title: Multi-Country Prospective ObserVAtionaL, Cohort Study of Patients With Moderate to Severe Chronic PlaqUE Psoriasis (VALUE)

acronym: VALUE

summary: This study will assess the use of risankizumab in adult patients with moderate to severe chronic plaque psoriasis and compare risankizumab to other commonly used biologics.

lead_sponsor: AbbVie

location_country:
Saudi Arabia
Italy
Spain
United Kingdom
Romania
Japan
Czechia
Poland
Austria
Australia
Argentina
Mexico
Canada
Switzerland
Hungary
Germany
Ireland
France
Colombia
Netherlands
United Arab Emirates

location_facility: Hospital Universitario Principe de Asturias /ID# 225085

location_facility: CHU de CAEN - Hopital de la Cote de Nacre /ID# 216245

location_facility: CHU Grenoble - Hopital Michallon /ID# 218437

location_facility: Fakultni nemocnice Kralovske Vinohrady /ID# 233184

location_facility: Japan Community Health care Organization Tokyo Yamate Medical Center /ID# 213389

location_facility: SimcoDerm Medical and Surgical Dermatology Center /ID# 213081

location_facility: Imperial College Healthcare NHS Trust /ID# 215978

location_facility: Nippon Life Saiseikai Public Interest Foundation Nippon Life Hospital /ID# 224743

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 213670

location_facility: KKing Abdulaziz Medical City- National Guard Hospital /ID# 224354

location_facility: University of British Columbia - Eye Care Centre, Vancouver General Hospital /ID# 213507

location_facility: Al-Mohammedi Medicine Professional Corporation /ID# 215408

location_facility: Gemeinschaftspraxis Dres. Anika Hünermund/Mario Pawlak /ID# 213113

location_facility: Ospedale Policlinico San Martino /ID# 218844

location_facility: Azienda Ospedaliera Universitaria Mater Domini- Campus Salvatore Venuta /ID# 218902

location_facility: Kingsway Dermatology & Aesthetics /ID# 217616

location_facility: CH Bigorre - Site de la Gespe /ID# 218563

location_facility: Gemeinschaftspraxis Rietkoetter und Jablonka /ID# 213482

location_facility: Ospedale Fiorini di Terracina /ID# 218557

location_facility: CHR Metz-Thionville - Hopital Bel-Air /ID# 225691

location_facility: Praxis fuer Innere Medizin/Rheumatologie /ID# 213653

location_facility: Dr Maksym Breslavets Medicine Professional Corporation /ID# 213338

location_facility: Dr Melinda Gooderham Medicine Professional Corporation /ID# 212133

location_facility: Praxis Dres. Bornemann/Reinerth /ID# 213368

location_facility: Presidio Ospedaliero San Salvatore /ID# 218719

location_facility: Hospital Universitario Puerta de Hierro, Majadahonda /ID# 225084

location_facility: NewLab Clinical Research Inc. /ID# 213521

location_facility: Kansai Medical University Hospital /ID# 213388

location_facility: Tallaght University Hospital /ID# 212999

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 218720

location_facility: Matsuyama Red Cross Hospital /ID# 224745

location_facility: Hospital Universitario Severo Ochoa /ID# 225087

location_facility: Private Office Cristina Echeverria /ID# 222082

location_facility: Brinkmann & Partner, Gladbeck, /ID# 214247

location_facility: A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 219032

location_facility: Kingston Hospital NHS Foundation Trust /ID# 215973

location_facility: Sociedad de Cirugía de Bogotá- Hospital de San José /ID# 222683

location_facility: Clinica Los Arcos Iztapalapa /Id# 216982

location_facility: Università degli Studi di Firenze /ID# 221383

location_facility: IRCCS Istituto Ortopedico Galeazzi /ID# 218867

location_facility: Hôpital d'instruction des armées Bégin /ID# 216167

location_facility: CHU de Rennes - PONTCHAILLOU /ID# 218248

location_facility: Nagoya City University Hospital /ID# 213363

location_facility: Hospital Universitario de Salamanca /ID# 225078

location_facility: Centro Especializado en Diabetes, Obesidad y Prevencion de Enfermedades Cardiova /ID# 216979

location_facility: Fujita Health University Hospital /ID# 224742

location_facility: Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 212960

location_facility: Centralny Szpital Kliniczny MSWiA w Warszawie /ID# 225415

location_facility: Fundacion Hospital Universidad del Norte /ID# 223428

location_facility: Hospital Universitario de Getafe /ID# 225086

location_facility: South Eastern Health and Social Care Trust /ID# 215477

location_facility: Asahikawa Medical University Hospital /ID# 213409

location_facility: Lima's Excellence in Allergy and Dermatology Research Inc /ID# 231973

location_facility: Duplicate_Praxis Dres. Kloss/Peterburgskiy /ID# 213960

location_facility: Centre Hospitalier de CHAMBERY /ID# 217572

location_facility: Fondazione PTV Policlinico Tor Vergata /ID# 219031

location_facility: Centro Dermatologico Del Country S de Rl de Cv /Id# 225460

location_facility: Grupo Clinico Catei Sociedad Civil /Id# 216978

location_facility: University of the Ryukyus Hospital /ID# 213394

location_facility: Hospital Universitario de Puerto Real /ID# 225103

location_facility: Inselspital, Universitätsspital Bern /ID# 212741

location_facility: CH Annecy Genevois Site Annecy /ID# 225786

location_facility: Praxis Dr. Konstantin Ertner /ID# 213640

location_facility: Klinikum Wels-Grieskirchen GmbH /ID# 216140

location_facility: Frimley Health NHS Foundation Trust /ID# 215976

location_facility: King Saud University Med City /ID# 219065

location_facility: AOU Universita degli Studi della Campania Luigi Vanvitelli /ID# 218546

location_facility: Northampton General Hospital /ID# 249297

location_facility: CEDIC Centro de Investigaciones Clinicas /ID# 217184

location_facility: Nemocnice Ceske Budejovice a.s. /ID# 216310

location_facility: Waldhotel Health & Medical Excellence /Id# 212743

location_facility: Hospital Universitari Son Espases /ID# 233286

location_facility: Hospital Universitario Lucus Augusti /ID# 233282

location_facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 215479

location_facility: CHU Amiens-Picardie Site Sud /ID# 216170

location_facility: Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 222464

location_facility: Psoriahue Med Interdisciplinar /ID# 217182

location_facility: Fundacion hospitalaria San Vicente de Paul /ID# 222680

location_facility: University Hospital Kyoto Prefectural University of Medicine /ID# 213396

location_facility: Hamilton Health Sciences Corporation /ID# 214053

location_facility: Praxis Dres. Kaspari /Schenck /ID# 213649

location_facility: Hospital Universitario Virgen de Valme /ID# 225104

location_facility: RM Pharma Specialists S.A de C.V. /ID# 225458

location_facility: Emiliano Baccarini Priv Practice /ID# 218581

location_facility: CMS3 Company for Medical Study /ID# 213676

location_facility: Cwm Taf Morgannwg University Health Board /ID# 215974

location_facility: Hospital Universitario Ramon y Cajal /ID# 225093

location_facility: Hospital Clinico Universitario Lozano Blesa /ID# 231663

location_facility: Dermatologie Quist - BAG Dres. Quist PartG /ID# 214249

location_facility: The Dudley Group NHS Foundation Trust /ID# 215839

location_facility: Praxis Dres. Ziegler & Partner /ID# 213647

location_facility: Radboud Universitair Medisch Centrum /ID# 213592

location_facility: Centre de Recherche St-Louis /ID# 216325

location_facility: Sanatorium profesora Arenbergera /ID# 215489

location_facility: Cambridge University Hospitals NHS Foundation Trust /ID# 215972

location_facility: Hospital Universitario del Sureste /ID# 226561

location_facility: Debreceni Egyetem Klinikai Kozpont /ID# 212959

location_facility: Centro Dermatológico Federico Lleras Acosta E.S.E /ID# 222686

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 222025

location_facility: Neki Servicios Medicos Profesionales S D Rl de Cv /Id# 216977

location_facility: Instituto de Neumonología y Dermatología /ID# 217429

location_facility: DermaKiel Allergie und Haut Centrum /ID# 213977

location_facility: The Queen Elizabeth Hospital, Kings Lynn NHS Foundation Trust /ID# 215476

location_facility: COPERNICUS Podmiot Leczniczy Sp. z o.o. - Szpital sw. Wojciecha Adalberta /ID# 225446

location_facility: Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 218718

location_facility: Azienda Ospedaliera di Perugia /ID# 219033

location_facility: Tokyo Medical University Hospital /ID# 217125

location_facility: Studiengesellschaft an der Hase GbR Praxis Weyergraf/Frick/Heiber /ID# 214466

location_facility: Hospital Universitario Miguel Servet /ID# 225080

location_facility: Takamatsu Red Cross Hospital /ID# 222875

location_facility: Weihe/Stavermann, Berlin, DE /ID# 214550

location_facility: Hospital Clínico Universitario de Santiago-CHUS /ID# 225076

location_facility: Hospital Universitario 12 de Octubre /ID# 238474

location_facility: South Infirmary Victoria University Hospital /ID# 213001

location_facility: Dlugosz-Wolf, Luedenscheid, DE /ID# 222000

location_facility: Universitatsklinikum Mannheim /ID# 214569

location_facility: Azienda Ospedaliera Universitaria Consorziale Policlinico /ID# 218558

location_facility: Hautarztpraxis Dr. med. Matthias Hoffmann /ID# 213444

location_facility: Azienda Ospedaliera Universitaria Federico II /ID# 218808

location_facility: IRCCS Policlinico San Donato /ID# 222002

location_facility: Nippon Medical School Hospital /ID# 213391

location_facility: Labderm S.C. Beata Bergler-Czop, Barbara Sido-Bergler /Id# 225447

location_facility: Angela Montgomery Medicine Professional Corporation /ID# 213615

location_facility: Northern Care Alliance NHS Group /ID# 218589

location_facility: Hospital Universitario Virgen de las Nieves /ID# 225107

location_facility: Caja de Compensación Familiar Cafam, Sede Centro de Atención En Salud Cafam Flor /ID# 222660

location_facility: Breitsprecher, Osnabrueck, DE /ID# 213672

location_facility: Hôpital d'Instruction des Armées Sainte-Anne /ID# 218888

location_facility: Sandwell and West Birmingham Hospitals NHS Trust /ID# 249294

location_facility: Hospital General de Mostoles /ID# 225088

location_facility: Farheen Mussani Medicine Professional Corporation /ID# 213811

location_facility: Hospital General Universitario Gregorio Maranon /ID# 231664

location_facility: Hospital Alvaro Cunqueiro CHUVI /ID# 225077

location_facility: ASST Spedali civili di Brescia /ID# 218717

location_facility: Azienda ULSS 8 Berica/Ospedale San Bortolo di Vicenza /ID# 218845

location_facility: The Jikei University Hospital /ID# 213393

location_facility: Markusovszky Egyetemi Oktatokorhaz /ID# 212961

location_facility: Fakultni nemocnice Hradec Kralove /ID# 222670

location_facility: Hospital Universitario Austral /ID# 217540

location_facility: CH Pontoise - Hopital René Dubos /ID# 216169

location_facility: Hospital Virgen de la Concha /ID# 233285

location_facility: Haut. Venen. Allergie. Zentrum Brunnehof /ID# 212742

location_facility: CHU de SAINT ETIENNE - Hopital Nord /ID# 216663

location_facility: Hopital de la Cavale Blanche /ID# 216495

location_facility: Universitaetsklinikum Magdeburg /ID# 215080

location_facility: Universitaetsklinikum Erlangen /ID# 213669

location_facility: Takamatsu Red Cross Hospital /ID# 241120

location_facility: Hospital Universitario de Bajadoz /ID# 225091

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 212958

location_facility: Kingston Hospital NHS Foundation Trust /ID# 230856

location_facility: Spitalul Clinic Judetean de Urgenta Sf. Spiridon Iasi /Id# 214335

location_facility: Jichi Medical University Hospital /ID# 213403

location_facility: Azienda Ospedaliera di Padova /ID# 221299

location_facility: York and Scarborough Teaching Hospitals NHS Foundation Trust /ID# 227940

location_facility: University Hospital Limerick /ID# 216997

location_facility: Medizinische Universitaet Wien /ID# 216138

location_facility: Azienda Ospedaliero Universitaria Pisana-Stabilimento di Santa Chiara /ID# 218555

location_facility: St.Luke's International Hospital /ID# 213392

location_facility: Hospital Santa María del Rosell /ID# 225100

location_facility: Praxis Dr. med. Alexander Zich /ID# 245751


title: Stryker Neurovascular Trevo® Retriever Registry

summary: The purpose of the Trevo® Retriever Registry is to collect real world performance data of the Trevo Retriever which is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Nogueira RG, Haussen DC, Liebeskind D, Jovin TG, Gupta R, Jadhav A, Budzik RF, Baxter B, Krajina A, Bonafe A, Malek A, Narata AP, Shields R, Zhang Y, Morgan P, Bartolini B, English J, Frankel MR, Veznedaroglu E; Trevo Registry and DAWN Trial Investigators. Stroke Imaging Selection Modality and Endovascular Therapy Outcomes in the Early and Extended Time Windows. Stroke. 2021 Jan;52(2):491-497. doi: 10.1161/STROKEAHA.120.031685. Epub 2021 Jan 12.

