Spots Global Cancer Trial Database for A Study of BBI608 Plus Weekly Paclitaxel to Treat Gastric and Gastro-Esophageal Junction Cancer
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Trial Identification
Brief Title: A Study of BBI608 Plus Weekly Paclitaxel to Treat Gastric and Gastro-Esophageal Junction Cancer
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
Study ID: NCT02178956
Study Description
Brief 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 chemotherapy.
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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinic - Arizona, Scottsdale, Arizona, United States
Colorado Cancer Research Program, Denver, Colorado, United States
Indiana University Health Goshen Center For Cancer Care, Goshen, Indiana, United States
Northern Indiana Cancer Research Consortium, South Bend, Indiana, United States
Siouxland Regional Cancer Center, Sioux City, Iowa, United States
Cancer Center of Kansas, Wichita, Kansas, United States
Ochsner NCI CORP, New Orleans, Louisiana, United States
Spectrum Health Butterworth, Grand Rapids, Michigan, United States
Munson Medical Center, Traverse City, Michigan, United States
Mayo Clinic - Rochester, Rochester, Minnesota, United States
Metro-Minnesota NCI CORP, Saint Louis Park, Minnesota, United States
Heartland NCORP, Saint Louis, Missouri, United States
New Hampshire Oncology Hematology - Concord, Concord, New Hampshire, United States
New Hampshire Oncology Hematology - Laconia, Laconia, New Hampshire, United States
Weill Medical College of Cornell University, New York, New York, United States
State University of New York Upstate Medical University, Syracuse, New York, United States
Indiana University Health University Hospital, Chapel Hill, North Carolina, United States
Ohio State University Medical Center, Columbus, Ohio, United States
The University of Oklahoma Health Sciences Center (OUHSC), Oklahoma City, Oklahoma, United States
Geisinger Medical Center, Danville, Pennsylvania, United States
Virginia Mason Medical Center, Seattle, Washington, United States
Swedish Cancer Institute/ Swedish Health Services, Seattle, Washington, United States
Saint Vincent Hospital CCOP, Green Bay, Wisconsin, United States
St. Mary's Hospital, Green Bay, Wisconsin, United States
Gundersen Lutheran Medical Center, La Crosse, Wisconsin, United States
Marshfield CCOP, Marshfield, Wisconsin, United States
Bankstown-Lidcombe, Bankstown, New South Wales, Australia
Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia
St Vincent's Hospital, Darlinghurst, New South Wales, Australia
Central coast area health (public), Gosford, New South Wales, Australia
Port Macquaries Base Hospital, Port Macquarie, New South Wales, Australia
Royal North Shore Hospital, St Leonards, New South Wales, Australia
Riverina Cancer Care Centre, Wagga Wagga, New South Wales, Australia
Royal Brisbane & Women's Hospital, Herston, Queensland, Australia
Sunshine Coast Hospital and Health Service, Nambour, Queensland, Australia
Gold Coast University Hospital, Southport, Queensland, Australia
Townsville Hospital, Townsville, Queensland, Australia
Princess Alexandra Hospital, Woolloongabba, Queensland, Australia
Flinders Medical Centre, Bedford Park, South Australia, Australia
Ashford Cancer Centre Research, Kurralta Park, South Australia, Australia
The Queen Elizabeth Hospital, Woodville, South Australia, Australia
Bendigo Hospital, Bendigo, Victoria, Australia
