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

Primary Purpose

Gastric Cancer, Gastroesophageal Junction Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
BBI608
Paclitaxel
Placebo
Sponsored by
Sumitomo Pharma America, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mayo Clinic - Arizona
  • Colorado Cancer Research Program
  • Indiana University Health Goshen Center For Cancer Care
  • Northern Indiana Cancer Research Consortium
  • Siouxland Regional Cancer Center
  • Cancer Center of Kansas
  • Ochsner NCI CORP
  • Spectrum Health Butterworth
  • Munson Medical Center
  • Mayo Clinic - Rochester
  • Metro-Minnesota NCI CORP
  • Heartland NCORP
  • New Hampshire Oncology Hematology - Concord
  • New Hampshire Oncology Hematology - Laconia
  • Weill Medical College of Cornell University
  • State University of New York Upstate Medical University
  • Indiana University Health University Hospital
  • Ohio State University Medical Center
  • The University of Oklahoma Health Sciences Center (OUHSC)
  • Geisinger Medical Center
  • Virginia Mason Medical Center
  • Swedish Cancer Institute/ Swedish Health Services
  • Saint Vincent Hospital CCOP
  • St. Mary's Hospital
  • Gundersen Lutheran Medical Center
  • Marshfield CCOP
  • Bankstown-Lidcombe
  • Chris O'Brien Lifehouse
  • St Vincent's Hospital
  • Central coast area health (public)
  • Port Macquaries Base Hospital
  • Royal North Shore Hospital
  • Riverina Cancer Care Centre
  • Royal Brisbane & Women's Hospital
  • Sunshine Coast Hospital and Health Service
  • Gold Coast University Hospital
  • Townsville Hospital
  • Princess Alexandra Hospital
  • Flinders Medical Centre
  • Ashford Cancer Centre Research
  • The Queen Elizabeth Hospital
  • Bendigo Hospital
  • Monash Health
  • Peninsula & South Eastern Haematology and Oncology Group
  • St Vincent's Hospital
  • Austin Hospital
  • Ballarat base hospital
  • Royal Melbourne Hospital
  • Sunshine Hospital
  • Ballarat Oncology and Haematology Services
  • Fiona Stanley Hospital
  • Imelda Ziekenhuis
  • UZ Antwerpen
  • UZ Brussel - Campus Jette
  • Institut Jules Bordet
  • Cliniques Universitaires Saint-Luc
  • CHU Ambroise Paré
  • UZ Leuven - Campus Gasthuisberg
  • AZ Sint-Lucas - Campus Sint-Lucas
  • CHU de Liège - Domaine Universitaire du Sart Tilman
  • Oncovida - Centro de Oncologia da Bahia
  • Instituto do Câncer do Ceará - Instituto do Câncer do Cear
  • Cetus Hospital Dia Oncologia
  • Hospital Erasto Gaertner
  • Hospital Bruno Born
  • Hospital da Cidade de Passo Fundo
  • UPCO - Unidade de Pesquisa Clinica em Oncologia LTDA
  • Clinica de Neoplasias Litoral
  • Fundaçao dr Amaral Carvalho
  • Hospital de Base de São José do Rio Preto
  • Inca-RJ
  • IEP São Lucas
  • Casa de Saúde Santa Marcelina
  • Specialised Hospital for Active Treatment in Oncology
  • UMHAT ""Dr. Georgi Stranski"" Dept. Medical Oncology
  • District Dispensery with Stationary - Sofia District
  • Multiprofile hospital for active treatment
  • UMHAT"Sv.Ivan Rilski"
  • Uni. Multiprofile Hospital for Active treatment Sveta Marina
  • COC - Vratsa Dept. of Palliative Care
  • The Ottawa Hospital Cancer Centre
  • Saint Michael's Hospital Li Ka Shing Knowledge Institute
  • Mount Sinai Hospital
  • Princess Margaret Hospital
  • Hopital Notre-Dame du CHUM
  • McGill University Health Centre - Montreal General Hospital
  • Cancer Hospital Chinese Academy of Medical Sciences
  • The 307th Hospital of Chinese People's Liberation Army
  • Beijing Cancer Hospital
  • Chinese PLA General Hospital
  • Fujian Medical University Union Hospital
  • Sun Yat-Sen University Cancer Center
  • Southern Medical University, Nanfang Hospital
  • Harbin Medical University Cancer Hospital
  • The First Affiliated Hospital of Zhengzhou University
  • Henan Cancer Hospital
  • Hunan Cancer Hospital
  • The 81 Hospital of the Chinese People's Liberation Army
  • Jiang Su Cancer Hospital
  • Jiangsu Province Hospital
  • The First Bethune Hospital of Jilin University
  • Jilin Cancer Hospital
  • The First Hospital of China Medical University
  • General Hospital of Ningxia Medical University
  • Fudan University Shanghai Cancer Center
  • Zhongshan Hospital
  • West China Hospital, Sichuan University
  • Tianjin Medical University Cancer Institute & Hospital
  • Xin Jiang Tumor Hospital, Xin Jiang Medical University
  • Sir Run Run Shaw Hospital School of Medicine, Zhejiang University
  • Zhejiang Cancer Hospital
  • Tongji Hospital
  • FN Hradec Kralove
  • Fakultni nemocnice Olomouc
  • Masarykuv onkologicky ustav
  • Vseobecna fakultni nemocnice v Praze
  • Nemocnice Na Bulovce
  • East Tallinn Central Hospital Oncology Center
  • Tartu University Hospital Clinic of Hematology and Oncology
  • Centre Antoine Lacassagne
  • Hopital Saint Joseph - Marseille
  • Centre Paul Papin
  • Centre Rene Gauducheau
  • Hopital Privé Jean Mermoz
  • Chd Vendee La Roche Sur Yon
  • Hospital of Poitiers
  • Hôpital Morvan - CHRU de Brest
  • CHU Estaing
  • CHU - Hôpital De La Timone
  • Centre Hospitalier De Mont De Marsan - Hopital Layné
  • Centre eugène marquis
  • CHU Saint Etienne
  • Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital
