A Study of BBI608 Plus Weekly Paclitaxel to Treat Gastric and Gastro-Esophageal Junction Cancer
BRIGHTER
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
2 other identifiers
interventional
714
21 countries
261
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 gastric-cancer
Started Oct 2014
Shorter than P25 for phase_3 gastric-cancer
261 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 27, 2014
CompletedFirst Posted
Study publicly available on registry
July 1, 2014
CompletedStudy Start
First participant enrolled
October 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 20, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 20, 2017
CompletedResults Posted
Study results publicly available
May 10, 2021
CompletedNovember 15, 2023
November 1, 2023
3 years
June 27, 2014
March 12, 2021
November 13, 2023
Conditions
Outcome Measures
Primary Outcomes (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.
36 months
Secondary Outcomes (4)
Progression Free Survival
36 months
Objective Response Rate
36 months
Disease Control Rate
36 months
Number of Patients With Adverse Events
36 months
Study Arms (2)
BBI608 plus Paclitaxel
EXPERIMENTALPlacebo plus Paclitaxel
PLACEBO COMPARATORInterventions
BBI608 480 mg orally two times daily (960 mg total daily dose)
Paclitaxel 80 mg/m2 I.V. infusion on Days 1, 8, and 15 of every 4-week cycle
Eligibility Criteria
You may qualify if:
- 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.
- +5 more criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (263)
Mayo Clinic - Arizona
Scottsdale, Arizona, 85259, United States
Colorado Cancer Research Program
Denver, Colorado, 80222, United States
Indiana University Health Goshen Center For Cancer Care
Goshen, Indiana, 46526, United States
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46628, United States
Siouxland Regional Cancer Center
Sioux City, Iowa, 51101, United States
Cancer Center of Kansas
Wichita, Kansas, 67214, United States
Ochsner NCI CORP
New Orleans, Louisiana, 70121, United States
Spectrum Health Butterworth
Grand Rapids, Michigan, 49503, United States
Munson Medical Center
Traverse City, Michigan, 49684, United States
Mayo Clinic - Rochester
Rochester, Minnesota, 55905, United States
Metro-Minnesota NCI CORP
Saint Louis Park, Minnesota, 55416, United States
Heartland NCORP
St Louis, Missouri, 63131, United States
New Hampshire Oncology Hematology - Concord
Concord, New Hampshire, 03106, United States
New Hampshire Oncology Hematology - Laconia
Laconia, New Hampshire, 03246, United States
Weill Medical College of Cornell University
New York, New York, 10065, United States
State University of New York Upstate Medical University
Syracuse, New York, 13210, United States
Indiana University Health University Hospital
Chapel Hill, North Carolina, 27516, United States
Ohio State University Medical Center
Columbus, Ohio, 43210, United States
The University of Oklahoma Health Sciences Center (OUHSC)
Oklahoma City, Oklahoma, 73104, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
Swedish Cancer Institute/ Swedish Health Services
Seattle, Washington, 98104, United States
Saint Vincent Hospital CCOP
Green Bay, Wisconsin, 54301, United States
St. Mary's Hospital
Green Bay, Wisconsin, 54307, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601, United States
Marshfield CCOP
Marshfield, Wisconsin, 54449, United States
Bankstown-Lidcombe
Bankstown, New South Wales, 2200, Australia
Chris O'Brien Lifehouse
Camperdown, New South Wales, 2050, Australia
St Vincent's Hospital
Darlinghurst, New South Wales, 2010, Australia
Central coast area health (public)
Gosford, New South Wales, 2250, Australia
Port Macquaries Base Hospital
Port Macquarie, New South Wales, 2444, Australia
Royal North Shore Hospital
