acronym: THOR

lead_sponsor: Janssen Research & Development, LLC

summary: The purpose of this study is to evaluate efficacy of erdafitinib versus chemotherapy or pembrolizumab in participants with advanced urothelial cancer harboring selected fibroblast growth factor receptor (FGFR) aberrations who have progressed after 1 or 2 prior treatments, at least 1 of which includes an anti-programmed death ligand 1(PD-[L]1) agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2).

location_facility: Institut Regional du Cancer de Montpellier Val d'Aurelle

location_facility: Transkarpathian Regional University Oncology Clinic

location_facility: UOC Oncologia Ospedale Provinciale di Macerata

location_facility: Dokkyo Medical University Saitama Medical Center

location_facility: Friedrich-Alexander Universitaet Urologische Universitaetskl

location_facility: Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy

location_facility: Saint-Petersburg Clinical Scientific And Practical Center For Special Types Of Medical Care

location_facility: 'Papageorgiou' General Hospital of Thessaloniki

location_facility: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

location_facility: Ist. Clinici Scientifici Maugeri - Unità Operativa di Oncolo

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: Kliniken Nordoberpfalz AG/Klinikum Weiden

location_facility: Fondazione Policlinico Universitario A. Gemelli IRCCS

location_facility: Medizinische Fakultät Mannheim der Universität Heidelberg

location_facility: Instituto de Oncologia de Sorocaba/Onco Clinicas Especializadas

location_facility: Privolzhsky District Medical Center under the Federal Medico-Biological Agency

location_facility: Multiprofile Hospital for Active Treatment 'Tokuda Hospital Sofia'

location_facility: Multifunctional clinical medical center 'Medical city'

location_facility: Renji Hospital, Shanghai Jiaotong University School of Medicine

location_facility: Instituto Brasileiro de Controle do Cancer - Sao Camilo Oncologia

location_facility: MI Dnipropetrovsk Region Clinical Hospital n a I.I.Mechnikov

location_facility: Municipal Institution 'Clinical Oncology Dispensary' Under Dnipropetrovsk Regional Council

location_facility: T.C. Saglik Bakanlıgi Goztepe Prof. Dr. Suleyman Yalcın Sehir Hastanesi

location_facility: The First Bethune Hospital of Jilin University

location_facility: University of Athens Medical School - Regional General Hospi

location_facility: Baskent University Adana Practice and Research Center Kisla Health Campus

location_facility: Centro Estatal de Cancerología de Chihuahua

location_facility: Regional Medical Clinical Center for Urology and Nephrology named after V.I. Shapoval

location_facility: Usl 7 Siena - Ospedale Alta Valdelsa ASL TOSCANA SUD-EST

location_facility: Istituto Oncologico Veneto Iov Irccs Padova

location_facility: FGBOU Vo Mordovian National Research State University N. A. N.P. Ogareva

location_facility: Zaporizhzhia medical Academy of postgraduate education, Zaporizhzhia Regoinal Clinical Hospital

location_facility: University Hospitals Bristol - Bristol Haematology & Oncolog

location_facility: The First Affiliated Hospital of Xi'an Jiaotong University

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Universitatsklinikum Schleswig Holstein Campus Lubeck

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Communal Noncommercial Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital'

location_facility: The Center for Cancer and Blood Disorders

location_facility: Tokyo Women's Medical University Hospital

location_facility: The First Affliated Hospital Of Nanchang University

location_facility: Multiprofile Hospital for Active Treatment 'Sveta Marina' EAD

location_facility: Centralny Szpital Kliniczny MSWiA w Warszawie

location_facility: Shengjing Hospital of China Medical University

location_facility: Azienda Ospedaliero - Universitaria Ospedali Riuniti

location_facility: Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo Alessandria

location_facility: Rabin Medical Center, Beilinson Hospital

location_facility: H. Santa Maria - Centro Hospitalar de Lisboa Norte

location_facility: The Christie NHS Foundation Trust - Christie Hospital

location_facility: University General Hospital of Rio Patras

location_facility: Guangzhou First Municipal People's Hospital

location_facility: Centre de radiothérapie et d'Oncologie médicale de l'Essonne

location_facility: State Institution Institute of Urology NAMS of Ukraine based on Kyiv City Clinical Oncology Center

location_facility: Champalimaud Foundation Champalimaud Centre

location_facility: Nucleo de Ensino e Pesquisa do Instituto Mario Penna

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Presidio Spedali Civili

location_facility: Institut Català D'Oncologia-Hospital Universitari Germans Trias I Pujol

location_facility: Ministerio da Saude - Instituto Nacional do Cancer

location_facility: Stadtisches Klinikum Braunschweig gGmbH-Klinik fur Urologie und Uroonkologie

location_facility: FSBSI 'N. N. Blokhin Russian Cancer Research Center'

location_facility: Chelyabinsk Regional Clinical Center Of Oncology And Nuclear Medicine

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base

location_facility: Institut de Cancérologie de l'Ouest (ICO)

location_facility: I.M. Sechenov First Moscow State Medical University

location_facility: ALTHAIA, Xarxa Assistencial Universitària de Manresa

location_facility: Istituti Ospitalieri di Cremona, AO di Cremona

location_facility: Pavlov First Saint Petersburg State Medical University

location_facility: Huadong Hospital Affiliated to Fudan University

location_facility: Russian Scientific Center of Roentgenoradiology

location_facility: Levine Cancer Institute, Carolinas HealthCare System

location_facility: National Hospital Organizaiton Shikoku Cancer Center

location_facility: GBUZ Oncology Centre #2 of Healthcare Department of Krasno

location_facility: Derriford Hospital-Department of Medical Oncology

location_facility: Uniwersytecki Szpital Kliniczny we Wrocławiu

location_facility: Ivano-Frankivsk Regional Clinical Hospital

location_facility: St. Helena Hospital - Martin-O'Neil Cancer Center

location_facility: University of Miami Sylvester Cancer Center

location_facility: Instituto D'Or de Pesquisa e Ensino (IDOR)

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz

location_facility: Országos Onkológiai Intézet, Urogenitális Tumorok és Klinikai Farmakológiai Osztály

location_facility: Inonu Universitesi Turgut Ozal Tip Merkezi, Ic Hastaliklari

location_facility: Universidade Federal De Minas Gerais - Hospital das Clínicas

location_facility: Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

location_facility: Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4

location_facility: Kobe City Medical Center General Hospital

location_facility: Fundacao Antonio Prudente - A.C. Camargo Cancer Center

location_facility: Chang-Gung Memorial Hospital, LinKou Branch

location_facility: Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

location_facility: Universitatsklinikum Carl Gustav Carcus Dresden

location_facility: CEPHO - Centro de Estudos e Pesquisa de Hematologia e Oncologia

location_facility: Russian Scientific Center of Radiology and Surgical Technologies

location_facility: University of Calif Davis Medical Center

location_facility: Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria alle Scotte

location_facility: Thunder Bay Regional Health Sciences Centre

location_facility: Municipal non-profit enterprise 'Regional Center of Oncology'

location_facility: Saskatchewan Cancer Agency (SCA) - Allan Blair Cancer Centre

location_facility: First Affiliated Hospital of Wenzhou Medical College

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Cancer Hospital Chinese Academy of Medical Sciences

location_facility: Sociedade Beneficente de Senhoras - Hospital Sírio Libanês

location_facility: GBUZ of Stavropol region Pyatigorsk Oncological Dispensary

location_facility: Seoul National University Bundang Hospital

location_facility: Private Medical Institution Euromedservice

location_facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

location_facility: Oncologia Medica-Città Della Salute E Della Scienza Di Torino

location_facility: INOVA Dwiight &Martha Schar Cancer Institute

location_facility: Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre

location_facility: Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge

location_facility: Yonsei University Wonju Severance Christian Hospital

location_facility: Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica

location_facility: Peninsula & South Eastern Haematology and Oncology Group

location_facility: LKH - Universitätsklinikum der PMU Salzburg

location_facility: Koo Foundation Sun Yat-Sen Cancer Center

title: A Phase 3 Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Subjects With Advanced Urothelial Cancer and Selected FGFR Gene Aberrations

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Turkey
Canada
France
Portugal
Hungary
United States
Ukraine
Belgium
China
Italy
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Bulgaria
Russian Federation
Israel


study_start_date_type: Actual

acronym: SUNRISE

intervention_type: Drug

lead_sponsor: Novartis Pharmaceuticals

summary: The purpose of this study was to demonstrate superiority of secukinumab at Week 16, based on Hidradenitis Suppurativa Clinical Response (HiSCR) rates versus placebo, along with the maintenance of efficacy of secukinumab at Week 52 in subjects with moderate to severe HS. Moreover, this study assessed the safety and tolerability of secukinumab.

status: Completed

title: A Randomized, Double-blind, Multicenter Study Assessing Short (16 Weeks) and Long-term Efficacy (up to 1 Year), Safety, and Tolerability of 2 Subcutaneous Secukinumab Dose Regimens in Adult Patients With Moderate to Severe Hidradenitis Suppurativa (SUNRISE)

primary_purpose: Treatment

type: EudraCT Number

source: euctr

enrollment_type: Actual

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

design_allocation: Randomized

study_completion_date_type: Actual

location_country:
Germany
Poland
Argentina
Vietnam
Turkey
Croatia
Czechia
Canada
France
Lithuania
Colombia
Slovakia
Hungary
Denmark
Switzerland
United States
India
Lebanon
Belgium
Malaysia
Philippines
Italy
Guatemala
United Kingdom
Singapore
Netherlands
Spain
Greece
South Africa
Bulgaria
Russian Federation
Israel

study_type: Interventional

ipd_sharing: Yes

lead_sponsor_type: industriel

status_simplified: Completed


type: Other Identifier

type: Registry Identifier

title: A Phase 3 Multicenter, Randomized, Double-blinded, Active-controlled, Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) Versus Lenvatinib in First-line Therapy of Participants With Advanced Hepatocellular Carcinoma (LEAP-002)

summary:
The purpose of this study is to evaluate the safety and efficacy of lenvatinib (E7080/MK-7902) in combination with pembrolizumab (MK-3745) versus lenvatinib in combination with placebo as first-line therapy for the treatment of advanced hepatocellular carcinoma in adult participants.

