title: AdaptResponse Clinical Trial

summary: The purpose of this clinical study is to test the hypothesis that market released Cardiac Resynchronization Therapy (CRT) devices which contain the AdaptivCRT® (aCRT) algorithm have a superior outcome compared to standard CRT devices in CRT indicated patients with normal atrio-ventricular (AV) conduction and left bundle branch block (LBBB).

ReferenceCitation: Wilkoff BL, Birnie D, Gold MR, Hersi AS, Jacobs S, Gerritse B, Kusano K, Leclercq C, Mullens W, Filippatos G. Differences in clinical characteristics and reported quality of life of men and women undergoing cardiac resynchronization therapy. ESC Heart Fail. 2020 Oct;7(5):2972-2982. doi: 10.1002/ehf2.12914. Epub 2020 Aug 13.

family: Wilkoff

full_name: Bruce L. Wilkoff

given: Bruce L.

name: University of Ottawa Heart Institute  Ottawa Ontario Canada

family: Birnie

full_name: David Birnie

given: David

name: Department of Cardiology Medical University of South Carolina  Charleston SC USA

family: Gold

full_name: Michael R. Gold

given: Michael R.

name: Faculty of Medicine King Saud University  Riyadh Saudi Arabia

family: Hersi

full_name: Ahmad S. Hersi

given: Ahmad S.

name: Medtronic Bakken Research Center  Maastricht The Netherlands

family: Jacobs

full_name: Sandra Jacobs

given: Sandra

family: Gerritse

full_name: Bart Gerritse

given: Bart

name: National Cerebral and Cardiovascular Center  Osaka Japan

family: Kusano

full_name: Kengo Kusano

given: Kengo

name: Department of Cardiology University of Rennes  Rennes France

family: Leclercq

full_name: Christophe Leclercq

given: Christophe

name: Department of Cardiology, Ziekenhuis Oost‐Limburg, Genk Belgium and Hasselt University  Hasselt Belgium

family: Mullens

full_name: Wilfried Mullens

given: Wilfried

name: School of Medicine National and Kapodistrian University of Athens  Athens Greece

name: School of Medicine University of Cyprus  Nicosia Cyprus

family: Filippatos

full_name: Gerasimos Filippatos

given: Gerasimos

journal_name: ESC Heart Failure

oa_colors: green gold

evidence: oa journal (via doaj)

ReferenceCitation: Filippatos G, Birnie D, Gold MR, Gerritse B, Hersi A, Jacobs S, Kusano K, Leclercq C, Mullens W, Wilkoff BL; AdaptResponse Investigators. Rationale and design of the AdaptResponse trial: a prospective randomized study of cardiac resynchronization therapy with preferential adaptive left ventricular-only pacing. Eur J Heart Fail. 2017 Jul;19(7):950-957. doi: 10.1002/ejhf.895. Review.

name: National and Kapodistrian University of Athens; School of Medicine; Athens Greece

name: University of Ottawa Heart Institute; Ottawa Ontario Canada

name: Medical University of South Carolina; Charleston SC USA

name: Medtronic plc, Bakken Research Center (BRC); Maastricht the Netherlands

name: King Saud University; College of Medicine, Department of Cardiac Sciences; Riyadh Saudi Arabia

full_name: Ahmad Hersi

given: Ahmad

name: National Cerebral and Cardiovascular Centre; Osaka Japan

name: University Hospital Rennes, University of Rennes I and CIC-IT 804; Rennes France

name: Department of Cardiology; Ziekenhuis Oost-Limburg; Genk Belgium

name: on behalf of the AdaptResponse Investigators

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

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_country:
Finland
Australia
Belgium
Russian Federation
Denmark
Taiwan
India
France
Japan
Poland
Slovakia
Norway
Canada
Korea, Republic of
Sweden
Saudi Arabia
Switzerland
Netherlands
Hungary
Puerto Rico
Portugal
United States
Germany
United Kingdom
Italy
Austria
Mexico
Spain

location_facility: EN Meshalkin National medical research center of the Ministry of Health of the Russian Federation

location_facility: North Memorial Heart and Vascular Institute

location_facility: Universitätsklinikum Schleswig-Holstein - Campus Lübeck

location_facility: Azienda Ospedaliero-Universitaria di Parma

location_facility: Florida Hospital Cardiovascular Research Institute

location_facility: Golden Jubilee National Hospital - NHS Trust

location_facility: Kliniken Maria Hilf GmbH Mönchengladbach - Krankenhaus St. Franziskus

location_facility: University of Pittsburgh Medical Center UPMC Presbyterian

location_facility: Berufsgenossenschaftliche Universitätsklinik Bergmannsheil GmbH

location_facility: Otto von Guericke Universität - Universitätsklinikum Magdeburg A.ö.R.

location_facility: Azienda Ospedaliera Spedali Civili di Brescia

location_facility: Saint Francis Medical Group Indiana Heart Physician

location_facility: Complexo Hospitalario Universitario de Vigo - Hospital Xeral Cíes

location_facility: University of Minnesota Medical Center Fairview

location_facility: National Taiwan University Hospital Hsin Chu Branch

location_facility: Wojewódzki Szpital Zespolony im. Ludwika Perzyny w Kaliszu

location_facility: MVZ am Küchwald GmbH ambulantes Herz Zentrum Chemnitz

location_facility: National Cerebral and Cardiovascular Center

location_facility: Phoenix Cardiovascular Research Group, LLC

location_facility: Landeskrankenhaus Innsbruck - Universitätskliniken

location_facility: Górnośląskie Centrum Medyczne im prof Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach

location_facility: Centre Hospitalier Universitaire de Grenoble-Hopital Albert Michallon

