Spots Global Cancer Trial Database for Study of Adagloxad Simolenin (OBI-822)/OBI-821 in the Adjuvant Treatment of Patients With Globo H Positive TNBC
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Trial Identification
Brief Title: Study of Adagloxad Simolenin (OBI-822)/OBI-821 in the Adjuvant Treatment of Patients With Globo H Positive TNBC
Official Title: The GLORIA Study: A Phase 3, Randomized, Open-Label Study of the Anti-Globo H Vaccine Adagloxad Simolenin (OBI-822)/OBI-821 in the Adjuvant Treatment of Patients With High Risk, Early Stage Globo H-Positive Triple Negative Breast Cancer
Study ID: NCT03562637
Conditions
Study Description
Brief Summary: The GLORIA study is a Phase III, randomized, open-label study to prospectively evaluate the efficacy and safety of adagloxad simolenin (OBI 822)/OBI-821 in the adjuvant treatment of patients with high risk, early stage Globo-H Positive TNBC.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Moores UCSD Cancer Center, La Jolla, California, United States
Kaiser Permanente Medical Center, San Diego, California, United States
UCSF Helen Diller Family Comprehensive Cancer Centre, San Francisco, California, United States
Miami Cancer Institute, Miami, Florida, United States
University of Chicago Medical, Chicago, Illinois, United States
University of Maryland Greenbaum Comprehensive Cancer Center, Baltimore, Maryland, United States
Henry Ford Medical Center, Detroit, Michigan, United States
North Mississippi Medical Center Hematology and Oncology Clinic, Tupelo, Mississippi, United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States
Northwest Medical Specialties, PLLC, Tacoma, Washington, United States
Westmead Hospital, Westmead, New South Wales, Australia
Cancer Care Service, Hervey Bay Hospital, Urraween, Queensland, Australia
Slade Pharmacy, East Melbourne, Victoria, Australia
Cabrini Malvern, Malvern, Victoria, Australia
Breast Cancer Research Centre, Nedlands, Western Australia, Australia
St Vincent's Hospital Sydney, Darlinghurst, , Australia
Gosford Hospital, Gosford, , Australia
St John of God Murdoch Hospital, Murdoch, , Australia
Eastern Health - Maroondah Hospital, Ringwood East, , Australia
Hospital Sao Rafael, Salvador, Bahia, Brazil
Suporte Nutricional e Quimioterapia, Fortaleza, Ceara, Brazil
Centro de Avaliacao de Medicamentos e Especialidades de Pesquisa, Serra, Espirito Santo, Brazil
Instituto Mario Penna, Belo Horizonte, Minas Gerais, Brazil
Maternidade e Cirurgia Nossa Senhora do Rocio, Campo Largo, Parana, Brazil
Centro de Tratamento Oncologico LTDA - CTO, Belém, Para, Brazil
Hospital do Capibaribe, Recife, Pernambuco, Brazil
Real Hospital Portugues de Beneficencia de Pernambuco, Recife, Pernambuco, Brazil
Centro de Pesquisa Vencer & Oncolinca, Teresina, Piaui, Brazil
Hospital de Clinicas de Porto Alegre, Barretos, Rio Grande Do Sul, Brazil
Oncosite-Centro de Pesquisa Clinica em Oncologia, Ijuí, Rio Grande Do Sul, Brazil
Hospital Escola da Universidade Federal de Pelotas, Pelotas, Rio Grande Do Sul, Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre, Porto Alegre, Rio Grande Do Sul, Brazil
Pontificia Universidade Catolica do Rio Grande do Sul (PUCRS) - Hospital Sao Lucas, Porto Alegre, Rio Grande Do Sul, Brazil
Hospital de Amor Amazonia, Porto Velho, Rondona, Brazil
Centro Oncologico de Roraima, Boa Vista, Roraima, Brazil
Clinica Supera, Chapeco, Santa Catarina, Brazil
Clinica de Neoplasias Litoral - Itajai, Itajaí, Santa Catarina, Brazil
Hospital de Cancer de Barretos, Barretos, Sao Paulo, Brazil
Hospital Amaral Carvalho de Jau, Jaú, Sao Paulo, Brazil
Centro de Pesquisa Clinica em Hematologia e Oncologia, Santo André, Sao Paulo, Brazil
Clinicia de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria, São Paulo, Sao Paulo, Brazil
Instituto Brasileiro de Controle do Cancer, São Paulo, Sao Paulo, Brazil
Instituto do Cancer do Estado de San Paulo, São Paulo, Sao Paulo, Brazil
Cancer Hospital CAMS, Beijing, Beijing, China
Peking University Cancer Hospital, Beijing, Beijing, China
Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, China
The First Hospital of Guangxi Medical University, Nanning, Guangxi, China
Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, China
Hubei Cancer Hospital, Wuhan, Hubei, China
Xiangya Hospital Central South University, Changsha, Hunan, China
Hunan Cancer Hospital, Changsha, Hunan, China
Jiangsu Province Hospital, Nanjing, Jiangsu, China
The First Hospital of Jilin University, Changchun, Jilin, China
Liaoning Cancer Hospital and Institute, Shenyang, Liaoning, China
The First Hospital of China Medical University, Shenyang, Liaoning, China
Sichuan Provincial People's Hospital, Chengdu, Sichuan, China
Tianjin Cancer Hospital, Tianjin, Tianjin, China
Sir Run Run Shaw Hospital, Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China
Cancer Institute and Hospital, Beijing, , China
Queen Mary Hospital, Hong Kong, , Hong Kong
