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

PHASE3CompletedINTERVENTIONAL
Enrollment

714

Participants

Timeline

Start Date

October 31, 2014

Primary Completion Date

September 20, 2017

Study Completion Date

September 20, 2017

Conditions
Gastric CancerGastroesophageal Junction Cancer
Interventions
DRUG

BBI608

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

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

Trial Locations (263)

1000

Institut Jules Bordet, Brussels

1083

Semmelweis Egyetem, Budapest

1090

UZ Brussel - Campus Jette, Brussels

1097

Egyesített Szent István és Szent László Kórház-Rendelőintéze, Budapest

1122

Országos Onkológiai Intézet, Budapest

1125

Semmelweis Egyetem, Budapest

1233

District Dispensery with Stationary - Sofia District, Sofia

Multiprofile hospital for active treatment, Sofia

1307

Universitätsklinik Carl-Gustav-Carus Dresden, Dresden

1606

"UMHATSv.Ivan Rilski", Sofia

1756

Specialised Hospital for Active Treatment in Oncology, Sofia

2010

St Vincent's Hospital, Darlinghurst

2050

Chris O'Brien Lifehouse, Camperdown

2065

Royal North Shore Hospital, St Leonards

2200

Bankstown-Lidcombe, Bankstown

2250

Central coast area health (public), Gosford

2444

Port Macquaries Base Hospital, Port Macquarie

2650

Riverina Cancer Care Centre, Wagga Wagga

UZ Antwerpen, Edegem

2820

Imelda Ziekenhuis, Bonheiden

3000

UZ Leuven - Campus Gasthuisberg, Leuven

COC - Vratsa Dept. of Palliative Care, Vratsa

3021

Sunshine Hospital, St Albans

3050

Royal Melbourne Hospital, Parkville

3065

St Vincent's Hospital, Fitzroy

3084

Austin Hospital, Heidelberg

Ballarat base hospital, Heidelberg

3165

Monash Health, East Bentleigh

Peninsula & South Eastern Haematology and Oncology Group, East Bentleigh

3355

Ballarat Oncology and Haematology Services, Wendouree

3550

Bendigo Hospital, Bendigo

4000

CHU de Liège - Domaine Universitaire du Sart Tilman, Liège

4029

Royal Brisbane & Women's Hospital, Herston

4102

Princess Alexandra Hospital, Woolloongabba

4103

Universitätsklinikum Leipzig, Leipzig

4215

Gold Coast University Hospital, Southport

4400

Josa Andras Oktato Korhaza, Nyíregyháza

4560

Sunshine Coast Hospital and Health Service, Nambour

4814

Townsville Hospital, Townsville

5004

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

5011

The Queen Elizabeth Hospital, Woodville

5037

Ashford Cancer Centre Research, Kurralta Park

5042

Flinders Medical Centre, Bedford Park

5700

Békés Megyei Pándy Kálmán Kórház, Gyula

5800

"UMHAT Dr. Georgi Stranski Dept. Medical Oncology", Pleven

6008

Fiona Stanley Hospital, Subiaco

7000

CHU Ambroise Paré, Mons

7400

Somogy Megyei Kaposi Mór Oktató Kórház, Kaposvár

7624

Pécsi Tudományegyetem Klinikai Központ, Pécs

8310

AZ Sint-Lucas - Campus Sint-Lucas, Brugge (Assebroek)