The primary hypotheses of this study are that lenvatinib plus pembrolizumab is superior to lenvatinib plus placebo with respect to progression-free survival (PFS) and overall survival (OS).

status: Active, not recruiting

study_completion_date_type: Anticipated

lead_sponsor: Merck Sharp & Dohme LLC

sponsor_collaborators:
Merck Sharp & Dohme LLC
Eisai Inc.

location_country:
Germany
Ireland
Poland
New Zealand
Australia
Japan
Thailand
Turkey
Chile
Canada
France
Colombia
United States
China
Italy
United Kingdom
Mexico
Korea, Republic of
Spain
Taiwan
Russian Federation

location_facility: Toranomon Hospital Kajigaya ( Site 0312)

location_facility: Zhongshan Hospital Fudan University ( Site 0096)

location_facility: Hiroshima University Hospital ( Site 0320)

location_facility: Hospital Universitario y Politecnico La Fe de Valencia ( Site 0505)

location_facility: City Clinical Oncology Center ( Site 0446)

location_facility: Eastern Regional Medical Center, Inc. ( Site 0626)

location_facility: Pyatigorsk Oncology Dispensary ( Site 0441)

location_facility: National Taiwan University Hospital ( Site 0523)

location_facility: Musashino Red Cross Hospital ( Site 0310)

location_facility: Wojewodzki Szpital Specjalistyczny nr 4 w Bytomiu ( Site 0419)

location_facility: Cancer Hospital Chinese Academy of Medical Sciences ( Site 0100)

location_facility: Sunnybrook Research Institute ( Site 0055)

location_facility: Centro di Riferimento Oncologico de Aviano Istituto Nazionale Tumori ( Site 0292)

location_facility: Policlinico Universitario Campus Biomedico ( Site 0288)

location_facility: Affiliated Tumor Hospital of Xinjiang Medical University ( Site 0109)

location_facility: Az Osp Univ Policlin Paolo Giaccone ( Site 0284)

location_facility: The University of Tokyo Hospital ( Site 0308)

location_facility: Administradora Country SA - Clinica del Country ( Site 0146)

location_facility: Kings College Hospital NHS Foundation Trust ( Site 0565)

location_facility: University of Kansas Cancer Center ( Site 0600)

location_facility: Universitaetsklinikum Wuerzburg ( Site 0186)

location_facility: Kagawa Prefectural Central Hospital ( Site 0325)

location_facility: CRYPTEX Investigacion Clinica S.A. de C.V. ( Site 0362)

location_facility: Hospital Universitario Virgen del Rocio ( Site 0509)

location_facility: Nottingham University Hospitals NHS Trust ( Site 0569)

location_facility: Stony Brook University Medical Center - Cancer Center ( Site 0612)

location_facility: The Third Xiangya Hospital of Central South University ( Site 0093)

location_facility: Pontificia Universidad Catolica de Chile ( Site 0070)

location_facility: Mater Misericordiae University Hospital ( Site 0241)

location_facility: Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0450)

location_facility: Hospital Universitari Vall d Hebron ( Site 0508)

location_facility: National Cancer Center Hospital ( Site 0307)

location_facility: Siriraj Hospital. Mahidol Univerisity ( Site 0213)

location_facility: Szpital Wojewodzki w Koszalinie im. Mikolaja Kopernika ( Site 0421)

location_facility: The Beatson West of Scotland Cancer Centre ( Site 0566)

location_facility: Fundacion Arturo Lopez Perez ( Site 0064)

location_facility: Hospital Universitario Ramon y Cajal ( Site 0514)

location_facility: Seoul National University Hospital ( Site 0462)

location_facility: Saga-Ken Medical Centre Koseikan ( Site 0323)

location_facility: McGill University Health Centre ( Site 0052)

location_facility: St Vincents Hospital Melbourne ( Site 0003)

location_facility: The Christie NHS Foundation Trust ( Site 0575)

location_facility: Inonu Universitesi Medical Fakultesi ( Site 0545)

location_facility: First Moscow State Medical University n.a. I.M.Sechenov ( Site 0453)

location_facility: The University of Arizona Cancer Center - North Campus ( Site 0621)

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0363)

location_facility: First Affiliated Hospital of Anhui Medical University ( Site 0095)

location_facility: Hospital Universitario La Paz ( Site 0510)

location_facility: Tampa General Medical Group ( Site 0629)

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust ( Site 0573)

location_facility: Otto-Von-Guericke-Universitaet Magdeburg ( Site 0182)

location_facility: Medical Care and Research S.A. de C.V. ( Site 0359)

location_facility: Monash Health-Monash Medical Centre ( Site 0004)

location_facility: Instituto Nacional de Cancerologia E.S.E ( Site 0142)

location_facility: Universitaetsklinikum Leipzig ( Site 0187)

location_facility: Harbin Medical University Cancer Hospital ( Site 0089)

location_facility: Complejo Hospitalario Universitario de Santiago ( Site 0506)

location_facility: Azienda Ospedaliero-Univers. Pisana Ospedale S. Chiara ( Site 0291)

location_facility: Yokohama City University Medical Center ( Site 0313)

location_facility: Oaxaca Site Management Organization S.C. ( Site 0366)

location_facility: Fondazione Salvatore Maugeri IRCCS. ( Site 0290)

location_facility: University of Miami, Sylvester Comprehensive Cancer Center ( Site 0596)

location_facility: Southern Medical University Nanfang Hospital ( Site 0102)

location_facility: Wuhan Union hospital Cancer Center ( Site 0105)

location_facility: National Cancer Center Hospital East ( Site 0306)

location_facility: Royal Free London NHS Foundation Trust ( Site 0567)

location_facility: Centro Medico Imbanaco de Cali S.A ( Site 0139)

location_facility: University of Oklahoma Health Science Center ( Site 0625)

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 0529)

location_facility: Instituto Clinico Oncologico del Sur ( Site 0067)

location_facility: Necmettin Erbakan Universitesi Meram Tip Fakultesi ( Site 0550)

location_facility: Chiang Mai University Maharaj Nakorn Chiang Mai Hospital ( Site 0211)

location_facility: Emory University Winship Cancer Institute ( Site 0639)

location_facility: Hospital General Universitario Gregorio Maranon ( Site 0504)

location_facility: Fudan University Shanghai Cancer Center ( Site 0086)

location_facility: National Hospital Organization Kyushu Medical Center ( Site 0321)

location_facility: Princess Alexandra Hospital ( Site 0007)

location_facility: Princess Margaret Cancer Centre ( Site 0050)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0418)

location_facility: West China Hospital of Sichuan University ( Site 0087)

location_facility: Oregon Health & Science University ( Site 0645)

location_facility: Abdurrahman Yurtaslan Onkoloji Hastanesi ( Site 0551)

location_facility: Central Texas Veterans Healthcare System ( Site 0617)

location_facility: China Medical University Hospital ( Site 0527)

location_facility: The First Affiliated Hospital of Zhejiang University ( Site 0097)

location_facility: Hospital General de Medellin Luz Castro de Gutierrez ( Site 0137)

location_facility: Taichung Veterans General Hospital ( Site 0526)

location_facility: Centre Hospitalier Regional du Orleans ( Site 0169)

location_facility: National Cheng Kung University Hospital ( Site 0528)

location_facility: Clinica Universidad Catolica del Maule ( Site 0065)

location_facility: Icahn School of Medicine at Mount Sinai ( Site 0611)

location_facility: Erzurum Ataturk University Faculty of Medicine ( Site 0546)

location_facility: Bezmi Alem Universitesi Tıp Fakultesi ( Site 0547)

location_facility: Pacific Hematology Oncology Associates ( Site 0588)

location_facility: Ospedale Sacro Cuore - Don Calabria ( Site 0289)

location_facility: Hospital Universitario Puerta de Hierro ( Site 0513)

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0365)

location_facility: Yonsei University Severance Hospital ( Site 0463)

location_facility: The First Affiliated Hospital of Xi an Jiaotong University ( Site 0090)

location_facility: Policlinico S. Orsola-Malpighi ( Site 0286)

location_facility: Chang Gung Medical Foundation. Linkou ( Site 0525)

location_facility: MTZ Clinical Research Sp. z o. o. ( Site 0427)

location_facility: Beth Israel Deaconess Medical Center ( Site 0716)

location_facility: Aichi Cancer Center Hospital ( Site 0316)

location_facility: London Health Sciences Centre ( Site 0053)

location_facility: Taipei Veterans General Hospital ( Site 0524)

location_facility: Akdeniz Universitesi Tip Fakultesi ( Site 0548)

location_facility: City of Hope Comprehensive Cancer Center ( Site 0587)

location_facility: Royal Prince Alfred Hospital ( Site 0001)

location_facility: Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital ( Site 0304)

location_facility: Fundacion Centro de Investigacion Clinica CIC ( Site 0141)

location_facility: Universitaetsklinikum Tuebingen ( Site 0179)

location_facility: Kanazawa University Hospital ( Site 0315)

location_facility: Wakayama Medical University Hospital ( Site 0318)

location_facility: St Vincents University Hospital ( Site 0242)

location_facility: Seoul National University Bundang Hospital ( Site 0464)

location_facility: Universitaetsklinikum Carl Gustav Carus der TU Dresden ( Site 0178)

location_facility: Universitaetsklinikum Essen ( Site 0188)

location_facility: Centro de Investigacion Medica Aguascalientes ( Site 0355)

location_facility: Massachusetts General Hospital ( Site 0603)

location_facility: Universitaetsklinikum Hamburg-Eppendorf ( Site 0184)

location_facility: CHU de Nancy Hopital Brabois Adultes ( Site 0164)

location_facility: Klinikum der Universitaet Aachen - RWTH ( Site 0185)

location_facility: Hacettepe Uni. Tip Fakultesi ( Site 0553)

location_facility: CHRU de Lille - Hopital Claude Huriez ( Site 0159)

location_facility: Trakya Universitesi Tip Fakultesi ( Site 0544)

location_facility: Universitaetsklinikum Frankfurt ( Site 0180)

status_simplified: Ongoing


acronym: ANCHOR-CRC

lead_sponsor: Pierre Fabre Medicament

summary: The purpose of this study is to evaluate the efficacy and safety of the combination of study drugs encorafenib, binimetinib and cetuximab in patients who have BRAF V600 mutant metastatic colorectal cancer and have not received any prior treatment for their metastatic disease.

sponsor_collaborators:
Pierre Fabre Medicament
Pfizer
Merck KGaA, Darmstadt, Germany
Ono Pharmaceutical Co. Ltd

location_facility: Hôpital Morvan CHRU de Brest Institut de cancérologie et d'hematologie

location_facility: Complejo Hospitalario De Navarra S Oncologia Medica

location_facility: GI Research Team, The Christie NHS Foundation Trust

location_facility: Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Institut Català d'Oncologia (ICO L'Hospitalet)

location_facility: Hospital Clínic I Provincial de Barcelona

location_facility: Hospital Universitario y Politécnico La FE

location_facility: Fondazione del Piemonte per l'Oncologia IRCC Candiolo

location_facility: IRCCS Ospedale Casa Sollievo della Sofferenza

title: Phase II, Open-label, Single Arm, Multicenter Study of Encorafenib, Binimetinib Plus Cetuximab in Subjects With Previously Untreated BRAF V600E -Mutant Metastatic Colorectal Cancer

location_country:
Italy
United Kingdom
Japan
Netherlands
Austria
Belgium
United States
Spain
France


acronym: THALES

lead_sponsor: AstraZeneca

summary: Study to investigate if the study drug ticagrelor and ASA is more effective than Placebo (inactive tablet) and ASA in preventing new stroke events

ReferenceType: derived

ReferenceCitation: Johnston SC, Amarenco P, Aunes M, Denison H, Evans SR, Himmelmann A, Jahreskog M, James S, Knutsson M, Ladenvall P, Molina CA, Nylander S, Rother J, Wang Y; THALES Investigators. Ischemic Benefit and Hemorrhage Risk of Ticagrelor-Aspirin Versus Aspirin in Patients With Acute Ischemic Stroke or Transient Ischemic Attack. Stroke. 2021 Nov;52(11):3482-3489. doi: 10.1161/STROKEAHA.121.035555. Epub 2021 Sep 3.