St Leonards, New South Wales, 2065, Australia
Riverina Cancer Care Centre
Wagga Wagga, New South Wales, 2650, Australia
Royal Brisbane & Women's Hospital
Herston, Queensland, 4029, Australia
Sunshine Coast Hospital and Health Service
Nambour, Queensland, 4560, Australia
Gold Coast University Hospital
Southport, Queensland, 4215, Australia
Townsville Hospital
Townsville, Queensland, 4814, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Flinders Medical Centre
Bedford Park, South Australia, 5042, Australia
Ashford Cancer Centre Research
Kurralta Park, South Australia, 5037, Australia
The Queen Elizabeth Hospital
Woodville, South Australia, 5011, Australia
Bendigo Hospital
Bendigo, Victoria, 3550, Australia
Monash Health
East Bentleigh, Victoria, 3165, Australia
Peninsula & South Eastern Haematology and Oncology Group
East Bentleigh, Victoria, 3165, Australia
St Vincent's Hospital
Fitzroy, Victoria, 3065, Australia
Austin Hospital
Heidelberg, Victoria, 3084, Australia
Ballarat base hospital
Heidelberg, Victoria, 3084, Australia
Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
Sunshine Hospital
St Albans, Victoria, 3021, Australia
Ballarat Oncology and Haematology Services
Wendouree, Victoria, 3355, Australia
Fiona Stanley Hospital
Subiaco, Western Australia, 6008, Australia
Imelda Ziekenhuis
Bonheiden, Antwerpen, 2820, Belgium
UZ Antwerpen
Edegem, Antwerpen, 2650, Belgium
Institut Jules Bordet
Brussels, Brussels Capital, 1000, Belgium
UZ Brussel - Campus Jette
Brussels, Brussels Capital, 1090, Belgium
Cliniques Universitaires Saint-Luc
Brussels, Brussels Capital, B-1200, Belgium
CHU Ambroise Paré
Mons, Hainaut, 7000, Belgium
UZ Leuven - Campus Gasthuisberg
Leuven, Vlaams Brabant, 3000, Belgium
AZ Sint-Lucas - Campus Sint-Lucas
Brugge (Assebroek), 8310, Belgium
CHU de Liège - Domaine Universitaire du Sart Tilman
Liège, 4000, Belgium
Instituto do Câncer do Ceará - Instituto do Câncer do Cear
Fortaleza, Ceará, 60430-230, Brazil
Oncovida - Centro de Oncologia da Bahia
Salvador, Estado de Bahia, 41820021, Brazil
Cetus Hospital Dia Oncologia
Belo Horizonte, Minas Gerais, 30150-270, Brazil
Hospital Erasto Gaertner
Curitiba, Paraná, 81520-060, Brazil
Hospital Bruno Born
Lajeado, Rio Grande do Sul, 95900000, Brazil
Hospital da Cidade de Passo Fundo
Passo Fundo, Rio Grande do Sul, 99010-260, Brazil
UPCO - Unidade de Pesquisa Clinica em Oncologia LTDA
Pelotas, Rio Grande do Sul, 96015-280, Brazil
Clinica de Neoplasias Litoral
Itajaí, Santa Catarina, 88301-220, Brazil
Fundaçao dr Amaral Carvalho
Jaú, São Paulo, 17210-080, Brazil
Hospital de Base de São José do Rio Preto
São José do Rio Preto, São Paulo, 15090-000, Brazil
Inca-RJ
Rio de Janeiro, 20231-050, Brazil
IEP São Lucas
São Paulo, 01236030, Brazil
Casa de Saúde Santa Marcelina
São Paulo, 08270-070, Brazil
Specialised Hospital for Active Treatment in Oncology
Sofia, Sofia-Grad, 1756, Bulgaria
UMHAT ""Dr. Georgi Stranski"" Dept. Medical Oncology
Pleven, 5800, Bulgaria
District Dispensery with Stationary - Sofia District
Sofia, 1233, Bulgaria
Multiprofile hospital for active treatment
Sofia, 1233, Bulgaria
UMHAT"Sv.Ivan Rilski"
Sofia, 1606, Bulgaria
Uni. Multiprofile Hospital for Active treatment Sveta Marina
Varna, 9010, Bulgaria
COC - Vratsa Dept. of Palliative Care
Vratsa, 3000, Bulgaria
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, K1H 8L6, Canada
Saint Michael's Hospital Li Ka Shing Knowledge Institute
Toronto, Ontario, M5B 1W8, Canada
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5, Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2C4, Canada
Hopital Notre-Dame du CHUM
Montreal, Quebec, H2L 2W5, Canada
McGill University Health Centre - Montreal General Hospital
Montreal, Quebec, H3G 1A4, Canada
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021, China
