 mg orally two times daily (960 mg total daily dose)
Other Names:
  • Napabucasin
  • BBI-608
  • BB608
Drug: Paclitaxel
Paclitaxel 80 mg/m2 I.V. infusion on Days 1, 8, and 15 of every 4-week cycle
Placebo Comparator: Placebo plus Paclitaxel
Drug: Paclitaxel
Paclitaxel 80 mg/m2 I.V. infusion on Days 1, 8, and 15 of every 4-week cycle
Other: Placebo
Orally two times daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 36 months
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.
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival
Time Frame: 36 months
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.
36 months
Objective Response Rate
Time Frame: 36 months
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.
36 months
Disease Control Rate
Time Frame: 36 months
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.
36 months
Number of Patients With Adverse Events
Time Frame: 36 months
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.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sumitomo Pharma America, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

September 20, 2017

Study Completion (Actual)

September 20, 2017

Study Registration Dates

First Submitted

June 27, 2014

First Submitted That Met QC Criteria

June 30, 2014

First Posted (Estimated)

July 1, 2014

Study Record Updates

Last Update Posted (Actual)

November 15, 2023

Last Update Submitted That Met QC Criteria

November 13, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BBI608-336
  • 2014-000774-18 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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