Back to resultsBemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression (FORTITUDE-101)
Primary Purpose
Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Bemarituzumab
mFOLFOX6
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, Bemarituzumab, FGFR2b Overexpression
Eligibility Criteria
Inclusion Criteria:
- Adults with unresectable, locally advanced or metastatic gastric or gastroesophageal junction cancer not amenable to curative therapy
- Fibroblast growth factor receptor 2b (FGFR2b) overexpression positive as determined by centrally performed immunohistochemistry (IHC) testing, based on tumor sample either archival (obtained within 6 months/180 days prior to signing pre-screening informed consent) or a fresh biopsy
- Eastern Cooperative Oncology Group (ECOG) less than or equal to 1
- Measurable disease or non-measurable, but evaluable disease, according to Response Evaluation Criteria in Solid Tumors (RECIST) V 1.1
- Participant has no contraindications to mFOLFOX6 chemotherapy
Adequate organ and bone marrow function:
- absolute neutrophil count greater than or equal to 1.5 times 10^9/L
- platelet count greater than or equal to 100 times 10^9/L
- hemoglobin ≥ 9 g/dL without red blood cell (RBC) transfusion within 7 days prior to the first dose of study treatment
- aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 3 times the upper limit of normal (ULN) (or less than 5 times ULN if liver involvement). Total bilirubin less than 1.5 times ULN (or less than 2 times ULN if liver involvement); with the exception of participants with Gilbert's disease)
- calculated or measured creatinine clearance (CrCl) of ≥ 30 mL/minute calculated using the formula of Cockcroft and Gault ([140 - Age]) × Mass [kg]/[72 × Creatinine mg/dL]) (x 0.85 if female)
- international normalized ratio (INR) or prothrombin time (PT) less than 1.5 times ULN except for participants receiving anticoagulation, who must be on a stable dose of anticoagulant therapy for 6 weeks prior to enrollment
Exclusion Criteria:
- Prior treatment for metastatic or unresectable disease (Note: prior adjuvant, neo-adjuvant, and peri-operative therapy is allowed if completed more than 6 months prior to first dose of study treatment)
- Prior treatment with any selective inhibitor of fibroblast growth factor - fibroblast growth factor receptor (FGF-FGFR) pathway
- Known human epidermal growth factor receptor 2 (HER2) positive
- Untreated or symptomatic central nervous system (CNS) disease or brain metastases
- Peripheral sensory neuropathy greater than or equal to Grade 2
- Clinically significant cardiac disease
- Other malignancy within the last 2 years (exceptions for definitively treated disease)
- Chronic or systemic ophthalmological disorders
- Major surgery or other investigational study within 28 days prior to first dose of study treatment
- Palliative radiotherapy within 14 days prior to the first dose of study treatment
- Abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer
Sites / Locations
- Alaska Oncology and Hematology LLCRecruiting
- Mayo Clinic ArizonaRecruiting
- The Oncology Institute Clinical ResearchRecruiting
- University of California Los AngelesRecruiting
- Mayo Clinic FloridaRecruiting
- Saint Francis Medical GroupRecruiting
- University of MichiganRecruiting
- Mayo Clinic RochesterRecruiting
- Healthier Hematology and Oncology Excelsior Integrated Medical GroupRecruiting
- White Plains Hospital Medical CenterRecruiting
- Levine Cancer Institute UniversityRecruiting
- FirstHealth Cancer CenterRecruiting
- Avera Cancer InstituteRecruiting
- Vanderbilt University Medical CenterRecruiting
- Inova Schar Cancer InstituteRecruiting
- Medical Oncology Associates, PSRecruiting
- Instituto Alexander FlemingRecruiting
- Hospital Universitario Fundacion FavaloroRecruiting
- Sociedad de Beneficencia Hospital ItalianoRecruiting
- Hospital Privado Universitario de CordobaRecruiting
- Hospital Provincial del CentenarioRecruiting
- Exelsus Oncologia ClinicaRecruiting
- Instituto Argentino de Diagnostico y Tratamiento IADTRecruiting
- Hospital Britanico de Buenos AiresRecruiting
- Liverpool HospitalRecruiting
- St John of God Murdoch HospitalRecruiting
- Universitair Ziekenhuis AntwerpenRecruiting
- Universitair Ziekenhuis GentRecruiting
- Universitair Ziekenhuis Leuven - Campus GasthuisbergRecruiting
- Centre Hospitalier Universitaire de Liege - Sart TilmanRecruiting
- Núcleo de Oncologia da BahiaRecruiting
- Centro de Oncologia MackenzieRecruiting
- Oncosite Centro de Pesquisa Clinica Em Oncologia LtdaRecruiting
- Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do SulRecruiting
- Clinica de Oncologia ReichowRecruiting
- Centro de Pesquisa E Ensino Em Oncologia de Santa Catarina - CepenRecruiting
- Instituto de Ensino e Pesquisa Sao Lucas Iep Sao LucasRecruiting
- Instituto Nacional de Cancer INCARecruiting
- Hospital Nove de Julho - DASARecruiting
- Instituto Brasileiro de Controle do Cancer IbccRecruiting
- Multiprofile Hospital for Active Treatment Park Hospital EOODRecruiting
- Specialized Hospital for Active Treatment of Oncology - Haskovo EOODRecruiting
- University Multiprofile Hospital for Active Treatment Dr Georgi Stranski EAD
- University Multiprofile Hospital for Active Treatment Pulmed OODRecruiting
- Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda EADRecruiting
- Multiprofile Hospital for Active Treatment Serdika EOODRecruiting
- Cross Cancer InstituteRecruiting
- The Ottawa Hospital Cancer CentreRecruiting
- Sunnybrook Research Institute Sunnybrook Health Sciences CentreRecruiting
- Jewish General HospitalRecruiting
- James Lind Centro de Investigacion del CancerRecruiting
- Clinica CIDORecruiting
- Centro de Estudios Clinicos SAGA SpaRecruiting
- Centro de Estudios Clinicos e Investigaciones Medicas CeCimRecruiting
- First Affiliated Hospital of Bengbu Medical CollegeRecruiting
- Anhui Provincial Cancer HospitalRecruiting
- Cancer Hospital of Chinese Academy of Medical SciencesRecruiting
- Peking Union Medical College Hospital, Chinese Academy of Medical SciencesRecruiting
- Chongqing University Three Gorges HospitalRecruiting
- Fujian Medical University Union HospitalRecruiting
- Fujian Cancer HospitalRecruiting
- The First Affiliated Hospital of Xiamen UniversityRecruiting
- Lanzhou University Second HospitalRecruiting
- Gansu Wuwei Tumour HospitalRecruiting
- Sun Yat-sen University Cancer CenterRecruiting
- Guangdong Provincial Peoples HospitalRecruiting