The 307th Hospital of Chinese People's Liberation Army
Beijing, Beijing Municipality, 100071, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510060, China
Southern Medical University, Nanfang Hospital
Guangzhou, Guangdong, 510515, China
Harbin Medical University Cancer Hospital
Heilongjiang, Heilongjiang, 150081, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450003, China
Henan Cancer Hospital
Zhengzhou, Henan, 450008, China
Hunan Cancer Hospital
Changsha, Hunan, 410006, China
The 81 Hospital of the Chinese People's Liberation Army
Nanjing, Jiangsu, 210002, China
Jiang Su Cancer Hospital
Nanjing, Jiangsu, 210009, China
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029, China
The First Bethune Hospital of Jilin University
Changchun, Jilin, 130021, China
Jilin Cancer Hospital
Jilin, Jilin, 130021, China
The First Hospital of China Medical University
Shenyang, Liaoning, 110002, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032, China
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300202, China
Xin Jiang Tumor Hospital, Xin Jiang Medical University
Ürümqi, Xinjiang, 830000, China
Sir Run Run Shaw Hospital School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310016, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
Tongji Hospital
Wuhan, 430030, China
FN Hradec Kralove
Hradec Králové, Královéhradecký kraj, 500 05, Czechia
Fakultni nemocnice Olomouc
Olomouc, Olomoucký kraj, 775 20, Czechia
Masarykuv onkologicky ustav
Brno, 656 53, Czechia
Vseobecna fakultni nemocnice v Praze
Prague, 128 08, Czechia
Nemocnice Na Bulovce
Prague, 180 81, Czechia
East Tallinn Central Hospital Oncology Center
Tallinn, Harju, 10138, Estonia
Tartu University Hospital Clinic of Hematology and Oncology
Tartu, Tartu, 51014, Estonia
Centre Antoine Lacassagne
Nice, Alpes-Maritimes, 06189 Cedex 2, France
Hopital Saint Joseph - Marseille
Marseille, Bouches-du-Rhône, 13008, France
Centre Paul Papin
Saint-Herblain, Loire-Atlantique, 44805, France
Centre Rene Gauducheau
Saint-Herblain, Loire-Atlantique, 44805, France
Hopital Privé Jean Mermoz
Lyon, Rhône, 69008, France
Chd Vendee La Roche Sur Yon
La Roche-sur-Yon, Vendée, 85925, France
Hospital of Poitiers
Poitiers, Vienne, 86021, France
Hôpital Morvan - CHRU de Brest
Brest, 29609, France
CHU Estaing
Clermont-Ferrand, 63003, France
CHU - Hôpital De La Timone
Marseille, 13385, France
Centre Hospitalier De Mont De Marsan - Hopital Layné
Mont-de-Marsan, 40024, France
Centre eugène marquis
Rennes, 35042, France
CHU Saint Etienne
Saint-Etienne, 42270, France
Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital
Toulouse, 31052, France
Institut Gustave Roussy
Villejuif, 94800, France
Klinikum Bogenhausen
München, Bavaria, 81925, Germany
Klinikum der Johann Wolfgang Goethe-Universität
Frankfurt am Main, Hesse, 60596, Germany
Ev. Krankenhaus Bielefeld
Bielefeld, North Rhine-Westphalia, 33611, Germany
Kliniken Essen-Mitte Evang. Huyssens-Stiftung
Essen, North Rhine-Westphalia, 45136, Germany
Johannes Gutenberg-Universitaet
Maintz, Rhineland-Palatinate, 55101, Germany
Universitätsklinik Carl-Gustav-Carus Dresden
Dresden, Saxony, 1307, Germany
Universitätsklinikum Leipzig
Leipzig, Saxony, 4103, Germany
Charite - Campus Benjamin Franklin (Cbf)
Berlin, 12200, Germany
Charite
Berlin, 13353, Germany
Klinikum Esslingen
Esslingen am Neckar, 73730, Germany
Facharztzentrum Eppendorf
Hamburg, 20249, Germany
OncoResearch Lerchenfeld GmbH
Hamburg, 22081, Germany
Pécsi Tudományegyetem Klinikai Központ
Pécs, Baranya, 7624, Hungary
Békés Megyei Pándy Kálmán Kórház
Gyula, Bekes County, 5700, Hungary
Petz Aladár Megyei Oktató Kórház
Győr, Győr-Moson-Sopron, 9024, Hungary
Debreceni Egyetem Klinikai Központ
Debrecen, Hajdú-Bihar, H-4032, Hungary
Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház- Rendelőinté