Monash Health, East Bentleigh, Victoria, Australia
Peninsula & South Eastern Haematology and Oncology Group, East Bentleigh, Victoria, Australia
St Vincent's Hospital, Fitzroy, Victoria, Australia
Austin Hospital, Heidelberg, Victoria, Australia
Ballarat base hospital, Heidelberg, Victoria, Australia
Royal Melbourne Hospital, Parkville, Victoria, Australia
Sunshine Hospital, St Albans, Victoria, Australia
Ballarat Oncology and Haematology Services, Wendouree, Victoria, Australia
Fiona Stanley Hospital, Subiaco, Western Australia, Australia
Imelda Ziekenhuis, Bonheiden, Antwerpen, Belgium
UZ Antwerpen, Edegem, Antwerpen, Belgium
UZ Brussel - Campus Jette, Brussel, Brussels Capital Region, Belgium
Institut Jules Bordet, Bruxelles, Brussels Capital Region, Belgium
Cliniques Universitaires Saint-Luc, Bruxelles, Brussels Capital Region, Belgium
CHU Ambroise Paré, Mons, Hainaut, Belgium
UZ Leuven - Campus Gasthuisberg, Leuven, Vlaams Brabant, Belgium
AZ Sint-Lucas - Campus Sint-Lucas, Brugge (Assebroek), , Belgium
CHU de Liège - Domaine Universitaire du Sart Tilman, Liège, , Belgium
Oncovida - Centro de Oncologia da Bahia, Salvador, Bahia, Brazil
Instituto do Câncer do Ceará - Instituto do Câncer do Cear, Fortaleza, Ceará, Brazil
Cetus Hospital Dia Oncologia, Belo Horizonte, Minas Gerais, Brazil
Hospital Erasto Gaertner, Curitiba, Paraná, Brazil
Hospital Bruno Born, Lajeado, Rio Grande Do Sul, Brazil
Hospital da Cidade de Passo Fundo, Passo Fundo, Rio Grande Do Sul, Brazil
UPCO - Unidade de Pesquisa Clinica em Oncologia LTDA, Pelotas, Rio Grande Do Sul, Brazil
Clinica de Neoplasias Litoral, Itajai, Santa Catarina, Brazil
Fundaçao dr Amaral Carvalho, Jaú, São Paulo, Brazil
Hospital de Base de São José do Rio Preto, São José do Rio Preto, São Paulo, Brazil
Inca-RJ, Rio de Janeiro, , Brazil
IEP São Lucas, São Paulo, , Brazil
Casa de Saúde Santa Marcelina, São Paulo, , Brazil
Specialised Hospital for Active Treatment in Oncology, Sofia, Sofia-Grad, Bulgaria
UMHAT ""Dr. Georgi Stranski"" Dept. Medical Oncology, Pleven, , Bulgaria
District Dispensery with Stationary - Sofia District, Sofia, , Bulgaria
Multiprofile hospital for active treatment, Sofia, , Bulgaria
UMHAT"Sv.Ivan Rilski", Sofia, , Bulgaria
Uni. Multiprofile Hospital for Active treatment Sveta Marina, Varna, , Bulgaria
COC - Vratsa Dept. of Palliative Care, Vratsa, , Bulgaria
The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada
Saint Michael's Hospital Li Ka Shing Knowledge Institute, Toronto, Ontario, Canada
Mount Sinai Hospital, Toronto, Ontario, Canada
Princess Margaret Hospital, Toronto, Ontario, Canada
Hopital Notre-Dame du CHUM, Montreal, Quebec, Canada
McGill University Health Centre - Montreal General Hospital, Montreal, Quebec, Canada
Cancer Hospital Chinese Academy of Medical Sciences, Beijing, Beijing, China
The 307th Hospital of Chinese People's Liberation Army, Beijing, Beijing, China
Beijing Cancer Hospital, Beijing, Beijing, China
Chinese PLA General Hospital, Beijing, Beijing, China
Fujian Medical University Union Hospital, Fuzhou, Fujian, China
Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, China
Southern Medical University, Nanfang Hospital, Guangzhou, Guangdong, China
Harbin Medical University Cancer Hospital, Heilongjiang, Heilongjiang, China
The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China
Henan Cancer Hospital, Zhengzhou, Henan, China
Hunan Cancer Hospital, Changsha, Hunan, China