lead_sponsor: Stryker Neurovascular

location_country:
Spain
Italy
Canada
Thailand
Switzerland
Hungary
Korea, Republic of
United States
France
Singapore
Germany
Czechia

location_facility: Peoria Radiology Research & Education Foundation

location_facility: California Pacific Medical Center (CPMC)

location_facility: Yale University / Yale-New Haven Hospital

location_facility: National Institute of Clinical Neurosciences

location_facility: Hospital Universitario Central De Asturias

location_facility: Good Samaritan Hospital Regional Medical Center

location_facility: University of Tennessee Medical Center Knoxville

location_facility: Center for Advanced Research Excellence (St. Mary's Medical Center)

location_facility: Methodist Healthcare - Memphis Hospitals

location_facility: La Fondation Ophtalmologique Adolphe de Rothschild

location_facility: St. Joseph's Hospital and Medical Center - Dignity Health (BNI Phoenix)

location_facility: Riverside Methodist Hospital/ Ohio Health Research Institute

location_facility: Emory University at Grady Memorial Hospital

location_facility: Oregon Stroke Center, Oregon Health & Science University (OHSU)

location_facility: Seoul National University Bundang Hospital

lead_sponsor_type: industriel

status_simplified: Completed


type: Other Identifier

title: Biomarker Study to Identify Subjects With Urothelial Cancer and Fibroblast Growth Factor Receptor Gene Aberrations

summary: The purpose of this non-interventional study is to identify participants with urothelial cancer (UC) and selected fibroblast growth factor receptor (FGFR) aberrations through molecular testing of their archival tumor tissue.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

lead_sponsor: Janssen Research & Development, LLC

location_country:
Brazil
Spain
Italy
Russian Federation
United Kingdom
Argentina
Ukraine
France
United States
Israel
Turkey
Belgium
Japan
Germany

location_facility: Polo Ospedaliero Unico Integrato- Presidio S.Camillo De Lellis Di Rieti

location_facility: State Budgetary Healthcare Institution Inter-regional Multi-specialty Hospital

location_facility: Izmir Katip Celebi University Ataturk Training and Research Hospital

location_facility: National Hospital Organization Sagamihara National Hospital

location_facility: Kartal Dr. Lutfi Kirdar Egitim ve Arastirma Hastanesi

location_facility: National Hospital Organization Mito Medical Center

location_facility: National Hospital Organization Osaka Minami Medical Center

location_facility: SCMI Santa Casa de Misericórdia de Itabuna

location_facility: Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospital

location_facility: Texas Oncology-Midland Allison Cancer Center

location_facility: SHI Sverdlovsk Regional Clinical Hospital #1

location_facility: Willamette Valley Cancer Institute and Research Center

location_facility: Communal Institution 'Regional Oncology Dispensary' of Zhytomyr Region Council

location_facility: Azienda Ospedaliera "Ospedale Civile" di Vimercate - Ospedal

location_facility: Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

location_facility: Associação Mário Penna/Núcleo de Ensino e Pesquisas

location_facility: Consultants in Medical Oncology and Hematology, P.C. - Abington

location_facility: Municipal Oncology Centre of Uzhgorod Central Municipal Clinical Hospitlal

location_facility: Communal Nonprofit Enterprise 'Regional Clinical Oncology Center of Kirovohrad Regional Council'

location_facility: Kitasato University Kitasato Institute Hospital

location_facility: Azienda Ulss 6 Euganea- Ospedale Di Camposampiero

location_facility: ME 'Poltava Regional Clinical Hospital n.a. M.V. Sklifosovsky of the Poltava Regional Council'

location_facility: Ospedale Buccheri La Ferla Fatebenefratelli

location_facility: Medical Oncology Hematology Consultants, PA

location_facility: Oncology Medical Clinics AV Medical group

location_facility: Municipal Non-profit enterprise 'Bukovinian clinical oncology center'

location_facility: Instituto de Oncologia de Sorocaba/Onco Clinicas Especializadas

location_facility: Azienda Ospedaliera Ospedale San Carlo Borromeo

location_facility: Adnan Menderes University Training and Research Hospital

location_facility: Cepeville - Centro de Hematologia e Oncologia

location_facility: IRPCC - Instituto Ribeiraopretano de Combate ao Cancer

location_facility: Hospital SS Annunziata - University G.D'Annunzio

location_facility: Azienda Ulss 8 Berica- Ospedale Di Vicenza

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

location_facility: Canakkale Onsekiz Mart University Health Practices and Research Hospital

location_facility: Santa Casa de Misericordia de Belo Horizonte

location_facility: Yaroslavl Regional Clinical Oncology Hospital

location_facility: Centre Hospitalier Eure-Seine - Hopitaux d'Evreux - Vernon

location_facility: Haydarpasa Numune Training and Research Hospital

location_facility: Instituto SENSUMED de Ensino e Pesquisa - Ruy França

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

location_facility: CHU de Liège - Domaine Universitaire du Sart Tilman

location_facility: SUBARU Health Insurance Society Ota Memorial Hospital

location_facility: Irmandade Santa Casa de Misericordia de Porto Alegre

location_facility: National Hospital Organization Osaka National Hospital

location_facility: FSBI A.V. Vishnevsky National Medical Research Center of Surgery of the MoH RF

location_facility: Dokkyo Medical University Saitama Medical Center

location_facility: Tomsk National Research Medical Center of the Russian Academy of Sciences

location_facility: Necmettin Erbakan University Meram Medical Faculty

location_facility: Communal Institution 'City hospital №7 of Kamianske' of Dnepropetrov'sk Regional Council

location_facility: Az. USL 12 di Viareggio Ospedale Versilia

location_facility: Texas Oncology-Baylor Charles A. Sammons Cancer Center

location_facility: Investigaciones Clinico Moleculares (ICM)

intervention_type: Other

status_simplified: Ongoing


status: Recruiting

primary_purpose: Treatment

intervention_type: Drug

acronym: Pan tumor Nivolumab Rollover Study

title: Pan-Tumor Study for Long Term Follow-up of Cancer Survivors Who Have Participated in Trials Investigating Nivolumab

lead_sponsor: Bristol-Myers Squibb

type: EudraCT Number

source: euctr

design_allocation: Non-Randomized

study_type: Interventional

enrollment_type: Anticipated

location_country:
Spain
Italy
United Kingdom
United States
Peru
Belgium
Japan
Romania
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
Israel
Mexico
Norway
Sweden
Brazil
Canada
Switzerland
Hungary
China
Germany
Denmark
Taiwan
Greece
Ireland
New Zealand
Finland
Korea, Republic of
France
Chile
Netherlands

location_facility: The University of Chicago Medical Center

location_facility: Hillman Cancer Center- U of Pitts Cancer Institute

location_facility: Fundacio Investigao Hospital General Universitario de Valencia FiHgU

location_facility: Centro Hospitalar de Lisboa Norte EPE - HPV

location_facility: UCSF Medical Center - Helen Diller Family Comprehensive Cancer Center - Melanoma Center

location_facility: GU Research Network/Urology Cancer Center

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alegre

location_facility: Centre Hospitalier Intercommunal de Creteil CHIC

location_facility: UniversitaetsSpital Zuerich - Dermatology

location_facility: Niigata University Medical and Dental Hospital

location_facility: Centro Oncologico y de Investigacion Buenos Aires

location_facility: Osaka Medical and Pharmaceutical University Hospital

location_facility: H. Lee Moffitt Cancer Center and Research Institute Hospital, Inc.

location_facility: Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

location_facility: Centro de Investigacion Clinica Montesur

location_facility: Pole Biologie Pathologie Genetique - CHU de Lille

location_facility: UW Health - UW Carbone Cancer Center - Medical Oncology Clinic

location_facility: University of Louisville-James Graham Brown Cancer Center

location_facility: Georgetown-Lombardi Comprehensive Cancer Center

location_facility: Instituto Portugues de Oncologio de Lisboa

location_facility: Centre Hospitalier Universitaire de Bordeaux Hospital Saint Andre

location_facility: Hospital Regional Universitario Carlos Haya

location_facility: Centro Oncologico MD ANDERSON Internacional Espana

location_facility: Advocate Medical Group - Park Ridge - Luther Ln - Oncology

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Orszagos Koranyi TBC es Pulmonologiai Intezet

location_facility: N.N. Blokhin National Medical Research Center of Oncology

location_facility: Cliniques Universitaires UCL de Mont-Godinne (CHU)

summary: Main Objective of this study is to examine long-term safety of nivolumab in participants on treatment and in follow up.


status: Terminated

title: LUME-Meso: Double Blind, Randomised, Multicentre, Phase II/III Study of Nintedanib in Combination With Pemetrexed / Cisplatin Followed by Continuing Nintedanib Monotherapy Versus Placebo in Combination With Pemetrexed / Cisplatin Followed by Continuing Placebo Monotherapy for the Treatment of Patients With Unresectable Malignant Pleural Mesothelioma

lead_sponsor: Boehringer Ingelheim

design_allocation: Randomized

ReferenceCitation: Scagliotti GV, Gaafar R, Nowak AK, Nakano T, van Meerbeeck J, Popat S, Vogelzang NJ, Grosso F, Aboelhassan R, Jakopovic M, Ceresoli GL, Taylor P, Orlandi F, Fennell DA, Novello S, Scherpereel A, Kuribayashi K, Cedres S, Sørensen JB, Pavlakis N, Reck M, Velema D, von Wangenheim U, Kim M, Barrueco J, Tsao AS. Nintedanib in combination with pemetrexed and cisplatin for chemotherapy-naive patients with advanced malignant pleural mesothelioma (LUME-Meso): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet Respir Med. 2019 Jul;7(7):569-580. doi: 10.1016/S2213-2600(19)30139-0. Epub 2019 May 15.

location_country:
Croatia
Spain
Italy
United Kingdom
United States
Belgium
Japan
South Africa
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
Israel
Turkey
Mexico
Norway
Sweden
Egypt
Canada
Germany
Denmark
France
Chile
Netherlands

location_facility: Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo

location_facility: FSBI "N.N Blokhin Med.Res.Cent.Onc."MoH of RF

location_facility: QEII Health Sciences Centre (Dalhousie University)

location_facility: Centro Hospitalar Lisboa Norte Hospital Pulido Valente

location_facility: Oslo Universitetssykehus HF, Radiumhospitalet

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: University Clinic for Pulmonary Diseases

location_facility: Istituto Nazionale per la Ricerca sul Cancro

location_facility: A.O.U. Senese Policlinico Santa Maria alle Scotte

location_facility: Centro Internacional de Estudios Clínicos - CIEC

location_facility: Greater PL Cent.Pulmo.&Thor.Surg.Eugenia&Janusz Zeyland

location_facility: Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg

location_facility: Eskisehir Osmangazi Üni. Sag. Uygulama ve Arastirma Has.

location_facility: St.Auton.Heal.Inst."Rep.Clin.Onc.Disp.of MoH of Rep. Tatarstan"

location_facility: Instituto Medico Especializado Alexander Fleming

location_facility: Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi

location_facility: University Hospital of Occupational and Environmental Health

location_facility: St. Olavs Hospital, Universitetssykehuset i Trondheim

location_facility: FSBI "N.N. Petrov National Medical Research Center of Oncology" of MoH of RF

location_facility: Onco.Cent. - Instit. of Maria Sklodowskiej-Curie

location_facility: Rigshospitalet, København, Onkologisk afdeling

location_facility: Azienda Sanitaria Ospedale S. Luigi Gonzaga

location_facility: Japan Labour Health and Safety Organization Okayama Rosai Hospital

location_facility: Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH

location_facility: Hyogo Prefectural Amagasaki General Medical Center

location_facility: National Cancer Institute, Cairo University

summary: This is a phase II/III confirmatory study designed to evaluate the safety and efficacy of nintedanib (BIBF 1120) in combination + (pemetrexed / cisplatin) followed by nintedanib (BIBF 1120) versus placebo + pemetrexed / cisplatin followed by placebo for the treatment of patients with unresectable malignant pleural mesothelioma.

status_simplified: Unknown


title: A Multicenter, Multiple-dose, Two-arm, Active-controlled, Double-blind, Double-dummy Study to Compare the Therapeutic Efficacy and Safety of Oral Doses of Cinacalcet HCl With Intravenous Doses of AMG 416 in Hemodialysis Subjects With Secondary Hyperparathyroidism

summary: The purpose of this study is to demonstrate that treatment with etelcalcetide (AMG 416) is not inferior to treatment with cinacalcet for lowering serum parathyroid hormone (PTH) levels by > 30% from baseline among patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT) who require management with hemodialysis.