- *Sun Yat-sen University Cancer CenterRecruiting
- Cancer Hospital of Shantou University Medical CollegeRecruiting
- The First Affiliated Hospital of Hainan Medical UniversityRecruiting
- Fourth Hospital of Hebei Medical UniversityRecruiting
- Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of ScienceandTechnologyRecruiting
- Harbin Medical University Cancer HospitalRecruiting
- Anyang Cancer HospitalRecruiting
- The First Affiliated Hospital of Henan University of science and TechnologyRecruiting
- Henan Cancer HospitalRecruiting
- The First Affiliated Hospital of Zhengzhou UniversityRecruiting
- Taihe Hospital Affiliated Hospital of Hubei University of MedicineRecruiting
- Hubei Cancer HospitalRecruiting
- The Cancer Center Union Hospital Tongji Medical College Huazhong University of Science and TechRecruiting
- Xiangya Hospital of Central South UniversityRecruiting
- Hunan Cancer HospitalRecruiting
- Nanjing First HospitalRecruiting
- The Second Affiliated Hospital of Soochow UniversityRecruiting
- Affiliated Hospital of Jiangnan UniversityRecruiting
- The Affiliated Hospital of Xuzhou Medical UniversityRecruiting
- The First Affiliated Hospital of Nanchang UniversityRecruiting
- The First Hospital of Jilin UniversityRecruiting
- China-Japan Union Hospital of Jilin UniversityRecruiting
- The First Affiliated Hospital of Jinzhou Medical UniversityRecruiting
- The First Hospital of China Medical UniversityRecruiting
- Liaoning Cancer HospitalRecruiting
- The First Affiliated Hospital of Xi an Jiaotong UniversityRecruiting
- Jinan Central HospitalRecruiting
- The Affiliated Cancer Hospital of Shandong First Medical UniversityRecruiting
- The Affiliated Hospital of Qingdao UniversityRecruiting
- Fudan University Shanghai Cancer CenterRecruiting
- Shanghai General HospitalRecruiting
- Shanghai East HospitalRecruiting
- Ruijin Hospital Shanghai Jiao Tong University School of MedicineRecruiting
- Changzhi Peoples HospitalRecruiting
- Linfen Central HospitalRecruiting
- Shanxi Province Cancer HospitalRecruiting
- Sichuan Cancer HospitalRecruiting
- The First Affiliated Hospital Zhejiang University School of MedicineRecruiting
- The Second Affiliated Hospital Zhejiang University School of MedicineRecruiting
- Sir Run Run Shaw Hospital Zhejiang University School of MedicineRecruiting
- Taizhou Hospital of Zhejiang ProvinceRecruiting
- Lishui Municipal central HospitalRecruiting
- The First Affiliate Hospital of Ningbo UniversityRecruiting
- Peoples Hospital of QuzhouRecruiting
- Beijing Cancer HospitalRecruiting
- Tianjin Medical University Cancer institute and hospitalRecruiting
- Institucion Prestadora de Servicios de Salud Sociedad Médica Rionegro S.A. Somer S.A.Recruiting
- Sociedad de Oncologia y Hematologia del CesarRecruiting
- Fundacion Cardiovascular de ColombiaRecruiting
- Instituto Cancerologico de Narino LtdaRecruiting
- Masarykuv onkologicky ustavRecruiting
- Fakultni nemocnice Hradec KraloveRecruiting
- Fakultni nemocnice OlomoucRecruiting
- Vseobecna fakultni nemocnice v PrazeRecruiting
- Fakultni Thomayerova nemocniceRecruiting
- RigshospitaletRecruiting
- North Estonia Medical Centre FoundationRecruiting
- Centre Hospitalier Universitaire Amiens Picardie - Hopital SudRecruiting
- Sainte Catherine - Institut du Cancer d AvignonRecruiting
- Centre Hospitalier Regional Universitaire de Besancon - Hopital Jean MinjozRecruiting
- Centre Hospitalier Universitaire de BrestRecruiting
- Centre Hospitalier Universitaire de Clermont Ferrand, Hôpital EstaingRecruiting
- Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude HuriezRecruiting
- Centre Leon BerardRecruiting
- Institut Mutualiste MontsourisRecruiting
- Hôpital Européen Georges PompidouRecruiting
- Centre Hospitalier Universitaire de Reims - Hôpital Robert DebréRecruiting
- Centre Hospitalier Universitaire Nord de Saint Etienne - Hôpital NordRecruiting
- Institut de cancerologie Strasbourg EuropeRecruiting
- Institut Gustave RoussyRecruiting
- Agios Savvas Anticancer HospitalRecruiting
- 251 General Airforce HospitalRecruiting
- General Hospital of Athens LaikoRecruiting
- Evgenidio Hospital I Agia TriasRecruiting
- Metropolitan HospitalRecruiting
- University Hospital of HeraklionRecruiting
- University Hospital of LarissaRecruiting
- University Hospital of PatrasRecruiting
- Anticancer Hospital of Thessaloniki TheageneioRecruiting
- Bioclinic of ThessalonikiRecruiting
- Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi OktatokorhazRecruiting
- Bekes Varmegyei Kozponti Korhaz Pandy Kalman TagkorhazRecruiting
- Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi OktatokorhazRecruiting
- Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhazi Josa Andras TagkorhazRecruiting
- Tolna Varmegyei Balassa Janos KorhazRecruiting
- Assuta Medical CenterRecruiting
- Hadassah Ein-Kerem Medical CenterRecruiting
- Meir Medical CenterRecruiting
- Istituto Ospedaliero Fondazione PoliambulanzaRecruiting
- Azienda Ospedaliera Rilievo Nazionale e Alta Specializzazione Garibaldi NesimaRecruiting
- Azienda Unita Sanitaria Locale LE Presidio Ospedaliero Vito Fazzi Polo Oncologico Giovanni Paolo IIRecruiting
- Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano NiguardaRecruiting
- Azienda Ospedaliero Universitaria di Cagliari Policlinico Duilio CasulaRecruiting
- Azienda Unita Saniataria Locale IRCCS di Reggio EmiliaRecruiting
- Università Cattolica del Sacro Cuore Policlinico Universitario Agostino GemelliRecruiting
- Azienda Ospedaliera San Giovanni AddolorataRecruiting
- IRCCS Istituto Clinico HumanitasRecruiting
- Azienda Ospedaliera Ordine Mauriziano di TorinoRecruiting
- Azienda Ospedaliera Cardinale Giovanni PanicoRecruiting
- Azienda Ospedaliero Universitaria Integrata Santa Maria della MisericordiaRecruiting
- Azienda Ospedaliera Universitaria Integrata di Verona Ospedale Civile Maggiore Borgo TrentoRecruiting
- Aichi Cancer CenterRecruiting
- Nagoya University HospitalRecruiting
- Chiba Cancer CenterRecruiting
- National Cancer Center Hospital EastRecruiting
- National Hospital Organization Shikoku Cancer CenterRecruiting
- National Hospital Organization Kyushu Cancer CenterRecruiting
- Gifu University HospitalRecruiting
- Hokkaido University HospitalRecruiting
- Hyogo Cancer CenterRecruiting
- Kobe City Medical Center General HospitalRecruiting
- Ishikawa Prefectural Central HospitalRecruiting
- Kagawa University HospitalRecruiting
- Yokohama City University Medical CenterRecruiting
- Kanagawa Prefectural Hospital Organization Kanagawa Cancer CenterRecruiting