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repository_institution: Uppsala University - Uppsala University Publications

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ReferenceCitation: Wang Y, Pan Y, Li H, Amarenco P, Denison H, Evans SR, Himmelmann A, James S, Birve F, Ladenvall P, Molina CA, Johnston SC; THALES Steering Committee and Investigators. Efficacy and Safety of Ticagrelor and Aspirin in Patients With Moderate Ischemic Stroke: An Exploratory Analysis of the THALES Randomized Clinical Trial. JAMA Neurol. 2021 Sep 1;78(9):1091-1098. doi: 10.1001/jamaneurol.2021.2440.

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publisher_dissemination: American Medical Association

ReferenceCitation: Yaghi S, de Havenon A, Rostanski S, Kvernland A, Mac Grory B, Furie KL, Kim AS, Easton JD, Johnston SC, Henninger N. Carotid Stenosis and Recurrent Ischemic Stroke: A Post-Hoc Analysis of the POINT Trial. Stroke. 2021 Jul;52(7):2414-2417. doi: 10.1161/STROKEAHA.121.034089. Epub 2021 May 4.

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ReferenceCitation: Amarenco P, Denison H, Evans SR, Himmelmann A, James S, Knutsson M, Ladenvall P, Molina CA, Wang Y, Johnston SC; THALES Steering Committee and Investigators*. Ticagrelor Added to Aspirin in Acute Nonsevere Ischemic Stroke or Transient Ischemic Attack of Atherosclerotic Origin. Stroke. 2020 Dec;51(12):3504-3513. doi: 10.1161/STROKEAHA.120.032239. Epub 2020 Nov 16.

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ReferenceCitation: Amarenco P, Denison H, Evans SR, Himmelmann A, James S, Knutsson M, Ladenvall P, Molina CA, Wang Y, Johnston SC; THALES Steering Committee and Investigators. Ticagrelor Added to Aspirin in Acute Ischemic Stroke or Transient Ischemic Attack in Prevention of Disabling Stroke: A Randomized Clinical Trial. JAMA Neurol. 2020 Nov 7;78(2):1-9. doi: 10.1001/jamaneurol.2020.4396. Online ahead of print. Erratum In: JAMA Neurol. 2021 Feb 1;78(2):253.

repository_institution: KTH Royal Institute of Technology - KTH Publication Database DiVA

ReferenceCitation: Johnston SC, Amarenco P, Denison H, Evans SR, Himmelmann A, James S, Knutsson M, Ladenvall P, Molina CA, Wang Y; THALES Investigators. Ticagrelor and Aspirin or Aspirin Alone in Acute Ischemic Stroke or TIA. N Engl J Med. 2020 Jul 16;383(3):207-217. doi: 10.1056/NEJMoa1916870.

ReferenceCitation: Johnston SC, Amarenco P, Denison H, Evans SR, Himmelmann A, James S, Knutsson M, Ladenvall P, Molina CA, Wang Y; THALES Investigators. The Acute Stroke or Transient Ischemic Attack Treated with Ticagrelor and Aspirin for Prevention of Stroke and Death (THALES) trial: Rationale and design. Int J Stroke. 2019 Oct;14(7):745-751. doi: 10.1177/1747493019830307. Epub 2019 Feb 12.

ReferenceCitation: Wong KSL, Amarenco P, Albers GW, Denison H, Easton JD, Evans SR, Held P, Himmelmann A, Kasner SE, Knutsson M, Ladenvall P, Minematsu K, Molina CA, Wang Y, Johnston SC; SOCRATES Steering Committee and Investigators. Efficacy and Safety of Ticagrelor in Relation to Aspirin Use Within the Week Before Randomization in the SOCRATES Trial. Stroke. 2018 Jul;49(7):1678-1685. doi: 10.1161/STROKEAHA.118.020553. Epub 2018 Jun 18.

evidence: oa repository (via OAI-PMH title and first author match)

repository_institution: University of California - eScholarship University of California

title: A Randomised, Double-Blind, Placebo-Controlled, International, Multicentre, Phase III Study to Investigate the Efficacy and Safety of Ticagrelor and ASA Compared With ASA in the Prevention of Stroke and Death in Patients With Acute Ischaemic Stroke or Transient Ischaemic Attack

location_country:
Germany
Poland
Argentina
Australia
Brazil
Thailand
Vietnam
Czechia
Canada
France
Slovakia
Hungary
Hong Kong
Ukraine
India
Romania
Belgium
China
Peru
Italy
Mexico
Korea, Republic of
Saudi Arabia
Spain
Taiwan
Bulgaria
Russian Federation
Sweden


summary: The study will compare the efficacy and safety of pembrolizumab plus trastuzumab in combination with standard of care (SOC) chemotherapy versus trastuzumab in combination with SOC chemotherapy in participants with HER2-positive gastric cancer. The primary hypotheses of the study are that pembrolizumab plus trastuzumab in combination with chemotherapy is superior to trastuzumab plus chemotherapy in terms of 1) progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR), and 2) overall survival (OS).

ReferenceCitation: Janjigian YY, Kawazoe A, Yanez P, Li N, Lonardi S, Kolesnik O, Barajas O, Bai Y, Shen L, Tang Y, Wyrwicz LS, Xu J, Shitara K, Qin S, Van Cutsem E, Tabernero J, Li L, Shah S, Bhagia P, Chung HC. The KEYNOTE-811 trial of dual PD-1 and HER2 blockade in HER2-positive gastric cancer. Nature. 2021 Dec;600(7890):727-730. doi: 10.1038/s41586-021-04161-3. Epub 2021 Dec 15.

oa_host_type: repository

repository_institution: Yonsei University Medical Library - YUHSpace

version: submittedVersion

repositories_concat: PubMed Central;ir.ymlib.yonsei.ac.kr

repositories_institution: Yonsei University Medical Library - YUHSpace

unpaywall_oa_status: green

publisher_dissemination: Springer-Nature

ReferenceCitation: Chung HC, Bang YJ, S Fuchs C, Qin SK, Satoh T, Shitara K, Tabernero J, Van Cutsem E, Alsina M, Cao ZA, Lu J, Bhagia P, Shih CS, Janjigian YY. First-line pembrolizumab/placebo plus trastuzumab and chemotherapy in HER2-positive advanced gastric cancer: KEYNOTE-811. Future Oncol. 2021 Feb;17(5):491-501. doi: 10.2217/fon-2020-0737. Epub 2020 Nov 10.

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories:
LIRIAS (KU Leuven)
PubMed Central
ir.ymlib.yonsei.ac.kr

repositories_concat: LIRIAS (KU Leuven);PubMed Central;ir.ymlib.yonsei.ac.kr

publisher_dissemination: Future Science Ltd

location_facility: Szpital Specjalistyczny w Koscierzynie Sp. z o.o. ( Site 1708)

location_facility: Niigata Cancer Center Hospital ( Site 2622)

location_facility: Manor Hospital Walsall England ( Site 1515)

location_facility: Hadassah Ein Kerem Medical Center ( Site 1604)

location_facility: Fifth Medical Center of CPLA General Hospital ( Site 2415)

location_facility: Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 2017)

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 2001)

location_facility: The Christie Hospital NHS Foundation Trust ( Site 1503)

location_facility: Soroka University Medical Center ( Site 1603)

location_facility: Abdurrahman Yurtaslan Onkoloji Egitim ve Arastirma Hastanesi ( Site 2006)

location_facility: UCLA Hematology/Oncology - Westwood (Building 200 Suite 120) ( Site 0045)

location_facility: University of Texas MD Anderson Cancer Center ( Site 0001)

location_facility: IEO Istituto Europeo di Oncologia ( Site 1105)

location_facility: Hospital Universitario Ramon y Cajal ( Site 1400)

location_facility: A.O.U. Universita degli Studi della Campania-Luigi Vanvitelli ( Site 1103)

location_facility: Hopital Jean Minjoz Besancon ( Site 0901)

location_facility: National Hospital Organization - Osaka National Hospital - Institute For Clinical Research ( Site 26

location_facility: University College London Hospital NHS Foundation Trust ( Site 1508)

location_facility: Universita Magna Graecia di Catanzaro ( Site 1107)

location_facility: CIONC - Centro Integrado de Oncologia de Curitiba ( Site 0205)

location_facility: Hospital Universitario Quiron Madrid ( Site 1407)

location_facility: Centro Investigación del Cáncer James Lind ( Site 0300)

location_facility: Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 2106)

location_facility: MI Kryviy Rih Center of Dnipropetrovsk Regional Council ( Site 2101)

location_facility: Chaim Sheba Medical Center. ( Site 1607)

location_facility: Universitaetsklinikum Carl Gustav Carus der Technischen Univ ( Site 1001)

location_facility: Blokhin National Medical Oncology ( Site 1805)

location_facility: Dolnoslaskie Centrum Onkologii. ( Site 1712)

location_facility: Hospital de Caridade de Ijui ( Site 0202)

location_facility: Hospital General Universitario de Elche ( Site 1404)

location_facility: Aichi Cancer Center Hospital ( Site 2617)

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location_facility: Zhongshan Hospital affiliated to Fudan University ( Site 2401)