ReferenceType: background

ReferenceCitation: Block GA, Bushinsky DA, Cheng S, Cunningham J, Dehmel B, Drueke TB, Ketteler M, Kewalramani R, Martin KJ, Moe SM, Patel UD, Silver J, Sun Y, Wang H, Chertow GM. Effect of Etelcalcetide vs Cinacalcet on Serum Parathyroid Hormone in Patients Receiving Hemodialysis With Secondary Hyperparathyroidism: A Randomized Clinical Trial. JAMA. 2017 Jan 10;317(2):156-164. doi: 10.1001/jama.2016.19468.

ReferenceCitation: Stollenwerk B, Iannazzo S, Akehurst R, Adena M, Briggs A, Dehmel B, Parfrey P, Belozeroff V. A Decision-Analytic Model to Assess the Cost-Effectiveness of Etelcalcetide vs. Cinacalcet. Pharmacoeconomics. 2018 May;36(5):603-612. doi: 10.1007/s40273-017-0605-2.

ReferenceCitation: Stollenwerk B, Iannazzo S, Cooper K, Belozeroff V. Exploring the potential value of improved care for secondary hyperparathyroidism with a novel calcimimetic therapy. J Med Econ. 2017 Oct;20(10):1110-1115. doi: 10.1080/13696998.2017.1360309. Epub 2017 Aug 14.

ReferenceCitation: Wu B, Melhem M, Subramanian R, Chen P, Jaramilla Sloey B, Fouqueray B, Hock MB, Skiles GL, Chow AT, Lee E. Clinical Pharmacokinetics and Pharmacodynamics of Etelcalcetide, a Novel Calcimimetic for Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease on Hemodialysis. J Clin Pharmacol. 2018 Jun;58(6):717-726. doi: 10.1002/jcph.1090. Epub 2018 Mar 13. Review.

ReferenceCitation: Block GA, Chertow GM, Sullivan JT, Deng H, Mather O, Tomlin H, Serenko M. An integrated analysis of safety and tolerability of etelcalcetide in patients receiving hemodialysis with secondary hyperparathyroidism. PLoS One. 2019 Mar 15;14(3):e0213774. doi: 10.1371/journal.pone.0213774. eCollection 2019.

ReferenceCitation: Wolf M, Block GA, Chertow GM, Cooper K, Fouqueray B, Moe SM, Sun Y, Tomlin H, Vervloet M, Oberbauer R. Effects of etelcalcetide on fibroblast growth factor 23 in patients with secondary hyperparathyroidism receiving hemodialysis. Clin Kidney J. 2019 Apr 26;13(1):75-84. doi: 10.1093/ckj/sfz034. eCollection 2020 Feb.

lead_sponsor: Amgen

location_country:
Spain
Italy
Lithuania
United States
Belgium
Czechia
Poland
Portugal
Austria
Russian Federation
Turkey
Sweden
Canada
Switzerland
Hungary
Germany
Denmark
Greece
Latvia
Estonia
New Zealand
France


title: A Multicenter, Controlled, Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of AMG 145

summary: This study will contribute to the evaluation of long-term safety, tolerability and efficacy of evolocumab (AMG 145) in adults with hyperlipidemia and adults with mixed dyslipidemia.

ReferenceCitation: Kasichayanula S, Grover A, Emery MG, Gibbs MA, Somaratne R, Wasserman SM, Gibbs JP. Clinical Pharmacokinetics and Pharmacodynamics of Evolocumab, a PCSK9 Inhibitor. Clin Pharmacokinet. 2018 Jul;57(7):769-779. doi: 10.1007/s40262-017-0620-7. Review.

ReferenceType: result

ReferenceCitation: Sattar N, Toth PP, Blom DJ, Koren MJ, Soran H, Uhart M, Elliott M, Cyrille M, Somaratne R, Preiss D. Effect of the Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitor Evolocumab on Glycemia, Body Weight, and New-Onset Diabetes Mellitus. Am J Cardiol. 2017 Nov 1;120(9):1521-1527. doi: 10.1016/j.amjcard.2017.07.047. Epub 2017 Jul 31.

ReferenceCitation: Hovingh GK, Raal FJ, Dent R, Stefanutti C, Descamps O, Masana L, Lira A, Bridges I, Coll B, Sullivan D. Long-term safety, tolerability, and efficacy of evolocumab in patients with heterozygous familial hypercholesterolemia. J Clin Lipidol. 2017 Nov - Dec;11(6):1448-1457. doi: 10.1016/j.jacl.2017.09.003. Epub 2017 Sep 22.

ReferenceCitation: Schmidt AF, Carter JL, Pearce LS, Wilkins JT, Overington JP, Hingorani AD, Casas JP. PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2020 Oct 20;10:CD011748. doi: 10.1002/14651858.CD011748.pub3.

ReferenceCitation: Sabatine MS, Giugliano RP, Wiviott SD, Raal FJ, Blom DJ, Robinson J, Ballantyne CM, Somaratne R, Legg J, Wasserman SM, Scott R, Koren MJ, Stein EA; Open-Label Study of Long-Term Evaluation against LDL Cholesterol (OSLER) Investigators. Efficacy and safety of evolocumab in reducing lipids and cardiovascular events. N Engl J Med. 2015 Apr 16;372(16):1500-9. doi: 10.1056/NEJMoa1500858. Epub 2015 Mar 15.

location_country:
Spain
Italy
United Kingdom
United States
South Africa
Belgium
Japan
Czechia
Poland
Hong Kong
Austria
Australia
Russian Federation
Norway
Sweden
Canada
Switzerland
Hungary
Germany
Denmark
Taiwan
New Zealand
Korea, Republic of
France
Netherlands

intervention_type: Biological


title: Multi-center Cross-sectional Epidemiological Study to Characterize the Prevalence and Distribution of Lipoprotein(a) Levels Among Patients With Established Cardiovascular Disease

summary: The study is conducted to improve knowledge about the epidemiology of Lipoprotein(a) in patients with established cardiovascular disease (CVD).

primary_purpose: Diagnostic

ipd_sharing: No

lead_sponsor: Novartis Pharmaceuticals

location_country:
Spain
Italy
United Kingdom
United States
Peru
Belgium
Iceland
Japan
Philippines
Romania
South Africa
Czechia
Poland
Hong Kong
Portugal
Slovenia
Austria
Australia
Russian Federation
Argentina
Puerto Rico
India
Israel
Turkey
Mexico
Norway
Malaysia
Sweden
Slovakia
Egypt
Brazil
Lebanon
Canada
Switzerland
Guatemala
Hungary
China
Germany
Bulgaria
Denmark
Taiwan
Greece
Thailand
Vietnam
Korea, Republic of
France
Chile
Colombia
Netherlands

intervention_type: Diagnostic Test


ipd_sharing: Yes

acronym: VESALIUS-CV

title: A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Impact of Evolocumab on Major Cardiovascular Events in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke

ipd_sharing_description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

location_country:
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
Belgium
Iceland
Romania
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
Mexico
Sweden
Slovakia
Brazil
Canada
Hungary
Germany
Bulgaria
Denmark
Taiwan
Greece
Latvia
Estonia
Finland
Korea, Republic of
France
Netherlands

location_facility: Multicare Institute for Research and Innovation

location_facility: University of North Carolina at Chapel Hill

location_facility: Almazov National Medical Research Centre

location_facility: Ordensklinikum Linz Barmherzige Schwestern

location_facility: Dr T G Elliott Incorporated - BC Diabetes

location_facility: Zakarpattia Oblast Clinical Center of Cardiology and Cardio Surgery

location_facility: Novant Health Heart and Vascular Institute

location_facility: Central Arkansas Veterans Healthcare System

location_facility: Clinique des Maladies Lipidiques de Quebec Incorporated

location_facility: Centre Hospitalier Universitaire de Lyon - Hopital Edouard Herriot

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Centre Hospitalier Universitair Ambroise Pare

location_facility: MUDr Ladislava Harrerova, kardiologicka ordinace

location_facility: Kardiologisch - Angiologische Praxis - Herzzentrum Bremen

location_facility: Spitalul Universitar de Urgenta Bucuresti

location_facility: Hudson Valley Cardiovascular Physicians PC

location_facility: Centre Hospitalier de Versailles - Hopital Andre Mignot

location_facility: Azienda Ospedaliero Universitaria Mater Domini

location_facility: Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz

location_facility: Centre Hospitalier Universitaire de Dijon - Hopital Francois Mitterrand

location_facility: Clinical Mayo de Urgencias Medicas Cruz Blanca SRL

location_facility: Bluewater Clinical Research Group Incorporated

location_facility: Medical Center for Specialized Medical Care of Cardiovascular Diseases OOD

location_facility: Tribe Clinical Research LLC DBA Mountain View Clinical Research

location_facility: City Clinical Hospital named after Zhadkevich

location_facility: Nebraska Western Iowa Health Care System

location_facility: Centre for Clinical and Basic Research Ballerup

location_facility: Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation

location_facility: FSBSI Tomsk National Research Medical Center of the Russian Academy of Sciences