- Kyoto University HospitalRecruiting
- Niigata Cancer Center HospitalRecruiting
- Kansai Medical University HospitalRecruiting
- Osaka International Cancer InstituteRecruiting
- Kindai University HospitalRecruiting
- Osaka University HospitalRecruiting
- Saitama Cancer CenterRecruiting
- Shizuoka Cancer CenterRecruiting
- The Cancer Institute Hospital of Japanese Foundation for Cancer ResearchRecruiting
- Keio University HospitalRecruiting
- Dong-A University HospitalRecruiting
- Kyungpook National University Chilgok HospitalRecruiting
- Chungnam National University HospitalRecruiting
- National Cancer CenterRecruiting
- The Catholic University of Korea Incheon St Marys HospitalRecruiting
- Jeonbuk National University Hospital
- Seoul National University Bundang HospitalRecruiting
- Korea University Anam HospitalRecruiting
- Seoul National University HospitalRecruiting
- Kangbuk Samsung HospitalRecruiting
- Severance Hospital Yonsei University Health SystemRecruiting
- Asan Medical CenterRecruiting
- Samsung Medical CenterRecruiting
- The Catholic University of Korea Seoul St Marys HospitalRecruiting
- Korea University Guro HospitalRecruiting
- Pauls Stradins Clinical University HospitalRecruiting
- Lietuvos sveikatos mokslu universiteto ligonine viesoji istaiga Kauno klinikosRecruiting
- Viesoji istaiga Klaipedos universitetine ligonineRecruiting
- Nacionalinis vezio institutasRecruiting
- Vilnius University Hospital Santaros Clinic Public InstitutionRecruiting
- Sarawak General HospitalRecruiting
- Hospital Kuala LumpurRecruiting
- University Malaya Medical CentreRecruiting
- Hospital Civil de Guadalajara Fray Antonio AlcaldeRecruiting
- Investigacion Biomedica para el Desarrollo de Farmacos SA de CVRecruiting
- Christus Muguerza Clinica Vidriera
- Investigación Biomédica para el Desarrollo de Fármacos SA de CVRecruiting
- Trials In Medicine SCRecruiting
- Centrum Onkologii im prof Franciszka LukaszczykaRecruiting
- Szpitale Pomorskie SpzooRecruiting
- Biokinetica SARecruiting
- Szpital Wojewodzki imienia Mikolaja Kopernika w KoszalinieRecruiting
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych i AdministracjiRecruiting
- SPZOZ Opolskie Centrum Onkologii imienia prof Tadeusza Koszarowskiego w OpoluRecruiting
- Wielkopolskie Centrum Onkologii imienia Marii Sklodowskiej-CurieRecruiting
- Wojewodzki Szpital im Sw Ojca Pio w PrzemysluRecruiting
- Kliniki Neuroradiochirurgii Spzoo Radom Centr Onkolo im Bohater Radomsk Czerwca -76 Szpital SpecjalRecruiting
- Centro Hospitalar e Universitario de Coimbra EPERecruiting
- Hospital da Senhora da Oliveira Guimaraes, EPERecruiting
- Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa MariaRecruiting
- Centro Hospitalar Universitario do Porto EPE - Hospital de Santo AntonioRecruiting
- Instituto Portugues de Oncologia do Porto Francisco Gentil, EPERecruiting
- Centro Hospitalar Universitario de Sao Joao, EPE - Hospital Sao JoaoRecruiting
- Centro Hospitalar de Entre o Douro e Vouga, EPE - Hospital Sao SebastiaoRecruiting
- Spitalul Judeţean de Urgenţă Dr.Constantin Opriş Baia MareRecruiting
- Institutul Clinic FundeniRecruiting
- Institutul Oncologic Prof Dr Alexandru Trestioreanu BucurestiRecruiting
- SC Medisprof SRLRecruiting
- Institutul Regional de Oncologie IasiRecruiting
- Ovidius Clinical HospitalRecruiting
- National Cancer Centre SingaporeRecruiting
- The Oncology CentreRecruiting
- Sandton Oncology CentreRecruiting
- Netcare Milpark HospitalRecruiting
- Hospital Universitario Reina SofiaRecruiting
- Hospital Regional Universitario de MalagaRecruiting
- Hospital Universitario Miguel ServetRecruiting
- Hospital Universitario de BurgosRecruiting
- Hospital Clinic i Provincial de BarcelonaRecruiting
- Hospital de la Santa Creu i Sant PauRecruiting
- Corporacio Sanitaria Parc TauliRecruiting
- Hospital Universitari i Politecnic La FeRecruiting
- Complexo Hospitalario Universitario de OurenseRecruiting
- Hospital DonostiaRecruiting
- Hospital General Universitario Gregorio MarañonRecruiting
- Hospital Universitario Puerta de Hierro MajadahondaRecruiting
- Hospital General Universitario Jose Maria Morales MeseguerRecruiting
- Sahlgrenska UniversitetssjukhusetRecruiting
- Karolinska Universitetssjukhuset HuddingeRecruiting
- Norrlands UniversitetssjukhusRecruiting
- Kaohsiung Medical University Chung-Ho Memorial HospitalRecruiting
- Kaohsiung Chang Gung Memorial HospitalRecruiting
- China Medical University HospitalRecruiting
- National Cheng Kung University HospitalRecruiting
- Tri-Service General HospitalRecruiting
- Linkou Chang Gung Memorial Hospital of Chang Gung Medical FoundationRecruiting
- King Chulalongkorn Memorial HospitalRecruiting
- Rajavithi HospitalRecruiting
- Ramathibodi HospitalRecruiting
- Siriraj HospitalRecruiting
- Baskent Universitesi Adana Doktor Turgut Noyan Uygulama ve Arastirma MerkeziRecruiting
- Doktor Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma HastanesiRecruiting
- Hacettepe Universitesi Tip FakultesiRecruiting
- Memorial Ankara HastanesiRecruiting
- Ankara Bilkent Sehir HastanesiRecruiting
- Antalya Egitim ve Arastirma HastanesiRecruiting
- Dicle Universitesi Tip FakultesiRecruiting
- Bezmialem Vakif Universitesi Tip Fakultesi HastanesiRecruiting
- Istanbul Universitesi Cerrahpasa Tip FakultesiRecruiting
- Goztepe Prof Dr Suleyman Yalcin Sehir HastanesiRecruiting
- Kartal Dr Lutfi Kirdar Sehir HastanesiRecruiting
- Izmir Ataturk Egitim ve Arastirma HastanesiRecruiting
- Kocaeli Universitesi Arastirma ve Uygulama HastanesiRecruiting
- Inonu Universitesi Turgut Ozal Tip MerkeziRecruiting
- Sakarya Universitesi Egitim ve Arastirma HastanesiRecruiting
- Ondokuz Mayis Universitesi Saglik Uygulama ve Arastirma MerkeziRecruiting
- Van Yuzuncu Yil Universitesi Dursun Odabas Tip Merkezi
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Bemarituzumab with mFOLFOX6
Placebo with mFOLFOX6
Arm Description
Outcomes
Primary Outcome Measures
Overall Survival
Overall survival in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants
Secondary Outcome Measures
Progression-free Survival (PFS)
PFS in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants
Objective Response Rate (ORR)
ORR in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants
Number of Participants who Experience a Treatment-emergent Adverse Event (TEAE)
Any clinically significant changes in vital signs, visual acuity, and clinical laboratory tests after first dose will be recorded as TEAEs.