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location_facility: Trakya Universitesi Tip Fakultesi ( Site 2015)

location_facility: The First Affiliated Hospital.Zhejiang University ( Site 2408)

location_facility: St Petersburg City Clinical Oncology Dispensary ( Site 1812)

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location_facility: Dana-Farber Cancer Institute [Boston, MA] ( Site 0010)

location_facility: Harbin Medical University Cancer Hospital ( Site 2407)

location_facility: The First Hospital Of Jilin University ( Site 2402)

location_facility: Clinic of National Cancer Institute ( Site 2104)

location_facility: Gunma Prefectural Cancer Center ( Site 2602)

location_facility: CEPON - Centro de Pesquisas Oncologicas ( Site 0200)

location_facility: Memorial Sloan-Kettering Cancer Center ( Site 0017)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (

location_facility: Memorial Sloan Kettering Cancer Center- Monmouth ( Site 0071)

location_facility: Malatya Inonu Universitesi Tip Fakultesi Hastanesi ( Site 2009)

location_facility: Sakarya Universitesi Egitim ve Arastirma Hastanesi ( Site 2012)

location_facility: Memorial Sloan-Kettering Cancer Center at West Harrison ( Site 0065)

location_facility: Southern Medical Day Care Centre ( Site 2207)

location_facility: Edith Wolfson Medical Center ( Site 1605)

location_facility: Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1801)

location_facility: Minnesota Oncology Hematology, PA ( Site 8001)

location_facility: Tallaght University Hospital ( Site 1513)

location_facility: Midwestern Regional Medical Center, Inc. ( Site 0059)

location_facility: Innere Medizin I, Universitaetsklinikum Tuebingen ( Site 1020)

location_facility: Dokuz Eylul Universitesi Tip Fakultesi Hastanesi ( Site 2011)

location_facility: Kansai Medical University Hospital ( Site 2618)

location_facility: Clinica Universidad Catolica del Maule ( Site 0305)

location_facility: Kobe City Medical Center General Hospital ( Site 2614)

location_facility: MI Precarpathian Clinical Oncology Center ( Site 2105)

location_facility: Pontificia Universidad Catolica de Chile ( Site 0301)

location_facility: National Hospital Organization Shikoku Cancer Center ( Site 2615)

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie ( Site 1709)

location_facility: Osaka International Cancer Institute ( Site 2613)

location_facility: IBCC - Instituto Brasileiro de Controle do Cancer ( Site 0204)

location_facility: Communal non profit enterprise Regional Clinical Oncology Center ( Site 2112)

location_facility: The Cancer Institute Hospital of JFCR ( Site 2610)

location_facility: Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 0902)

location_facility: Ataturk Universitesi Tip Fakultesi Hastanesi ( Site 2000)

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location_facility: Seattle Cancer Care Alliance ( Site 0038)

location_facility: Hospital Germans Trias i Pujol. ICO de Badalona ( Site 1410)

location_facility: The First Affiliated Hospital of Xiamen University ( Site 2431)

location_facility: Medizinische Hochschule Hannover ( Site 1019)

location_facility: Instituto do Cancer do Ceara ( Site 0208)

location_facility: Centro Regional de Sub Especialidades Medicas SA ( Site 0502)

location_facility: UC Irvine Medical Center/Chao Family Comprehensive Cancer Center ( Site 0050)

location_facility: National Cancer Center Hospital East ( Site 2605)

location_facility: Chelyabinsk Regional Clinical Oncological Dispensary ( Site 1815)

location_facility: Royal Marsden NHS Foundation Trust ( Site 1512)

location_facility: Fundacion Arturo Lopez Perez FALP ( Site 0302)

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location_facility: University of Miami Sylvester Comprehensive Cancer Center - Plantation ( Site 0026)

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location_facility: Seoul National University Hospital ( Site 2703)

location_facility: Podolsky City Clinical Hospital ( Site 1817)

location_facility: Xiangya Hospital Central-South University ( Site 2426)

location_facility: Fudan University Shanghai Cancer Center ( Site 2424)

location_facility: Kumamoto University Hospital ( Site 2601)

location_facility: Medical Centre LLC Oncolife ( Site 2103)

location_facility: Cancer Hospital Affiliated to Xinjiang Medical University ( Site 2430)

location_facility: Osaka General Medical Center ( Site 2624)

location_facility: Hospital Universitario Marques de Valdecilla ( Site 1405)

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location_facility: Oncology & Hematology Assoc. SW Virginia, Inc., DBA Blue Ridge Cancer Care ( Site 8000)

location_facility: Charite-Universitaetsmedizin Berlin Campus Virchow-Klinikum ( Site 1026)

location_facility: Instituto Nacional del Cancer ( Site 0303)

location_facility: Hospital Nossa Senhora da Conceicao ( Site 0203)

location_facility: Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 1715)

location_facility: Ninewells Hospital and Medical School ( Site 1504)

location_facility: C.H.R.U. de Brest - Hopital Morvan ( Site 0913)

location_facility: Fujian Provincial Cancer Hospital ( Site 2418)

location_facility: Beth Israel Deaconess Medical Center ( Site 0070)

location_facility: Ibaraki Prefectural Central Hospital ( Site 2611)

location_facility: Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 1710)

location_facility: Washington University School of Medicine ( Site 0040)

location_facility: Uniwersytecki Szpital Kliniczny im. J. M. Radeckiego we Wroclawiu ( Site 1705)

location_facility: Medical Center Asklepion LLC ( Site 2115)

location_facility: Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0201)

location_facility: Hiroshima City Hiroshima Citizens Hospital ( Site 2625)

location_facility: Tokyo Metropolitan Komagome Hospital ( Site 2606)

location_facility: Southeastern Regional Medical Center, Inc. ( Site 0058)

title: A Phase III, Randomized, Double-blind Trial Comparing Trastuzumab Plus Chemotherapy and Pembrolizumab With Trastuzumab Plus Chemotherapy and Placebo as First-line Treatment in Participants With HER2 Positive Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (KEYNOTE 811)

enrollment_type: Anticipated

location_country:
Germany
Ireland
Poland
New Zealand
Australia
Brazil
Japan
Turkey
Chile
France
United States
Ukraine
China
Italy
Guatemala
United Kingdom
Korea, Republic of
Spain
Russian Federation
Israel


lead_sponsor: Sanofi

summary:
Primary Objective:

To evaluate the efficacy of KEVZARA (sarilumab) in participants with polymyalgia rheumatica (PMR) as assessed by the proportion of participants with sustained remission for sarilumab with a shorter corticosteroid (CS) tapering regimen as compared to placebo with a longer CS tapering regimen.

Secondary Objectives:

To demonstrate the efficacy of sarilumab in participants with PMR compared to placebo, in combination with a CS taper with regards to:
Clinical responses (such as components of sustained remission, disease remission rates, time to first disease flare) over time.
Cumulative CS (including prednisone) exposure.
To assess the safety (including immunogenicity) and tolerability of sarilumab in participants with PMR.
To measure sarilumab serum concentrations in participants with PMR.
To assess the effect of sarilumab in reducing glucocorticoid toxicity as measured by the composite glucocorticoid toxicity index (GTI) questionnaire.

sponsor_collaborators:
Sanofi
Regeneron Pharmaceuticals

location_facility:
Investigational Site Number 2760007
Investigational Site Number 8260009
Investigational Site Number 3760005
Investigational Site Number 2760003
Investigational Site Number 1240010
Investigational Site Number 0360004
Investigational Site Number 2760008
Investigational Site Number 0320002
Investigational Site Number 3800005
Investigational Site Number 0560001
Investigational Site Number 5280008
Investigational Site Number 8400011
Investigational Site Number 6430002
Investigational Site Number 6430004
Investigational Site Number 7240008
Investigational Site Number 2500014
Investigational Site Number 8400022
Investigational Site Number 0360002
Investigational Site Number 8260004
Investigational Site Number 3800004
Investigational Site Number 3760003
Investigational Site Number 8400015
Investigational Site Number 5280007
Investigational Site Number 3920002
Investigational Site Number 3480001
Investigational Site Number 6430003
Investigational Site Number 3800003
Investigational Site Number 1240005
Investigational Site Number 1240003
Investigational Site Number 3920001
Investigational Site Number 8400006
Investigational Site Number 1240001
Investigational Site Number 5280003
Investigational Site Number 2500002
Investigational Site Number 7240006
Investigational Site Number 3760002
Investigational Site Number 8260001
Investigational Site Number 2500005
Investigational Site Number 6430001
Investigational Site Number 0360003
Investigational Site Number 2760004
Investigational Site Number 2500011
Investigational Site Number 8400014
Investigational Site Number 7240004
Investigational Site Number 3800002
Investigational Site Number 5280002
Investigational Site Number 2500016
Investigational Site Number 2760002
Investigational Site Number 5280005
Investigational Site Number 2500010
Investigational Site Number 8400003
Investigational Site Number 7560002
Investigational Site Number 2760001
Investigational Site Number 7560001
Investigational Site Number 8260003
Investigational Site Number 0560003
Investigational Site Number 1240007
Investigational Site Number 2760009
Investigational Site Number 2500004
Investigational Site Number 8400005
Investigational Site Number 3920005
Investigational Site Number 3760001
Investigational Site Number 3800008
Investigational Site Number 2500015
Investigational Site Number 7240001
Investigational Site Number 7240005
Investigational Site Number 0360001
Investigational Site Number 0320005
Investigational Site Number 8260007
Investigational Site Number 6430008
Investigational Site Number 8400025
Investigational Site Number 8400009
Investigational Site Number 7240007
Investigational Site Number 3920003
Investigational Site Number 0320001
Investigational Site Number 3760004
Investigational Site Number 8400002
Investigational Site Number 2330001
Investigational Site Number 8260002
Investigational Site Number 7240002
Investigational Site Number 0320003
Investigational Site Number 3800001
Investigational Site Number 5280004
Investigational Site Number 2500003

status: Terminated

title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Sarilumab in Patients With Polymyalgia Rheumatica

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

location_country:
Germany
Italy
Hungary
Argentina
Israel
Australia
Japan
Netherlands
Switzerland
Belgium
United Kingdom
United States
Spain
Canada
Estonia
Russian Federation
France

status_simplified: Unknown


acronym: PRECONNECT

lead_sponsor: Institut de Recherches Internationales Servier

summary:
The purpose of this study is to collect additional safety and efficacy data during treatment with trifluridine / tipiracil in patients with a pretreated metastatic colorectal cancer (mCRC).