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Zentrum fuer klinische Studien - Dr Hanusch GmbH

location_facility: State Institution National Scientific Center Acad MD Strazhesko Institute of cardiology of NAMS Ukr

location_facility: KO-MED Centra Kliniczne Spzoo KO-MED Centra Kliniczne Zamosc

location_facility: Vilnius University Hospital Santaros Clinic Public Institution

location_facility: Moscow SBHI City Clinical Hospital 15 n a O M Filatov of Moscow Healthcare Department

location_facility: Texas Institute for Kidney and Endocrine Disorders

location_facility: Center for Clinical and Basic Research Aalborg

location_facility: The Catholic University of Korea Seoul St Marys Hospital

location_facility: Saint Petersburg SBHI City Hospital 38 named after N A Semashko

location_facility: Szpital Uniwersytecki nr 1 im dr Antoniego Jurasza w Bydgoszczy

location_facility: University Multiprofile Hospital for Active Treatment Dr Georgi Stranski EAD

location_facility: Centre Hospitalier Universitaire de Grenoble - Hopital Nord Michallon

location_facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz

location_facility: University Multiprofile Hospital for Active Treatment Sveti Georgi EAD

location_facility: Wojewodzki Specjalistyczny Szpital im dr Wladyslawa Bieganskiego w Lodzi

location_facility: Northwell Health Lenox Hill Heart and Vascular

location_facility: SBHI of Vladimirskaya region City Hospital 4 of Vladimir

location_facility: FSBSI Scientific Research Institute of Therapy and preventive medicine

location_facility: Instituto de Investigaciones Clinicas Mar del Plata

location_facility: Seoul National University Bundang Hospital

location_facility: Universitaets-Herzzentrum Freiburg - Bad Krozingen

location_facility: Ciprec - Centro de Investigacion y Prevencion Cardiovascular

location_facility: Hospital Universitario Fundacion Favaloro

location_facility: Medinova East London Dedicated Research Centre

location_facility: Multiprofile Hospital for Active Treatment Sveta Anna Sofia AD

location_facility: Queen Elizabeth II Health Sciences Centre, Halifax Infirmary

location_facility: Communal Noncommercial Institution Consultative and Diagnostic Center of Desnianskyi District of Kyi

location_facility: Clinical Best Solutions Sp zoo Spolka komandytowa

location_facility: Szpital Grochowski imienia Doktora medycyny Rafala Masztaka Spzoo

location_facility: Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universität Frankfurt am Main

location_facility: Cardiology Associates of Fairfield County, PC

location_facility: Samodzielny Publiczny Zakład Opieki Zdrowotnej w Lecznej

location_facility: Universitaetsklinikum Carl Gustav Carus, Medizinische Klinik und Poliklinik III

location_facility: Specialty Hospital for Active treatment in Cardiology Sveti Georgi - Pernik OOD

location_facility: Central City Clinical Hospital 1 of the Oktyabrsky District

location_facility: Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska

location_facility: NZOZ Specjalistyczna Przychodnia Lekarska Medikard

location_facility: Ewa Mirek-Bryniarska Specjalistyczna Praktyka Lekarska

location_facility: Onze Lieve Vrouw Ziekenhuis - campus Aalst

location_facility: Regional Budget Healthcare Institution Cardiology Dispensary

location_facility: Curtin University Centre of Clinical Research and Education

location_facility: Kyiv City Clinical Emergency Medical Care Hospital

location_facility: Budget Healthcare Institution of Omsk region Medical-sanitary unit 9

location_facility: Vinnytsia M I Pyrogov Regional Clinical Hospital Vinnytsia M I Pyrogov National Medical University

location_facility: South Texas Cardiovascular Consultants PLLC

location_facility: Albert Schweitzer Ziekenhuis, Locatie Dordwijk

location_facility: Centro Hospitalar de Lisboa Ocidental, EPE - Hospital de Santa Cruz

location_facility: Specjalistyczna Poradnia Kardiologiczna i Nadcisnienia Tetniczego Beata Wozakowska-Kaplon

location_facility: SC Centrul Medical de Diagnostic si Tratament Ambulator Neomed S.R.L

location_facility: Medinova North London Dedicated Research Centre

location_facility: Treant Zorggroep, locatie Scheper ziekenhuis Emmen

location_facility: Centrum Kardiologiczne Pro Corde Spzoo Centrum Kardiologicne Pro Corde Wroclaw

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: SBHI of Nizhny Novgorod region Nizhny Novgorod regional clinical hospital na N A Semashko

location_facility: I Medizinische Klinik Gesundheitsverbund Landkreis Konstanz

location_facility: Centrum Medyczne Pulawska spzoo Centrum Medyczne Pulawska NZOZ

location_facility: Multiprofile Hospital for Active Treatment - Haskovo AD

location_facility: Hospital Clinico Universitario Virgen de la Victoria

location_facility: Miedziowe Centrum Zdrowia Spolka Akcyjna

location_facility: WMCHealth Heart and Vascular Institute Kingston Division of Cardiology

location_facility: Charite Universitätsmedizin Berlin, Charité Campus Virchow-Klinikum

location_facility: Dace Teterovska Doctor Practice in Endocrinology

location_facility: Harbor University of California Los Angeles Medical Center

location_facility: National Medical Research Center for therapy and preventive medicine

location_facility: Centre Hospitalier Régional Universitaire de Lille - Institut Coeur Poumon

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Jellinger and Lerman MD PA dba The Center for Diabetes and Endocrine Care

location_facility: Icba - Instituto Cardiovascular de Buenos Aires

location_facility: Universita degli Studi Gabriele D Annunzio di Chieti e Pescara

location_facility: Kirov Regional State Budget Healthcare Institution Kirov City Clinical Hospital 1

location_facility: State Budgetary Health Institution City Hospital 4 of the City of Sochi

location_facility: Northern Light Eastern Maine Medical Center

location_facility: MeDiNova West London Quality Research Site

location_facility: Centro Hospitalar do Baixo Vouga, EPE - Hospital Infante Dom Pedro

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

location_facility: Ambulatory for special outpatient medical aid in Cardiology-Private Practice Dr Elena Dotcheva EOOD

location_facility: Jacksonville Center for Clinical Research

location_facility: Policlinico Universitario Campus Biomedico

location_facility: Communal Noncommercial enterprise "City Hospital #8" of Kharkiv City Council

location_facility: Tomasz Blicharski Lubelskie Centrum Diagnostyczne

location_facility: Yonsei University Wonju Severance Christian Hospital

location_facility: Pauls Stradins Clinical University Hospital

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar

location_facility: State Budget Institution of Ryazan Region Regional Clinical Hospital

location_facility: Medizinisches Versorgungszentrum im Altstadt-Carree Fulda

location_facility: Centro Hospitalar e Universitario de Coimbra EPE

location_facility: Futuremeds spolka z ograniczona odpowiedzialnoscia

location_facility: McGill University Health Centre - Montreal General Hospital

location_facility: SBHI of Moscow City clinical hospital 64 of Moscow Healthcare department

location_facility: Regional State Budget Helthcare Institution Smolensk Regional Clinical Hospital

location_facility: First City Clinical Hospital na E E Volosevich

location_facility: Praxispont Belvarosi Maganegeszsegugyi Kozpont

location_facility: Centre Hospitalier Universitaire de Nimes

location_facility: Konstantopoulio - Agia Olga Hospital of Nea Ionia

location_facility: Institut de recherches cliniques de Montreal

location_facility: Universitair Ziekenhuis Leuven - Campus Gasthuisberg

location_facility: Zespol Przychodni Specjalistycznych Diab-End-Cor Sp z oo

location_facility: My Endo Diabetes and Endocrinology Center

location_facility: Dr Lakatos Ferenc Private Cardiology Practice

location_facility: MUDr Zbynek Kosek, kardiologicka ambulance sro

location_facility: Saint Petersburg State Budget Healthcare Institution Pokrovskaya City Hospital

location_facility: Sint Antonius Ziekenhuis, locatie Nieuwegein

location_facility: Intercard Spzoo Centrum Kardiologii Inwazyjnej Elektroterapii i Angiologii w Krosnie

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: Ziekenhuis Netwerk Antwerpen Stuivenberg

location_facility: Complexo Hospitalario Universitario A Coruña

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics Public Institution

location_facility: Deutsches Herzzentrum München des Freistaates Bayern

location_facility: Fondazione Toscana Gabriele Monasterio Ospedale del Cuore G Pasquinucci

location_facility: Instituto de Investigaciones Metabolicas - Idim

location_facility: Diagnostic-Consultative Center Convex EOOD

location_facility: Medinova South London Dedicated Research Centre

location_facility: Universitaetsklinikum Allgemeines Krankenhaus Wien

location_facility: NZOZ Przychodnia Specjalistyczna Andrzej Wittek Henryk Rudzki spolka jawna

location_facility: Fifth Multiprofile Hospital for Active Treatment - Sofia EAD

location_facility: Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre

location_facility: Podhalanski Szpital Specjalistyczny im Jana Pawla II w Nowym Targu

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet

location_facility: State Budget Medical Institution Sverdlovsk Regional Clinical Hospital N1

location_facility: Heart Health Institute Research Incorporated

location_facility: National Scientific Center "M.D. Strazhesko Institute of Cardiology"

location_facility: Highlands Clinical Research Facility, Raigmore Hospital

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

location_facility: Cardiology Consultants of Philadelphia CCP

location_facility: Saint Petersburg State Budget Healthcare Institution City Polyclinic 109

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: LaPorte County Institute for Clinical Research

location_facility: Instituto de Investigaciones Clinicas Zarate

location_facility: Clinical Best Solutions Spolka z ograniczona odpowiedzialnoscia Spolka komandytowa

location_facility: Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada SC

location_facility: Betegapolo Irgalmas Rend - Budai Irgalmasrendi Korhaz

location_facility: Spitalul Clinic Universitar de Urgenta Elias

location_facility: Centre Hospitalier Universitaire de Nantes - Hopital Guillaume et Rene Laennec

location_facility: Metropolitan Cardiovascular Consultants LLC

location_facility: University of Colorado Memorial Health System

location_facility: Westside Medical Associates of Los Angeles

location_facility: Instituto de Pesquisa Clinica de Campinas

location_facility: Balatonmariafurdo Kozseg Onkormanyzatanak Haziorvosi Rendeloje

location_facility: CARINTART Sp zoo Krakowskie Centrum Diagnostyczno-Kliniczne

location_facility: Centre Hospitalier Regional Universitaire de Montpellier - Hopital Arnaud de Villeneuve

location_facility: Instituto Medico DAMIC - Fundacion Rusculleda

location_facility: Kardio Vaclavik sro, Interni a kardiologicka ambulance

location_facility: Siauliai Republican Hospital, Public Institution

location_facility: Bacs-Kiskun Megyei Korhaz Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Oktato Korhaza

location_facility: State Autonomous Healthcare Institution of the Tyumen region Medical Scientific Practical Center

location_facility: Piedmont Medical Group Research of Rocky Mount

location_facility: Centre Hospitalier Universitaire de Nice - Hopital Pasteur

location_facility: Center for Clinical and Basic Research Tallinn

location_facility: North Shore Diabetes and Endocrine Associates

location_facility: Kardiologijos ir reabilitacijos klinika, UAB

location_facility: Hamilton Health Sciences Hamilton General Hospital

location_facility: Hospices Civils de Lyon Groupement Hospitalier Est, Hopital Louis Pradel

location_facility: prof MUDr Lubomir Elbl, CSc, Kardiologicka ambulance

location_facility: Narodny ustav srdcovych a cievnych chorob, as

location_facility: Centro de investigacion Cardiometabolica

location_facility: Center for Clinical Research Pardubice, sro

location_facility: Azienda Ospedaliero Universitaria di Bologna Policlinico S Orsola Malpighi

location_facility: NSHI Departmental Hospital at the station Barnaul of OJSC Russian Railways

location_facility: Samodzielny Publiczny Specjalistyczny Szpital Zachodni im swietego Jana Pawla II

location_facility: Unidade Local de Saude de Matosinhos - Hospital Pedro Hispano

location_facility: Northwell Health Physician Partners Cardiology

location_facility: Multiprofile Hospital for Active Treatment- Medical Complex- Sveti Ivan Rilski EOOD

location_facility: SBHI of Novosibirsk Region City clinical hospital 1

location_facility: National Multiprofile Transport Hospital Tzar Boris III

location_facility: KO-MED Centra Kliniczne Spzoo KO-MED Centra Kliniczne Staszow

location_facility: KO-MED Centra Kliniczne Spzoo KO-MED Centra Kliniczne Pulawy

location_facility: Instituto de Investigaciones Clínicas Rosario-Sanatorio Delta

location_facility: Cinme - Centro de Investigaciones Metabolicas

location_facility: Centro de Especialidades Medicas - Cemedic

location_facility: Centrum Szybkiej Diagnostyki Kardiologicznej Kardiomed M Zabowka E Zabowka Spolka cywilna

location_facility: Benedor sro - Kardiologicka, cevni a interni ambulance

location_facility: Cardiovascular Research Foundation of Southern California

location_facility: Western Centre for Public Health and Family Medicine - Western University

location_facility: Hospital da Senhora da Oliveira, Guimaraes, EPE

location_facility: Kansas City Veterans Affairs Medical Center

location_facility: Szegedi Tudomanyegyetem Szent Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar

location_facility: University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD

location_facility: Oleksandrivska Clinical Hospital of Kyiv

location_facility: State Institution National Scientific Center Acad Strazhesko Institute of Cardiology