Szolnok, Jász-Nagykun-Szolnok, 5004, Hungary
Josa Andras Oktato Korhaza
Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400, Hungary
Semmelweis Egyetem
Budapest, 1083, Hungary
Egyesített Szent István és Szent László Kórház-Rendelőintéze
Budapest, 1097, Hungary
Országos Onkológiai Intézet
Budapest, 1122, Hungary
Semmelweis Egyetem
Budapest, 1125, Hungary
Somogy Megyei Kaposi Mór Oktató Kórház
Kaposvár, 7400, Hungary
The E. Wolfson Medical Center [Oncology]
Holon, Central District, 58100, Israel
Meir Medical Center
Kfar Saba, Central District, 44281, Israel
Rabin Medical Center - Beilinson Hospital
Petah Tikva, Central District, 49100, Israel
Hadassah Medical Organisation
Jerusalem, Jerusalem, 91120, Israel
Soroka Medical Center [Oncology]
Beersheba, Southern District, 84101, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Tel Aviv, 64239, Israel
Rambam Health Care Campus
Haifa, 31096, Israel
Irccs Irst
Meldola, Forli, 47014, Italy
AUSL della Romagna, Osp. degli Infermi
Faenza, Ravenna, 48018, Italy
Ospedale Umberto I, AOU Ospedali Riuniti Umberto I - GM.Lanc
Ancona, 60126, Italy
IRCCS Ospedale Oncologico "Giovanni Paolo II"
Bari, 701264, Italy
Humanitas Gavazzeni
Bergamo, 24125, Italy
Policlinico S.Orsola Malpighi, AOU di Bologna
Bologna, 40138, Italy
PO Garibaldi-Nesima, ARNAS Garibaldi
Catania, 95100, Italy
Azienda Ospedaliera "Istituti Ospitalieri" di Cremona
Cremona, 26100, Italy
AOU S.Martino, IRCCS, IST-Istituto Nazionale Ricerca Sul Can
Genova, 16132, Italy
Azienda Ospedaliera Fatebenefratelli e Oftalmico
Milan, 20121, Italy
Istituto Oncologico Veneto IOV-IRCCS
Padua, 35128, Italy
Ospedale Guglielmo da Saliceto, AUSL Piacenza
Piacenza, 29100, Italy
Unità di Biostatistica e Sperimentazioni Cliniche IRST
Ravenna, 48100, Italy
Ospedale Molinette, AO Città della Salute e della Scienza di
Torino, 10126, Italy
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, 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, Hyōgo, 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
Chūō, 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
Hospital of Lithuanian University of Health sciences
Kaunas, Kaunas County, LT-45434, Lithuania
Hospital of Lithuanian University of Health Sciences
Kaunas, Kaunas County, LT-50009, Lithuania
Respublikine Panevezio ligonine
Panevezys, Panevežio Apskritis, LT-35144, Lithuania
National Cancer Institute
Vilnius, Vilnius County, LT-08860, Lithuania
Klaipeda University Hospital
Klaipėda, LT-92288, Lithuania
Vilniaus Universiteto ligonines Santariskiu Klinikos
Vilnius, LT-08661, Lithuania
Siauliai County Hospital
Šiauliai, Šiauliu Apskritis, LT-76231, Lithuania
NZOZ Centrum Medyczne HCP Lecznictwo Stacjonarne
Poznan, Greater Poland Voivodeship, 61-485, Poland
Centrum Onkologii im. F.Lukaszczyka
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland
Szpital Specjalistyczny im. L. Rydygiera w Krakowie
Krakow, Lesser Poland Voivodeship, 31-108, Poland
Europejskie Centrum Zdrowia Otwock, Szpital im. F. Chopina
Otwock, Masovian Voivodeship, 05-400, Poland
Centrum Onkologii Instytut im. M. Sklodowskiej-Curie
Warsaw, Masovian Voivodeship, 02-781, Poland
Magodent sp. z o.o. Szpital Onkologiczny
Warsaw, Masovian Voivodeship, 03-291, Poland
Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onko
Brzozów, Podkarpackie Voivodeship, 36-20, Poland
Wojewodzkie Centrum Onkologii w Gdansku
Gdansk, Pomeranian Voivodeship, 80-210, Poland
Zachodniopomorskie Centrum Onkologii
Szczecin, West Pomeranian Voivodeship, 71-730, Poland
Wojewodzki Szpital Specjalistyczny im. M.Kopernika
Lodz, Łódź Voivodeship, 93-510, Poland
Radiotherapy Center CJ radioterapie si chimioterapie adulti
Floreşti, Cluj, 407280, Romania
Centrul de Oncologie Sf. Nectarie
Craiova, Dolj, 200347, Romania