Eligible patients may receive an early access to trifluridine / tipiracil through this clinical study until progression of disease, unacceptable toxicity, investigator decision, patient refusal or until market authorization or reimbursement has been granted by the relevant Authority of the country where that patient is treated or until trifluridine / tipiracil is available by a doctor's prescription or can be accessed from another source or Sponsor decision.

ReferenceCitation: Ozet A, Dane F, Aykan NF, Yalcin S, Evrensel T, Ozkan M, Karabulut B, Ormeci MN, Atasev O, Vidot L, Cicin I. Safety and efficacy of trifluridine/tipiracil in previously treated metastatic colorectal cancer: PRECONNECT Turkey. Future Oncol. 2022 Sep;18(29):3267-3276. doi: 10.2217/fon-2022-0455. Epub 2022 Aug 30.

oa_host_type: publisher

repositories_concat: closed

ReferenceCitation: Zaniboni A, Barone CA, Banzi MC, Bergamo F, Blasi L, Bordonaro R, Bartolomeo MD, Costanzo FD, Frassineti GL, Garufi C, Giuliani F, Latiano TP, Martinelli E, Personeni N, Racca P, Tamburini E, Tonini G, Besse MG, Spione M, Falcone A. Italian results of the PRECONNECT study: safety and efficacy of trifluridine/tipiracil in metastatic colorectal cancer. Future Oncol. 2021 Jun;17(18):2315-2324. doi: 10.2217/fon-2020-1278. Epub 2021 Mar 5.

oa_host_type: closed

ReferenceCitation: Bachet JB, Wyrwicz L, Price T, Cremolini C, Phelip JM, Portales F, Ozet A, Cicin I, Atlan D, Becquart M, Vidot L, Mounedji N, Van Cutsem E, Taieb J, Falcone A. Safety, efficacy and patient-reported outcomes with trifluridine/tipiracil in pretreated metastatic colorectal cancer: results of the PRECONNECT study. ESMO Open. 2020 Jun;5(3):e000698. doi: 10.1136/esmoopen-2020-000698.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - memSIC

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

repositories:
HAL
LIRIAS (KU Leuven)
PubMed Central

repositories_concat: HAL;LIRIAS (KU Leuven);PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Elsevier

sponsor_collaborators: Institut de Recherches Internationales Servier

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location_facility: CHU Robert DEBRE service d'hepato-gastroenterologie / Cancérologie Digestive

location_facility: Istituto Clinico Humanitas I.R.C.C.S Dipartimento di Oncologia Medica ed Ematologia

location_facility: Clinical and diagn.Centre of Medics-rey Inter. Group LLC - Hospital of Israeli Oncology "LISOD

location_facility: Hôpital Nord Franche-Comté - Site du Mittan Service d'oncologie médicale

location_facility: Institutul Regional de Oncologie Iasi Clinica de Oncologie Medicala

location_facility: Marmara University Pendik Training and Research Hospital

location_facility: Azienda Ospedaliero-Universitaria Careggi Struttura Complessa Oncologia Medica

location_facility: Policlinico Universitario Agostino Gemelli U.O.C. di Oncologia Medica

location_facility: UZ Leuven Campus Gasthuisberg Digestieve Oncologie

location_facility: Groupe Hospitalier Pitié Salpêtrière Service d'hépato-gastro-entérologie

location_facility: Centro Hospitalar de Lisboa Norte E.P.E. - H. Santa Maria Serviço de Oncologia Médica

location_facility: Ist.Scientifico Romagnolo per lo Studio e la Cura dei Tumori Department of Clinical Oncology

location_facility: Instituto Português de Oncologia do Porto Serviço de Oncologia Médica

location_facility: Cliniques Universitaires St. Luc Oncologie médicale

location_facility: Wielkopolskie Centrum Onkologii im Marii Sklodowskiej-Curie Oddzial Chemioterapii

location_facility: Hopital Privé Jean Mermoz Service de Gastro entérologie et d'Oncologie médicale

location_facility: Ege University Faculty of Medicine Medical Oncology Department

location_facility: Hospital A C Camargo Unidade de Pesquisa Clínica

location_facility: Cabrini Hospital Cabrini Haematology and Oncology Centre

location_facility: Onkologicky ustav sv. Alzbety,s.r.o. Interna Klinika VSZ a SP a OUSA

location_facility: Centre Antoine Lacassagne Dpt d'Oncologie Médicale

location_facility: Klinicki bolnicki centar Zagreb Klinika za onkologiju

location_facility: Hopital Privé Les Bonnettes Pharmacie centrale

location_facility: Franco-British Institue Department of Medical Oncology

location_facility: Universitair Ziekenhuis Antwerpen Oncologie

location_facility: Spitalul Clinic "Fundeni" Departament Oncologie Medicala - Gastroenterologie

location_facility: Hôpital Trousseau Hépato-gastroentérologie et cancérologie digestive

location_facility: A.O.U. Pisana-Ospedale Santa Chiara U.O. di Oncologia Medica 2

location_facility: Hôpital Nord Pôle Digestif Urologie-Andrologie

location_facility: CHD - Les Oudairies service d'hepato-gastroenterologie

location_facility: Hospital Garcia de Orta Serviço de Oncologia Médica

location_facility: Policlinico Universitario Campus Biomedico UOC di Oncologia Medica

location_facility: CHU de Grenoble Oncologie médicale Hépato-gastroentérologie - 7D

location_facility: Specialized hospital for active treatment in oncology

location_facility: ARNAS - Azienda Ospedaliera Garibaldi - Nesima Struttura Complessa di Oncologia Medica

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori S.S. Oncologia Medica Gastrenterologia

location_facility: CHU de Poitiers Pole Régional de Cancérologie

location_facility: St Vincent's Hospital The Kinghorn Cancer Centre

location_facility: AMO Assistencia Multidisciplinar em Oncologia GEM Assistencia Medica Especializada

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP Núcleo de Pesquisa

location_facility: St Vincent's Hospital (Melbourne) Cancer Centre

location_facility: Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie Klinika Gastroenterologii Onkologicznej

location_facility: Hôpital Universitaire Erasme Gastro-Entérologie

location_facility: Istituto Oncologico Veneto IOV - IRCCS Unità Operativa Complessa Oncologia Medica 1

location_facility: Ist.Tumori "Giovanni Paolo II" IRCCS Osp.Oncologico di Bari U.O.C. di Oncologia Medica

location_facility: Bialostockie Centrum Onkologii im Marii Curie-Sklodowskiej Oddzial Onkologii Klinicznej im Dr Ewy Pileckiej z pododdzialem Chemioterapii Dziennej

location_facility: Ospedale Civile Santo Spirito Struttura Complessa di Oncologia Medica

location_facility: Erciyes University Mehmet Kemal Dedeman Hematology Oncology

location_facility: Instituto Brasileiro de Controle do Câncer Unidadde de Pesquisa Clínica

location_facility: Uniwersyteckie Centrum Kliniczne Klinika Onkologii i Radioterapii

location_facility: CHU de la Timone Hépato-Gastro-Entérologie

location_facility: Centre de lutte contre le cancer Francois Baclesse UCP Digestif

location_facility: Centro Hospitalar de São João E.P.E. Serviço de Oncologia

location_facility: Instituto Português de Oncologia de Coimbra Serviço de Oncologia Médica

location_facility: Kyiv City Clinical Oncological Centre Day care facility

location_facility: Hôpital Haut-Lévèque Hépato-gastroentérologie et oncologie digestive

location_facility: Azienda Ospedaliera "Civico-Di Cristina" - Ospedale Civico Oncologia Medica

location_facility: Gazi University Faculty of Medicine Medical Oncology Department

location_facility: Klinicki bolnicki centar Rijeka Klinika za radioterapiju i onkologiju

location_facility: Arcispedale Santa Maria Nuova Unità di Oncologia

location_facility: IRCSS Casa Sollievo della Sofferenza Dipartimento Onco-Ematologia

location_facility: Institut Sainte Catherine Institut Sainte Catherine

location_facility: Military Medical Academy - MHAT Oncology clinic

location_facility: The Canberra Hospital Cancer,Ambulatory & Community Health Service (CACHS) Bldg 19

location_facility: CHU Toulouse Rangueil Oncologie médicale digestive

location_facility: Hospital Mãe de Deus Centro Intergrado de Pesquisa

location_facility: Centro Hospitalar e Universitário de Comibra E.P.E. Serviço de Oncologia Médica

location_facility: Hôpital Saint-Antoine Service d'Oncologie Médicale

location_facility: A.O.U. Città della Salute e della Scienza di Torino S.C. Oncologia Medica 1 - Colo-Rectal Cancer Unit

location_facility: Institutul Oncologic "Prof. Dr. I. Chiricuta" Cluj Napoca Oncologie Medicala

location_facility: Hôpital Européen Georges Pompidou Oncologie Hépatogastroenterologie-oncologie digestive

location_facility: Opolskie Centrum Onkologii im. Tadeusza Koszarowskiego Oddzial Onkologii Klinicznej

location_facility: The Queen Elizabeth Hospital Haematology and Oncology Unit

location_facility: Treatment-diagnostic Centre PJSC "House of medicine"

location_facility: Vychodoslovensky onkologicky ustav Oddelenie klinickej onkologie

location_facility: Centre Eugène Marquis Service d'Oncologie Médicale

location_facility: CHU Hôpital du Bocage/ François Mitterrand Hépato-gastroentérologie

location_facility: Royal Brisbane & Women's Hospital Clinical Research Unit

location_facility: Hacettepe University Faculty of Medicine

location_facility: Fondazione Poliambulanza Istituto Ospedaliero Clinical Oncology

title: An Open-label Early Access Phase IIIb Study of Trifluridine / Tipiracil (S 95005/TAS-102) in Patients With a Pretreated Metastatic Colorectal Cancer (PRECONNECT)

ipd_sharing_description:
Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.

Access can be requested for all interventional clinical studies:

used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.

In addition, access can be requested for all interventional clinical studies in patients:

sponsored by Servier
with a first patient enrolled as of 1 January 2004 onwards
for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.

location_country: Ireland Italy Poland Slovenia Portugal Slovakia Romania Australia Brazil Belgium Panama Croatia Turkey Bulgaria Ukraine France


summary:
The purpose of this study was to confirm the preliminary evidence from early clinical trials that midostaurin may provide clinical benefit not only to AML patients with the FLT3-mutations but also in FLT3-MN (SR<0.05) AML (FLT3 mutant to wild type signal ratio below the 0.05 clinical cut-off).