9010

Uni. Multiprofile Hospital for Active treatment Sveta Marina, Varna

9024

Petz Aladár Megyei Oktató Kórház, Győr

10065

Weill Medical College of Cornell University, New York

10126

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

10138

East Tallinn Central Hospital Oncology Center, Tallinn

12200

Charite - Campus Benjamin Franklin (Cbf), Berlin

13008

Hopital Saint Joseph - Marseille, Marseille

13210

State University of New York Upstate Medical University, Syracuse

13353

Charite, Berlin

13385

CHU - Hôpital De La Timone, Marseille

16132

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

17822

Geisinger Medical Center, Danville

20121

Azienda Ospedaliera Fatebenefratelli e Oftalmico, Milan

20249

Facharztzentrum Eppendorf, Hamburg

22081

OncoResearch Lerchenfeld GmbH, Hamburg

24125

Humanitas Gavazzeni, Bergamo

26100

"Azienda Ospedaliera Istituti Ospitalieri di Cremona", Cremona

27516

Indiana University Health University Hospital, Chapel Hill

28007

H.G.U. G. Marañón, Madrid

28033

M.D. Anderson Cancer Center Madrid, Madrid

28034

H.U. R. y Cajal, Madrid

28040

H.C. S.Carlos, Madrid

28222

H.U.P Hierro-Majadahonda, Majadahonda

29100

Ospedale Guglielmo da Saliceto, AUSL Piacenza, Piacenza

29609

Hôpital Morvan - CHRU de Brest, Brest

30120

H.U.V.Arrixaca, Murcia

31052

Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital, Toulouse

31096

Rambam Health Care Campus, Haifa

33611

Ev. Krankenhaus Bielefeld, Bielefeld

35042

Centre eugène marquis, Rennes

35128

Istituto Oncologico Veneto IOV-IRCCS, Padua

40024

Centre Hospitalier De Mont De Marsan - Hopital Layné, Mont-de-Marsan

40138

Policlinico S.Orsola Malpighi, AOU di Bologna, Bologna

41009

H.U.V. Macarena, Seville

41013

H.U.V. del Rocío, Seville

42270

CHU Saint Etienne, Saint-Etienne

43210

Ohio State University Medical Center, Columbus

44281

Meir Medical Center, Kfar Saba

44805

Centre Paul Papin, Saint-Herblain

Centre Rene Gauducheau, Saint-Herblain

45136

Kliniken Essen-Mitte Evang. Huyssens-Stiftung, Essen

46014

C.H.G.U.de Valencia, Valencia

46526

Indiana University Health Goshen Center For Cancer Care, Goshen

46628

Northern Indiana Cancer Research Consortium, South Bend

47014

Irccs Irst, Meldola

48018

AUSL della Romagna, Osp. degli Infermi, Faenza

48100

Unità di Biostatistica e Sperimentazioni Cliniche IRST, Ravenna

49100

Rabin Medical Center - Beilinson Hospital, Petah Tikva

49503

Spectrum Health Butterworth, Grand Rapids

49684

Munson Medical Center, Traverse City

50009

H.U. Miguel Servet, Zaragoza

51014

Tartu University Hospital Clinic of Hematology and Oncology, Tartu

51101

Siouxland Regional Cancer Center, Sioux City

54301

Saint Vincent Hospital CCOP, Green Bay

54307

St. Mary's Hospital, Green Bay

54449

Marshfield CCOP, Marshfield

54601

Gundersen Lutheran Medical Center, La Crosse

55101

Johannes Gutenberg-Universitaet, Maintz

55416

Metro-Minnesota NCI CORP, Saint Louis Park

55905

Mayo Clinic - Rochester, Rochester

58100

The E. Wolfson Medical Center [Oncology], Holon

60126

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

60596

Klinikum der Johann Wolfgang Goethe-Universität, Frankfurt am Main

63003

CHU Estaing, Clermont-Ferrand

63131

Heartland NCORP, St Louis

64239

Tel Aviv Sourasky Medical Center, Tel Aviv

67214

Cancer Center of Kansas, Wichita

69008

Hopital Privé Jean Mermoz, Lyon

70121

Ochsner NCI CORP, New Orleans

73104

The University of Oklahoma Health Sciences Center (OUHSC), Oklahoma City

73730

Klinikum Esslingen, Esslingen am Neckar

80222

Colorado Cancer Research Program, Denver

81925

Klinikum Bogenhausen, München

84101

Soroka Medical Center [Oncology], Beersheba

85259

Mayo Clinic - Arizona, Scottsdale

85925

Chd Vendee La Roche Sur Yon, La Roche-sur-Yon