Overall Survival
Overall survival in all randomized participants
Progression-free Survival (PFS)
PFS in all randomized participants
Objective Response Rate (ORR)
ORR in all randomized participants
Duration of Response (DOR)
DOR in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants
Disease Control Rate
Disease Control Rate in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants
Mean Subjective Score in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30)
Measured in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants
Change from Baseline Score in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30)
Measured in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants
Stomach Cancer Related Symptom Mean Subjective Score as Measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Stomach (EORTC-QLQ-STO22)
Measured in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants
Change from Baseline in Stomach Cancer Related Symptom Score as Measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Stomach (EORTC-QLQ-STO22)
Measured in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants
Mean Subjective Score in Visual Analogue Scale (VAS) as Measured by the EuroQol 5-dimensional 5-levels (EQ-5D-5L)
Measured in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants
Change from Baseline of Visual Analogue Scale (VAS) as Measured by the EuroQol 5-dimensional 5-levels (EQ-5D-5L)
Measured in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants
Time to Deterioration in Stomach Cancer Related Symptom Score as Measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Stomach (EORTC-QLQ-STO22)
Measured in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants
Time to Deterioration in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30) Score
Measured in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants
Time to Deterioration in Visual Analogue Scale (VAS) as Measured by the EuroQol 5-dimensional 5-levels (EQ-5D-5L) Score
Measured in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants
Time to Deterioration in Physical Function Score as Measured by a Subscale of European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30)
Measured in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants
Maximum Observed Concentration (Cmax) of Bemarituzumab in Combination with mFOLFOX6 in Plasma
Observed Concentration at the End of a Dose Interval (Ctrough) of Bemarituzumab in Combination with mFOLFOX6 in Plasma
Number of Participants with an Anti-bemarituzumab Antibody Formation
Full Information
NCT ID
NCT05052801
First Posted
September 13, 2021
Last Updated
October 18, 2023
Sponsor
Amgen
Collaborators
Zai Lab (China only)
1. Study Identification
Unique Protocol Identification Number
NCT05052801
Brief Title
Bemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression
Acronym
FORTITUDE-101
Official Title
A Randomized, Multi-center, Double-blind, Placebo-controlled Phase 3 Study of Bemarituzumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer With FGFR2b Overexpression
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 7, 2022 (Actual)
Primary Completion Date
August 18, 2025 (Anticipated)
Study Completion Date
August 18, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen
Collaborators
Zai Lab (China only)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The main objective of this study is to compare efficacy of bemarituzumab combined with oxaliplatin, leucovorin, and 5-fluorouracil (5-FU) (mFOLFOX6) to placebo plus mFOLFOX6 as assessed by overall survival (OS) in participants with FGFR2b ≥10% 2+/3+ tumor cell staining (FGFR2b ≥10% 2+/3+TC)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
Keywords
Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, Bemarituzumab, FGFR2b Overexpression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
516 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bemarituzumab with mFOLFOX6
Arm Type
Experimental
Arm Title
Placebo with mFOLFOX6
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Bemarituzumab
Intervention Description
Intravenous (IV) infusion
Intervention Type
Drug
Intervention Name(s)
mFOLFOX6
Intervention Description
mFOLFOX6 administered as a combination of oxaliplatin and leucovorin as IV infusions. 5-FU administered as bolus followed by additional administration as IV infusion.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
IV infusion
Primary Outcome Measure Information:
Title
Overall Survival
Description
Overall survival in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants
Time Frame
Up to approximately 3.5 years
Secondary Outcome Measure Information:
Title
Progression-free Survival (PFS)
Description
PFS in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants
Time Frame
Up to approximately 3.5 years
Title
Objective Response Rate (ORR)
Description
ORR in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants
Time Frame
Up to approximately 3.5 years
Title
Number of Participants who Experience a Treatment-emergent Adverse Event (TEAE)
Description
Any clinically significant changes in vital signs, visual acuity, and clinical laboratory tests after first dose will be recorded as TEAEs.
Time Frame
Up to approximately 3.5 years
Title
Overall Survival
Description
Overall survival in all randomized participants
Time Frame
Up to approximately 3.5 years
Title
Progression-free Survival (PFS)
Description
PFS in all randomized participants
Time Frame
Up to approximately 3.5 years
Title
Objective Response Rate (ORR)
Description
ORR in all randomized participants
Time Frame
Up to approximately 3.5 years
Title
Duration of Response (DOR)
Description
DOR in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants
Time Frame
Up to approximately 3.5 years
Title
Disease Control Rate
Description
Disease Control Rate in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants
Time Frame
Up to approximately 3.5 years
Title
Mean Subjective Score in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30)
Description
Measured in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants
Time Frame
Up to approximately 3.5 years
Title
Change from Baseline Score in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30)
Description
Measured in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants
Time Frame
Baseline up to approximately 3.5 years
Title
Stomach Cancer Related Symptom Mean Subjective Score as Measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Stomach (EORTC-QLQ-STO22)
Description
Measured in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants
Time Frame
Up to approximately 3.5 years
Title
Change from Baseline in Stomach Cancer Related Symptom Score as Measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Stomach (EORTC-QLQ-STO22)
Description
Measured in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants
Time Frame
Baseline up to approximately 3.5 years
Title
Mean Subjective Score in Visual Analogue Scale (VAS) as Measured by the EuroQol 5-dimensional 5-levels (EQ-5D-5L)
Description
Measured in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants
Time Frame
Up to approximately 3.5 years
Title
Change from Baseline of Visual Analogue Scale (VAS) as Measured by the EuroQol 5-dimensional 5-levels (EQ-5D-5L)
Description
Measured in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants
Time Frame
Baseline up to approximately 3.5 years
Title
Time to Deterioration in Stomach Cancer Related Symptom Score as Measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Stomach (EORTC-QLQ-STO22)
Description
Measured in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants
Time Frame
Up to approximately 3.5 years
Title
Time to Deterioration in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30) Score
Description
Measured in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants
Time Frame
Up to approximately 3.5 years
Title
Time to Deterioration in Visual Analogue Scale (VAS) as Measured by the EuroQol 5-dimensional 5-levels (EQ-5D-5L) Score
Description
Measured in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants
Time Frame
Up to approximately 3.5 years
Title
Time to Deterioration in Physical Function Score as Measured by a Subscale of European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30)
Description
Measured in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants
Time Frame
Day 1 up to approximately 3.5 years
Title
Maximum Observed Concentration (Cmax) of Bemarituzumab in Combination with mFOLFOX6 in Plasma
Time Frame
Day 1 up to approximately 3.5 years
Title
Observed Concentration at the End of a Dose Interval (Ctrough) of Bemarituzumab in Combination with mFOLFOX6 in Plasma
Time Frame
Day 1 up to approximately 3.5 years
Title
Number of Participants with an Anti-bemarituzumab Antibody Formation
Time Frame
Day 1 up to approximately 3.5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults with histologically documented unresectable, locally advanced or metastatic gastric or gastroesophageal junction cancer not amenable to curative therapy
Fibroblast growth factor receptor 2b (FGFR2b) ≥10% 2+/3+ tumor cell staining as determined by centrally performed immunohistochemistry (IHC) testing, based on tumor sample either archival (obtained within 6 months/180 days prior to signing pre-screening informed consent) or a fresh biopsy
