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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
First received
Last updated
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
Health authority
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.

Study Design


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
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