86021

Hospital of Poitiers, Poitiers

91120

Hadassah Medical Organisation, Jerusalem

94800

Institut Gustave Roussy, Villejuif

95100

PO Garibaldi-Nesima, ARNAS Garibaldi, Catania

98101

Virginia Mason Medical Center, Seattle

98104

Swedish Cancer Institute/ Swedish Health Services, Seattle

100021

Cancer Hospital Chinese Academy of Medical Sciences, Beijing

100071

The 307th Hospital of Chinese People's Liberation Army, Beijing

100142

Beijing Cancer Hospital, Beijing

100853

Chinese PLA General Hospital, Beijing

110002

The First Hospital of China Medical University, Shenyang

115478

Russian Oncological Research Center n.a. N.N. Blokhin RAMS, Moscow

129301

City Clinical Hospital #40, Moscow

130021

The First Bethune Hospital of Jilin University, Changchun

Jilin Cancer Hospital, Jilin

150081

Harbin Medical University Cancer Hospital, Heilongjiang

190121

Military Medical Academy n.a. S.M. Kirov, Saint Petersburg

195067

Northwestern State Medical University n.a. Mechnikov, Saint Petersburg

197022

First Pavlov State Medical University of Saint-Petersburg, Saint Petersburg

197758

GBUZ Saint Petersburg clinical scientific and practical cent, Saint Petersburg

198255

SPb State Budget Institution Oncology Dispansery, Saint Petersburg

200032

Fudan University Shanghai Cancer Center, Shanghai

Zhongshan Hospital, Shanghai

200347

Centrul de Oncologie Sf. Nectarie, Craiova

200385

Oncolab, Craiova

210002

The 81 Hospital of the Chinese People's Liberation Army, Nanjing

210009

Jiang Su Cancer Hospital, Nanjing

210029

Jiangsu Province Hospital, Nanjing

300202

Tianjin Medical University Cancer Institute & Hospital, Tianjin

300239

Oncomed, Timișoara

Spitalul Clinic Municipal de Urgenta Timisoara, Timișoara

310016

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

310022

Zhejiang Cancer Hospital, Hangzhou

350001

Fujian Medical University Union Hospital, Fuzhou

350040

Guz Clinical Oncology Dispensary #1, Krasnodar

357502

GBUZ of Stavropol Territory Pyatigorsk Oncology Dispensary, Pyatigorsk

407280

Radiotherapy Center CJ radioterapie si chimioterapie adulti, Floreşti

410006

Hunan Cancer Hospital, Changsha

430030

Tongji Hospital, Wuhan

430031

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

450003

The First Affiliated Hospital of Zhengzhou University, Zhengzhou

450008

Henan Cancer Hospital, Zhengzhou

450054

Republican Clinical Oncology Dispensary, Ufa

510060

Sun Yat-Sen University Cancer Center, Guangzhou

510515

Southern Medical University, Nanfang Hospital, Guangzhou

550245

Spitalul Clinic Judetean de Urgenta Sibiu, Sibiu

610041

West China Hospital, Sichuan University, Chengdu

614066

GUZ Perm Regional Oncology Dispensary, Perm

700106

Centrul de Oncologie Euroclinic, Iași

700483

Institutul Regional de Oncologie Iasi, Lasi

701264

"IRCCS Ospedale Oncologico Giovanni Paolo II", Bari

750004

General Hospital of Ningxia Medical University, Yinchuan

830000

Xin Jiang Tumor Hospital, Xin Jiang Medical University, Ürümqi

41820021

Oncovida - Centro de Oncologia da Bahia, Salvador

95900000

Hospital Bruno Born, Lajeado

03106

New Hampshire Oncology Hematology - Concord, Concord

03246

New Hampshire Oncology Hematology - Laconia, Laconia

B-1200

Cliniques Universitaires Saint-Luc, Brussels

60430-230

Instituto do Câncer do Ceará - Instituto do Câncer do Cear, Fortaleza

30150-270

Cetus Hospital Dia Oncologia, Belo Horizonte

81520-060

Hospital Erasto Gaertner, Curitiba

99010-260

Hospital da Cidade de Passo Fundo, Passo Fundo

96015-280

UPCO - Unidade de Pesquisa Clinica em Oncologia LTDA, Pelotas

88301-220

Clinica de Neoplasias Litoral, Itajaí

17210-080

Fundaçao dr Amaral Carvalho, Jaú

15090-000

Hospital de Base de São José do Rio Preto, São José do Rio Preto