Eastern Cooperative Oncology Group (ECOG) less than or equal to 1
Measurable disease or non-measurable, but evaluable disease, according to Response Evaluation Criteria in Solid Tumors (RECIST) V 1.1
Participant has no contraindications to mFOLFOX6 chemotherapy
Adequate organ and bone marrow function:
absolute neutrophil count greater than or equal to 1.5 times 10^9/L
platelet count greater than or equal to 100 times 10^9/L
hemoglobin ≥ 9 g/dL without red blood cell (RBC) transfusion within 7 days prior to the first dose of study treatment
aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 3 times the upper limit of normal (ULN) (or less than 5 times ULN if liver involvement). Total bilirubin less than 1.5 times ULN (or less than 2 times ULN if liver involvement); with the exception of participants with Gilbert's disease)
calculated or measured creatinine clearance (CrCl) of ≥ 30 mL/minute calculated using the formula of Cockcroft and Gault ([140 - Age]) × Mass [kg]/[72 × Creatinine mg/dL]) (x 0.85 if female)
international normalized ratio (INR) or prothrombin time (PT) less than 1.5 times ULN except for participants receiving anticoagulation, who must be on a stable dose of anticoagulant therapy for 6 weeks prior to enrollment
Exclusion Criteria:
Prior treatment for metastatic or unresectable disease (Note: prior adjuvant, neo-adjuvant, and peri-operative therapy is allowed if completed more than 6 months prior to first dose of study treatment)
Prior treatment with any selective inhibitor of fibroblast growth factor - fibroblast growth factor receptor (FGF-FGFR) pathway
Known human epidermal growth factor receptor 2 (HER2) positive
Untreated or symptomatic central nervous system (CNS) disease or brain metastases
Peripheral sensory neuropathy greater than or equal to Grade 2
Clinically significant cardiac disease
Other malignancy within the last 2 years (exceptions for definitively treated disease)
Chronic or systemic ophthalmological disorders
Major surgery or other investigational study within 28 days prior to first dose of study treatment
Palliative radiotherapy within 14 days prior to the first dose of study treatment
Evidence of or recent history (within 6 months) of corneal defects, corneal ulcerations, keratitis, or keratoconus, history of corneal transplant, or other known abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amgen Call Center
Phone
866-572-6436
Email
medinfo@amgen.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Alaska Oncology and Hematology LLC
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Individual Site Status
Recruiting
Facility Name
Mayo Clinic Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Individual Site Status
Recruiting
Facility Name
The Oncology Institute Clinical Research
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Name
Mayo Clinic Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Recruiting
Facility Name
Saint Francis Medical Group
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Name
Healthier Hematology and Oncology Excelsior Integrated Medical Group
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11220
Country
United States
Individual Site Status
Recruiting
Facility Name
White Plains Hospital Medical Center
City
White Plains
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Individual Site Status
Recruiting
Facility Name
Levine Cancer Institute University
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Individual Site Status
Recruiting
Facility Name
FirstHealth Cancer Center
City
Pinehurst
State/Province
North Carolina
ZIP/Postal Code
28374
Country
United States
Individual Site Status
Recruiting
Facility Name
Avera Cancer Institute
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57108
Country
United States
Individual Site Status
Recruiting
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Name
Inova Schar Cancer Institute
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Oncology Associates, PS
City
Spokane
State/Province
Washington
ZIP/Postal Code
99208
Country
United States
Individual Site Status
Recruiting
Facility Name
Instituto Alexander Fleming
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1426ANZ
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Fundacion Favaloro
City
Ciudad Autonoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1093AAS
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Sociedad de Beneficencia Hospital Italiano
City
Cordoba
State/Province
Córdoba
ZIP/Postal Code
5000
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Hospital Privado Universitario de Cordoba
City
Cordoba
State/Province
Córdoba
ZIP/Postal Code
X5016KEH
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Hospital Provincial del Centenario
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2002KDS
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Exelsus Oncologia Clinica
City
San Miguel de Tucuman
State/Province
Tucuman
ZIP/Postal Code
4000
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Instituto Argentino de Diagnostico y Tratamiento IADT
City
Buenos Aires
ZIP/Postal Code
C1122AAL
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Hospital Britanico de Buenos Aires
City
Buenos Aires
ZIP/Postal Code
C1280AEB
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Liverpool Hospital
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Individual Site Status
Recruiting
Facility Name
St John of God Murdoch Hospital
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Individual Site Status
Recruiting
Facility Name
Universitair Ziekenhuis Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire de Liege - Sart Tilman
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Núcleo de Oncologia da Bahia
City
Salvador
State/Province
Bahia
ZIP/Postal Code
40170-110
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Centro de Oncologia Mackenzie
City
Curitiba
State/Province
Paraná
ZIP/Postal Code
80440-220
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Oncosite Centro de Pesquisa Clinica Em Oncologia Ltda
City
Ijui
State/Province
Rio Grande Do Sul
ZIP/Postal Code
98700-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90610-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Clinica de Oncologia Reichow
City
Blumenau
State/Province
Santa Catarina
ZIP/Postal Code
89010-340
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Centro de Pesquisa E Ensino Em Oncologia de Santa Catarina - Cepen
City
Florianopolis
State/Province
Santa Catarina
ZIP/Postal Code
88020-210
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Instituto de Ensino e Pesquisa Sao Lucas Iep Sao Lucas
City
Santo Andre
State/Province
São Paulo
ZIP/Postal Code
09060-650
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Instituto Nacional de Cancer INCA
City
Rio de Janeiro
ZIP/Postal Code
20231-050
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital Nove de Julho - DASA
City
São Paulo
ZIP/Postal Code
01409-001
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Instituto Brasileiro de Controle do Cancer Ibcc
City
São Paulo
ZIP/Postal Code
04014-002
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Multiprofile Hospital for Active Treatment Park Hospital EOOD
City
Branipole Village
ZIP/Postal Code
4109
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Specialized Hospital for Active Treatment of Oncology - Haskovo EOOD
City
Haskovo
ZIP/Postal Code
6300
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
University Multiprofile Hospital for Active Treatment Dr Georgi Stranski EAD
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Individual Site Status
Terminated
Facility Name
University Multiprofile Hospital for Active Treatment Pulmed OOD
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda EAD
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Multiprofile Hospital for Active Treatment Serdika EOOD
City
Sofia
ZIP/Postal Code
1632
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Individual Site Status
Recruiting
Facility Name
The Ottawa Hospital Cancer Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Individual Site Status
Recruiting
Facility Name
Sunnybrook Research Institute Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Individual Site Status
Recruiting
Facility Name
James Lind Centro de Investigacion del Cancer
City
Temuco
State/Province
Cautín
ZIP/Postal Code
4800827
Country
Chile
Individual Site Status
Recruiting
Facility Name
Clinica CIDO
City
Temuco
State/Province
Cautín
ZIP/Postal Code
4810218
Country
Chile
Individual Site Status
Recruiting
Facility Name
Centro de Estudios Clinicos SAGA Spa
City
Santiago
ZIP/Postal Code
7500653
Country
Chile
Individual Site Status
Recruiting
Facility Name
Centro de Estudios Clinicos e Investigaciones Medicas CeCim
City
Santiago
ZIP/Postal Code
8320000
Country
Chile
Individual Site Status
Recruiting
Facility Name
First Affiliated Hospital of Bengbu Medical College
City
Bengbu
State/Province
Anhui
ZIP/Postal Code
233099
Country
China
Individual Site Status
Recruiting
Facility Name
Anhui Provincial Cancer Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230031
Country
China
Individual Site Status
Recruiting
Facility Name
Cancer Hospital of Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Name