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

location_facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)

location_facility: London Health Sciences Centre - University Campus

location_facility: Unidade Local de Saude do Baixo Alentejo, EPE - Hospital José Joaquim Fernandes

location_facility: The College of Medicine & King Khalid University Hospital, King Saud University

location_facility: Centre Hospitalier Universitaire de Amiens - Hôpital SU

location_facility: Cardiovascular Research Center of South Florida

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: Almazov National Medical Research Centre

location_facility: Hospital Universitario Nuestra Señora de Candelaria

location_facility: Glacier View Research Institute Cardiology

location_facility: Ziekenhuis Oost Limburg - Campus St.-Jan

location_facility: Märkische Gesundheitsholding GmbH & Co. KG - Klinikum Lüdenscheid

location_facility: Royal Brompton & Harefield NHS Foundation Trust - Royal Brompton Hospital

location_facility: King Faisal Specialist Hospital & Research Center

location_facility: Azienda Ospedaliera Universitaria Integrata Verona

location_facility: Virginia Commonwealth University Health System

location_facility: Universitätsklinikum Jena - Friedrich Schiller Universität

location_facility: Prairie Education and Research Cooperative

location_facility: The University of Vermont Medical Center Inc

location_facility: CAMC Health Education & Research Institute Inc

location_facility: Herz- und Diabeteszentrum NRW - Ruhr-Universität Bochum

location_facility: Washington University School of Medicine

location_facility: University Hospitals Case Medical Center

location_facility: Stredoslovensky ustav srdcovych a cievnych chorob a.s

location_facility: Seoul National University Bundang Hospital

location_facility: groupe Hospitalier de L'Institut Catholique de Lille - Hôpital Saint-Philibert

location_facility: The University of Texas (UT) Southwestern Medical Center

location_facility: Scripps Green Hospital Scripps Clinic Torrey Pines

location_facility: Helse Bergen HF - Haukeland Universitetssjukehus

location_facility: Medical University of South Carolina (MUSC)

location_facility: Immanuel Diakonie Group - Evangelisch-Freikirchlichen Krankenhaus und Herzzentrum Brandenburg

location_facility: Saitama Medical Center Jichi Medical University

location_facility: Oklahoma Heart Hospital Research Foundation

location_facility: Centennial Heart Cardiovascular Consultants LLC

location_facility: Weill Medical College of Cornell University

location_facility: Hospital Universitario Virgen de las Nieves

location_facility: Cardiology Institute of Northwest Florida

location_facility: University of South Florida Health (USF)

location_facility: CHRU de Montpellier - Hôpital Arnaud de Villeneuve

location_facility: CHI St. Luke's Heath Baylor College of Medicine Medical Center

location_facility: Keimyung University Dongsan Medical Center

location_facility: Manchester University NHS Foundation Trust - Wythenshawe Hospital

location_facility: AV Vishnevsky Institute of Surgery of the Ministry of Health of the Russian Federation

location_facility: Praxisklinik Herz und Gefässe - Akademische Lehrpraxisklinik der TU Dresden

location_facility: Liverpool Heart and Chest Hospital NHS Foundation Trust

location_facility: Klinikum der Universität München - Campus Großhadern

location_facility: Amphia Ziekenhuis - Locatie Molengracht Breda

location_facility: Massachusetts General Hospital (Boston MA)

location_facility: Wojewódzki Szpital Specjalistyczny im. Stefana Kardynała Wyszyńskiego


ReferenceType: derived

ReferenceCitation: Nicolau JC, Bhatt DL, Hohnloser SH, Kimura T, Lip GYH, Miede C, Nordaby M, Oldgren J, Steg PG, Ten Berg JM, Godoy LC, Cannon CP; RE-DUAL PCI Steering Committee and Investigators. Dabigatran Dual Therapy vs Warfarin Triple Therapy Post-Percutaneous Coronary Intervention in Patients with Atrial Fibrillation With/Without a Proton Pump Inhibitor: A Pre-Specified Analysis of the RE-DUAL PCI Trial. Drugs. 2020 Jul;80(10):995-1005. doi: 10.1007/s40265-020-01323-x.

family: Nicolau

full_name: José C. Nicolau

given: José C.

sequence: first

family: Bhatt

full_name: Deepak L. Bhatt

given: Deepak L.

sequence: additional

family: Hohnloser

full_name: Stefan H. Hohnloser

given: Stefan H.

family: Kimura

full_name: Takeshi Kimura

given: Takeshi

family: Lip

full_name: Gregory Y. H. Lip

given: Gregory Y. H.

family: Miede

full_name: Corinna Miede

given: Corinna

family: Nordaby

full_name: Matias Nordaby

given: Matias

family: Oldgren

full_name: Jonas Oldgren

given: Jonas

family: Steg

full_name: Philippe Gabriel Steg

given: Philippe Gabriel

family: ten Berg

full_name: Jurriën M. ten Berg

given: Jurriën M.

family: Godoy

full_name: Lucas C. Godoy

given: Lucas C.

family: Cannon

full_name: Christopher P. Cannon

given: Christopher P.

name: The RE-DUAL PCI Steering Committee and Investigators

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Drugs

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

evidence: oa repository (via OAI-PMH doi match)