location_facility: MeDiNova Warwickshire Quality Research Site

location_facility: Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou

location_facility: Medical and Sanitary Unit of Open Joint Stock Company Kharkiv Tractor Plant

location_facility: Medinova Northamptonshire Dedicated Research Site

location_facility: Centro de Estudios Clinicos de Queretaro

location_facility: Markhot Ferenc Oktatokorhaz es Rendelointezet

location_facility: Presidio Ospedaliero Santa Maria delle Grazie

location_facility: North York Diagnostic and Cardiac Centre

location_facility: Regional State Budget Health care Institution Altay Regional Cardiology Dispensary

location_facility: BHI of Republic Udmurtiya City clinical hospital 9 of Ministry of healthcare of Republic Udmurtiya

location_facility: Clinical Best Solutions Sp zoo Spolka komandytowa Gabinet Lekarski

location_facility: Cardresearch Cardiologia Assistencial de Pesquisa

location_facility: Instituto de Investigaciones Clinicas Bahia Blanca

location_facility: Center for Clinical Trials of Sacramento Inc

location_facility: Kardiologicke centrum MUDr Janky Skrobakove sro

location_facility: Centro de Investigaciones Clinicas del Litoral

location_facility: IBPClin Instituto Brasil de Pesquisa Clinica

location_facility: Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil

location_facility: Instituto de Investigaciones Clinicas de San Nicolas

location_facility: Fundaçao Hospitalar Sao Francisco de Assis

location_facility: Puc Trials - Núcleo de Pesquisa Clínica da Escola de Medicina da Pucpr/Epicenter

location_facility: SBHI Scientific Research Institute Regional Clinical Hospital 1 named after S V Ochapovsky

location_facility: Private Small Enterprise, Medical Center Pulse

location_facility: Samara Regional Clinical Cardiology Dispensary

location_facility: Azienda Ospedaliero Universitaria Integrata di Udine

location_facility: The University of Iowa College of Public Health

location_facility: American Heart of Poland Sa Malopolskie Centrum Sercowo-Naczyniowe PAKS - Chrzanow

location_facility: Marek Piepiorka Gabinet Kardiologiczno-Internistyczny

location_facility: Universite Catholique de Louvain Cliniques Universitaires Saint Luc

location_facility: General Hospital of Athens Georgios Gennimatas

location_facility: Ciad - Consultorio Integral de Atencion al Diabetico

location_facility: Centre Hospitalier de Pau - Hopital Francois Mitterrand

location_facility: Soproni Erzsebet Oktato Korhaz es Rehabilitacios Intezet

location_facility: Centre Hospitalier Universitaire Amiens - Hopital Sud

location_facility: Hospital Universitario de Gran Canaria Doctor Negrin

location_facility: Semmelweis Egyetem Varosmajori Sziv- es Ergyogyaszati Klinika

location_facility: Cardiovascular Research Center of South Florida

location_facility: Nemocnice Pardubickeho kraje as, Svitavska nemocnice

location_facility: FSBI Heart and Vessels Diseases complex problems Scientific Research Institution

location_facility: Institutul de Urgenţă pentru Boli Cardiovasculare "Prof. Dr. C. C. Iliescu",

location_facility: FSBI Russian Cardiology Research and Production Complex

location_facility: University Hospitals of Derby and Burton NHS Foundation Trust

location_facility: Clinical Hospital named after S R Mirotvortsev

location_facility: Centre Hospitalier Universitaire de Marseille - Hôpital de la Timone

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej w Wegrowie

location_facility: LMC Clinical Research Incorporated Thornhill

location_facility: Applied Medical Informatics Research Incorporated

location_facility: Instituto do Coracao do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

location_facility: Centre intégré de santé et de services sociaux (CISSS) des Laurentides - Unité de recherche clini

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska

location_facility: Instituto de Cardiologia de Corrientes Juana Francisca Cabral

location_facility: Papageorgiou General Hospital of Thessaloniki

location_facility: Centro de Pesquisas em Diabetes e Doencas Endocrino Metabolicas

location_facility: University Hospitals Cleveland Medical Center

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Albert Schweitzer Ziekenhuis location Dordwijk

location_facility: Midwest Cardiovascular Research Foundation

location_facility: Clinical Research Center Spzoo Medic-R Spolka Komandytowa

location_facility: University of Florida and Shands Hospital

location_facility: Hospital Clinico Universitario de Valladolid

location_facility: Jahn Ferenc Del-pesti Korhaz es Rendelointezet

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Regional Clinical Hospital 2 of the Ministry of Health Krasnodar region

location_facility: Hospital Universitario Virgen de las Nieves

location_facility: Center for Clinical and Basic Research Vejle

location_facility: Ivano-Frankivsk Regional Clinical Cardiology Center of Ivano-Frankivsk Regional Council

location_facility: Associacao Protectora dos Diabeticos de Portugal

location_facility: Communal Non-commercial enterprise "City Hospital #6 "of Zaporizhzhia City Council

location_facility: Bajcsy-Zsilinszky Korhaz es Rendelointezet

location_facility: Division of Cardiovascular Research at Peconic Bay Medical Center

location_facility: Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda EAD

location_facility: Adelaide Cardiology Practice - Leabrook Clinic

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

location_facility: SMH Cardiology Clinical Trials Incorporated

location_facility: Gottsegen Gyorgy Orszagos Kardiologiai Intezet

location_facility: Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul

location_facility: Diabetologische Gemeinschaftspraxis Dr Schaper und Dr Faulmann

location_facility: University Multiprofile Hospital for Active Treatment and Emergency Medicine N I Pirogov EAD

location_facility: Wojewodzki Szpital Zespolony im Ludwika Rydygiera w Toruniu

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: SBHI Medical and sports dispensary of Krasnogvardeisky district of Saint Petersburg

location_facility: Communal Healthcare Institution Kharkiv City Clinical Hospital No27

location_facility: Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

location_facility: Multiprofile Regional Hospital for Active Treatment Dr Stefan Cherkezov AD

summary: This study will assess the effect of lowering low-density lipoprotein cholesterol (LDL-C) with evolocumab on major cardiovascular events in adults without a prior myocardial infarction (MI) or stroke who are at high risk of a cardiovascular event.


acronym: LIFE

title: Effect of 3-month Treatment With F2695 (75mg OD) on Improving Functional Recovery of Patients With Ischemic Stroke. A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-Controlled Study

lead_sponsor: Pierre Fabre Medicament

location_country:
Portugal
Spain
Italy
Russian Federation
Czech Republic
Switzerland
Sweden
Hungary
France
Belgium
Germany

location_facility: State Budget Healthcare Institution "City clinical hospital #20"

location_facility: Hospital Clínico Universitario de Santiago de Compostela

location_facility: State Institution "Saint Petersburg I.I. Dzhanelidze Research Institute of Emergency"

location_facility: Centro Hospitalar do Porto / Hospital Geral de Santo António

location_facility: Centre Hospitalier Universitaire de Saint Etienne, Hôpital Nord

location_facility: Smolensk State Medical Academy of RosZdrav

location_facility: Scientific Research Neurology Institute of Russian Academy of Medical Services

location_facility: Debreceni Egyetem Orvos- és Egészségtudományi Centrum

location_facility: Municipal Medical Institute "N.I.Pirogov City Clinical hospital #1"

location_facility: Centre Hospitalier Universitaire de Poitiers Hôpital de la Milétrie

location_facility: Azienda Sanitaria Ospedaliera "San Giovanni Battista"

location_facility: State Institution of Healthcare of Moscow City "City Clinical Hospital #61"

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: State Healthcare Institution "Samara M.I.Kalinin Regional Clinical Hospital"

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Hospital Universitario de Girona Doctor Josep Trueta

location_facility: Professor S.V. Ochapovsky Territorial Clinical Hospital #1

location_facility: Hospital Clinico Universitario de Valladolid

location_facility: Hopital Jean Minjoz Centre Hospitalier Universitaire Besancon

location_facility: Universitätsklinik Charité, Campus Mitte

location_facility: Non-state Healthcare Institution "N.A. Semashko Central Clinical Hospital #2 of JSC "Russian Railway

location_facility: Municipal Healthcare Institution "Municipal Clinical Hospital # 3"

summary: The purpose of the study is to assess the efficacy of a new serotonin-norepinephrine reuptake inhibitor (SNRI) nin functional recovery after ischemic stroke.


title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II Study Evaluating the Efficacy and Safety of Onartuzumab in Combination With Bevacizumab or Onartuzumab Monotherapy in Patients With Recurrent Glioblastoma

summary: This randomized, double-blind, placebo-controlled, multicenter phase II study will evaluate the safety and efficacy of onartuzumab in combination with bevacizumab as compared to bevacizumab alone in participants with recurrent glioblastoma. Participants will be randomized 1:1 to receive either placebo plus bevacizumab every 3 weeks, or onartuzumab plus bevacizumab. Study treatment will continue until disease progression, unacceptable toxicity, participants or physician decision to discontinue, or death.

lead_sponsor: Hoffmann-La Roche

location_country:
Spain
Italy
United Kingdom
Canada
Switzerland
United States
France
Germany

location_facility: Presidio Ospedaliero Marconi Bufalini; U.O. di Oncologia

location_facility: Az. Osp. Pisana Ospedale S. Chiara; U.O. Di Reumatologia

location_facility: Hospital Regional Universitario Carlos Haya; Servicio de Oncologia

location_facility: Cedars Sinai Medical Center; Neurosurgery

location_facility: Hôpital Central; Departement de Neuro-Oncologie

location_facility: Nottingham City Hospital; David Evans Centre

location_facility: McGill University; Montreal Neurological Institute; Oncology

location_facility: Northshore University Health System; Cardiology

location_facility: Institut Catala d Oncologia Hospital Duran i Reynals

location_facility: A.O. Universitaria Di Parma; Oncologia Medica

location_facility: Fondazione IRCCS Ospedale Maggiore Policlinico; Gastroenterologia

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Hopital de La Timone - CHU de Marseille; Service de neuro-oncologie - Hôpital Adultes - 12ème étage

location_facility: Hamilton Health Sciences - Juravinski Cancer Centre

location_facility: University of Alabama At Birmingham; Neuro-Oncology

location_facility: Seattle Cancer Care Alliance; Investigational Drug Service

location_facility: Princess Margaret Hospital; Pencer Brain Tumour Centre, 18-727

location_facility: Fondazione IRCCS Istituto Neurologico C. Besta; Neuro-oncologia Sperimentale e Terapia Genica

location_facility: Clinica Universitaria de Navarra; Servicio de Oncologia

location_facility: Klinikum Joh.Wolfg.Goethe-UNI Senckenbergisches Institut für Neuroonkologie

location_facility: Universitatsklinikum Hamburg-Eppendorf; Klinik und Poliklinik fur Neurochirurgie

location_facility: Universitätsklinikum Bonn; Medizinische Klinik und Poliklinik I; Allgemeine Innere Medizin

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

location_facility: Ospedale Bellaria; U.O. Oncologia Medica

location_facility: Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie

location_facility: Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building)

location_facility: Centre Val Aurelle Paul Lamarque; Medecine B3

location_facility: Hopital Pitié Salpétrière - CHU; Service de neurologie 2 - Mazarin

location_facility: Uni Klinikum München - Großhardern; Med. Klinik U. Poliklinik III - Abt. Onkologie u. Hämatologie

location_facility: Hospital Clinic i Provincial; Servicio de Farmacia

location_facility: Universitätsspital Zürich; Klinik für Neurologie

location_facility: Klinikum der Johannes Gutenberg Uni Mainz; Studienz. Neurologie, Klinik und Poliklinik Neurologie

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

location_facility: HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia

location_facility: Sarah Cannon Cancer Center - Tennessee Oncology, Pllc


title: A Phase III, Randomized, Double-blinded Study Comparing the Combination of the BRAF Inhibitor, Dabrafenib and the MEK Inhibitor, Trametinib to Dabrafenib and Placebo as First-line Therapy in Subjects With Unresectable (Stage IIIC) or Metastatic (Stage IV) BRAF V600E/K Mutation-positive Cutaneous Melanoma

summary: This was a two-arm, double-blinded, randomized, Phase III study comparing dabrafenib and trametinib combination therapy to dabrafenib administered with a placebo (dabrafenib monotherapy). Subjects with histologically confirmed cutaneous melanoma that is either Stage IIIC (unresectable) or Stage IV, and BRAF V600E/K mutation positive were screened for eligibility. Subjects who had prior systemic anti-cancer treatment in the advanced or metastatic setting were not eligible although prior systemic treatment in the adjuvant setting was allowed. Subjects were stratified according to the baseline lactate dehydrogenase level and BRAF genotype.