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100032
Country
China
Individual Site Status
Recruiting
Facility Name
Chongqing University Three Gorges Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400037
Country
China
Individual Site Status
Recruiting
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Individual Site Status
Recruiting
Facility Name
Fujian Cancer Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Xiamen University
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361003
Country
China
Individual Site Status
Recruiting
Facility Name
Lanzhou University Second Hospital
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
730030
Country
China
Individual Site Status
Recruiting
Facility Name
Gansu Wuwei Tumour Hospital
City
Wuwei
State/Province
Gansu
ZIP/Postal Code
733000
Country
China
Individual Site Status
Recruiting
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510030
Country
China
Individual Site Status
Recruiting
Facility Name
Guangdong Provincial Peoples Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510180
Country
China
Individual Site Status
Recruiting
Facility Name
*Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510700
Country
China
Individual Site Status
Recruiting
Facility Name
Cancer Hospital of Shantou University Medical College
City
Shantou
State/Province
Guangdong
ZIP/Postal Code
515031
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Hainan Medical University
City
Haikou
State/Province
Hainan
ZIP/Postal Code
570102
Country
China
Individual Site Status
Recruiting
Facility Name
Fourth Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050011
Country
China
Individual Site Status
Recruiting
Facility Name
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of ScienceandTechnology
City
Wuhan
State/Province
Hebei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150000
Country
China
Individual Site Status
Recruiting
Facility Name
Anyang Cancer Hospital
City
Anyang
State/Province
Henan
ZIP/Postal Code
455001
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Henan University of science and Technology
City
Luoyang
State/Province
Henan
ZIP/Postal Code
471000
Country
China
Individual Site Status
Recruiting
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Individual Site Status
Recruiting
Facility Name
Taihe Hospital Affiliated Hospital of Hubei University of Medicine
City
Shiyan
State/Province
Hubei
ZIP/Postal Code
442000
Country
China
Individual Site Status
Recruiting
Facility Name
Hubei Cancer Hospital
City
Wuhan City
State/Province
Hubei
ZIP/Postal Code
430079
Country
China
Individual Site Status
Recruiting
Facility Name
The Cancer Center Union Hospital Tongji Medical College Huazhong University of Science and Tech
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Individual Site Status
Recruiting
Facility Name
Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China
Individual Site Status
Recruiting
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410006
Country
China
Individual Site Status
Recruiting
Facility Name
Nanjing First Hospital
City
Nanjing City
State/Province
Jiangsu
ZIP/Postal Code
210006
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215004
Country
China
Individual Site Status
Recruiting
Facility Name
Affiliated Hospital of Jiangnan University
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214122
Country
China
Individual Site Status
Recruiting
Facility Name
The Affiliated Hospital of Xuzhou Medical University
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221002
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330000
Country
China
Individual Site Status
Recruiting
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Individual Site Status
Recruiting
Facility Name
China-Japan Union Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130022
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Jinzhou Medical University
City
Jinzhou
State/Province
Liaoning
ZIP/Postal Code
121000
Country
China
Individual Site Status
Recruiting
Facility Name
The First Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110001
Country
China
Individual Site Status
Recruiting
Facility Name
Liaoning Cancer Hospital
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110042
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Xi an Jiaotong University
City
XI An
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Name
Jinan Central Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250013
Country
China
Individual Site Status
Recruiting
Facility Name
The Affiliated Cancer Hospital of Shandong First Medical University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250117
Country
China
Individual Site Status
Recruiting
Facility Name
The Affiliated Hospital of Qingdao University
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266000
Country
China
Individual Site Status
Recruiting
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Name
Shanghai General Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200080
Country
China
Individual Site Status
Recruiting
Facility Name
Shanghai East Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200123
Country
China
Individual Site Status
Recruiting
Facility Name
Ruijin Hospital Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201800
Country
China
Individual Site Status
Recruiting
Facility Name
Changzhi Peoples Hospital
City
Changzhi
State/Province
Shanxi
ZIP/Postal Code
046000
Country
China
Individual Site Status
Recruiting
Facility Name
Linfen Central Hospital
City
Linfen
State/Province
Shanxi
ZIP/Postal Code
100032
Country
China
Individual Site Status
Recruiting
Facility Name
Shanxi Province Cancer Hospital
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030013
Country
China
Individual Site Status
Recruiting
Facility Name
Sichuan Cancer Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Affiliated Hospital Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Individual Site Status
Recruiting
Facility Name
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310016
Country
China
Individual Site Status
Recruiting
Facility Name
Taizhou Hospital of Zhejiang Province
City
Linhai
State/Province
Zhejiang
ZIP/Postal Code
317000
Country
China
Individual Site Status
Recruiting
Facility Name
Lishui Municipal central Hospital
City
Lishui
State/Province
Zhejiang
ZIP/Postal Code
323000
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliate Hospital of Ningbo University
City
Ningbo
State/Province
Zhejiang
ZIP/Postal Code
315010
Country
China
Individual Site Status
Recruiting
Facility Name
Peoples Hospital of Quzhou
City
Quzhou
State/Province
Zhejiang
ZIP/Postal Code
324000
Country
China
Individual Site Status
Recruiting
Facility Name
Beijing Cancer Hospital
City
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Name
Tianjin Medical University Cancer institute and hospital
City
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Name
Institucion Prestadora de Servicios de Salud Sociedad Médica Rionegro S.A. Somer S.A.
City
Rionegro
State/Province
Antioquia
ZIP/Postal Code
054040
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Sociedad de Oncologia y Hematologia del Cesar
City
Valledupar
State/Province
Cesar
ZIP/Postal Code
200001
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Fundacion Cardiovascular de Colombia
City
Bucaramanga
State/Province
Santander
ZIP/Postal Code
681017
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Instituto Cancerologico de Narino Ltda
City
Pasto
ZIP/Postal Code
520002
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Masarykuv onkologicky ustav
City
Brno
ZIP/Postal Code
656 53
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice Olomouc
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Vseobecna fakultni nemocnice v Praze
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Fakultni Thomayerova nemocnice
City
Praha 4
ZIP/Postal Code
140 59
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Name
North Estonia Medical Centre Foundation
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire Amiens Picardie - Hopital Sud
City
Amiens Cedex 1
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Name
Sainte Catherine - Institut du Cancer d Avignon
City
Avignon cedex 9
ZIP/Postal Code
84918
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Regional Universitaire de Besancon - Hopital Jean Minjoz
City
Besançon
ZIP/Postal Code
25030
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire de Brest
City
Brest
ZIP/Postal Code
29200
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire de Clermont Ferrand, Hôpital Estaing
City
Clermont-Ferrand cedex 1
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Leon Berard
City
Lyon cedex 8
ZIP/Postal Code
69373
Country
France
Individual Site Status
Recruiting
Facility Name
Institut Mutualiste Montsouris
City
Paris Cedex 14
ZIP/Postal Code
75674
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital Européen Georges Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire de Reims - Hôpital Robert Debré
City
Reims Cedex
ZIP/Postal Code
51092
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire Nord de Saint Etienne - Hôpital Nord
City
Saint Priest en Jarez
ZIP/Postal Code
42270
Country
France
Individual Site Status
Recruiting
Facility Name
Institut de cancerologie Strasbourg Europe
City
Strasbourg cedex
ZIP/Postal Code