This study evaluated the efficacy and safety of midostaurin in combination with daunorubicin or idarubicin and cytarabine for induction and intermediate-dose cytarabine for consolidation, and midostaurin single agent post-consolidation therapy in newly diagnosed patients with FLT3-MN (SR<0.05) AML.

location_facility:
Novartis Investigative Site
University of Chicago Medical Center .
Dana Farber Cancer Institute
Oregon Health and Science Univ

title: A Phase III, Randomized, Double-blind Study of Chemotherapy With Daunorubicin or Idarubicin and Cytarabine for Induction and Intermediate Dose Cytarabine for Consolidation Plus Midostaurin (PKC412) or Chemotherapy Plus Placebo in Newly Diagnosed Patients With FLT-3 Mutation Negative Acute Myeloid Leukemia (AML)

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Turkey
Czechia
France
Portugal
Switzerland
United States
Belgium
Italy
Norway
Austria
Spain
Taiwan
Bulgaria
Israel


acronym: POLARIX

lead_sponsor: Hoffmann-La Roche

summary: This Phase III, randomized, double-blind, placebo-controlled study will compare the efficacy, safety, and pharmacokinetics of polatuzumab vedotin plus R-CHP versus R-CHOP in participants with previously untreated diffuse large B-cell lymphoma (DLBCL).

ReferenceCitation: Varma G, Wang J, Diefenbach C. Polatuzumab vedotin in relapsed / refractory aggressive B-cell lymphoma. Expert Rev Anticancer Ther. 2022 Aug;22(8):795-803. doi: 10.1080/14737140.2022.2093191. Epub 2022 Jun 27.

publisher_dissemination: Informa

ReferenceCitation: Tilly H, Morschhauser F, Sehn LH, Friedberg JW, Trneny M, Sharman JP, Herbaux C, Burke JM, Matasar M, Rai S, Izutsu K, Mehta-Shah N, Oberic L, Chauchet A, Jurczak W, Song Y, Greil R, Mykhalska L, Bergua-Burgues JM, Cheung MC, Pinto A, Shin HJ, Hapgood G, Munhoz E, Abrisqueta P, Gau JP, Hirata J, Jiang Y, Yan M, Lee C, Flowers CR, Salles G. Polatuzumab Vedotin in Previously Untreated Diffuse Large B-Cell Lymphoma. N Engl J Med. 2022 Jan 27;386(4):351-363. doi: 10.1056/NEJMoa2115304. Epub 2021 Dec 14.

evidence: open (via free article)

repository_institution: Washington University School of Medicine - Digital Commons@Becker

publisher_dissemination: Massachusetts Medical Society

location_facility: West Virginia Uni Med. Center - Robert Byrd Health Science

location_facility: Auckland City Hospital, Cancer and Blood Research

location_facility: Florida Cancer Specialists & Research Institute

location_facility: Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital

location_facility: Westmead Hospital; Outpatient Pharmacy University Clinic

location_facility: Barts Health NHS Trust; Bartholomew's H., King George V Building

location_facility: University of Michigan Health System; UMH Internal Medicine/Hematology-Oncology

location_facility: Washington University; Wash Uni. Sch. Of Med

location_facility: Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O)

location_facility: Roswell Park Cancer Institute; Grace Cancer Drug Center

location_facility: InVO - Institut für Versorgungsforschung in der Onkologie GbR

location_facility: Univerzita Karlova v Praze 1. Lekarska Fakulta

location_facility: AUSL di Reggio Emilia, IRCCS, P.O. Arcispedale Santa Maria Nuova

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: Texas Oncology San Antonio Medical Center

location_facility: Emory University; Investigational Drug Service

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust. Freeman Hospital

location_facility: Fakultni Nemocnice Kralovske Vinohrady (FNKV); Interni Hematologicka Klinika

location_facility: Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences

location_facility: Pôle de Cancérologie ? CHU de Saint?Etienne'

location_facility: Medizinische Universitaet Innsbruck - Universitaetsklinik fuer Innere Medizin III

location_facility: University Hospital Kyoto Prefectural University of Medicine

location_facility: University of Louisville Hospital; The James Graham Brown Cancer Center

location_facility: Seattle Cancer Care Alliance; Investigational Drug Service

location_facility: Fakultni Nemocnice Hradec Kralove (FNHK); IV. Interni Hematologicka Klinika

location_facility: Centre Hospitalier de La Cote Basque; Hematologie

location_facility: Canterbury Health Laboratories; Immunology/Rheumatology

location_facility: Universita degli Studi Di Brescia - Azienda Ospedaliera Spedali Civili di Brescia

location_facility: Feofaniya Center of Haematology and Chemotherapy of Haemoblastosis

location_facility: Clinique Victor Hugo - Centre Jean Bernard

location_facility: Kobe City Medical Center General Hospital

location_facility: University of Pittsburgh Medical Center Cancer Center; Pharmacy

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: CIUSSS de l Est de l Ile de Montreal - Hopital Maisonneuve Rosemont

location_facility: Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology

location_facility: Pusan National University Yangsan Hospital; hemato-oncology

location_facility: Tennessee Oncology - Chattanooga; Tennessee Oncology - East Third Street

location_facility: Khmelnytskyi Regional Hospital; Department of Hemathology

location_facility: Memorial Sloan Kettering Cancer Center at Westchester

location_facility: Centre Hospitalier de l'Universite de Montreal - Pavillon E (PEA)

location_facility: East Kent Hospitals University NHS Foundation Trust

location_facility: CH Bretagne Atlantique; Médecine interne

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Centro de Hematologia e Hemoterapia - HEMOCENTRO UNICAMP

location_facility: Samodzielny Publiczny Zak?ad Opieki Zdrowotnej Zespó? Szpitali Miejskich w Chorzowie

location_facility: Centre Hospitalier de Quimper Cornouaille (CHIC); Médecine interne-Maladies du sang

location_facility: Hopital Pontchaillou; Hematologie Clinique

location_facility: Ohio State University; B406 Starling-Loving Hall

location_facility: Oncology Associates of Southwest Virginia, Inc.

location_facility: Hopital Henri Mondor; Hematologie Clinique

location_facility: SPZOZ Ministerstwa Spraw Wewn?trznych i Administracji w Poznaniu; Oddzia? Hematologii

location_facility: University Health Network; Princess Margaret Hospital; Medical Oncology Dept

location_facility: Institut Gustave Roussy; Unite D'Hematologie

location_facility: Wojskowy Instytut Medyczny - Panstwowy Instytut Badawczy

location_facility: CHRU DE STRASBOURG; Département d?Hématologie et Oncologie

location_facility: University of North Carolina at Chapel Hill

location_facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine

location_facility: CHU Amiens - Hopital Sud; Hematologie Clinique et Therapie Cellulaire

location_facility: Wiener Gesundheitsverbund ? Klinik Ottakring

location_facility: Paracelsus Medizinischen Privatuniversitaet-Salzburger Landeskliniken (SALK)

location_facility: Azienda Ospedaliera Universitaria Senese

location_facility: Austin Hospital; Cancer Clinical Trials Centre

location_facility: Ronald Reagan UCLA Medical Center; Drug Information Center

location_facility: Universitätsspital Basel Gynäkologie - Onkologie

location_facility: Hôpital Albert Michallon; Hematologie Clinique

location_facility: Dana Farber Cancer Institute; Lymphoma Program

location_facility: Nottingham City Hospital; Dept of Haematology

location_facility: Centrum Onkologii-Instytut im. M. Sklodowskiej Curie

location_facility: Institut d'Hématologie de Basse Normandie

location_facility: L'Union Mutualiste de la Gestion des Eaux Claires - Institut Daniel Hollard

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori - s.c. Ematologia

location_facility: The University of Adelaide - The Queen Elizabeth Hospital (TQEH)

location_facility: Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic

location_facility: Ankara University Faculty of Medicine Cebeci Hospital

location_facility: Vehbi Koc Vakfi (VKV) - Amerikan Hastanesi

location_facility: Hirslanden Medical Center - Tumorzentrum

location_facility: Universita degli Studi di Roma ''La Sapienza" - Clinica Ematologica

location_facility: Hôpital Saint-Louis; Service d'Hématologie

location_facility: Gh Necker Enfants Malades; Hematologie Clinique

location_facility: Levine Cancer Institute - Clincal Trials Administration

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology

location_facility: Hopital Cantonal Universitaire De Geneve

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: University Hospitals of Leicester NHS Trust - Leicester Royal Infirmary

location_facility: Oncology/Hematology Care Clinical Trials LLC

location_facility: Shanghai East Hospital, Tongji University

location_facility: Azienda Ospedaliero Universitaria Maggiore della Carita di Novara

location_facility: Kaohsiung Medical University Hospital, Cancer Center

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: University of Utah; Huntsman Cancer Hospital

location_facility: MNE Lviv Territorial Medical Association Clinical Hospital for Palliative Care

location_facility: China Medical University Hospital; Clinical Research Center Clinical Pharmacy

location_facility: National Cancer Center; Medical Oncology

location_facility: McMaster University Medical Center, Juravinski Cancer Centre, Hamilton Health Sciences

location_facility: Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino; Ospedale Molinette

location_facility: Wojewódzki Szpital Specjalistyczny im. M. Kopernika; Klinika Hematologii UM w ?odzi

location_facility: Memorial Sloan Kettering Cancer Center - Commack

location_facility: Hopital Haut-Leveque - Centre Francois Magendie; Service d'Hematologie Clinique

location_facility: Communal Institution 'Cherkassy Regional Oncology Dispensary' of the Cherkassy Regional Council

location_facility: University Hospitals Case Medical Center

location_facility: Hospital of the University of Pennsylvania

location_facility: The First Affiliated Hospital of College of Medicine, Zhejiang University

location_facility: Centre Hospitalier de Saint Brieuc - Hôpital Yves Le Foll

location_facility: Northwest Cancer Specialists - Portland (SW Barnes Rd)

location_facility: Medical University of South Carolina Hospital

location_facility: Fox Chase Cancer Center; Hematology/Oncology

location_facility: Tianjin Medical University Cancer Institute & Hospital

location_facility: Florida Cancer Specialists - Fort Myers (New Hampshire Ct)

title: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of Polatuzumab Vedotin in Combination With Rituximab and CHP (R-CHP) Versus Rituximab and CHOP (R-CHOP) in Previously Untreated Patients With Diffuse Large B-Cell Lymphoma

location_country:
Germany
Poland
New Zealand
Australia
Brazil
Japan
Turkey
Czechia
Canada
France
Hong Kong
Switzerland
United States
Ukraine
Belgium
China
Italy
United Kingdom
Austria
Korea, Republic of
Spain
Taiwan
Russian Federation


summary: This is a Phase III, multicenter, open-label, randomized study designed to evaluate the efficacy, safety, and pharmacokinetics of cobimetinib plus atezolizumab compared with pembrolizumab in treatment-naive participants with advanced BRAFV600 wild-type melanoma.