ReferenceCitation: Schadendorf D, Robert C, Dummer R, Flaherty KT, Tawbi HA, Menzies AM, Banerjee H, Lau M, Long GV. Pyrexia in patients treated with dabrafenib plus trametinib across clinical trials in BRAF-mutant cancers. Eur J Cancer. 2021 Aug;153:234-241. doi: 10.1016/j.ejca.2021.05.005. Epub 2021 Jul 2.

ReferenceCitation: Syeda MM, Wiggins JM, Corless BC, Long GV, Flaherty KT, Schadendorf D, Nathan PD, Robert C, Ribas A, Davies MA, Grob JJ, Gasal E, Squires M, Marker M, Garrett J, Brase JC, Polsky D. Circulating tumour DNA in patients with advanced melanoma treated with dabrafenib or dabrafenib plus trametinib: a clinical validation study. Lancet Oncol. 2021 Mar;22(3):370-380. doi: 10.1016/S1470-2045(20)30726-9. Epub 2021 Feb 12.

ReferenceCitation: Robert C, Grob JJ, Stroyakovskiy D, Karaszewska B, Hauschild A, Levchenko E, Chiarion Sileni V, Schachter J, Garbe C, Bondarenko I, Gogas H, Mandalá M, Haanen JBAG, Lebbé C, Mackiewicz A, Rutkowski P, Nathan PD, Ribas A, Davies MA, Flaherty KT, Burgess P, Tan M, Gasal E, Voi M, Schadendorf D, Long GV. Five-Year Outcomes with Dabrafenib plus Trametinib in Metastatic Melanoma. N Engl J Med. 2019 Aug 15;381(7):626-636. doi: 10.1056/NEJMoa1904059. Epub 2019 Jun 4.

ReferenceCitation: Long GV, Grob JJ, Nathan P, Ribas A, Robert C, Schadendorf D, Lane SR, Mak C, Legenne P, Flaherty KT, Davies MA. Factors predictive of response, disease progression, and overall survival after dabrafenib and trametinib combination treatment: a pooled analysis of individual patient data from randomised trials. Lancet Oncol. 2016 Dec;17(12):1743-1754. doi: 10.1016/S1470-2045(16)30578-2. Epub 2016 Nov 16.

ReferenceCitation: Long GV, Stroyakovskiy D, Gogas H, Levchenko E, de Braud F, Larkin J, Garbe C, Jouary T, Hauschild A, Grob JJ, Chiarion-Sileni V, Lebbe C, Mandalà M, Millward M, Arance A, Bondarenko I, Haanen JB, Hansson J, Utikal J, Ferraresi V, Kovalenko N, Mohr P, Probachai V, Schadendorf D, Nathan P, Robert C, Ribas A, DeMarini DJ, Irani JG, Swann S, Legos JJ, Jin F, Mookerjee B, Flaherty K. Dabrafenib and trametinib versus dabrafenib and placebo for Val600 BRAF-mutant melanoma: a multicentre, double-blind, phase 3 randomised controlled trial. Lancet. 2015 Aug 1;386(9992):444-51. doi: 10.1016/S0140-6736(15)60898-4. Epub 2015 May 31.

ReferenceCitation: Schadendorf D, Amonkar MM, Stroyakovskiy D, Levchenko E, Gogas H, de Braud F, Grob JJ, Bondarenko I, Garbe C, Lebbe C, Larkin J, Chiarion-Sileni V, Millward M, Arance A, Mandalà M, Flaherty KT, Nathan P, Ribas A, Robert C, Casey M, DeMarini DJ, Irani JG, Aktan G, Long GV. Health-related quality of life impact in a randomised phase III study of the combination of dabrafenib and trametinib versus dabrafenib monotherapy in patients with BRAF V600 metastatic melanoma. Eur J Cancer. 2015 May;51(7):833-40. doi: 10.1016/j.ejca.2015.03.004. Epub 2015 Mar 17.

ReferenceCitation: Menzies AM, Ashworth MT, Swann S, Kefford RF, Flaherty K, Weber J, Infante JR, Kim KB, Gonzalez R, Hamid O, Schuchter L, Cebon J, Sosman JA, Little S, Sun P, Aktan G, Ouellet D, Jin F, Long GV, Daud A. Characteristics of pyrexia in BRAFV600E/K metastatic melanoma patients treated with combined dabrafenib and trametinib in a phase I/II clinical trial. Ann Oncol. 2015 Feb;26(2):415-21. doi: 10.1093/annonc/mdu529. Epub 2014 Nov 18.

ReferenceCitation: Long GV, Stroyakovskiy D, Gogas H, Levchenko E, de Braud F, Larkin J, Garbe C, Jouary T, Hauschild A, Grob JJ, Chiarion Sileni V, Lebbe C, Mandalà M, Millward M, Arance A, Bondarenko I, Haanen JB, Hansson J, Utikal J, Ferraresi V, Kovalenko N, Mohr P, Probachai V, Schadendorf D, Nathan P, Robert C, Ribas A, DeMarini DJ, Irani JG, Casey M, Ouellet D, Martin AM, Le N, Patel K, Flaherty K. Combined BRAF and MEK inhibition versus BRAF inhibition alone in melanoma. N Engl J Med. 2014 Nov 13;371(20):1877-88. doi: 10.1056/NEJMoa1406037. Epub 2014 Sep 29.

location_country:
Spain
Greece
Italy
Australia
Netherlands
Argentina
Canada
Russian Federation
Ukraine
Sweden
United States
France
United Kingdom
Germany


title: A Randomized, Multicenter, Open-label, Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

acronym: RESONATE™

summary: The purpose of the study is to evaluate whether treatment with ibrutinib as a monotherapy results in a clinically significant improvement in progression free survival (PFS) as compared to treatment with ofatumumab in patients with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

ReferenceCitation: Munir T, Brown JR, O'Brien S, Barrientos JC, Barr PM, Reddy NM, Coutre S, Tam CS, Mulligan SP, Jaeger U, Kipps TJ, Moreno C, Montillo M, Burger JA, Byrd JC, Hillmen P, Dai S, Szoke A, Dean JP, Woyach JA. Final analysis from RESONATE: Up to six years of follow-up on ibrutinib in patients with previously treated chronic lymphocytic leukemia or small lymphocytic lymphoma. Am J Hematol. 2019 Dec;94(12):1353-1363. doi: 10.1002/ajh.25638. Epub 2019 Oct 13.

ReferenceCitation: Coutre SE, Byrd JC, Hillmen P, Barrientos JC, Barr PM, Devereux S, Robak T, Kipps TJ, Schuh A, Moreno C, Furman RR, Burger JA, O'Dwyer M, Ghia P, Valentino R, Chang S, Dean JP, James DF, O'Brien SM. Long-term safety of single-agent ibrutinib in patients with chronic lymphocytic leukemia in 3 pivotal studies. Blood Adv. 2019 Jun 25;3(12):1799-1807. doi: 10.1182/bloodadvances.2018028761.

ReferenceCitation: Byrd JC, Hillmen P, O'Brien S, Barrientos JC, Reddy NM, Coutre S, Tam CS, Mulligan SP, Jaeger U, Barr PM, Furman RR, Kipps TJ, Thornton P, Moreno C, Montillo M, Pagel JM, Burger JA, Woyach JA, Dai S, Vezan R, James DF, Brown JR. Long-term follow-up of the RESONATE phase 3 trial of ibrutinib vs ofatumumab. Blood. 2019 May 9;133(19):2031-2042. doi: 10.1182/blood-2018-08-870238. Epub 2019 Mar 6.

ReferenceCitation: O'Brien SM, Jaglowski S, Byrd JC, Bannerji R, Blum KA, Fox CP, Furman RR, Hillmen P, Kipps TJ, Montillo M, Sharman J, Suzuki S, James DF, Chu AD, Coutre SE. Prognostic Factors for Complete Response to Ibrutinib in Patients With Chronic Lymphocytic Leukemia: A Pooled Analysis of 2 Clinical Trials. JAMA Oncol. 2018 May 1;4(5):712-716. doi: 10.1001/jamaoncol.2017.5604.

ReferenceCitation: Brown JR, Moslehi J, O'Brien S, Ghia P, Hillmen P, Cymbalista F, Shanafelt TD, Fraser G, Rule S, Kipps TJ, Coutre S, Dilhuydy MS, Cramer P, Tedeschi A, Jaeger U, Dreyling M, Byrd JC, Howes A, Todd M, Vermeulen J, James DF, Clow F, Styles L, Valentino R, Wildgust M, Mahler M, Burger JA. Characterization of atrial fibrillation adverse events reported in ibrutinib randomized controlled registration trials. Haematologica. 2017 Oct;102(10):1796-1805. doi: 10.3324/haematol.2017.171041. Epub 2017 Jul 27.

ReferenceCitation: Barr PM, Brown JR, Hillmen P, O'Brien S, Barrientos JC, Reddy NM, Coutre S, Mulligan SP, Jaeger U, Furman RR, Cymbalista F, Montillo M, Dearden C, Robak T, Moreno C, Pagel JM, Burger JA, Suzuki S, Sukbuntherng J, Cole G, James DF, Byrd JC. Impact of ibrutinib dose adherence on therapeutic efficacy in patients with previously treated CLL/SLL. Blood. 2017 May 11;129(19):2612-2615. doi: 10.1182/blood-2016-12-737346. Epub 2017 Apr 3.

ReferenceCitation: Maddocks KJ, Ruppert AS, Lozanski G, Heerema NA, Zhao W, Abruzzo L, Lozanski A, Davis M, Gordon A, Smith LL, Mantel R, Jones JA, Flynn JM, Jaglowski SM, Andritsos LA, Awan F, Blum KA, Grever MR, Johnson AJ, Byrd JC, Woyach JA. Etiology of Ibrutinib Therapy Discontinuation and Outcomes in Patients With Chronic Lymphocytic Leukemia. JAMA Oncol. 2015 Apr;1(1):80-7. doi: 10.1001/jamaoncol.2014.218.