The University of Hong Kong, Hong Kong, , Hong Kong
Dong-A University Hospital, Busan, , Korea, Republic of
National Cancer Center, Goyang-si, , Korea, Republic of
Inha University Hospital, Incheon, , Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
The Catholic University of Korea, St. Vincent's Hospital, Suwon-si, , Korea, Republic of
Clinica Oncor - Centro de Infusion e Investigacion Oncologia de Satillo, Saltillo, Coahuila, Mexico
Instituto Nacional de Cancerologia, Ciudad de mexico, Del Tialpan, Mexico
Centro Medico Zambrano Hellion, San Pedro Garza Garcia, Nuevo Leon, Mexico
Icaro Investigaciones en Medicina S.A. de C.V., Chihuahua, , Mexico
Instituto Nacional de Enfermedades Neoplasicas, Lima, Surquillo, Peru
Instituto Regional de Enfermedades Neoplasicas del Sur, Arequipa, , Peru
Hospital Nacional Edgardo Rebagliati Martins, Unidad de Investigacion de Oncologia Medica, Lima, , Peru
Unidad de Investigacion - Oncologia Medica Clinica San Felipe, Lima, , Peru
University Clinical Centre - Hospital, Teaching Dept of Oncology and Radiotherapy, Gdańsk, , Poland
Independent Public Healthcare Facility University Hospital in Cracow, Kraków, , Poland
Central Teaching Hospital of the MOI in Warsaw, Warsaw, , Poland
Maria Sklodowska-Curie National Institute of Oncology, Warsaw, , Poland
Contemporary Therapy Centre, Łódź, , Poland
Polish Mother's Memorial Hospital Research Instistute, Łódź, , Poland
Nat. Research Mordovia State University, Saransk, Republic Of Mordovia, Russian Federation
SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary", Arkhangelsk, , Russian Federation
LLC Evimed, Chelyabinsk, , Russian Federation
Krasnoyarsk Territorial Clinical Oncology Center named after A.I. Kryzhanovsky, Krasnoyarsk, , Russian Federation
FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin", Moscow, , Russian Federation
SBIH of Moscow city "Moscow city oncology hospital №62" of Moscow Healthcare department, Moscow, , Russian Federation
SBIH of Nizhniy Novgorod region, Nizhny Novgorod, , Russian Federation
BHI of Omsk region "Clinical Oncology Dispensary", Omsk, , Russian Federation
Orenburg Regional Clinical Oncological Center, Orenburg, , Russian Federation
FSBI "Clinical Research and Practical Center for specialized medical care (oncology)", Pesochnyy, , Russian Federation
N.N. Petrov National Medical Research Center of Oncology, Pesochnyy, , Russian Federation
LLC Medaid, Saint Petersburg, , Russian Federation
SPb SBIH "City Clinical Oncological Dispensary", Saint-Petersburg, , Russian Federation
Klinika Luch, Ltd., St. Petersburg, , Russian Federation
SI "SRI of Oncology of Tomsk RC of Siberian Branch of RAMS", Tomsk, , Russian Federation
SBHI "Volgograd Regional Oncology Dispensary #3", Volzhskiy, , Russian Federation
SBIH of Yaroslavl region "Regional Clinical Oncological Hospital", Yaroslavl, , Russian Federation
Netcare Milpark Hospital, Johannesburg, Gauteng, South Africa
Wits Clinical Research, a division of Wits Health Consortium (Pty) Ltd, Johannesburg, Gauteng, South Africa
Medical Oncology Centre of Rosebank, Johannesburg, Gauteng, South Africa
Changhua Christian Hospital, Changhua, , Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, , Taiwan
China Medical University Hospital, Taichung, , Taiwan
Chung Shan Medical University, Taichung, , Taiwan
National Cheng Kung University Hospital, Tainan, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Chang Gung Memorial Hospital, Taipei, Taipei, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Koo Foundation Sun Yat-Sen Cancer Center, Taipei, , Taiwan
Tri-Service General Hospital, Taipei, , Taiwan
Mackay Memorial Hospital, Taipei, , Taiwan
Dnipropetrovsk Medical Academy of the Ministry of Health of Ukraine, Dnipro, , Ukraine
City Clinical Hospital #4, Dnipro, , Ukraine
CI Transcarpathian Cl Onc Center Dep of Surgery#1 SHEI Ivano-Frankivsk NMU, Ivano-Frankivsk, , Ukraine
Grigoriev Institute for Medical Radiology and Oncology of the NAMSU, Kharkiv, , Ukraine
Regional Center of Oncology, Kharkiv, , Ukraine
CI of Healthcare Regional Clinical Specialized Dispensary of the Radiation Protection, Kharkiv, , Ukraine
CI of Kherson Reg Council Kherson Regional Oncologic Dispensary, Kherson, , Ukraine
CI Kryvyi Rih Oncological Dispensary of DRC, Kryvyi Rih, , Ukraine
Medical Center of Vision Partner, Kyiv, , Ukraine
First Private Clinic, Kyiv, , Ukraine
Medical Center Verum, Kyiv, , Ukraine
Kyiv Сity Clinical Oncological Center, Kyiv, , Ukraine
Treatment-Prevention Institution Volyn Regional Oncological Dispensary, Lutsk, , Ukraine
Odesa Regional Oncologic Dispensary, Odesa, , Ukraine
CI Zaporizhzhia Regional Clinical Oncological Dispensary of ZRC, Zaporizhzhia, , Ukraine
CI Reg. Oncol. Dispanser, Zhytomyr, , Ukraine
Contact Details
Name: Hope Rugo, MD
Affiliation: University of California, San Francisco
Role: STUDY_CHAIR
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