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

license_normalized: no license

repository_institution: Uppsala University - Uppsala University Publications

evidence: oa repository (via pmcid lookup)

repositories_institution: Uppsala University - Uppsala University Publications

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: De Caterina R, Procopio A, Lopez Sendon JL, Raev D, Mehta SR, Opolski G, Oldgren J, Steg PG, Hohnloser SH, Lip GYH, Kimura T, Kleine E, Ten Berg JM, Bhatt DL, Miede C, Nordaby M, Cannon CP; RE-DUAL PCI Steering Committee and Investigators. Comparison of Dabigatran Plus a P2Y(12) Inhibitor With Warfarin-Based Triple Therapy Across Body Mass Index in RE-DUAL PCI. Am J Med. 2020 Nov;133(11):1302-1312. doi: 10.1016/j.amjmed.2020.03.045. Epub 2020 May 7.

family: De Caterina

full_name: Raffaele De Caterina

given: Raffaele

family: Procopio

full_name: Antonio Procopio

given: Antonio

family: Lopez Sendon

full_name: José-Luis Lopez Sendon

given: José-Luis

family: Raev

full_name: Dimitar Raev

given: Dimitar

family: Mehta

repository_institution: Universidad Autónoma de Madrid - Biblos-e Archivo

repositories_institution: Universidad Autónoma de Madrid - Biblos-e Archivo

title: Comparison of Dabigatran Plus a P2Y12 Inhibitor With Warfarin-Based Triple Therapy Across Body Mass Index in RE-DUAL PCI

ReferenceCitation: Berry NC, Mauri L, Steg PG, Bhatt DL, Hohnloser SH, Nordaby M, Miede C, Kimura T, Lip GYH, Oldgren J, Ten Berg JM, Cannon CP. Effect of Lesion Complexity and Clinical Risk Factors on the Efficacy and Safety of Dabigatran Dual Therapy Versus Warfarin Triple Therapy in Atrial Fibrillation After Percutaneous Coronary Intervention: A Subgroup Analysis From the REDUAL PCI Trial. Circ Cardiovasc Interv. 2020 Apr;13(4):e008349. doi: 10.1161/CIRCINTERVENTIONS.119.008349. Epub 2020 Apr 7.

name: Mid-Atlantic Permanente Medical Group, McLean, VA (N.C.B.).

name: Université de Paris, FACT, INSERM U_1148 and Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, France (P.G.S.).

name: Brigham and Women’s Hospital Heart and Vascular Center and Harvard Medical School, Boston, MA (D.L.B., C.P.C.).

name: Johann Wolfgang Goethe University, Frankfurt am Main, Germany (S.H.H.).

name: Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany (M.N.).

name: HMS Analytical Software GmbH, Weimar (Lahn), Germany (C.M.).

name: Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart and Chest Hospital, United Kingdom (G.Y.H.L.).

name: Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Denmark (G.Y.H.L).

name: Uppsala Clinical Research Center and Department of Medical Sciences, Uppsala University, Sweden (J.O.).

name: St Antonius Ziekenhuis, Nieuwegein, the Netherlands (J.M.t.B.).

name: on behalf of the REDUAL PCI Steering Committee and Investigators

publisher: Ovid Technologies (Wolters Kluwer Health)

ReferenceCitation: Hohnloser SH, Steg PG, Oldgren J, Nickenig G, Kiss RG, Ongen Z, Navarro Estrada JL, Oude Ophuis T, Lip GYH, Nordaby M, Kleine E, Ten Berg JM, Bhatt DL, Cannon CP; RE-DUAL PCI Steering Committee and Investigators. Renal Function and Outcomes With Dabigatran Dual Antithrombotic Therapy in Atrial Fibrillation Patients After PCI. JACC Cardiovasc Interv. 2019 Aug 26;12(16):1553-1561. doi: 10.1016/j.jcin.2019.05.050.

ReferenceCitation: Chi G, Kerneis M, Kalayci A, Liu Y, Mehran R, Bode C, Halperin JL, Verheugt FWA, Wildgoose P, van Eickels M, Lip GYH, Cohen M, Peterson ED, Fox KAA, Gibson CM. Safety and efficacy of non-vitamin K oral anticoagulant for atrial fibrillation patients after percutaneous coronary intervention: A bivariate analysis of the PIONEER AF-PCI and RE-DUAL PCI trial. Am Heart J. 2018 Sep;203:17-24. doi: 10.1016/j.ahj.2018.06.003. Epub 2018 Jun 13.

repository_institution: University of Birmingham - University of Birmingham Research Portal

repository_institution: Aalborg Universitet - VBN Forskningsportal

repositories_institution: Aalborg Universitet - VBN Forskningsportal

title: Safety and efficacy of non–vitamin K oral anticoagulant for atrial fibrillation patients after percutaneous coronary intervention: A bivariate analysis of the PIONEER AF-PCI and RE-DUAL PCI trial

ReferenceCitation: Cannon CP, Bhatt DL, Oldgren J, Lip GYH, Ellis SG, Kimura T, Maeng M, Merkely B, Zeymer U, Gropper S, Nordaby M, Kleine E, Harper R, Manassie J, Januzzi JL, Ten Berg JM, Steg PG, Hohnloser SH; RE-DUAL PCI Steering Committee and Investigators. Dual Antithrombotic Therapy with Dabigatran after PCI in Atrial Fibrillation. N Engl J Med. 2017 Oct 19;377(16):1513-1524. doi: 10.1056/NEJMoa1708454. Epub 2017 Aug 27.