67065
Country
France
Individual Site Status
Recruiting
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Individual Site Status
Recruiting
Facility Name
Agios Savvas Anticancer Hospital
City
Athens
ZIP/Postal Code
11522
Country
Greece
Individual Site Status
Recruiting
Facility Name
251 General Airforce Hospital
City
Athens
ZIP/Postal Code
11525
Country
Greece
Individual Site Status
Recruiting
Facility Name
General Hospital of Athens Laiko
City
Athens
ZIP/Postal Code
11526
Country
Greece
Individual Site Status
Recruiting
Facility Name
Evgenidio Hospital I Agia Trias
City
Athens
ZIP/Postal Code
11528
Country
Greece
Individual Site Status
Recruiting
Facility Name
Metropolitan Hospital
City
Athens
ZIP/Postal Code
18547
Country
Greece
Individual Site Status
Recruiting
Facility Name
University Hospital of Heraklion
City
Heraklion - Crete
ZIP/Postal Code
71500
Country
Greece
Individual Site Status
Recruiting
Facility Name
University Hospital of Larissa
City
Larissa
ZIP/Postal Code
41110
Country
Greece
Individual Site Status
Recruiting
Facility Name
University Hospital of Patras
City
Patra
ZIP/Postal Code
26504
Country
Greece
Individual Site Status
Recruiting
Facility Name
Anticancer Hospital of Thessaloniki Theageneio
City
Thessaloniki
ZIP/Postal Code
54007
Country
Greece
Individual Site Status
Recruiting
Facility Name
Bioclinic of Thessaloniki
City
Thessaloniki
ZIP/Postal Code
54622
Country
Greece
Individual Site Status
Recruiting
Facility Name
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktatokorhaz
City
Gyor
ZIP/Postal Code
9024
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktatokorhaz
City
Miskolc
ZIP/Postal Code
3526
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhazi Josa Andras Tagkorhaz
City
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Tolna Varmegyei Balassa Janos Korhaz
City
Szekszard
ZIP/Postal Code
7100
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Assuta Medical Center
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Individual Site Status
Recruiting
Facility Name
Hadassah Ein-Kerem Medical Center
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Individual Site Status
Recruiting
Facility Name
Meir Medical Center
City
Kfar Saba
ZIP/Postal Code
4428164
Country
Israel
Individual Site Status
Recruiting
Facility Name
Istituto Ospedaliero Fondazione Poliambulanza
City
Brescia
ZIP/Postal Code
25124
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Rilievo Nazionale e Alta Specializzazione Garibaldi Nesima
City
Catania
ZIP/Postal Code
95122
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Unita Sanitaria Locale LE Presidio Ospedaliero Vito Fazzi Polo Oncologico Giovanni Paolo II
City
Lecce
ZIP/Postal Code
73100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
City
Milano
ZIP/Postal Code
20162
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliero Universitaria di Cagliari Policlinico Duilio Casula
City
Monserrato CA
ZIP/Postal Code
09042
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Unita Saniataria Locale IRCCS di Reggio Emilia
City
Reggio Emilia
ZIP/Postal Code
42100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Università Cattolica del Sacro Cuore Policlinico Universitario Agostino Gemelli
City
Roma
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera San Giovanni Addolorata
City
Roma
ZIP/Postal Code
00184
Country
Italy
Individual Site Status
Recruiting
Facility Name
IRCCS Istituto Clinico Humanitas
City
Rozzano MI
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Ordine Mauriziano di Torino
City
Torino
ZIP/Postal Code
10128
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Cardinale Giovanni Panico
City
Tricase
ZIP/Postal Code
73039
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliero Universitaria Integrata Santa Maria della Misericordia
City
Udine
ZIP/Postal Code
33100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Universitaria Integrata di Verona Ospedale Civile Maggiore Borgo Trento
City
Verona
ZIP/Postal Code
37126
Country
Italy
Individual Site Status
Recruiting
Facility Name
Aichi Cancer Center
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nagoya University Hospital
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
466-8560
Country
Japan
Individual Site Status
Recruiting
Facility Name
Chiba Cancer Center
City
Chiba-shi
State/Province
Chiba
ZIP/Postal Code
260-8717
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Cancer Center Hospital East
City
Kashiwa-shi
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Shikoku Cancer Center
City
Matsuyama-shi
State/Province
Ehime
ZIP/Postal Code
791-0280
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Kyushu Cancer Center
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
811-1395
Country
Japan
Individual Site Status
Recruiting
Facility Name
Gifu University Hospital
City
Gifu-shi
State/Province
Gifu
ZIP/Postal Code
501-1194
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hokkaido University Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hyogo Cancer Center
City
Akashi-shi
State/Province
Hyogo
ZIP/Postal Code
673-8558
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kobe City Medical Center General Hospital
City
Kobe-shi
State/Province
Hyogo
ZIP/Postal Code
650-0047
Country
Japan
Individual Site Status
Recruiting
Facility Name
Ishikawa Prefectural Central Hospital
City
Kanazawa-shi
State/Province
Ishikawa
ZIP/Postal Code
920-8530
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kagawa University Hospital
City
Kita-gun
State/Province
Kagawa
ZIP/Postal Code
761-0793
Country
Japan
Individual Site Status
Recruiting
Facility Name
Yokohama City University Medical Center
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
232-0024
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
241-8515
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kyoto University Hospital
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
606-8507
Country
Japan
Individual Site Status
Recruiting
Facility Name
Niigata Cancer Center Hospital
City
Niigata-shi
State/Province
Niigata
ZIP/Postal Code
951-8566
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kansai Medical University Hospital
City
Hirakata-shi
State/Province
Osaka
ZIP/Postal Code
573-1191
Country
Japan
Individual Site Status
Recruiting
Facility Name
Osaka International Cancer Institute
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
541-8567
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kindai University Hospital
City
Osakasayama-shi
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Individual Site Status
Recruiting
Facility Name
Osaka University Hospital
City
Suita-shi
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Individual Site Status
Recruiting
Facility Name
Saitama Cancer Center
City
Kitaadachi-gun
State/Province
Saitama
ZIP/Postal Code
362-0806
Country
Japan
Individual Site Status
Recruiting
Facility Name
Shizuoka Cancer Center
City
Sunto-gun
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Individual Site Status
Recruiting
Facility Name
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
City
Koto-ku
State/Province
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Individual Site Status
Recruiting
Facility Name
Keio University Hospital
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Individual Site Status
Recruiting
Facility Name
Dong-A University Hospital
City
Busan
ZIP/Postal Code
49201
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Kyungpook National University Chilgok Hospital
City
Daegu
ZIP/Postal Code
41404
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Chungnam National University Hospital
City
Daejeon
ZIP/Postal Code
35015
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
National Cancer Center
City
Goyang-si Gyeonggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
The Catholic University of Korea Incheon St Marys Hospital
City
Incheon
ZIP/Postal Code
21431
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Jeonbuk National University Hospital
City
Jeonju-si, Jeollabuk-do
ZIP/Postal Code
54907
Country
Korea, Republic of
Individual Site Status
Terminated
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si, Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Kangbuk Samsung Hospital
City
Seoul
ZIP/Postal Code
03181
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Severance Hospital Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
The Catholic University of Korea Seoul St Marys Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Pauls Stradins Clinical University Hospital
City
Riga
ZIP/Postal Code
1002
Country
Latvia
Individual Site Status
Recruiting
Facility Name
Lietuvos sveikatos mokslu universiteto ligonine viesoji istaiga Kauno klinikos
City
Kaunas
ZIP/Postal Code
50161
Country
Lithuania
Individual Site Status
Recruiting
Facility Name
Viesoji istaiga Klaipedos universitetine ligonine
City
Klaipeda
ZIP/Postal Code
92288
Country
Lithuania
Individual Site Status
Recruiting
Facility Name
Nacionalinis vezio institutas
City
Vilnius
ZIP/Postal Code
08660
Country
Lithuania
Individual Site Status
Recruiting
Facility Name
Vilnius University Hospital Santaros Clinic Public Institution
City
Vilnius
ZIP/Postal Code
08661
Country
Lithuania
Individual Site Status
Recruiting
Facility Name
Sarawak General Hospital
City
Kuching