Oncolab
Craiova, Dolj, 200385, Romania
Institutul Regional de Oncologie Iasi
Lasi, Lasi, 700483, Romania
Sp. Jud. de Urg. "Dr. Constantin Opris" Baia Mare
Baia Mare, Maramureş, 430031, Romania
Oncomed
Timișoara, Timiș County, 300239, Romania
Spitalul Clinic Municipal de Urgenta Timisoara
Timișoara, Timiș County, 300239, Romania
Med Life
Bucharest, 010719, Romania
Spitalul Clinic CF 2
Bucharest, 011464, Romania
Institutul Clinic Fundeni
Bucharest, 022328, Romania
Centrul de Oncologie Euroclinic
Iași, 700106, Romania
Spitalul Clinic Judetean de Urgenta Sibiu
Sibiu, 550245, Romania
Republican Clinical Oncology Dispensary
Ufa, Bahkortostan, Respublika, 450054, Russia
Military Medical Academy n.a. S.M. Kirov
Saint Petersburg, Leningradskaya Oblast', 190121, Russia
Russian Oncological Research Center n.a. N.N. Blokhin RAMS
Moscow, Moscow, 115478, Russia
City Clinical Hospital #40
Moscow, Moscow, 129301, Russia
GUZ Perm Regional Oncology Dispensary
Perm, Permskiy Kray, 614066, Russia
Northwestern State Medical University n.a. Mechnikov
Saint Petersburg, Sankt-Peterburg, 195067, Russia
First Pavlov State Medical University of Saint-Petersburg
Saint Petersburg, Sankt-Peterburg, 197022, Russia
GBUZ Saint Petersburg clinical scientific and practical cent
Saint Petersburg, Sankt-Peterburg, 197758, Russia
SPb State Budget Institution Oncology Dispansery
Saint Petersburg, Sankt-Peterburg, 198255, Russia
GBUZ of Stavropol Territory Pyatigorsk Oncology Dispensary
Pyatigorsk, Stavropol Kray, 357502, Russia
Guz Clinical Oncology Dispensary #1
Krasnodar, 350040, Russia
Seoul National University Bundang Hospital
Seongnam, Gyeonggido, 463-707, South Korea
Samsung Medical Center
Seoul, Seoul Teugbyeolsi, 135-710, South Korea
Asan medical Center
Seoul, Seoul Teugbyeolsi, 138-736, South Korea
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, 138-736, South Korea
H.U.V. Macarena
Seville, Andalusia, 41009, Spain
Institut Català d'Oncologia-Hospital Germans Trias i Pujol
Badalona, Barcelona, 08916, Spain
C.A.AV-H.Ntra.Sra.de Sonsoles
Ávila, Castille and León, 05004, Spain
H.U.P Hierro-Majadahonda
Majadahonda, Madrid, 28222, Spain
H.del Mar
Barcelona, 08003, Spain
Hospital Universitario Vall d'Hebrón
Barcelona, 08035, Spain
H.Sta.Creu i St.Pau
Barcelona, 08041, Spain
H.U. de Burgos
Burgos, 09006, Spain
Institut Catalá d´Oncología (I.C.O.)
L'Hospitalet de Llobregat, 08907, Spain
H.G.U. G. Marañón
Madrid, 28007, Spain
M.D. Anderson Cancer Center Madrid
Madrid, 28033, Spain
H.U. R. y Cajal
Madrid, 28034, Spain
H.C. S.Carlos
Madrid, 28040, Spain
H.U.V.Arrixaca
Murcia, 30120, Spain
H.U.V. del Rocío
Seville, 41013, Spain
C.H.G.U.de Valencia
Valencia, 46014, Spain
H.U. Miguel Servet
Zaragoza, 50009, Spain
Aberdeen Royal Infirmary
Aberdeen, Aberdeen City, AB25 2ZN, United Kingdom
The Beatson West Of Scotland Cancer Centre
Glasgow, Glasgow City, G12 0YH, United Kingdom
Royal Surrey County Hospital
Guildford, Surrey, GU2 7XX, United Kingdom
The Royal Marsden Hospital
Sutton, Surrey, SM2 5PT, United Kingdom
The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital
Sutton, Surrey, SM2 5PT, United Kingdom
Belfast City Hospital
Belfast, BT9 7AB, United Kingdom
St. Georges Hospital
London, SE1 2PR, United Kingdom
Christie Hospital NHS Foundation Trust
Manchester, M20 4BX, United Kingdom
Southampton University Hospital
Southampton, SO16 6YD, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Marilyn Fontaine
- Organization
- Sumitomo Dainippon Pharma Oncology
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2014
First Posted
July 1, 2014
Study Start
October 1, 2014
Primary Completion
September 20, 2017
Study Completion
September 20, 2017
Last Updated
November 15, 2023
Results First Posted
May 10, 2021
Record last verified: 2023-11