name: From the Baim Institute for Clinical Research (C.P.C., J.L.J.), Brigham and Women’s Hospital, Heart and Vascular Center, and Harvard Medical School (C.P.C., D.L.B.), and the Cardiology Division, Massachusetts General Hospital, and Harvard Medical School (J.L.J.) — all in Boston; Uppsala Clinical Research Center and Department of Medical Sciences, Uppsala University, Uppsala, Sweden (J.O.); the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham (G.Y.H.L.), Boehringer Ingelheim,...

repository_institution: University of Szeged - SZTE Publicatio Repozitórium - SZTE - Repository of Publications

location_country:
Finland
Greece
Australia
Belgium
Russian Federation
Denmark
Taiwan
India
Croatia
France
Japan
Poland
Slovakia
Norway
Thailand
Argentina
Canada
Slovenia
Korea, Republic of
Colombia
Chile
Sweden
Hong Kong
Netherlands
Bulgaria
Singapore
Hungary
Ireland
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
Israel
New Zealand
Spain
Turkey

location_facility: State Budg.Healthc.Instit.Samara Reg.Clin.Cardiology Dispens

location_facility: Mission Cardiovascular Research Institute

location_facility: Independent Public Clin.Hosp.#4, Cardiology Clinic,Lubilin

location_facility: Altaiskyi Reg.Cardiologic Dispensary,Cardiology Dept,Barnaul

location_facility: Karlovarska Reg.Hosp, Cardiology Dept, Karlovy Vary

location_facility: Herz- und Gefäßzentrum (HGZ-Göttingen) am Krankenhaus Neu Bethlehem

location_facility: Richmond Cardiology Associates Research, LLC

location_facility: INCOR e Hospital das Clínicas da Universidade de São Paulo

location_facility: Central Hospital of Medical Academy, Warsaw

location_facility: Royal Bournemouth and Christchurch Hospital

location_facility: St. Antonius ziekenhuis, locatie Nieuwegein

location_facility: Hospitals of Pardubice Region, Internal Department, Svitavy

location_facility: Shaare Zedek Medical Center, Jerusalem 91031

location_facility: Sint-Niklaas - HOSP AZ Nikolaas (Campus St-Niklaas)

location_facility: University of Utah Health Sciences Center

location_facility: Instituto Nacional de Cardiologia Ignacio Chavez

location_facility: Oslo Universitetssykehus HF, Rikshospitalet

location_facility: Novant Health Heart and Vascular Institute

location_facility: Instituto de Cardiologia Rio Grande do Sul

location_facility: The Catholic University of Korea, Seoul St.Mary's Hospital

location_facility: CHUC - Centro Hospitalar e Universitário de Coimbra, EPE

location_facility: City Clin.Hosp.#15 n.a.O.M.Filatov,Cardiology Dept.#2,Moscow

location_facility: Clinical Hosp.Merkur,Clin.Internal Med,Cardiology Dep,Zagreb

location_facility: North-Western Fed.Med.Resear.Centr na V.I.Almazov,Cardio.dep

location_facility: Siyami Ersek Gogus Kalp ve Damar Cerrahisi Hastanesi

location_facility: National Hospital Organization Kanazawa Medical Center

location_facility: Clinical Hospital Sstre Milosrdnice, Cardiology Dept, Zagreb

location_facility: Instituto Cardiovascular de Buenos Aires

location_facility: Istanbul Universitesi Kardiyoloji Enstitusu

location_facility: Saint Mary's Medical Center dba Essentia Health Saint Mary's Medical Center

location_facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel

location_facility: Univ. of Szeged, 2nd Dept. of Internal Med., Haematology

location_facility: General Hospital of Athens Konstantopoulio-Agia Olga

location_facility: State Budg.Healthc.Instit Volgograd RegClin.Cardiology Centr

location_facility: Lower Silesian Spec.Hosp.T.Marciniaka,Cardiology Dep,Wroclaw

location_facility: Hosp.of Pardubice Reg,Orlickoustecka,Internal Dept, Ustinad

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: University Hospital of Thessaloniki AHEPA

location_facility: Keski-Pohjanmaan keskussairaala, Kardiologian pkl, Kokkola

location_facility: Consultorios Asociados de Endocrinología e Invest Clínica

location_facility: Instituto Dante Pazzanese de Cardiologia

location_facility: National Hospital Organization Hokkaido Medical Center

location_facility: B and M Patel Cardiac Centre, Shree Krishna Hospital,

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Oslo Universitetssykehus HF, Ullevål sykehus

location_facility: Bayview Physicians Services PC dba Cardiovascular Associates

location_facility: Centro Especializado en Terapia Endovascular (CETEN)