ReferenceCitation: Byrd JC, Brown JR, O'Brien S, Barrientos JC, Kay NE, Reddy NM, Coutre S, Tam CS, Mulligan SP, Jaeger U, Devereux S, Barr PM, Furman RR, Kipps TJ, Cymbalista F, Pocock C, Thornton P, Caligaris-Cappio F, Robak T, Delgado J, Schuster SJ, Montillo M, Schuh A, de Vos S, Gill D, Bloor A, Dearden C, Moreno C, Jones JJ, Chu AD, Fardis M, McGreivy J, Clow F, James DF, Hillmen P; RESONATE Investigators. Ibrutinib versus ofatumumab in previously treated chronic lymphoid leukemia. N Engl J Med. 2014 Jul 17;371(3):213-23. doi: 10.1056/NEJMoa1400376. Epub 2014 May 31.

lead_sponsor: Pharmacyclics LLC.

location_country:
Poland
Spain
Ireland
Austria
Australia
Italy
United Kingdom
United States
France
Belgium

location_facility:
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Site # 544
Site # 506
Site # 502
Site # 517
Site # 516
Site # 210
Site # 549
Site # 500
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Site # 032
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Site #408
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Site #107
Site # 127
Site #038
Site # 200
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Site # 509
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Site # 554
Site # 552
Site # 130
Site # 390
Site # 404
Site # 510
Site # 349
Site # 396
Site # 096
Site # 501
Site # 515
Site # 522


title: A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled Study of Ivosidenib or Enasidenib in Combination With Induction Therapy and Consolidation Therapy Followed by Maintenance Therapy in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome With Excess Blasts-2, With an IDH1 or IDH2 Mutation, Respectively, Eligible for Intensive Chemotherapy.

lead_sponsor: Stichting Hemato-Oncologie voor Volwassenen Nederland

location_country: Luxembourg Spain Ireland Austria Australia Estonia Finland Lithuania Netherlands Switzerland Sweden France Belgium Norway Germany

location_facility:
BE-Brugge-AZBRUGGE
FR-Tours cedex-BRETONNEAU
DE-Bonn-UNIBONN
AU-Melbourne-SVHM
NO-Oslo-OSLOUH
NL-Groningen-UMCG
ES-Barcelona-PARCDESALUTMAR
FR-Clamart-HIAPERCY
FR-Nice-CAL
CH-St. Gallen-KSSG
DE-Ulm-UNIKLINKULM
BE-Yvoir-MONTGODINNE
DE-Wuppertal-HELIOSGESUNDHEIT
DE-Mainz-UNIMEDIZINMAINZ
AT-Vienna-HANUSCH
FR-Angers-CHUANGERS
NL-Leiden-LUMC
AU-Perth-FSH
NO-Stavanger-HELSESTAVANGER
CH-Fribourg-HFR
FR-Rouen cedex-BECQUEREL
DE-Hamm-EVKHAMM
DE-Luedenscheid-KLINIKUMLUEDENSCHEID
DE-München-IRZTUM
AU-Adelaide-RAH
NL-Leeuwarden-MCL
FI-Helsinki-HUS
CH-Luzern-LUKS
NL-Amsterdam-VUMC
CH-Zürich-USZ
NL-Amersfoort-MEANDERMC
DE-Essen-KEM
BE-Brussel-UZBRUSSEL
DE-Homburg-UNIKLINIKSAARLAND
ES-Madrid-CSGREGORIOMARANON
FR-Poitiers-CHUPOITERS
DE-Goch-KKLE
IE-Dublin 8-STJAMES
BE-Hasselt-VIRGAJESSE
SE-Stockholm-KAROLINSKAHUDDINGE
DE-Herne-MARIENHOSPITALHERNE
AU-Melbourne-AUSTIN
DE-Dortmund-JOHODORTMUND
AU-Sydney-SVHS
DE-Hamburg-ASKLEPIOSSTGEORG
NL-Amsterdam-OLVG
AU-Hobart TAS-RHOBART
AU-Canberra-CANBERRAHOSPITAL
DE-Tübingen-MEDUNITUEBINGEN
AU-Melbourne-MONASH
FR-Strasbourg cedex-HAUTEPIERRE
CH-Bern-INSEL
NL-Utrecht-UMCUTRECHT
CH-Basel-USB
ES-Barcelona-MUTUATERRASSA
AU-Sydney-CONCORD
DE-Passau-KLINIKUMPASSAU
FR-Lens-CHLENS
EE-Tartu-TARTU
FR-Nice-LARCHET
AU-Sydney-WSAH
DE-Berlin-VIVANTESURBAN
NL-Zwolle-ISALA
ES-Palma-SSIB
NL-Amsterdam-AMC
NL-Breda-AMPHIA
DE-Lemgo-KLINIKUMLIPPE
FR-Créteil cedex-CHUMONDOR
DE-Hamburg-UKE
IE-Galway-UHGALWAY
IE-Cork-CUH
DE-Lebach-CARITASKHLEBACH
DE-Minden-MUEHLENKREISKLINKEN
ES-Valencia-MALVARROSA
DE-Oldenburg-KLINIKUMOLDENBURG
CH-Geneve (14)-HCUGE
AU-Waratah-CALVARYMATER
FR-Paris cedex 10-SAINTLOUIS
NO-Bergen-HELSEBERGEN
ES-Tarragona-JOAN
FR-Bayonne-CHCOTEBASQUE
FI-Tampere-TAYS
AT-Linz-ORDENSKLINIKUM
DE-Bad Saarow-HELIOSBADSAAROW
AU-Sydney-RNSH
DE-Traunstein-TSSOB
DE-Trier-MUTTERHAUS
FR-Limoges-CHULIMOGES
FR-Bobigny-AVICENNE
FR-Clermont-Ferrand-ESTAING
AU-Launceston TAS-LAUNCESTON
DE-Bochum-RUB
FR-Montpellier-STELOI
FR-Marseille-IPC
BE-Roeselare-AZDELTA
ES-Barcelona-ICODURANREYNALS
DE-Meschede-HOCHSAUERLAND
FR-Nantes-CHUNANTES
NL-Enschede-MST
FR-Villejuif-GUSTAVEROUSSY
AU-Adelaide-FLINDERS
ES-Barcelona-GERMANTRIALS
DE-Bremen-KBM
DE-Berlin-VIVANTESNEUKOLLN
FR-Reims-CHREIMS
SE-Uppsala-UPPSALAUH
DE-Berlin-CAMPUSBENFRANKLIN
FR-Vandoeuvre Les Nancy-CHRUNANCY
NL-Nieuwegein-ANTONIUS
DE-Hanau-KLINIKUMHANAU
BE-Leuven-UZLEUVEN
DE-Esslingen-KLINIKUMESSLINGEN
NL-Eindhoven-MAXIMAMC
FR-Orléans-CHORLEANS
NL-Rotterdam-ErasmusMC
BE-Bruxelles-STLUC
DE-Düsseldorf-MEDUNIDUESSELDORF
FR-Rennes cedex 9-CHURENNES
FR-Grenoble cedex 9-CHUGRENOBLE
DE-Stuttgart-KLINIKUMSTUTTGART
DE-Ludwigshafen-KLILU
DE-Mainz-KLINKUNIMAINZ
NL-Arnhem-RIJNSTATE
FR-Toulouse-CHUTOULOUSE
BE-Haine-Saint-Paul-JOLIMONT
AU-Douglas-TOWNSVILLE
FR-Paris cedex 12-SAINTANTOINE
DE-Karlsruhe-KLINIKUMKARLSRUHE
DE-Magdeburg-OVGU
BE-Gent-UZGENT
DE-Offenburg-ORTENAUKLINIKUM
FR-Le Chesnay cedex-CHVERSAILLES
AT-Innsbruck-IMED
BE-Brussel-BORDET
AU-Perth-RPH
LU-Luxembourg-CHL
BE-Liege-CHRCITADELLE
DE-Villingen-Schwenningen-SBKVS
CH-Lausanne-CHUV
BE-Liege-CHULIEGE
DE-Braunschweig-KLINIKUMBRAUNSCHWEIG
DE-Hamburg-ASKLEPIOS
CH-Bellinzona-IOSI
IE-Dublin 9-BEAUMONT
NL-Den Bosch-JBZ
AU-Melbourne-RMELBOURNE
AU-Melbourne-ALFRED
FR-Besançon Cedex-JEANMINJOZ
FR-Lyon Pierre Benite cedex-LYONSUD
NL-Delft-RDGG
DE-Hannover-MHHANNOVER
FR-Lille-CHULILLE
AU-Perth-SCGH
DE-Giessen-UKGM
FR-Argenteuil-CHARGENTEUIL
FR-Chambery-CHMETROPOLESAVOIE
DE-München-MEDUNIMUNCHIN
NL-Maastricht-MUMC
NO-Tromsø-NORTHNOORWEGEN
ES-Girona-ICSTRUETA
FR-Mulhouse-GHRMSA
DE-Hannover-SILOAHKRH
FR-Lyon-LEONBERARD
FR-Amiens-CHUAMIENS
DE-Berlin-CAMPUSVIRCHOW
LT-Vilnius-SANTA
ES-Barcelona-CLINICUB
SE-Lund-SUH
BE-Antwerpen-ZNASTUIVENBERG
NL-Den Haag-HAGA
FR-Paris cedex 15-NECKER
NO-Trondheim-STOLAV
NL-Nijmegen-RADBOUDUMC
DE-Flensburg-MALTESER
NL-Dordrecht-ASZ
AT-Graz-MEDUNIGRAZ
AU-Camperdown-RPA
DE-Stuttgart-DIAKSTUTTGART
ES-Barcelona-SANTPAU
FR-Pessac Cedex-CHUBORDEAUX
AU-Brisbane-PAH
ES-Barcelona-VHEBRON

summary: AML and MDS-EB2 are malignancies of the bone marrow. The standard treatment for these diseases is chemotherapy. Patients participating have a special type of this disease because the leukemia cells (blasts) have developed an error in the genetic material (DNA). This error is called an IDH1 mutation or an IDH2 mutation (a mutation is a change in the DNA), which leads to changes in specific substances in the leukemia cells. This trial will investigate whether the addition of the new drugs Ivosidenib (for patients with IDH1 mutation) or Enasidenib (for patients with IDH2 mutation) to the standard treatment of chemotherapy controle the disease more effectively and for a longer period.


title: The BEACON Study (Breast Cancer Outcomes With NKTR-102): A Phase 3 Open-Label, Randomized, Multicenter Study of NKTR-102 Versus Treatment of Physician's Choice (TPC) in Patients With Locally Recurrent or Metastatic Breast Cancer Previously Treated With an Anthracycline, a Taxane and Capecitabine

acronym: BEACON

summary:
The study is designed as an open-label, randomized, parallel, two arm, multicenter, international Phase 3 study in patients with recurrent or metastatic breast cancer previously treated with cytotoxic chemotherapy regimens.

The primary study objective is to compare overall survival of patients who receive NKTR-102 given once every 21 days to patients who receive treatment of Physician's Choice selected from a list of seven single-agent intravenous therapies.

ReferenceCitation: Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19. Review.

ReferenceCitation: Cortés J, Rugo HS, Awada A, Twelves C, Perez EA, Im SA, Gómez-Pardo P, Schwartzberg LS, Diéras V, Yardley DA, Potter DA, Mailliez A, Moreno-Aspitia A, Ahn JS, Zhao C, Hoch U, Tagliaferri M, Hannah AL, O'Shaughnessy J. Prolonged survival in patients with breast cancer and a history of brain metastases: results of a preplanned subgroup analysis from the randomized phase III BEACON trial. Breast Cancer Res Treat. 2017 Sep;165(2):329-341. doi: 10.1007/s10549-017-4304-7. Epub 2017 Jun 13. Erratum in: Breast Cancer Res Treat. 2017 Nov;166(1):327-328.

ReferenceCitation: Twelves C, Cortés J, O'Shaughnessy J, Awada A, Perez EA, Im SA, Gómez-Pardo P, Schwartzberg LS, Diéras V, Yardley DA, Potter DA, Mailliez A, Moreno-Aspitia A, Ahn JS, Zhao C, Hoch U, Tagliaferri M, Hannah AL, Rugo HS. Health-related quality of life in patients with locally recurrent or metastatic breast cancer treated with etirinotecan pegol versus treatment of physician's choice: Results from the randomised phase III BEACON trial. Eur J Cancer. 2017 May;76:205-215. doi: 10.1016/j.ejca.2017.02.011. Epub 2017 Mar 27.