20231-050

Inca-RJ, Rio de Janeiro

01236030

IEP São Lucas, São Paulo

08270-070

Casa de Saúde Santa Marcelina, São Paulo

K1H 8L6

The Ottawa Hospital Cancer Centre, Ottawa

M5B 1W8

Saint Michael's Hospital Li Ka Shing Knowledge Institute, Toronto

M5G 1X5

Mount Sinai Hospital, Toronto

M5G 2C4

Princess Margaret Hospital, Toronto

H2L 2W5

Hopital Notre-Dame du CHUM, Montreal

H3G 1A4

McGill University Health Centre - Montreal General Hospital, Montreal

500 05

FN Hradec Kralove, Hradec Králové

775 20

Fakultni nemocnice Olomouc, Olomouc

656 53

Masarykuv onkologicky ustav, Brno

128 08

Vseobecna fakultni nemocnice v Praze, Prague

180 81

Nemocnice Na Bulovce, Prague

06189 Cedex 2

Centre Antoine Lacassagne, Nice

H-4032

Debreceni Egyetem Klinikai Központ, Debrecen

Unknown

Aichi Cancer Center Hospital, Nagoya

National Cancer Center Hospital East, Kashiwa

National Hospital Organization Shikoku Cancer Center, Matsuyama

Hokkaido University Hospital, Sapporo

Kobe City Medical Center General Hospital, Kobe

Saku Central Hospital Advanced Care Center, Saku

Osaka University Hospital, Suita

Saitama Cancer Center, Kita-Adachi

Shizuoka Cancer Center, Sunto

Tochigi Cancer Center, Utsunomiya

National Cancer Center Hospital, Chūō

Kyorin University Hospial, Mitaka

Chiba Cancer Center, Chiba

Gifu University Hospital, Gifu

Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka

LT-45434

Hospital of Lithuanian University of Health sciences, Kaunas

LT-50009

Hospital of Lithuanian University of Health Sciences, Kaunas

LT-35144

Respublikine Panevezio ligonine, Panevezys

LT-08860

National Cancer Institute, Vilnius

LT-92288

Klaipeda University Hospital, Klaipėda

LT-08661

Vilniaus Universiteto ligonines Santariskiu Klinikos, Vilnius

LT-76231

Siauliai County Hospital, Šiauliai

61-485

NZOZ Centrum Medyczne HCP Lecznictwo Stacjonarne, Poznan

85-796

Centrum Onkologii im. F.Lukaszczyka, Bydgoszcz

31-108

Szpital Specjalistyczny im. L. Rydygiera w Krakowie, Krakow

05-400

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

02-781

Centrum Onkologii Instytut im. M. Sklodowskiej-Curie, Warsaw

03-291

Magodent sp. z o.o. Szpital Onkologiczny, Warsaw

36-20

Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onko, Brzozów

80-210

Wojewodzkie Centrum Onkologii w Gdansku, Gdansk

71-730

Zachodniopomorskie Centrum Onkologii, Szczecin

93-510

Wojewodzki Szpital Specjalistyczny im. M.Kopernika, Lodz

010719

Med Life, Bucharest

011464

Spitalul Clinic CF 2, Bucharest

022328

Institutul Clinic Fundeni, Bucharest

463-707

Seoul National University Bundang Hospital, Seongnam

135-710

Samsung Medical Center, Seoul

138-736

Asan medical Center, Seoul

Seoul National University Hospital, Seoul

08916

Institut Català d'Oncologia-Hospital Germans Trias i Pujol, Badalona

05004

C.A.AV-H.Ntra.Sra.de Sonsoles, Ávila

08003

H.del Mar, Barcelona

08035

Hospital Universitario Vall d'Hebrón, Barcelona

08041

H.Sta.Creu i St.Pau, Barcelona

09006

H.U. de Burgos, Burgos

08907

Institut Catalá d´Oncología (I.C.O.), L'Hospitalet de Llobregat

AB25 2ZN

Aberdeen Royal Infirmary, Aberdeen

G12 0YH

The Beatson West Of Scotland Cancer Centre, Glasgow

GU2 7XX

Royal Surrey County Hospital, Guildford

SM2 5PT

The Royal Marsden Hospital, Sutton

The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital, Sutton

BT9 7AB

Belfast City Hospital, Belfast

SE1 2PR

St. Georges Hospital, London

M20 4BX

Christie Hospital NHS Foundation Trust, Manchester

SO16 6YD

Southampton University Hospital, Southampton

All Listed Sponsors
lead

Sumitomo Pharma America, Inc.

INDUSTRY

NCT02178956 - A Study of BBI608 Plus Weekly Paclitaxel to Treat Gastric and Gastro-Esophageal Junction Cancer | Biotech Hunter | Biotech Hunter