location_facility: Specialized Hosp.f.Active Treatment, Cardiology Dept, Yambol

location_facility: Asklepios Klinik Langen-Seligenstadt GmbH

location_facility: MHAT "Sv. Vrach" EOOD, Cardiology Dept., Sandanski

location_facility: Hospital de Base - Fac Med de Sao Jose do Rio Preto

location_facility: University of Florida College of Medicine

location_facility: HYKS, Kardiologian klinikka, Sydän- ja keuhkokeskus

location_facility: Istanbul Mehmet Akif Ersoy Egitim ve Arastirma Hastanesi

location_facility: Carl-von-Basedow Klinikum Saalekreis gGmgH

location_facility: Herz- und Diabeteszentrum Nordrhein-Westfalen, Bad Oeynhausen

location_facility: Cntr of CV Surgery na Bakulev,Surg.Treatm of Inter.Path.dept

location_facility: Cukurova Universitesi Tip Fakultesi Kardiyoloji AnabilimDali

location_facility: Gottsegen Gyorgy Hungarian Instit.of Cardiology,Budapest

location_facility: Osaka City Hospital Organization Osaka City General Hospital

location_facility: City Pokrovskiy Hospital, Cardiology Dept., Saint Petersburg

location_facility: Thunder Bay Regional Health Science Centre

location_facility: Independent Public Healthcare, Dept. of Cardiology, Pulawy

location_facility: Irmandade da Santa Casa de Misericordia de Curitiba

location_facility: MHAT "Deva Maria", Dept. of Cardiology, Burgas

location_facility: State Autonomous Healthc Insti City Clin Hosp#7,Cardio,Kazan

location_facility: Reg.Hosp Kielce,Swietokrzyskie,1.Clinic of Cardiology,Kielce

location_facility: St. Josef- und St. Elisabeth-Hospital gGmbH

location_facility: National Hospital Organization Takasaki General Medical Center

location_facility: Türkiye Yüksek Ihtisas Egitim ve Arastirma Hastanesi

location_facility: City Clin.Hosp#51,Moscow Healthcare Dep.X-ray surgery method

location_facility: Institute for Clinical and Experimental Medicine

location_facility: Hippokration Hospital, Univ Clinic of Cardiology

location_facility: University General Hospital of Heraklion

location_facility: Tokyo Women's Medical University Hospital

location_facility: Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi

location_facility: Klinikum der Stadt Ludwigshafen am Rhein gGmbH

location_facility: Ziekenhuis Netwerk Antwerpen (ZNA) - Campus Middelheim

location_facility: Japanese Red Cross Nagoya Daini Hospital

location_facility: Regional Clinical Hospital No.3, Cardiology Dept,Chelyabinsk

location_facility: Westküstenkliniken Brunsbüttel und Heide gGmbH

location_facility: Midwest Cardiovascular Research and Education Foundation

location_facility: General Hospital of Attica "Sismanoglio - Amalia Fleming"

location_facility: General Hospital of Chios, Department of Cardiology

location_facility: Kansas City Veterans Administration Medical Center

location_facility: Prince of Wales Hosp, Dept of Med & Therapeutics

location_facility: Ospedale Molinette, AO Città della Salute e della

location_facility: Märkische Gesundheitsholding GmbH & Co. KG, Klinikum Lüdenscheid

location_facility: Ondokuz Mayis Universitesi Tip Fakultesi

location_facility: Swissmed Vascular Sp. Z.o.o Hosp., Cardiology Dept., Gdansk

location_facility: National Hospital Organization Saitama National Hospital

location_facility: Kardiocentrum Nitra,Internal Medicine Dept, Nitra

location_facility: General Hospital Izola, Cardiology Department

location_facility: Shri Krishna Hrudayalaya and Critical Care

location_facility: City Clin.Univ.MPHAT EOOD,Clin.of Cardiology, Sofia

location_facility: Erciyes Universitesi Tip Fakultesi Kardiyoloji Anabilim Dali

location_facility: Bacs-Kiskun Megyei Onkormanyzat Hospital

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi

location_facility: ASST Papa Giovanni XXIII - A.O. Papa Giovanni XXIII

title: A Prospective Randomised, Open Label, Blinded Endpoint (PROBE) Study to Evaluate DUAL Antithrombotic Therapy With Dabigatran Etexilate (110mg and 150mg b.i.d.) Plus Clopidogrel or Ticagrelor vs. Triple Therapy Strategy With Warfarin (INR 2.0 - 3.0) Plus Clopidogrel or Ticagrelor and Aspirin in Patients With Non Valvular Atrial Fibrillation (NVAF) That Have Undergone a Percutaneous Coronary Intervention (PCI) With Stenting

summary:
The main objective of this study is to compare a Dual Antithrombotic Therapy (DAT) regimen of 110mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (110mg dabigatran etexilate (DE) DAT) and 150mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (150mg DE-DAT) with a Triple Antithrombotic Therapy (TAT) combination of warfarin plus clopidogrel or ticagrelor plus Aspirin (ASA) <= 100mg once daily (warfarin-TAT) in patients with Atrial Fibrillation that undergo a PCI with stenting (elective or due to an Acute Coronary Syndrome).

The study aims to show non-inferiority of each dose of DE-DAT when compared to Warfarin-TAT in terms of safety. Safety will be determined by comparing the rates of bleeding events, assessed using the modified International Society of Thrombosis and Haemostasis classification of Major Bleeding and Clinically Relevant Non Major Bleeding Events.


title: A Multicenter, Randomized, Placebo-controlled, Double-blind, 16 Week Study to Evaluate the Efficacy and Safety of Amantadine HCl Extended Release Tablets in Parkinson's Disease Subjects With Levodopa-Induced Dyskinesias

acronym: ALLAY-LID-I

summary: This study was terminated early due to slow enrollment with 87 of 162 planned subjects enrolled. The purpose of this multi-center, randomized, double-blind, parallel-group, 16 week study is to compare the efficacy and safety of two different dose levels of Amantadine Extended Release Tablets to placebo for the treatment of levodopa induced dyskinesia in patients with Parkinson's disease.

study_start_date_type: Actual

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Osmotica Pharmaceutical US LLC

location_country:
United States
France
Spain
Germany
Canada

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Unknown


title: A Multicenter, Randomized, Placebo-controlled, Double-blind, 26 Week Study to Evaluate the Efficacy and Safety of Amantadine HCl Extended Release Tablets in Parkinson's Disease Subjects With Levodopa-Induced Dyskinesias

acronym: ALLAY-LID-II

summary: The purpose of this multi-center, randomized, double-blind, parallel-group, 26 week study is to compare the efficacy and safety of two different dose levels of Amantadine Extended Release Tablets to placebo for the treatment of levodopa induced dyskinesia in patients with Parkinson's disease.

