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

NCT ID: NCT02178956

Last Updated: 2023-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 714 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2017-09-20

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.

Conditions

Gastric Cancer; Gastroesophageal Junction Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

BBI608 plus Paclitaxel

Group Type: EXPERIMENTAL

BBI608

Intervention Type: DRUG

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

Paclitaxel

Intervention Type: DRUG

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

Placebo plus Paclitaxel

Group Type: PLACEBO_COMPARATOR

Paclitaxel

Intervention Type: DRUG

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

Placebo

Intervention Type: OTHER

Orally two times daily

Interventions

BBI608

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

Intervention Type: DRUG

Paclitaxel

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

Intervention Type: DRUG

Placebo

Orally two times daily

Intervention Type: OTHER

Other Intervention Names

Napabucasin; BB608; BBI-608

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sumitomo Pharma America, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

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

St 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

Institut Jules Bordet

Brussels, Brussels Capital, Belgium

UZ Brussel - Campus Jette

Brussels, Brussels Capital, Belgium

Cliniques Universitaires Saint-Luc

Brussels, Brussels Capital, 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

Instituto do Câncer do Ceará - Instituto do Câncer do Cear

Fortaleza, Ceará, Brazil

Oncovida - Centro de Oncologia da Bahia

Salvador, Estado de Bahia, 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

Itajaí, 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 Municipality, China

The 307th Hospital of Chinese People's Liberation Army

Beijing, Beijing Municipality, China

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Chinese PLA General Hospital

Beijing, Beijing Municipality, 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 Municipality, China

Zhongshan Hospital

Shanghai, Shanghai Municipality, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China

Xin Jiang Tumor Hospital, Xin Jiang Medical University

Ürümqi, 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 Králové, Královéhradecký kraj, Czechia

Fakultni nemocnice Olomouc

Olomouc, Olomoucký kraj, Czechia

Masarykuv onkologicky ustav

Brno, , Czechia

Vseobecna fakultni nemocnice v Praze

Prague, , Czechia

Nemocnice Na Bulovce

Prague, , Czechia

East Tallinn Central Hospital Oncology Center

Tallinn, Harju, Estonia

Tartu University Hospital Clinic of Hematology and Oncology

Tartu, Tartu, Estonia

Centre Antoine Lacassagne

Nice, Alpes-Maritimes, France

Hopital Saint Joseph - Marseille

Marseille, Bouches-du-Rhône, France

Centre Paul Papin

Saint-Herblain, Loire-Atlantique, France

Centre Rene Gauducheau

Saint-Herblain, Loire-Atlantique, France

Hopital Privé Jean Mermoz

Lyon, Rhône, France

Chd Vendee La Roche Sur Yon

La Roche-sur-Yon, Vendée, France

Hospital of Poitiers

Poitiers, Vienne, France

Hôpital Morvan - CHRU de Brest

Brest, , France

CHU Estaing

Clermont-Ferrand, , France

CHU - Hôpital De La Timone

Marseille, , France

Centre Hospitalier De Mont De Marsan - Hopital Layné

Mont-de-Marsan, , France

Centre eugène marquis

Rennes, , France

CHU Saint Etienne

Saint-Etienne, , France

Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital

Toulouse, , France

Institut Gustave Roussy

Villejuif, , France

Klinikum Bogenhausen

München, Bavaria, Germany

Klinikum der Johann Wolfgang Goethe-Universität

Frankfurt am Main, Hesse, Germany

Ev. Krankenhaus Bielefeld

Bielefeld, North Rhine-Westphalia, Germany

Kliniken Essen-Mitte Evang. Huyssens-Stiftung

Essen, North Rhine-Westphalia, Germany

Johannes Gutenberg-Universitaet

Maintz, Rhineland-Palatinate, Germany

Universitätsklinik Carl-Gustav-Carus Dresden

Dresden, Saxony, Germany

Universitätsklinikum Leipzig

Leipzig, Saxony, Germany

Charite - Campus Benjamin Franklin (Cbf)

Berlin, , Germany

Charite

Berlin, , Germany

Klinikum Esslingen

Esslingen am Neckar, , Germany

Facharztzentrum Eppendorf

Hamburg, , Germany

OncoResearch Lerchenfeld GmbH

Hamburg, , Germany

Pécsi Tudományegyetem Klinikai Központ

Pécs, Baranya, Hungary

Békés Megyei Pándy Kálmán Kórház

Gyula, Bekes County, Hungary

Petz Aladár Megyei Oktató Kórház

Győr, Győr-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

Nyíregyháza, 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

The E. Wolfson Medical Center [Oncology]