State/Province
Sarawak
ZIP/Postal Code
93586
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Kuala Lumpur
City
Kuala Lumpur
State/Province
Wilayah Persekutuan
ZIP/Postal Code
50586
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
University Malaya Medical Centre
City
Kuala Lumpur
State/Province
Wilayah Persekutuan
ZIP/Postal Code
59100
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Civil de Guadalajara Fray Antonio Alcalde
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44280
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Investigacion Biomedica para el Desarrollo de Farmacos SA de CV
City
Zapopan
State/Province
Jalisco
ZIP/Postal Code
45070
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Christus Muguerza Clinica Vidriera
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
64570
Country
Mexico
Individual Site Status
Terminated
Facility Name
Investigación Biomédica para el Desarrollo de Fármacos SA de CV
City
Aguascalientes
ZIP/Postal Code
20010
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Trials In Medicine SC
City
Mexico
ZIP/Postal Code
06720
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Centrum Onkologii im prof Franciszka Lukaszczyka
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Individual Site Status
Recruiting
Facility Name
Szpitale Pomorskie Spzoo
City
Gdynia
ZIP/Postal Code
81-519
Country
Poland
Individual Site Status
Recruiting
Facility Name
Biokinetica SA
City
Jozefow
ZIP/Postal Code
05-410
Country
Poland
Individual Site Status
Recruiting
Facility Name
Szpital Wojewodzki imienia Mikolaja Kopernika w Koszalinie
City
Koszalin
ZIP/Postal Code
75-581
Country
Poland
Individual Site Status
Recruiting
Facility Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych i Administracji
City
Olsztyn
ZIP/Postal Code
10-228
Country
Poland
Individual Site Status
Recruiting
Facility Name
SPZOZ Opolskie Centrum Onkologii imienia prof Tadeusza Koszarowskiego w Opolu
City
Opole
ZIP/Postal Code
45-060
Country
Poland
Individual Site Status
Recruiting
Facility Name
Wielkopolskie Centrum Onkologii imienia Marii Sklodowskiej-Curie
City
Poznan
ZIP/Postal Code
61-866
Country
Poland
Individual Site Status
Recruiting
Facility Name
Wojewodzki Szpital im Sw Ojca Pio w Przemyslu
City
Przemysl
ZIP/Postal Code
37-700
Country
Poland
Individual Site Status
Recruiting
Facility Name
Kliniki Neuroradiochirurgii Spzoo Radom Centr Onkolo im Bohater Radomsk Czerwca -76 Szpital Specjal
City
Radom
ZIP/Postal Code
26-600
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centro Hospitalar e Universitario de Coimbra EPE
City
Coimbra
ZIP/Postal Code
3004-561
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Hospital da Senhora da Oliveira Guimaraes, EPE
City
Guimaraes
ZIP/Postal Code
4835-044
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Centro Hospitalar Universitario do Porto EPE - Hospital de Santo Antonio
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Centro Hospitalar Universitario de Sao Joao, EPE - Hospital Sao Joao
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Centro Hospitalar de Entre o Douro e Vouga, EPE - Hospital Sao Sebastiao
City
Santa Maria da Feira
ZIP/Postal Code
4520-211
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Spitalul Judeţean de Urgenţă Dr.Constantin Opriş Baia Mare
City
Baia Mare
ZIP/Postal Code
430031
Country
Romania
Individual Site Status
Recruiting
Facility Name
Institutul Clinic Fundeni
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Individual Site Status
Recruiting
Facility Name
Institutul Oncologic Prof Dr Alexandru Trestioreanu Bucuresti
City
Bucuresti
ZIP/Postal Code
022338
Country
Romania
Individual Site Status
Recruiting
Facility Name
SC Medisprof SRL
City
Cluj-Napoca
ZIP/Postal Code
400058
Country
Romania
Individual Site Status
Recruiting
Facility Name
Institutul Regional de Oncologie Iasi
City
Iasi
ZIP/Postal Code
700483
Country
Romania
Individual Site Status
Recruiting
Facility Name
Ovidius Clinical Hospital
City
Ovidiu
ZIP/Postal Code
905900
Country
Romania
Individual Site Status
Recruiting
Facility Name
National Cancer Centre Singapore
City
Singapore
ZIP/Postal Code
168583
Country
Singapore
Individual Site Status
Recruiting
Facility Name
The Oncology Centre
City
Durban
ZIP/Postal Code
4001
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Sandton Oncology Centre
City
Gauteng
ZIP/Postal Code
2021
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Netcare Milpark Hospital
City
Johannesburg
ZIP/Postal Code
2196
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Reina Sofia
City
Cordoba
State/Province
Andalucía
ZIP/Postal Code
14004
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Regional Universitario de Malaga
City
Malaga
State/Province
Andalucía
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
State/Province
Aragón
ZIP/Postal Code
50009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario de Burgos
City
Burgos
State/Province
Castilla León
ZIP/Postal Code
09006
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinic i Provincial de Barcelona
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Corporacio Sanitaria Parc Tauli
City
Sabadell
State/Province
Cataluña
ZIP/Postal Code
08208
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari i Politecnic La Fe
City
Valencia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Name
Complexo Hospitalario Universitario de Ourense
City
Ourense
State/Province
Galicia
ZIP/Postal Code
32005
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Donostia
City
San Sebastian
State/Province
País Vasco
ZIP/Postal Code
20014
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General Universitario Gregorio Marañon
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Puerta de Hierro Majadahonda
City
Madrid
ZIP/Postal Code
28220
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General Universitario Jose Maria Morales Meseguer
City
Murcia
ZIP/Postal Code
30008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Sahlgrenska Universitetssjukhuset
City
Göteborg
ZIP/Postal Code
413 45
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Karolinska Universitetssjukhuset Huddinge
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Norrlands Universitetssjukhus
City
Umea
ZIP/Postal Code
901 85
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
80756
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
83301
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
70403
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Tri-Service General Hospital
City
Taipei
ZIP/Postal Code
11490
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation
City
Taoyuan
ZIP/Postal Code
33305
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
King Chulalongkorn Memorial Hospital
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Rajavithi Hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Ramathibodi Hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Siriraj Hospital
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Baskent Universitesi Adana Doktor Turgut Noyan Uygulama ve Arastirma Merkezi
City
Adana
ZIP/Postal Code
01250
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Doktor Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Hacettepe Universitesi Tip Fakultesi
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Memorial Ankara Hastanesi
City
Ankara
ZIP/Postal Code
06520
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Ankara Bilkent Sehir Hastanesi
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Antalya Egitim ve Arastirma Hastanesi
City
Antalya
ZIP/Postal Code
07100
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Dicle Universitesi Tip Fakultesi
City
Diyarbakir
ZIP/Postal Code
21080
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Istanbul Universitesi Cerrahpasa Tip Fakultesi
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi
City
Istanbul
ZIP/Postal Code
34722
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Kartal Dr Lutfi Kirdar Sehir Hastanesi
City
Istanbul
ZIP/Postal Code
34865
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Izmir Ataturk Egitim ve Arastirma Hastanesi
City
Izmir
ZIP/Postal Code
35150
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Kocaeli Universitesi Arastirma ve Uygulama Hastanesi
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Inonu Universitesi Turgut Ozal Tip Merkezi
City
Malatya
ZIP/Postal Code
44280
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Sakarya Universitesi Egitim ve Arastirma Hastanesi
City
Sakarya
ZIP/Postal Code
54290
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Ondokuz Mayis Universitesi Saglik Uygulama ve Arastirma Merkezi
City
Samsun
ZIP/Postal Code
55200
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Van Yuzuncu Yil Universitesi Dursun Odabas Tip Merkezi
City
Van
ZIP/Postal Code
65000
Country
Turkey
Individual Site Status
Completed
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
IPD Sharing Time Frame
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
IPD Sharing Access Criteria
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
IPD Sharing URL
https://www.amgen.com/datasharing
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
Bemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression
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