location_facility:
Hospital de la Santa Creu i Sant Pau
Hospital General de Cataluna


status: Completed

lead_sponsor: Pierre Fabre Medicament

location_country:
Italy
France
Spain
Germany
Czech Republic

acronym: PERLES

type: EudraCT Number

source: euctr

title: PERMIXON® 160 mg Hard Capsule Versus Placebo in the Treatment of Symptomatic Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia

summary: The aim of this study is to support the efficacy of Permixon 160 mg b.i.d. in treating subjects with symptomatic Benign Prostatic Hyperplasia (BPH), compared to placebo, using Tamsulosine LP 0.4 mg as a reference treatment.

status_simplified: Completed


title: CENTAUR: Efficacy and Safety Study of Cenicriviroc for the Treatment of Nonalcoholic Steatohepatitis (NASH) in Adult Subjects With Liver Fibrosis

acronym: CENTAUR

summary: The purpose of this study is to determine whether cenicriviroc is effective and safe in the treatment of nonalcoholic steatohepatitis (NASH) in adult participants with liver fibrosis.

ReferenceCitation: Ratziu V, Sanyal A, Harrison SA, Wong VW, Francque S, Goodman Z, Aithal GP, Kowdley KV, Seyedkazemi S, Fischer L, Loomba R, Abdelmalek MF, Tacke F. Cenicriviroc Treatment for Adults With Nonalcoholic Steatohepatitis and Fibrosis: Final Analysis of the Phase 2b CENTAUR Study. Hepatology. 2020 Sep;72(3):892-905. doi: 10.1002/hep.31108. Epub 2020 Jul 21.

name: Hôpital Pitié Salpêtrière and Sorbonne Université Paris France

family: Ratziu

full_name: Vlad Ratziu

given: Vlad

name: Department of Gastroenterology Virginia Commonwealth University Richmond VA

family: Sanyal

full_name: Arun Sanyal

given: Arun

name: Pinnacle Clinical Research San Antonio TX

family: Harrison

full_name: Stephen A. Harrison

given: Stephen A.

name: Department of Medicine and Therapeutics Chinese University of Hong Kong Hong Kong People's Republic of China

family: Wong

full_name: Vincent Wai‐Sun Wong

given: Vincent Wai‐Sun

name: Gastroenterology and Hepatology Antwerp University Hospital University of Antwerp Antwerp Belgium

family: Francque

full_name: Sven Francque

given: Sven

name: Center for Liver Diseases Inova Fairfax Medical Campus Falls Church VA

family: Goodman

full_name: Zachary Goodman

given: Zachary

name: NIHR Nottingham Biomedical Research Centre Nottingham University Hospitals NHS Trust and University of Nottingham Nottingham UK

family: Aithal

full_name: Guruprasad P. Aithal

given: Guruprasad P.

name: Liver Care Network Swedish Medical Center Seattle WA

family: Kowdley

full_name: Kris V. Kowdley

given: Kris V.

family: Seyedkazemi

full_name: Star Seyedkazemi

given: Star

family: Fischer

full_name: Laurent Fischer

given: Laurent

name: Division of Gastroenterology Department of Medicine University of California San Diego, La Jolla CA

name: NAFLD Research Center Department of Medicine University of California San Diego, La Jolla CA

family: Loomba

full_name: Rohit Loomba

given: Rohit

name: Division of Gastroenterology & Hepatology Department of Medicine Duke University Durham NC

family: Abdelmalek

full_name: Manal F. Abdelmalek

given: Manal F.

name: Department of Medicine III University Hospital Aachen Aachen Germany

name: Department of Gastroenterology & Hepatology Charité University Medical Center Berlin Berlin Germany

family: Tacke

full_name: Frank Tacke

given: Frank

journal_name: Hepatology

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

repository_normalized: HAL

repository_institution: University of Nottingham - Repository@Nottingham

url: https://nottingham-repository.worktribe.com/5069801/1/cenicriviroc 2020 accepted hep.31108

url_for_landing_page: https://nottingham-repository.worktribe.com/5069801/1/Cenicriviroc 2020 Accepted Hep.31108

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Lefebvre E, Moyle G, Reshef R, Richman LP, Thompson M, Hong F, Chou HL, Hashiguchi T, Plato C, Poulin D, Richards T, Yoneyama H, Jenkins H, Wolfgang G, Friedman SL. Antifibrotic Effects of the Dual CCR2/CCR5 Antagonist Cenicriviroc in Animal Models of Liver and Kidney Fibrosis. PLoS One. 2016 Jun 27;11(6):e0158156. doi: 10.1371/journal.pone.0158156. eCollection 2016.