ReferenceCitation: Perez EA, Awada A, O'Shaughnessy J, Rugo HS, Twelves C, Im SA, Gómez-Pardo P, Schwartzberg LS, Diéras V, Yardley DA, Potter DA, Mailliez A, Moreno-Aspitia A, Ahn JS, Zhao C, Hoch U, Tagliaferri M, Hannah AL, Cortes J. Etirinotecan pegol (NKTR-102) versus treatment of physician's choice in women with advanced breast cancer previously treated with an anthracycline, a taxane, and capecitabine (BEACON): a randomised, open-label, multicentre, phase 3 trial. Lancet Oncol. 2015 Nov;16(15):1556-1568. doi: 10.1016/S1470-2045(15)00332-0. Epub 2015 Oct 22.

lead_sponsor: Nektar Therapeutics

location_country:
Spain
Italy
Russian Federation
Netherlands
United Kingdom
Canada
Korea, Republic of
United States
France
Belgium
Germany

location_facility: Carolinas Hematology Oncology Associates

location_facility: Centre Hospitalier Universitaire Ambroise Paré

location_facility: Yakima Valley Memorial Hospital/North Star Lodge

location_facility: Frontier Cancer Center and Blood Institute

location_facility: Istituto Nazionale tumori Regina Elena IRCCS

location_facility: Medical Oncology Associates of Wyoming Valley, PC

location_facility: Northwest Georgia Oncology Centers, P.C.

location_facility: Texas Oncology-Midland Allison Cancer Center

location_facility: GZA Ziekenhuizen, Campus St Augustinus, CLINICAL TRIALS ONCOLOGY

location_facility: Peachtree Hematology Oncology Consultants

location_facility: PMK Medical Group, Inc., DBA Ventura County Hematology Oncology Specialists

location_facility: Louisville Oncology Clinical Research Program

location_facility: Institut Paoli Calmettes, Service Pharmacie

location_facility: ICO l´Hospitalet - Hospital Duran i Reynals

location_facility: Odette Cancer Centre OCC Clinical Research

location_facility: Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

location_facility: Texas Oncology-Beaumont, Mamie McFaddin Ward Cancer Center

location_facility: Hematology Oncology Associates of the Treasure Coast

location_facility: Hematology-Oncology Associates of Northern NJ, PA

location_facility: Centre Régional de Lutte Contre le Cancer Nantes Atlantique René Gauducheau

location_facility: Istituto tumori Giovanni Paolo II-ospedale oncologico, Oncologia Medica e Sperimentale

location_facility: UZ Leuven, Campus Gasthuisberg, trialbureau Algemene Medische Oncologie

location_facility: State Institution "Russian Oncology Research Centre named after N.N. Blokhin RAMS"

location_facility: Cancer Clinical Trials Centre, Weston Park Hospital

location_facility: Clinical Trials Unit, Velindre Cancer Centre

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Non-state Health Institution "Dorozhnaya Clinical Hospital of OAO "Russian Railways"

location_facility: Scientific Research Oncology Institute named after N.N. Petrov

location_facility: Centra Regional de Lutte contre le Cancer

location_facility: Providence Health System - Southern California d/b/a Roy and Patricia Disney Family Cancer Center

location_facility: Centre Hospitalier Universitaire de Liège- Site du Sart Tilman

location_facility: Hopital Tenon Service oncologie médicale

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Hematology-oncology Department, Ewha Womans University Mokdong Hospital

location_facility: Desert Hematology Oncology Medical Group

location_facility: Seoul National University Bundang Hospital

location_facility: Sciode Medical Associates, PLLC, d.b.a. Eastchester Center for Cancer Care

location_facility: Institut Bergonie Service Oncologie Médicale

location_facility: Texas Oncology-Dallas Presbyterian Hospital

location_facility: Hematology-oncology Department, Ajou University Hospital

location_facility: Azienda Ospedaliero Universitaria Pisana, U.O. Oncologia Medica

location_facility: The Christie Hospitals NHS Foundation Trust

location_facility: St. Petersburg State Budget Healthcare Institution "City Clinical Oncology Dispensary"

location_facility: Texas Oncology-Baylor Charles A. Sammons Cancer Center


acronym: ACT IV

title: An International, Randomized, Double-Blind, Controlled Study of Rindopepimut/GM-CSF With Adjuvant Temozolomide in Patients With Newly Diagnosed, Surgically Resected, EGFRvIII-positive Glioblastoma

lead_sponsor: Celldex Therapeutics

ReferenceCitation: Weller M, Butowski N, Tran DD, Recht LD, Lim M, Hirte H, Ashby L, Mechtler L, Goldlust SA, Iwamoto F, Drappatz J, O'Rourke DM, Wong M, Hamilton MG, Finocchiaro G, Perry J, Wick W, Green J, He Y, Turner CD, Yellin MJ, Keler T, Davis TA, Stupp R, Sampson JH; ACT IV trial investigators. Rindopepimut with temozolomide for patients with newly diagnosed, EGFRvIII-expressing glioblastoma (ACT IV): a randomised, double-blind, international phase 3 trial. Lancet Oncol. 2017 Oct;18(10):1373-1385. doi: 10.1016/S1470-2045(17)30517-X. Epub 2017 Aug 23.

location_country:
Spain
Italy
United Kingdom
United States
Peru
Belgium
Czechia
Austria
Australia
India
Israel
Mexico
Brazil
Canada
Switzerland
Hungary
Germany
Taiwan
Greece
New Zealand
Thailand
France
Colombia
Netherlands

location_facility: Mater Adult Hospital, Mater Misericordiae Health Services Brisbane Limited

location_facility: CHUV, Centre Hospitalier Universitaire Vaudois

location_facility: Stanford Cancer Institute, Stanford University

location_facility: Umiversity Hospital (Fakultni Nemocnice)

location_facility: University Hospitals, Case Medical Center (Cleveland)

location_facility: Radboud University Nijmegen Medical Center

location_facility: Barrow Neurological Institute at St. Joseph's Hospital and Medical Center

location_facility: University of South Alabama Mitchell Cancer Institute

location_facility: Allina Health, Abbott Northwestern Hospital, John Nasseff Neuroscience Institute

location_facility: Columbia University Medical Center - The Neurologic Institute of New York

location_facility: Vas Megyei Markusovszky Lajos Általános Rehabilitációs és Gyógyfürdő Kórház, Egyetemi Oktatókórház Nonprofit Zrt

location_facility: Medical University of South Carolina - Department of Neuroscience

location_facility: The Preston Robert Tisch Brain Tumor Center at Duke University Medical Center

location_facility: UO Oncologie Medica Dipartimento Oncologico

location_facility: Waikato Hospital, Regional Cancer Centre

location_facility: University of Utah Department of Neurosurgery

location_facility: Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház, Sugárterápiás Osztály

location_facility: Universitaetsklinikum Heidelberg, Neurologische Klinik, IM Neuenheimer Feld 672

location_facility: The Crown Princess Mary Cancer Centre, Westmead Hospital

location_facility: British Columbia Cancer Agency, Vancouver Clinic

location_facility: Johns Hopkins University School of Medicine

location_facility: New Jersey Neuroscience Institute, JFK Medical Center

location_facility: Hospital Mae de Deus-Centro de Pesquisa em Oncologia Clinica

location_facility: Hospital Central "Ignacio Morones Prieto"

location_facility: Covenant Clinic / Iowa Spine and Brain Institute

location_facility: St. Mary's of Michigan Medical Center/Field Neurosciences Institute

location_facility: Debreceni Egyetem Orvos- és Egészségtudományi Centrum Onkológiai Intézet

location_facility: University of Tennessee Medical Center - Knoxville

location_facility: Szegedi Tudományegyetem Onkoterápiás Klinika

location_facility: London Regional Cancer Program, London Health Sciences Centre

location_facility: Centre Hospitalier de l'Universite de Montreal (CHUM) - Hopital Notre-Dame

location_facility: Medizinische Universität Wien, Innere Medizin I, Onkologie

location_facility: University Hospital Hamburg Kopf und Neurozentrum

location_facility: Edward W. Sparrow Hospital Association - Sparrow Regional Cancer Center

location_facility: Hopitaux Universitaires de Geneve-HUG-Centre d'Oncologie

location_facility: Kaiser Permanente, Redwood City Medical Center

location_facility: University of Massachusetts Memorial Medical Center

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Dr. Rai Memorial Medical Centre, Chennai

location_facility: Servicios Medicos de Investigacion Clinica Sc

location_facility: Waikato Hospital, Regional Cancer Center

location_facility: Dr. Senchkenbergisches Institut fur Neuroonkologie

location_facility: Universita e AO Citta delia Scienza, Universita Di Torino

location_facility: Dra. Sonia Del Barco Berron, ICO Girona Avda,

location_facility: Inselspital, Universitatsspital Bern, Universitatsklinik fur Medizinische Onkologie, Freiburgstrasse

location_facility: Guy's and St Thomas' NHS, Westminister Bridge Road

location_facility: University of Pittsburgh Cancer Institute

location_facility: Ensayos Clínicos y Medicina de Alta Especialidad, S.C.

location_facility: Northwestern University Robert H. Lurie Comprehensive Cancer Center

location_facility: Országos Onkológiai Intézet Sugárterápiás Osztály

location_facility: Providence Portland Medical Center, Oncology & Hematology Care

location_facility: Instituto do Câncer do Estado de São Paulo - ICESP

location_facility: University of Manitoba-Cancer Care Manitoba

location_facility: The Long Island Brain Tumor Center at Neurology Surgery, P.C.

location_facility: Montreal Neurological Institute and Hospital

location_facility: Medical University Innsbruck, Dept of Neurology, Anichstrabe 35

location_facility: Kaiser Permanente Hawaii Moanalua Medical Center

location_facility: Institut de Cancerologie de L'Quest-Center Rane Gauducheau

location_facility: HCG Shanti Mukand Hospital - Curie Cancer Centre, Delhi

location_facility: Center for Cancer and Blood Disorders, PC

location_facility: Amrita Institute of Medical Sciences and Research Centre, Kochi

location_facility: LSU Health Sciences Center, Feist-Weiller Cancer Center

location_facility: Chang Gung Memorial Hospital Linkou Branch

location_facility: University of Wisconsin Paul P Carbone Comprehensive Cancer Center

location_facility: Brain Tumor Center, University Hospital Zurich

location_facility: Dana-Farber Cancer Institute and Mass General Hospital

location_facility: Real e Benemerita Associação Portuguesa de Beneficiência/ Hospital São José

location_facility: Edinburgh Cancer Centre Western General Hospital

location_facility: Winship Cancer Institute, Emory University School of Medicine

location_facility: Fundação Faculdade Regional de Medicina de de São José do Rio Preto - Hospital de Base

location_facility: Institut de Cancerologie de I'Quest-Paul Papin

location_facility: ICO Badalona-Hospital Germans Trias i Pujol

location_facility: Fondazione IRCCS Instituto Neurologico Carlo Besta

location_facility: Sree Chitra Tirunal Institute for Medical Sciences & Technology, Thiruvananthapuram

location_facility: The Bristol Haematology and Oncology Centre

location_facility: HCG - Bangalore Institute of Oncology, Bangalore

location_facility: Pécsi Tudományegyetem Általános Orvostudományi Kar

location_facility: Lehigh Valley Physician Group-Hematology-Oncology Associates

location_facility: University of Virginia Healthcare System

location_facility: Klinik und Poliklinik fur Neurologie der Universitat Regensburg

location_facility: Institut de Cancerologie de l'ouest-Center Rene Gauducheau

location_facility: University of Arkansas for Medical Sciences

location_facility: University of Cincinnati Cancer Institute

location_facility: Kantonsspital Aarau Medizinische Onkologie Tellstrasse

location_facility: Mount Sinai Medical Center, Comprehensive Cancer Center

location_facility: Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute

location_facility: Centro de Pesquisas Clinicas da Fundação Dr Amaral Carvalho

location_facility: Oncology Institute of Southern Switzerland (IOSI)

location_facility: BC Cancer Agency - Vancouver Island Centre

location_facility: Marathwada Regional Cancer Centre and Research Institute - Government

location_facility: Hospital Civil de Guadalajara "Fray Antonio Alcalde"

summary:
This 2-arm, randomized, phase III study will investigate the efficacy and safety of the addition of rindopepimut (an experimental cancer vaccine that may act to promote anti-cancer effects in patients who have tumors that express the EGFRvIII protein) to the current standard of care (temozolomide) in patients with recently diagnosed glioblastoma, a type of brain cancer.

All patients will be administered temozolomide, the standard treatment for glioblastoma. Half the patients will be randomly assigned to receive rindopepimut and half the patients will be randomly assigned to receive a control called keyhole limpet hemocyanin.

Patients will be treated in a blinded fashion (neither the patient or the doctor will know which arm of the study the patient is on). Patients will be treated until disease progression or intolerance to therapy and all patients will be followed for survival.


title: An Open-label Extension Study of the Long-term Safety, Tolerability and Efficacy of GSK2402968 in Subjects With Duchenne Muscular Dystrophy

lead_sponsor: GlaxoSmithKline

location_country:
Spain
Italy
United Kingdom
Belgium
Japan
Poland
Russian Federation
Australia
Argentina
Israel
Turkey
Norway
Brazil
Canada
Hungary
Germany
Bulgaria
Denmark
Taiwan
Czech Republic
Korea, Republic of
France
Chile
Netherlands

summary: The purpose of this study is to explore long-term safety, tolerability and efficacy of GSK2402968 in DMD subjects who previously participated in either DMD114117 or DMD114044.