575
Participants
Start Date
December 5, 2018
Primary Completion Date
December 30, 2025
Study Completion Date
December 30, 2027
adagloxad simolenin combined with OBI-821
In the neoadjuvant and adjuvant phases of the study for a total of 100 weeks; subcutaneously injections.
Globo H IHC Assay
The Globo H IHC assay will be used to identify eligible patients who may clinically benefit from the OBI-822 treatment, defined by Globo H expression.
Standard of care treatment
Standard of care treatment consisting of observation alone, adjuvant capecitabine or platinum monotherapy over a 100 week period.
National Taiwan University Hospital, Taipei
Changhua Christian Hospital, Changhua
National Cheng Kung University Hospital, Tainan City
Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City
St Vincent's Hospital Sydney, Darlinghurst
Westmead Hospital, Westmead
Netcare Milpark Hospital, Johannesburg
Wits Clinical Research, a division of Wits Health Consortium (Pty) Ltd, Johannesburg
Medical Oncology Centre of Rosebank, Johannesburg
Gosford Hospital, Gosford
Victoria Breast & Oncology Care, East Melbourne
Eastern Health - Maroondah Hospital, Ringwood East
Cabrini Malvern, Malvern
Cancer Care Service, Hervey Bay Hospital, Urraween
St John of God Murdoch Hospital, Murdoch
CI Reg. Oncol. Dispanser, Zhytomyr
National Cancer Center, Goyang-si
Chang Gung Medical Foundation Linkou, Taipei
Taipei Veterans General Hospital, Taipei
Koo Foundation Sun Yat-Sen Cancer Center, Taipei
Tri-Service General Hospital, Taipei
Seoul National University Bundang Hospital, Seongnam-si
Instituto Nacional de Cancerologia, Mexico City
Hospital de Cancer de Barretos, Barretos
Instituto Nacional de Enfermedades Neoplasicas, Lima
Hospital Nacional Edgardo Rebagliati Martins, Unidad de Investigacion de Oncologia Medica, Lima
Unidad de Investigacion - Oncologia Medica Clinica San Felipe, Lima
Magee-Womens Hospital of UPMC, Pittsburgh
Hospital Maria Auxiliadora, Lima
The Catholic University of Korea, St. Vincent's Hospital, Suwon
Investigacion Biomedica para el Desarrollo de Farmacos, S.A. de. C.V, Aguascalientes
University of Maryland Greenbaum Comprehensive Cancer Center, Baltimore
Inha University Hospital, Incheon
Bons Secours St. Francis Medical Oncology Center, Midlothian
Clinica Oncor - Centro de Infusion e Investigacion Oncologia de Satillo, Saltillo
Centro Estatal de Cancerologia, Chihuahua City
Icaro Investigaciones en Medicina S.A. de C.V., Chihuahua City
Scientia Investigacion Clinica S.C., Chihuahua City
Miami Cancer Institute, Miami
Investigacion Biomedica para el Desarrollo de Farmacos, Zapopan
Henry Ford Medical Center, Detroit
Dnipropetrovsk Medical Academy of the Ministry of Health of Ukraine, Dnipro
City Clinical Hospital #4, Dnipro
Dong-A University Hospital, Busan
Centro Oncologico Estatal Instituto de Seguridad Social del Estado de Mexico y Municipios, Toluca
Sociedad Administradora de Servicios de Salud S.C., Morelia
University of Chicago Medical, Chicago
Suporte Nutricional e Quimioterapia, Fortaleza
CI of Healthcare Regional Clinical Specialized Dispensary of the Radiation Protection, Kharkiv
Centro Medico Zambrano Hellion, San Pedro Garza García
CI of Kherson Reg Council Kherson Regional Oncologic Dispensary, Kherson
CI Transcarpathian Cl Onc Center Dep of Surgery#1 SHEI Ivano-Frankivsk NMU, Ivano-Frankivsk
University of Texas Health Science Center at San Antonio, San Antonio
Moores UCSD Cancer Center, La Jolla
Kaiser Permanente Medical Center, San Diego
UCSF Helen Diller Family Comprehensive Cancer Centre, San Francisco
Northwest Medical Specialties, PLLC, Tacoma
Oncosite-Centro de Pesquisa Clinica em Oncologia, Ijuí