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

repository_institution: Columbia University - Columbia Academic Commons

ReferenceCitation: Friedman S, Sanyal A, Goodman Z, Lefebvre E, Gottwald M, Fischer L, Ratziu V. Efficacy and safety study of cenicriviroc for the treatment of non-alcoholic steatohepatitis in adult subjects with liver fibrosis: CENTAUR Phase 2b study design. Contemp Clin Trials. 2016 Mar;47:356-65. doi: 10.1016/j.cct.2016.02.012. Epub 2016 Mar 2.

location_country:
Italy
Hong Kong
Germany
France
Poland
Belgium
Australia
Spain
United States
United Kingdom


type: Other Identifier

title: A PHASE 3, RANDOMIZED, DOUBLE-BLIND STUDY OF PF-05280586 VERSUS RITUXIMAB FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH CD20-POSITIVE, LOW TUMOR BURDEN, FOLLICULAR LYMPHOMA

summary: This study will compare the safety and effectiveness of PF-05280586 versus rituximab-EU in patients with CD20-positive, low tumor burden follicular lymphoma. The primary hypothesis to be tested in this study is that the effectiveness of PF-05280586, as measured by the Overall Response Rate, is similar to that of rituximab-EU.

ReferenceCitation: Courville J, Nastoupil L, Kaila N, Kelton J, Zhang J, Alcasid A, Nava-Parada P. Factors Influencing Infusion-Related Reactions Following Dosing of Reference Rituximab and PF-05280586, a Rituximab Biosimilar. BioDrugs. 2021 Jul;35(4):459-468. doi: 10.1007/s40259-021-00487-6. Epub 2021 Jun 21.

family: Courville

full_name: Jocelyn Courville

given: Jocelyn

family: Nastoupil

full_name: Loretta Nastoupil

given: Loretta

family: Kaila

full_name: Nitin Kaila

given: Nitin

family: Kelton

full_name: John Kelton

given: John

family: Zhang

full_name: Jeffrey Zhang

given: Jeffrey

family: Alcasid

full_name: Ann Alcasid

given: Ann

family: Nava-Parada

full_name: Pilar Nava-Parada

given: Pilar

journal_name: BioDrugs

ReferenceCitation: Sharman JP, Liberati AM, Ishizawa K, Khan T, Robbins J, Alcasid A, Rosenberg JA, Aurer I. A Randomized, Double-Blind, Efficacy and Safety Study of PF-05280586 (a Rituximab Biosimilar) Compared with Rituximab Reference Product (MabThera(®)) in Subjects with Previously Untreated CD20-Positive, Low-Tumor-Burden Follicular Lymphoma (LTB-FL). BioDrugs. 2020 Apr;34(2):171-181. doi: 10.1007/s40259-019-00398-7.

family: Sharman

full_name: Jeff P. Sharman

given: Jeff P.

family: Liberati

full_name: Anna Marina Liberati

given: Anna Marina

family: Ishizawa

full_name: Kenichi Ishizawa

given: Kenichi

family: Khan

full_name: Tahira Khan

given: Tahira

family: Robbins

full_name: Jeffery Robbins

given: Jeffery

family: Rosenberg

full_name: Julie Ann Rosenberg

given: Julie Ann

family: Aurer

full_name: Igor Aurer

given: Igor

title: A Randomized, Double-Blind, Efficacy and Safety Study of PF-05280586 (a Rituximab Biosimilar) Compared with Rituximab Reference Product (MabThera®) in Subjects with Previously Untreated CD20-Positive, Low-Tumor-Burden Follicular Lymphoma (LTB-FL)

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

location_country:
Peru
Greece
Romania
Belgium
Russian Federation
Ukraine
India
Spain
Croatia
France
Japan
Poland
Thailand
Korea, Republic of
South Africa
Switzerland
Philippines
Puerto Rico
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Lebanon
Mexico
Georgia
Belarus
Turkey

location_facility: Hospital das Clinicas da Universidade Federal de Goias \ Centro de Pesquisa Clinica

location_facility: Compassionate Care Research Group, Inc., at Compassionate Cancer Care Medical Group, Inc.

location_facility: R.K. Birla Cancer Center, Sawai Man Singh Hospital

location_facility: Klinikum Chemnitz gGmbH - Institut fuer Interventionelle Radiologie und Neuroradiologie

location_facility: University Hospital Center Zagreb, Department of Pathology and Cytology

location_facility: SBHI of Moscow City Clinical Hospital n.a. S.P.Botkin of Healthcare Department of Moscow

location_facility: LTD "Research Institute of Clinical Medicine"

location_facility: Municipal Non-Profit Enterprise "Regional Oncology Centre"

location_facility: Healthcare Institution 'Minsk City Clinical Oncology Dispensary'

location_facility: State Budgetary Healthcare Institution "Republican Clinical Oncology Dispensary of the Ministry

location_facility: University Hospital Centre "Sestre Milosrdnice"

location_facility: Positron Emission Tomography (PET) Centre

location_facility: Spitalul Clinic Coltea, Clinica de Hematologie

location_facility: N.P. Bechtereva Institute of Human Brain of the Russian Academy of Sciences

location_facility: Centre Hospitalier Universitaire Cote de Nacre

location_facility: Podilskyy Regional Oncology Center, Chemotherapy Department

location_facility: CAEP - Centro Avancado de Estudos e Pesquisas LTDA

location_facility: Federal State-Financed Institution 'North-Caucasian Research and Clinical Center'

location_facility: Euromedic Wroclawskie Centrum Medyczne II

location_facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

location_facility: Centro Hospitalar do Porto-Hospital de Santo Antonio E.P.E.

location_facility: Uniao Brasileira de Educacao e Assistencia (UBEA) - Hospital Sao Lucas da PUCRS -

location_facility: Cirurgia y Ginecobstetricia de Oaxaca, S.A de C.V.