  • Institut Gustave Roussy
  • Klinikum Bogenhausen
  • Klinikum der Johann Wolfgang Goethe-Universität
  • Ev. Krankenhaus Bielefeld
  • Kliniken Essen-Mitte Evang. Huyssens-Stiftung
  • Johannes Gutenberg-Universitaet
  • Universitätsklinik Carl-Gustav-Carus Dresden
  • Universitätsklinikum Leipzig
  • Charite - Campus Benjamin Franklin (Cbf)
  • Charite
  • Klinikum Esslingen
  • Facharztzentrum Eppendorf
  • OncoResearch Lerchenfeld GmbH
  • Pécsi Tudományegyetem Klinikai Központ
  • Békés Megyei Pándy Kálmán Kórház
  • Petz Aladár Megyei Oktató Kórház
  • Debreceni Egyetem Klinikai Központ
  • Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház- Rendelőinté
  • Josa Andras Oktato Korhaza
  • Semmelweis Egyetem
  • Egyesített Szent István és Szent László Kórház-Rendelőintéze
  • Országos Onkológiai Intézet
  • Semmelweis Egyetem
  • Somogy Megyei Kaposi Mór Oktató Kórház
  • Soroka Medical Center [Oncology]
  • The E. Wolfson Medical Center [Oncology]
  • Meir Medical Center
  • Rabin Medical Center - Beilinson Hospital
  • Tel Aviv Sourasky Medical Center
  • Hadassah Medical Organisation
  • Rambam Health Care Campus
  • Irccs Irst
  • AUSL della Romagna, Osp. degli Infermi
  • Ospedale Umberto I, AOU Ospedali Riuniti Umberto I - GM.Lanc
  • IRCCS Ospedale Oncologico "Giovanni Paolo II"
  • Humanitas Gavazzeni
  • Policlinico S.Orsola Malpighi, AOU di Bologna
  • PO Garibaldi-Nesima, ARNAS Garibaldi
  • Azienda Ospedaliera "Istituti Ospitalieri" di Cremona
  • AOU S.Martino, IRCCS, IST-Istituto Nazionale Ricerca Sul Can
  • Azienda Ospedaliera Fatebenefratelli e Oftalmico
  • Istituto Oncologico Veneto IOV-IRCCS
  • Ospedale Guglielmo da Saliceto, AUSL Piacenza
  • Unità di Biostatistica e Sperimentazioni Cliniche IRST
  • Ospedale Molinette, AO Città della Salute e della Scienza di
  • Aichi Cancer Center Hospital
  • National Cancer Center Hospital East
  • National Hospital Organization Shikoku Cancer Center
  • Hokkaido University Hospital
  • Kobe City Medical Center General Hospital
  • Saku Central Hospital Advanced Care Center
  • Osaka University Hospital
  • Saitama Cancer Center
  • Shizuoka Cancer Center
  • Tochigi Cancer Center
  • National Cancer Center Hospital
  • Kyorin University Hospial
  • Chiba Cancer Center
  • Gifu University Hospital
  • Osaka Medical Center for Cancer and Cardiovascular Diseases
  • Seoul National University Bundang Hospital
  • Samsung Medical Center
  • Asan medical Center
  • Seoul National University Hospital
  • Hospital of Lithuanian University of Health sciences
  • Hospital of Lithuanian University of Health Sciences
  • Respublikine Panevezio ligonine
  • National Cancer Institute
  • Klaipeda University Hospital
  • Vilniaus Universiteto ligonines Santariskiu Klinikos
  • Siauliai County Hospital
  • Centrum Onkologii im. F.Lukaszczyka
  • Szpital Specjalistyczny im. L. Rydygiera w Krakowie
  • Europejskie Centrum Zdrowia Otwock, Szpital im. F. Chopina
  • Centrum Onkologii Instytut im. M. Sklodowskiej-Curie
  • Magodent sp. z o.o. Szpital Onkologiczny
  • Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onko
  • Wojewodzkie Centrum Onkologii w Gdansku
  • NZOZ Centrum Medyczne HCP Lecznictwo Stacjonarne
  • Zachodniopomorskie Centrum Onkologii
  • Wojewodzki Szpital Specjalistyczny im. M.Kopernika
  • Radiotherapy Center CJ radioterapie si chimioterapie adulti
  • Centrul de Oncologie Sf. Nectarie
  • Oncolab
  • Sp. Jud. de Urg. "Dr. Constantin Opris" Baia Mare
  • Oncomed
  • Spitalul Clinic Municipal de Urgenta Timisoara
  • Med Life
  • Spitalul Clinic CF 2
  • Institutul Clinic Fundeni
  • Centrul de Oncologie Euroclinic
  • Institutul Regional de Oncologie Iasi
  • Spitalul Clinic Judetean de Urgenta Sibiu
  • Republican Clinical Oncology Dispensary
  • Military Medical Academy n.a. S.M. Kirov
  • Russian Oncological Research Center n.a. N.N. Blokhin RAMS
  • City Clinical Hospital #40
  • GUZ Perm Regional Oncology Dispensary
  • Northwestern State Medical University n.a. Mechnikov
  • First Pavlov State Medical University of Saint-Petersburg
  • GBUZ Saint Petersburg clinical scientific and practical cent
  • SPb State Budget Institution Oncology Dispansery
  • GBUZ of Stavropol Territory Pyatigorsk Oncology Dispensary
  • Guz Clinical Oncology Dispensary #1
  • H.U.V. Macarena
  • Institut Català d'Oncologia-Hospital Germans Trias i Pujol
  • C.A.AV-H.Ntra.Sra.de Sonsoles
  • H.U.P Hierro-Majadahonda
  • H.del Mar
  • Hospital Universitario Vall d'Hebrón
  • H.Sta.Creu i St.Pau
  • H.U. de Burgos
  • Institut Catalá d´Oncología (I.C.O.)
  • H.G.U. G. Marañón
  • M.D. Anderson Cancer Center Madrid
  • H.U. R. y Cajal
  • H.C. S.Carlos
  • H.U.V.Arrixaca
  • H.U.V. del Rocío
  • C.H.G.U.de Valencia
  • H.U. Miguel Servet
  • Aberdeen Royal Infirmary
  • The Beatson West Of Scotland Cancer Centre
  • Royal Surrey County Hospital
  • The Royal Marsden Hospital
  • The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital
  • Belfast City Hospital
  • St. Georges Hospital
  • Christie Hospital NHS Foundation Trust
  • Southampton University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BBI608 plus Paclitaxel