ReferenceCitation: de Azevedo SJ, de Melo AC, Roberts L, Caro I, Xue C, Wainstein A. First-line atezolizumab monotherapy in patients with advanced BRAFV600 wild-type melanoma. Pigment Cell Melanoma Res. 2021 Sep;34(5):973-977. doi: 10.1111/pcmr.12960. Epub 2021 Feb 15.

publisher_dissemination: Wiley

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Metropolitan Hospital; Dept. of Oncology

location_facility: Hospital Universitario Miguel Servet; Servicio Oncologia

location_facility: University Hospitals of North Midlands NHS Trust-Royal Stoke University Hospital

location_facility: Hospital Universitario Son Espases; Servicio de Oncologia

location_facility: Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O)

location_facility: Dartmouth-Hitchcock Medical Center; Hematology/Oncology

location_facility: Hospital Universitario Virgen Macarena; Servicio de Oncologia

location_facility: Zentrum für Dermatoonkologie, Universitäts-Hautklinik Tübingen

location_facility: Centre Hospitalier Le Mans; Dermatologie

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Oncologia

location_facility: Thomas Jefferson University Hospital;Medical Oncology

location_facility: IRCCS Istituto Nazionale Tumori Fondazione Pascale; Oncologia Medica B

location_facility: Johannes Wesling Klinikum Minden; Hämatologie, Onkologie, Hämostaseologie und Palliativmedizin

location_facility: Orszagos Onkologiai Intezet; Borgyogyaszati Osztaly

location_facility: Amphia Ziekenhuis, locatie Langendijk;Oncology

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

location_facility: Pecsi Tudomanyegyetem AOK; Borgyogyaszati Klinika

location_facility: Clinica Universitaria de Navarra; Servicio de oncología

location_facility: University of Szeged Szent-Györgyi Albert Clinical Center; Department of Dermatology and Allergology

location_facility: Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia

location_facility: Western General Hospital; Edinburgh Cancer Center

location_facility: IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A

location_facility: Hospital Clínic i Provincial; Servicio de Oncología

location_facility: University of California at Irvine Medical Center; Department of Oncology

location_facility: Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu.

location_facility: Medizinische Hochschule Hannover; Klinik für Dermatologie, Allergologie und Venerologie

location_facility: TriHealth Hatton Institute; Surgical Education

location_facility: M.D Anderson Cancer Center; Uni of Texas At Houston

location_facility: Forsythe Memorial Hospital Inc., dba Novant Health Oncology Specialists

location_facility: Klinik Johann Wolfgang von Goethe Uni; Klinik für Dermatologie, Venerologie und Allergologie

location_facility: Antoni Van Leeuwenhoek Ziekenhuis; Inwendige Geneeskunde

location_facility: Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia

location_facility: Erasmus Mc - Daniel Den Hoed Kliniek; Interne Oncologie

location_facility: USC Norris Cancer Center; USC Oncology Hematology Newport Beach

location_facility: Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico

location_facility: Copernicus Podmiot Medyczny Sp. z o.o. Wojewodzkie Centrum Onkologii

location_facility: Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii

location_facility: A.O.U. Cons. Policlinico Bari - Consorzlale Policlinico; Scienze Biomediche e Oncologia Umana

location_facility: FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"

location_facility: Centre Eugene Marquis; Service d'oncologie

location_facility: Instituto Nacional de Cancer - INCa; Oncologia

location_facility: Massachusetts General Hospital;Hematology/ Oncology

location_facility: HELIOS Klinikum Erfurt; Klinik für Dermatologie & Allergologie

location_facility: Azienda Osp Uni Seconda Università Degli Studi Di Napoli; Unità Operativa Oncologia Medica

location_facility: Guys & St Thomas Hospital; Department of Oncology

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Hopital l Archet 2; Ginestriere, Service de; Dermatologie

location_facility: A.O. Universitaria Policlinico Di Modena; Ematologia

location_facility: Groupe Hospitalier Bichat Claude Bernard

location_facility: Hopital Saint Andre CHU De Bordeaux; Dermatologie

location_facility: SRH Wald-Klinikum Gera; Klinik für Hautkrankheiten und Allergologie

location_facility: City of Hope Comprehensive Cancer Center

location_facility: Instituto Valenciano Oncologia; Oncologia Medica

location_facility: UKSH Kiel; Klinik für Dermatologie, Venerologie und Allergologie

location_facility: Klinikum der Ludwigs-Maximilians-Universität München; Dermatologie

location_facility: COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej

location_facility: Azienda Ospedaliero - Universitaria Pisana U.O. Oncologia Medica 2 Universitaria - Polo Oncologico

location_facility: Zachodniopomorskie Centrum Onkologii, Osrodek Innowacyjnosci, Rozwoju i Badan Klinicznych

location_facility: UF Health Cancer Center at Orlando Health

location_facility: Hospital General Universitario de Valencia; Servicio de oncologia

location_facility: Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Dermatologie

location_facility: University of Michigan; Michigan Institute for Clinical and Health Research (MICHR)

location_facility: Universitatsklinikum Essen; Klinik für Dermatologie

location_facility: Anticancer Hospital Ag. Savas ; 2Nd Dept. of Oncology - Internal Medicine

location_facility: Hopital Charles Nicolle; Dermatologie Serv.

location_facility: FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"

location_facility: Universitatsklinikum Mainz; Klinik und Poliklinik fur Dermatologie

location_facility: Leicester Royal Infirmary; Dept. of Medical Oncology

location_facility: Klinikum Mannheim Klinik fuer Dermatologie, Venerologie und Allergologie

location_facility: BRISTOL ONCOLOGY CENTRE; CLINICAL TRIALS UNIT; R & D department

location_facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2

location_facility: Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica

location_facility: IFO - Istituto Regina Elena; Oncologia Medica

title: A Phase III, Open-Label, Multicenter, Two Arm, Randomized Study to Investigate the Efficacy and Safety of Cobimetinib Plus Atezolizumab Versus Pembrolizumab in Patients With Previously Untreated Advanced BRAF V600 Wild-Type Melanoma

location_country:
Germany
Italy
Poland
Hungary
United Kingdom
Australia
Brazil
Netherlands
Belgium
United States
Korea, Republic of
Spain
Greece
Russian Federation
France


title: A Phase 2, Open-Label, 2-Cohort, Multicenter Study of INCB050465, a PI3Kδ Inhibitor, in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a BTK Inhibitor (CITADEL-205)

summary: This is a Phase 2, open-label, 2-cohort study designed to evaluate the efficacy and safety of 2 parsaclisib treatment regimens in participants with relapsed or refractory mantle cell lymphoma (MCL) previously treated either with or without a Bruton's tyrosine kinase (BTK) inhibitor.

design_allocation: Non-Randomized

ipd_sharing_description: Individual participant data (IPD) will be made available to interested researchers after the end of study, a thorough analysis, and the publication of the data in the clinical study report (CSR). As required, results of the data will be posted to ClinicalTrials.gov. Upon request, individual investigators may obtain IPD from the sponsor. The format for data delivery will be determined between sponsor and investigator.

lead_sponsor: Incyte Corporation

location_country:
Germany
Italy
Poland
Israel
United Kingdom
Denmark
Belgium
United States
Spain
Czechia
France

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: Hadassah Hebrew University Medical Center Ein Karem Hadassah

location_facility: Hospices Civils de Lyon Centre Hospitalier Lyon Sud

location_facility: Beskidzkie Centrum Onkologii Im.Jana Pawla Ii

location_facility: Hospital General Universitario Morales Meseguer

location_facility: Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza

location_facility: Chru Hopitaux de Tours, Hospital Bretonneau

location_facility: Nu-Med Centrum Diagnostykii I Terapii Onkologicznej

location_facility: Hospital Universitario Y Politecnic La Fe

location_facility: Yakima Valley Memorial Hospital/North Star

location_facility: Centre Hospitalier Departemental - La-Roche-Sur-Yon - Les Oudairies

location_facility: Fondazione Irccs Istituto Nazionale Dei Tumori

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Centre Hospitalier Universitaire Henri Mondor

location_facility: University College London Hospitals (Uclh)

location_facility: Centrum Onkologii-Instytut Im. Marii Sklodowskiej-Curie

location_facility: Hospital General Universitari Vall D Hebron

location_facility: Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle Scotte

location_facility: Szpital Specjalistyczny W Brzozowie, Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza

location_facility: Universitaire Ziekenhuis Leuven - Gasthuisberg

location_facility: University of Alabama At Birmingham Comprehensive Cancer Center

location_facility: Fundacion Jimenez Diaz University Hospital

location_facility: Fakultni Nemocnice Kralovske Vinohadry, Interni Hematologicka Klinika

location_facility: Odense Universitetshospital (Ouh) (Odense University Hospital)

location_facility: Rabin Medical Center - Beilinson Hospital

location_facility: Chu de Clermont - Ferrand- Hospital Estaing

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii

location_facility: Centre Hospitalier Universitaire de Poitiers


title: Randomized, Double-Blind, Placebo-Controlled, Three-Arm, 12-Month, Safety and Efficacy Study of TRx0237 Monotherapy in Subjects With Alzheimer's Disease Followed by a 12-Month Open-Label Treatment

summary: The purpose of this study is to determine the safety and efficacy of TRx0237 16 mg/day and 8 mg/day in the treatment of subjects with Alzheimer's Disease compared to placebo. In addition, an open-label, delayed-start phase is included to demonstrate a disease-modifying effect of TRx0237.

lead_sponsor: TauRx Therapeutics Ltd

location_country:
Italy
Poland
United Kingdom
Belgium
United States
Spain
Canada
France

location_facility: NZOZ Wielospecjalistyczna Poradnia Lekarska Synapsis

location_facility: Neuro-Behavioral Clinical Research, Inc.

location_facility: Georgia Neurology and Sleep Medicine Associates

location_facility: Josephson Wallack Munshower Neurology P.C.

location_facility: CRC Gerontopole Cite de la Sante, Hôpital La Grave

location_facility: Alzheimer's Research and Treatment Center

location_facility: Clinica Neurologica Santa Maria della Misericordia

location_facility: IRCCS Centro S. Giovanni di Dio Fatebenefratelli

location_facility: Azienda Ospedaliera San Gerardo - Clinica Neurologica

location_facility: University of Perugia, Ospedale S.M. della Misericordia

location_facility: Ospedale San Giovanni Calibita Fatebenefratelli

location_facility: Emerald Coast Center for Neurological Disorders

location_facility: Miami Dade Medical Research Institute, LLC

location_facility: Istituto Neurologico Casimiro Mondino, IRCCS

location_facility: L&C Professional Medical Research Institute

location_facility: Hospital Universitario QuironSalud Madrid

location_facility: Centro de salud de San Juan, Unidad de Investigación Neurociencias


title: A Phase 2, Randomized, Open-Label Study Comparing Oral Ixazomib/Dexamethasone and Oral Pomalidomide/Dexamethasone in Relapsed and/or Refractory Multiple Myeloma

summary:
The main aim of this study is to learn if ixazomib, given with dexamethasone, stops the cancer from getting worse in people with relapsed or refractory multiple myeloma. It will be compared to another medicine called pomalidomide, given with dexamethasone with people with the same condition. Relapsed means the previous cancer treatment stopped working, over time. Refractory means they did not respond to previous cancer treatment. Another aim is to check for side effects from the study medicines.