Holon, Central District, Israel

Meir Medical Center

Kfar Saba, Central District, Israel

Rabin Medical Center - Beilinson Hospital

Petah Tikva, Central District, Israel

Hadassah Medical Organisation

Jerusalem, Jerusalem, Israel

Soroka Medical Center [Oncology]

Beersheba, Southern District, Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, Tel Aviv, 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

Milan, , Italy

Istituto Oncologico Veneto IOV-IRCCS

Padua, , 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-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, Lithuania

Hospital of Lithuanian University of Health Sciences

Kaunas, Kaunas County, Lithuania

Respublikine Panevezio ligonine

Panevezys, Panevežio Apskritis, Lithuania

National Cancer Institute

Vilnius, Vilnius County, Lithuania

Klaipeda University Hospital

Klaipėda, , Lithuania

Vilniaus Universiteto ligonines Santariskiu Klinikos

Vilnius, , Lithuania

Siauliai County Hospital

Šiauliai, Šiauliu Apskritis, Lithuania

NZOZ Centrum Medyczne HCP Lecznictwo Stacjonarne

Poznan, Greater Poland Voivodeship, Poland

Centrum Onkologii im. F.Lukaszczyka

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Szpital Specjalistyczny im. L. Rydygiera w Krakowie

Krakow, Lesser Poland Voivodeship, Poland

Europejskie Centrum Zdrowia Otwock, Szpital im. F. Chopina

Otwock, Masovian Voivodeship, Poland

Centrum Onkologii Instytut im. M. Sklodowskiej-Curie

Warsaw, Masovian Voivodeship, Poland

Magodent sp. z o.o. Szpital Onkologiczny

Warsaw, Masovian Voivodeship, Poland

Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onko

Brzozów, Podkarpackie Voivodeship, Poland

Wojewodzkie Centrum Onkologii w Gdansku

Gdansk, Pomeranian Voivodeship, Poland

Zachodniopomorskie Centrum Onkologii

Szczecin, West Pomeranian Voivodeship, Poland

Wojewodzki Szpital Specjalistyczny im. M.Kopernika

Lodz, Łódź Voivodeship, Poland

Radiotherapy Center CJ radioterapie si chimioterapie adulti

Floreşti, Cluj, Romania

Centrul de Oncologie Sf. Nectarie

Craiova, Dolj, Romania

Oncolab

Craiova, Dolj, Romania

Institutul Regional de Oncologie Iasi

Lasi, Lasi, Romania

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

Baia Mare, Maramureş, Romania

Oncomed

Timișoara, Timiș County, Romania

Spitalul Clinic Municipal de Urgenta Timisoara

Timișoara, Timiș County, Romania

Med Life

Bucharest, , Romania

Spitalul Clinic CF 2

Bucharest, , Romania

Institutul Clinic Fundeni

Bucharest, , Romania

Centrul de Oncologie Euroclinic

Iași, , Romania

Spitalul Clinic Judetean de Urgenta Sibiu

Sibiu, , Romania

Republican Clinical Oncology Dispensary

Ufa, Bahkortostan, Respublika, Russia

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

Saint Petersburg, Leningradskaya Oblast', Russia

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

Moscow, Moscow, Russia

City Clinical Hospital #40

Moscow, Moscow, Russia

GUZ Perm Regional Oncology Dispensary

Perm, Permskiy Kray, Russia

Northwestern State Medical University n.a. Mechnikov

Saint Petersburg, Sankt-Peterburg, Russia

First Pavlov State Medical University of Saint-Petersburg

Saint Petersburg, Sankt-Peterburg, Russia

GBUZ Saint Petersburg clinical scientific and practical cent

Saint Petersburg, Sankt-Peterburg, Russia

SPb State Budget Institution Oncology Dispansery

Saint Petersburg, Sankt-Peterburg, Russia

GBUZ of Stavropol Territory Pyatigorsk Oncology Dispensary

Pyatigorsk, Stavropol Kray, Russia

Guz Clinical Oncology Dispensary #1

Krasnodar, , Russia

Seoul National University Bundang Hospital

Seongnam, Gyeonggido, South Korea

Samsung Medical Center

Seoul, Seoul Teugbyeolsi, South Korea

Asan medical Center

Seoul, Seoul Teugbyeolsi, South Korea

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi, South Korea

H.U.V. Macarena

Seville, Andalusia, Spain

Institut Català d'Oncologia-Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain

C.A.AV-H.Ntra.Sra.de Sonsoles

Ávila, Castille and 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.)

L'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

Seville, , 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

Countries

United States; Australia; Belgium; Brazil; Bulgaria; Canada; China; Czechia; Estonia; France; Germany; Hungary; Israel; Italy; Japan; Lithuania; Poland; Romania; Russia; South Korea; Spain; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2014-000774-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BBI608-336

Identifier Type: -

Identifier Source: org_study_id