Placebo plus Paclitaxel

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Progression Free Survival
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.
Objective Response Rate
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.
Disease Control Rate
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.
Number of Patients With Adverse Events
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.

Full Information

First Posted
June 27, 2014
Last Updated
April 4, 2022
Sponsor
Sumitomo Pharma America, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02178956
Brief Title
A Study of BBI608 Plus Weekly Paclitaxel to Treat Gastric and Gastro-Esophageal Junction Cancer
Acronym
BRIGHTER
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 Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
September 20, 2017 (Actual)
Study Completion Date
September 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sumitomo Pharma America, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Gastroesophageal Junction Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
714 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BBI608 plus Paclitaxel
Arm Type
Experimental
Arm Title
Placebo plus Paclitaxel
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
BBI608
Other Intervention Name(s)
Napabucasin, BB608, BBI-608
Intervention Description
BBI608 480 mg orally two times daily (960 mg total daily dose)
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Paclitaxel 80 mg/m2 I.V. infusion on Days 1, 8, and 15 of every 4-week cycle
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Orally two times daily
Primary Outcome Measure Information:
Title
Overall Survival
Description
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.
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Progression Free Survival
Description
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.
Time Frame
36 months
Title
Objective Response Rate
Description
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.
Time Frame
36 months
Title
Disease Control Rate
Description
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.
Time Frame
36 months
Title
Number of Patients With Adverse Events
Description
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.
Time Frame
36 months

10. Eligibility

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

12. IPD Sharing Statement

Learn more about this trial

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

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