At the first visit, the study doctor will check who can take part. Participants who can take part will be picked for 1 of 2 treatments by chance.

Ixazomib capsules, given with dexamethasone tablets
Pomalidomide capsules, given with dexamethasone tablets

All participants will take their study medicine on specific days during a 28-day cycle.

The 1st dose of study medicines in each 28-day cycle will take place in the clinic, The other doses of the study medicines will be taken at home. This will happen for 6 cycles. After this, all study medicines will be taken at home.

After treatment, participants will visit the clinic every 12 weeks for a check-up.

If participants cannot attend their clinic for an important reason (for example, due to the COVID-19 pandemic), the clinic will make alternative arrangements using their local procedures.

ReferenceCitation: Dimopoulos MA, Schjesvold F, Doronin V, Vinogradova O, Quach H, Leleu X, Montes YG, Ramasamy K, Pompa A, Levin MD, Lee C, Mellqvist UH, Fenk R, Demarquette H, Sati H, Vorog A, Labotka R, Du J, Darif M, Kumar S. Oral ixazomib-dexamethasone vs oral pomalidomide-dexamethasone for lenalidomide-refractory, proteasome inhibitor-exposed multiple myeloma: a randomized Phase 2 trial. Blood Cancer J. 2022 Jan 24;12(1):9. doi: 10.1038/s41408-021-00593-2.

repository_institution: University of Oslo - Duo Research Archive

repositories_concat: PubMed Central;www.duo.uio.no

ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

lead_sponsor: Millennium Pharmaceuticals, Inc.

location_country:
Germany
Italy
Israel
Norway
Denmark
Australia
Sweden
Netherlands
United Kingdom
Belgium
United States
Spain
Greece
Turkey
Czechia
Canada
Russian Federation
France

location_facility: Centre Antoine Lacassagne Centre Regional de Lutte Contre Le Cancer

location_facility: Hospital Universitari de Girona Dr Josep Trueta

location_facility: Azienda Ospedaliero Universitaria Di Modena Policlinico

location_facility: Theageneio Anticancer Oncology Hospital of Thessaloniki

location_facility: Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST

location_facility: Azienda Sanitaria Ospedaliera S Luigi Gonzaga

location_facility: ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia

location_facility: Ege Universitesi Tip Fakultesi Hastanesi

location_facility: Erciyes Universitesi Tip Fakultesi Hastanesi

location_facility: Oslo Universitetssykehus HF Rikshospitalet

location_facility: Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi

location_facility: Kirov Research Institute of Haematology and Blood Transfusion

location_facility: Centre Hospitalier Bretagne Atlantique Vannes

location_facility: Azienda Ospedaliera Ospedali Riuniti Marche Nord

location_facility: Fondazione del Piemonte per lOncologia (IRCCS)

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

location_facility: Gazi University Medical Faculty Gazi Hospital

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Centre Jean Bernard Clinique Victor Hugo

location_facility: Uberortliche Gemeinschaftspraxis Pasing und Furstenfeldbruck

location_facility: Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi

location_facility: Ankara University Medical Faculty Cebeci Hospital

location_facility: Centro Di Riferimento Oncologico Della Basilicata

location_facility: Azienda Ospedaliera Citta della Salute e della Scienza di Torino

location_facility: Hospital d Instructions des Armees Percy


acronym: ANDHI

summary: The purpose of this study is to investigate the effect of benralizumab on the rate of asthma exacerbations, patient reported quality of life and lung function during the 24-week treatment in patients with uncontrolled, severe asthma with an eosinophilic phenotype. A subset of patients will be assessed for their ongoing chronic rhinosinusitis with nasal polyps. The study design has been updated to include a 56-week open label ANDHI in Practice (ANDHI IP) sub study upon the completion of the 24-week double-blind period of the ANDHI study.

ReferenceCitation: Chong LY, Piromchai P, Sharp S, Snidvongs K, Webster KE, Philpott C, Hopkins C, Burton MJ. Biologics for chronic rhinosinusitis. Cochrane Database Syst Rev. 2021 Mar 12;3(3):CD013513. doi: 10.1002/14651858.CD013513.pub3.

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

repository_institution: University of East Anglia - UEA Digital Repository

ReferenceCitation: Harrison TW, Chanez P, Menzella F, Canonica GW, Louis R, Cosio BG, Lugogo NL, Mohan A, Burden A, McDermott L, Garcia Gil E, Zangrilli JG; ANDHI study investigators. Onset of effect and impact on health-related quality of life, exacerbation rate, lung function, and nasal polyposis symptoms for patients with severe eosinophilic asthma treated with benralizumab (ANDHI): a randomised, controlled, phase 3b trial. Lancet Respir Med. 2021 Mar;9(3):260-274. doi: 10.1016/S2213-2600(20)30414-8. Epub 2020 Dec 22. Erratum In: Lancet Respir Med. 2021 Jan 25;:

repositories_concat: HAL

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

title: A Multicenter, Randomized, Double-blind, Parallel Group, Placebo Controlled, Phase 3b Study to Evaluate the Safety and Efficacy of Benralizumab 30 mg sc in Patients With Severe Asthma Uncontrolled on Standard of Care Treatment

location_country:
Finland
Germany
Italy
Norway
United Kingdom
Denmark
Sweden
Netherlands
Austria
Belgium
United States
Spain
Canada
France


acronym: TANGO

lead_sponsor: Biogen

summary:
The primary objective of the placebo-controlled period is to evaluate the safety and tolerability of BIIB092 in participants with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or with mild AD. The secondary objectives of the placebo-controlled period are to evaluate the efficacy of multiple doses of BIIB092 in slowing cognitive and functional impairment in participants with MCI due to AD or with mild AD, and to evaluate the immunogenicity of BIIB092 after multiple doses in participants with MCI due to AD or with mild AD.

The primary objective of the long-term extension period is to evaluate the long-term safety and tolerability of BIIB092 in participants with MCI due to AD or with mild AD.

location_facility: Charite - Campus Berlin Buch, Experimental and Clinical Research Center (ECRC)

location_facility: Brigham and Women's Hospital Department of Neurology

location_facility: Synexus Clinical Research US, Inc. - The Villages

location_facility: Irvine Center for Clinical Research, Inc.

location_facility: Synexus Clinical Research US, Inc. - Orlando

location_facility: Azienda Ospedaliero Universitaria Policlinico Paolo

location_facility: Rhode Island Mood & Memory Research Institute

location_facility: Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza

location_facility: Cleveland Clinic Lou Ruvo Center for Brain Health

location_facility: Mazowiecki Szpital Wojewódzki w Warszawie Sp z oo

location_facility: Studienzentrum fur Neurologie und Psychiatrie

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie

location_facility: Emory University Cognitive Neurology Clinic & ADRC

location_facility: Advanced Memory Enhancement Center of NJ

location_facility: Sahlgrenska Universitetssjukhuset, Mölndal Sjukhus

location_facility: The Research Center of Southern California

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: ISPG - Institut fuer Studien zur Psychischen Gesundheit

location_facility: The Cognitive Research Center of New Jersey

location_facility: New York University Medical Center PRIME

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet

location_facility: Mary S. Easton Center for Alzheimer's Disease Research, UCLA

location_facility: Neuropsychiatric Research Center of Southwest Florida

location_facility: IRCCS Centro San Giovanni di Dio Fatebenefratelli

location_facility: Research Center for Clinical Studies West

location_facility: Groupe Hospitalier Pellegrin - Hôpital Pellegrin

location_facility: Institut fuer Schlaganfall- und Demenzforschung (ISD)

title: Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety, Tolerability, and Efficacy of BIIB092 in Subjects With Mild Cognitive Impairment Due to Alzheimer's Disease or With Mild Alzheimer's Disease

ipd_sharing_description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/

location_country:
Germany
Italy
Poland
Australia
Japan
Sweden
United States
Spain
France


title: Phase 2 Study of MCLA-128-based Combinations in Metastatic Breast Cancer (MBC): MCLA-128/Trastuzumab/Chemotherapy in HER2-positive MBC and MCLA-128/Endocrine Therapy in Estrogen Receptor Positive and Low HER2 Expression MBC

summary:
A Phase 2, open-label, multicenter international study will be performed to evaluate the efficacy of MCLA-128-based combinations. Three combination treatments will be evaluated, two in Cohort 1 and one in Cohort 2.

MCLA-128 is given in combinations in two metastatic breast cancer (MBC) populations, HER2-positive/amplified (Cohort 1) and Estrogen Receptor-positive/low HER2 expression (Cohort2).

Two combinations treatments will be evaluated in Cohort 1, the doublet and triplet. Initially MCLA-128 is given in combination with trastuzumab in the doublet. After the safety of the doublet has been assessed in 4-6 patients, MCLA-128 is given in combination with trastuzumab and vinorelbine in the triplet, in parallel to the efficacy expansion of the doublet.

The doublet and triplet combinations are both evaluated in two steps with an initial safety run-in followed by a cohort efficacy expansion. In total up to 40 patients evaluable for efficacy are included in both the doublet and triplet.

In Cohort 2 MCLA-128 is administered in combination with the same previous endocrine therapy on which progressive disease is radiologically documented. A total of up to 40 patients evaluable for efficacy are included in the Cohort 2.

ipd_sharing: No

lead_sponsor: Merus N.V.

location_country:
Portugal
United Kingdom
Netherlands
Belgium
United States
Spain
France

location_facility: Vall D'Hebron Institute of Oncology (VHIO)