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

Gastric Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02178956
• Other study ID #: BBI608-336
• Secondary ID: 2014-000774-18
• Status: Completed
• Phase: Phase 3
• Start date: October 2014
• Est. completion date: September 20, 2017

Study information

• Verified date: November 2023
• Source: Sumitomo Pharma America, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 714
• Est. completion date: September 20, 2017
• Est. primary completion date: September 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gastric Cancer
• Gastroesophageal Junction Cancer
• Stomach Neoplasms

Intervention

Drug:
• BBI608
BBI608 480 mg orally two times daily (960 mg total daily dose)
• Paclitaxel
Paclitaxel 80 mg/m2 I.V. infusion on Days 1, 8, and 15 of every 4-week cycle

Other:
• Placebo
Orally two times daily

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Sumitomo Pharma America, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Brazil,  Bulgaria,  Canada,  China,  Czechia,  Estonia,  France,  Germany,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Lithuania,  Poland,  Romania,  Russian Federation,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	36 months
Secondary	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.	36 months
Secondary	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.	36 months
Secondary	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.	36 months