The 81 Hospital of the Chinese People's Liberation Army, Nanjing, Jiangsu, China
Jiang Su Cancer Hospital, Nanjing, Jiangsu, China
Jiangsu Province Hospital, Nanjing, Jiangsu, China
The First Bethune Hospital of Jilin University, Changchun, Jilin, China
Jilin Cancer Hospital, Jilin, Jilin, China
The First Hospital of China Medical University, Shenyang, Liaoning, China
General Hospital of Ningxia Medical University, Yinchuan, Ningxia, China
Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China
Zhongshan Hospital, Shanghai, Shanghai, China
West China Hospital, Sichuan University, Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute & Hospital, Tianjin, Tianjin, China
Xin Jiang Tumor Hospital, Xin Jiang Medical University, Urumqi, Xinjiang, China
Sir Run Run Shaw Hospital School of Medicine, Zhejiang University, Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China
Tongji Hospital, Wuhan, , China
FN Hradec Kralove, Hradec Kralove, Královéhradecký Kraj, Czechia
Fakultni nemocnice Olomouc, Olomouc, Olomoucký Kraj, Czechia
Masarykuv onkologicky ustav, Brno, , Czechia
Vseobecna fakultni nemocnice v Praze, Praha 2, , Czechia
Nemocnice Na Bulovce, Praha 8, , Czechia
East Tallinn Central Hospital Oncology Center, Tallinn, Harjumaa, Estonia
Tartu University Hospital Clinic of Hematology and Oncology, Tartu, Tartumaa, Estonia
Centre Antoine Lacassagne, Nice, Alpes-Maritimes, France
Hopital Saint Joseph - Marseille, Marseille, Bouches-du-Rhône, France
Centre Paul Papin, St Herblain Cedex, Loire-Atlantique, France
Centre Rene Gauducheau, St Herblain Cedex, Loire-Atlantique, France
Hopital Privé Jean Mermoz, Lyon, Rhône, France
Chd Vendee La Roche Sur Yon, La Roche sur Yon Cedex 9, Vendée, France
Hospital of Poitiers, Poitiers, Vienne, France
Hôpital Morvan - CHRU de Brest, Brest Cedex, , France
CHU Estaing, Clermont-Ferrand, , France
CHU - Hôpital De La Timone, Marseille, , France
Centre Hospitalier De Mont De Marsan - Hopital Layné, Mont de Marsan Cedex, , France
Centre eugène marquis, Rennes, , France
CHU Saint Etienne, Saint Etienne, , France
Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital, Toulouse cedex, , France
Institut Gustave Roussy, Villejuif, , France
Klinikum Bogenhausen, München, Bayern, Germany
Klinikum der Johann Wolfgang Goethe-Universität, Frankfurt/Main, Hessen, Germany
Ev. Krankenhaus Bielefeld, Bielefeld, Nordrhein-Westfalen, Germany
Kliniken Essen-Mitte Evang. Huyssens-Stiftung, Essen, Nordrhein-Westfalen, Germany
Johannes Gutenberg-Universitaet, Maintz, Rheinland-Pfalz, Germany
Universitätsklinik Carl-Gustav-Carus Dresden, Dresden, Sachsen, Germany
Universitätsklinikum Leipzig, Leipzig, Sachsen, Germany
Charite - Campus Benjamin Franklin (Cbf), Berlin, , Germany
Charite, Berlin, , Germany
Klinikum Esslingen, Esslingen, , Germany
Facharztzentrum Eppendorf, Hamburg, , Germany
OncoResearch Lerchenfeld GmbH, Hamburg, , Germany
Pécsi Tudományegyetem Klinikai Központ, Pécs, Baranya, Hungary
Békés Megyei Pándy Kálmán Kórház, Gyula, Békés, Hungary
Petz Aladár Megyei Oktató Kórház, Gyor, Gyor-Moson-Sopron, Hungary
Debreceni Egyetem Klinikai Központ, Debrecen, Hajdú-Bihar, Hungary
Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház- Rendelőinté, Szolnok, Jász-Nagykun-Szolnok, Hungary
Josa Andras Oktato Korhaza, Nyiregyhaza, Szabolcs-Szatmár-Bereg, Hungary
Semmelweis Egyetem, Budapest, , Hungary
Egyesített Szent István és Szent László Kórház-Rendelőintéze, Budapest, , Hungary
Országos Onkológiai Intézet, Budapest, , Hungary