Cancer Hospital Chinese Academy of Medical Sciences, Beijing
Cancer Institute and Hospital, Beijing
Beijing Cancer Hospital, Beijing
Liaoning Cancer Hospital and Institute, Shenyang
The First Hospital of China Medical University, Shenyang
"FSBSI Russian Oncological Scientific Center n.a. N.N. Blokhin", Moscow
The First Hospital of Jilin University, Changchun
"SBIH of Moscow city Moscow city oncology hospital №62 of Moscow Healthcare department", Moscow
"SBIH of Yaroslavl region Regional Clinical Oncological Hospital", Yaroslavl
Harbin Medical University Cancer Hospital, Harbin
"SBIH of Arkhangelsk region Arkhangelsk Clinical Oncological Dispensary", Arkhangelsk
LLC Medaid, Saint Petersburg
"SPb SBIH City Clinical Oncological Dispensary", Saint Petersburg
Klinika Luch, Ltd., Saint Petersburg
N.N. Petrov National Medical Research Center of Oncology, Pesochnyy
Jiangsu Province Hospital, Nanjing
Tianjin Cancer Hospital, Tianjin
Sir Run Run Shaw Hospital, Hangzhou
Zhejiang Cancer Hospital, Hangzhou
"SBHI Volgograd Regional Oncology Dispensary #3", Volzhskiy
Xiangya Hospital Central South University, Changsha
Hunan Cancer Hospital, Changsha
Nat. Research Mordovia State University, Saransk
Hubei Cancer Hospital, Wuhan
Orenburg Regional Clinical Oncological Center, Orenburg
Sun Yat-Sen University Cancer Center, Guangzhou
The First Affiliated Hospital of Guangxi Medical University, Nanning
Sichuan Provincial People's Hospital, Chengdu
"BHI of Omsk region Clinical Oncology Dispensary", Omsk
Krasnoyarsk Territorial Clinical Oncology Center named after A.I. Kryzhanovsky, Krasnoyarsk
Rutgers Cancer Institute of New Jersey, New Brunswick
Breast Cancer Research Centre, Nedlands
Hospital de Clinicas de Porto Alegre, Barretos
Chung Shan Medical University Hospital, Taichung
Centro de Avaliacao de Medicamentos e Especialidades de Pesquisa, Serra
Hospital Sao Rafael, Salvador
Instituto Mario Penna, Belo Horizonte
Maternidade e Cirurgia Nossa Senhora do Rocio, Campo Largo
Hospital das Clinicas - Universidade Federal do Parana, Curitiba
Centro de Tratamento Oncologico LTDA - CTO, Belém
Hospital do Capibaribe, Recife
Real Hospital Portugues de Beneficencia de Pernambuco, Recife
Centro de Pesquisa Vencer & Oncolinca, Teresina
Hospital Escola da Universidade Federal de Pelotas, Pelotas
Irmandade da Santa Casa de Misericordia de Porto Alegre, Porto Alegre
Pontificia Universidade Catolica do Rio Grande do Sul (PUCRS) - Hospital Sao Lucas, Porto Alegre
Hospital de Amor Amazonia, Porto Velho
Centro Oncologico de Roraima, Boa Vista
Clinica Supera, Chapecó
Clinica de Neoplasias Litoral - Itajai, Itajaí
Hospital Amaral Carvalho de Jau, Jaú
Centro de Pesquisa Clinica em Hematologia e Oncologia, Santo André
Clinicia de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria, São Paulo
Instituto Brasileiro de Controle do Cancer, São Paulo
Instituto do Cancer do Estado de San Paulo, São Paulo
Queen Mary Hospital, Hong Kong
Instituto Regional de Enfermedades Neoplasicas del Sur, Arequipa
University Clinical Centre - Hospital, Teaching Dept of Oncology and Radiotherapy, Gdansk
Independent Public Healthcare Facility University Hospital in Cracow, Krakow
Contemporary Therapy Centre, Lodz
Polish Mother's Memorial Hospital Research Instistute, Lodz
Central Teaching Hospital of the MOI in Warsaw, Warsaw
Maria Sklodowska-Curie National Institute of Oncology, Warsaw
Seoul National University Hospital, Seoul
Asan Medical Center, Seoul
The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul
Severance Hospital, Yonsei University Health System, Seoul
Medical Center of Vision Partner, Kyiv
Medical Center Verum, Kyiv
Kyiv Сity Clinical Oncological Center, Kyiv
Lead Sponsor
OBI Pharma, Inc
INDUSTRY