Semmelweis Egyetem, Budapest, , Hungary
Somogy Megyei Kaposi Mór Oktató Kórház, Kaposvár, , Hungary
Soroka Medical Center [Oncology], Beer Sheva, HaDarom, Israel
The E. Wolfson Medical Center [Oncology], Holon, HaMerkaz, Israel
Meir Medical Center, Kfar Saba, HaMerkaz, Israel
Rabin Medical Center - Beilinson Hospital, Petah Tikva, HaMerkaz, Israel
Tel Aviv Sourasky Medical Center, Tel Aviv, Tel-Aviv, Israel
Hadassah Medical Organisation, Jerusalem, Yerushalayim, Israel
Rambam Health Care Campus, Haifa, , Israel
Irccs Irst, Meldola, Forli, Italy
AUSL della Romagna, Osp. degli Infermi, Faenza, Ravenna, Italy
Ospedale Umberto I, AOU Ospedali Riuniti Umberto I - GM.Lanc, Ancona, , Italy
IRCCS Ospedale Oncologico "Giovanni Paolo II", Bari, , Italy
Humanitas Gavazzeni, Bergamo, , Italy
Policlinico S.Orsola Malpighi, AOU di Bologna, Bologna, , Italy
PO Garibaldi-Nesima, ARNAS Garibaldi, Catania, , Italy
Azienda Ospedaliera "Istituti Ospitalieri" di Cremona, Cremona, , Italy
AOU S.Martino, IRCCS, IST-Istituto Nazionale Ricerca Sul Can, Genova, , Italy
Azienda Ospedaliera Fatebenefratelli e Oftalmico, Milano, , Italy
Istituto Oncologico Veneto IOV-IRCCS, Padova, , Italy
Ospedale Guglielmo da Saliceto, AUSL Piacenza, Piacenza, , Italy
Unità di Biostatistica e Sperimentazioni Cliniche IRST, Ravenna, , Italy
Ospedale Molinette, AO Città della Salute e della Scienza di, Torino, , Italy
Aichi Cancer Center Hospital, Nagoya, Aichi, Japan
National Cancer Center Hospital East, Kashiwa, Chiba, Japan
National Hospital Organization Shikoku Cancer Center, Matsuyama, Ehime, Japan
Hokkaido University Hospital, Sapporo, Hokkaido, Japan
Kobe City Medical Center General Hospital, Kobe, Hyogo, Japan
Saku Central Hospital Advanced Care Center, Saku, Nagano, Japan
Osaka University Hospital, Suita, Osaka, Japan
Saitama Cancer Center, Kita-Adachi, Saitama, Japan
Shizuoka Cancer Center, Sunto, Shizuoka, Japan
Tochigi Cancer Center, Utsunomiya, Tochigi, Japan
National Cancer Center Hospital, Chuo, Tokyo, Japan
Kyorin University Hospial, Mitaka, Tokyo, Japan
Chiba Cancer Center, Chiba, , Japan
Gifu University Hospital, Gifu, , Japan
Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, , Japan
Seoul National University Bundang Hospital, SeongNam, Gyeonggido, Korea, Republic of
Samsung Medical Center, Seoul, Seoul Teugbyeolsi, Korea, Republic of
Asan medical Center, Seoul, Seoul Teugbyeolsi, Korea, Republic of
Seoul National University Hospital, Seoul, Seoul Teugbyeolsi, Korea, Republic of
Hospital of Lithuanian University of Health sciences, Kaunas, Kauno Apskritis, Lithuania
Hospital of Lithuanian University of Health Sciences, Kaunas, Kauno Apskritis, Lithuania
Respublikine Panevezio ligonine, Panevezys, Panevežio Apskritis, Lithuania
National Cancer Institute, Vilnius, Vilniaus Apskritis, Lithuania
Klaipeda University Hospital, Klaipeda, , Lithuania
Vilniaus Universiteto ligonines Santariskiu Klinikos, Vilnius, , Lithuania
Siauliai County Hospital, Siauliai, Šiauliu Apskritis, Lithuania
Centrum Onkologii im. F.Lukaszczyka, Bydgoszcz, Kujawsko-pomorskie, Poland
Szpital Specjalistyczny im. L. Rydygiera w Krakowie, Krakow, Malopolskie, Poland
Europejskie Centrum Zdrowia Otwock, Szpital im. F. Chopina, Otwock, Mazowieckie, Poland
Centrum Onkologii Instytut im. M. Sklodowskiej-Curie, Warszawa, Mazowieckie, Poland
Magodent sp. z o.o. Szpital Onkologiczny, Warszawa, Mazowieckie, Poland
Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onko, Brzozow, Podkarpackie, Poland
Wojewodzkie Centrum Onkologii w Gdansku, Gdansk, Pomorskie, Poland
NZOZ Centrum Medyczne HCP Lecznictwo Stacjonarne, Poznan, Wielkopolskie, Poland
Zachodniopomorskie Centrum Onkologii, Szczecin, Zachodniopomorskie, Poland
Wojewodzki Szpital Specjalistyczny im. M.Kopernika, Lodz, Łódzkie, Poland
Radiotherapy Center CJ radioterapie si chimioterapie adulti, Floresti, Cluj, Romania
Centrul de Oncologie Sf. Nectarie, Craiova, Dolj, Romania
Oncolab, Craiova, Dolj, Romania
Sp. Jud. de Urg. "Dr. Constantin Opris" Baia Mare, Baia-Mare, Maramures, Romania
Oncomed, Timisoara, Timis, Romania
Spitalul Clinic Municipal de Urgenta Timisoara, Timisoara, Timis, Romania
Med Life, Bucuresti, , Romania
Spitalul Clinic CF 2, Bucuresti, , Romania
Institutul Clinic Fundeni, Bucuresti, , Romania
Centrul de Oncologie Euroclinic, Iasi, , Romania
Institutul Regional de Oncologie Iasi, Lasi, , Romania
Spitalul Clinic Judetean de Urgenta Sibiu, Sibiu, , Romania
Republican Clinical Oncology Dispensary, Ufa, Bahkortostan, Respublika, Russian Federation
Military Medical Academy n.a. S.M. Kirov, Saint Petersburg, Leningradskaya Oblast', Russian Federation
Russian Oncological Research Center n.a. N.N. Blokhin RAMS, Moscow, Moskva, Russian Federation
City Clinical Hospital #40, Moscow, Moskva, Russian Federation
GUZ Perm Regional Oncology Dispensary, Perm, Permskiy Kray, Russian Federation
Northwestern State Medical University n.a. Mechnikov, Saint Petersburg, Sankt-Peterburg, Russian Federation
First Pavlov State Medical University of Saint-Petersburg, Saint Petersburg, Sankt-Peterburg, Russian Federation
GBUZ Saint Petersburg clinical scientific and practical cent, Saint Petersburg, Sankt-Peterburg, Russian Federation
SPb State Budget Institution Oncology Dispansery, Saint Petersburg, Sankt-Petersburg, Russian Federation
GBUZ of Stavropol Territory Pyatigorsk Oncology Dispensary, Pyatigorsk, Stavropol'skiy Kray, Russian Federation
Guz Clinical Oncology Dispensary #1, Krasnodar, , Russian Federation
H.U.V. Macarena, Sevilla, Andalucía, Spain
Institut Català d'Oncologia-Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain
C.A.AV-H.Ntra.Sra.de Sonsoles, Avila, Castilla Y León, Spain
H.U.P Hierro-Majadahonda, Majadahonda, Madrid, Spain
H.del Mar, Barcelona, , Spain
Hospital Universitario Vall d'Hebrón, Barcelona, , Spain
H.Sta.Creu i St.Pau, Barcelona, , Spain
H.U. de Burgos, Burgos, , Spain
Institut Catalá d´Oncología (I.C.O.), Hospitalet de Llobregat, , Spain
H.G.U. G. Marañón, Madrid, , Spain
M.D. Anderson Cancer Center Madrid, Madrid, , Spain
H.U. R. y Cajal, Madrid, , Spain
H.C. S.Carlos, Madrid, , Spain
H.U.V.Arrixaca, Murcia, , Spain
H.U.V. del Rocío, Sevilla, , Spain
C.H.G.U.de Valencia, Valencia, , Spain
H.U. Miguel Servet, Zaragoza, , Spain
Aberdeen Royal Infirmary, Aberdeen, Aberdeen City, United Kingdom
The Beatson West Of Scotland Cancer Centre, Glasgow, Glasgow City, United Kingdom
Royal Surrey County Hospital, Guildford, Surrey, United Kingdom
The Royal Marsden Hospital, Sutton, Surrey, United Kingdom
The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital, Sutton, Surrey, United Kingdom
Belfast City Hospital, Belfast, , United Kingdom
St. Georges Hospital, London, , United Kingdom
Christie Hospital NHS Foundation Trust, Manchester, , United Kingdom
Southampton University Hospital, Southampton, , United Kingdom
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