location_facility: Klinikum Chemnitz gGmbH - Klinik fuer Nuklearmedizin

location_facility: Gen. Hosp. of Athens "Evangelismos - Eye Hosp.- Polikliniki"

location_facility: SI 'Republican Research and Practice Centre of Oncology and Medical Radiology n.a. N.N. Alexandrov'

location_facility: Kliniken Ostalb, Stauferklinikum Schwaebisch Gmuend, Zentrum fuer Innere Medizin

location_facility: Hospital das Clinicas da Faculdade de Medicina da USP / Fundacao Faculdade de Medicina MEC MPAS

location_facility: Drs Sulman & Partners Specialist Radiologists

location_facility: Klinikum Chemnitz gGmbH - Zentralapotheke

location_facility: Willamette Valley Cancer Institute and Research Center

location_facility: Policlinico Universitario Campus Bio- Medico-U.O.C. di Ematologia Trapianto Cellule Staminali

location_facility: Private medical institution "Euromedservice"

location_facility: SBHI of Stavropol Region "Pyatigorsk Interdistrict Oncology Dispensary

location_facility: San Antonio Military Medical Center- Department of Pharmacy

location_facility: EGE-RAD Bilgisayarli Tomografi Ozel Saglik Hizmetleri ve Malzemeleri Tic.Ltd.Sti.

location_facility: Centro de Imagens da Faculdade de Medicina - INCT Medicina Nuclear - PET/CT

location_facility: "SBHI of NNR ""Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko"""

location_facility: U.O. di Ematologia e CTMO - Istituti Ospedalieri di Cremona

location_facility: Kobe City Medical Center General Hospital

location_facility: Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi

location_facility: Royal United Hospitals Bath NHS Foundation Trust

location_facility: Hospital das Clinicas Universidade Federal de Minas Gerais

location_facility: Pharmacy Department, Centre Hospitalier De Jolimont - Lobbes

location_facility: FSBI "Russian Research Centre of Radiology and Surgical Technologies" of MoH of RF

location_facility: Euromedic Wroclawskie Centrum Medyczne III

location_facility: Institutul Oncologic Prof. Dr. Ion Chiricuta, Laborator Radiologie si Imagistica Medicala

location_facility: FSBI 'Russian Research Centre of Radiology and Surgical Technologies

location_facility: Innovative Clinical Research Institute (ICRI)

location_facility: National Hospital Organization Disaster Medical Center

location_facility: Cardiology Unit,Department of Medicine, Faculty of Medicine, Ramathibodi Hospital,

location_facility: University Hospital Center Zagreb, Department of Radiology

location_facility: National Hospital Organization Kanazawa Medical Center

location_facility: Dolnoslaskie Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku

location_facility: Saint Francis Medical Center, Saint Francis Cancer Treatment Center

location_facility: Dr. Abdurrahman Yurtaslan Ankara Onkoloji Eg. ve Aras.

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: Healthcare Institution "Brest Regional Oncologic Dispensary"

location_facility: Jehangir Clinical Development Centre Pvt. Ltd.

location_facility: PET/CT facility: Grand Hopital de Charleroi (GHdC) - site Notre-Dame

location_facility: Radiodiagnostic CETIR - Clinica del Pilar

location_facility: National Hospital Organization Sendai Medical Center

location_facility: GBUZ of Yaroslavl Region "Regional Clinical Hospital"

location_facility: Branch office of LLC 'PET-Technology' at Ufa city

location_facility: Hospital Santa Izabel - Setor de Bioimagem

location_facility: Casa de Saude Santa Marcelina (Centro de Pesquisa Santa Marcelina)

location_facility: Non-state healthcare institution "Road Clinical Hospital of Joint Stock Company "Russian Railways"

location_facility: CDI - Centro de Diagnostico por Imagem do Hospital Sao Lucas da PUCRS

location_facility: Rajiv Gandhi Cancer Institute & Research Center (RGCIRC)

location_facility: Clinica de Hematologie-Institutul Oncologic, Prof. Dr. Ion Chiricuta

location_facility: Ege Universitesi Tip Fakultesi Ic Hastaliklari Anabilim Dali

location_facility: Unidade Local de Saude de Matosinhos E.P.E. - Hospital Pedro Hispano S.A.

location_facility: Central de Misturas Intravenosas do Hospital de Clinicas de Porto Alegre

location_facility: US Oncology Investigational Products Center (IPC)

location_facility: Russian Cancer Research Centre them N.N. Blokhin

location_facility: Klinika Nowotworow Ukladu Chlonnego Centrum Onkologii - Instytut im. M. Sklodowskiej-Curie

location_facility: National Hospital Organization Nagasaki Medical Center

location_facility: DokuSan Gesellschaft fuer Medizinische Studien mbH & Co. KG

location_facility: Showa University Northern Yokohama Hospital

location_facility: FSBSI 'N.N.Blokhin Russian Cancer Research Center' of MoH of RF

location_facility: Gen.Hosp.of Athens "Evangelismos-Eye Hosp.-polikiliniki"

location_facility: Inonu Universitesi Tip Fakultesi Turgut Ozal Tip Merkezi

location_facility: Lewis Hall Singletary Oncology Center At John D. Archbold Memorial Hospital

location_facility: Phylasis Clinicas Research S. de R.L. de C.V.

location_facility: City Hospitals Sunderland NHS Foundation Trust-Sunderland Royal Hospital

location_facility: FSBI 'National Medical Oncology Research Centre n.a. N.N.Petrov'

location_facility: National Hospital Organization Tokyo Medical Center

location_facility: University of Philippines Manila-Philippine General Hospital

location_facility: U.O. Ematologia 1 - IRCCS AOU San Martino-IST

location_facility: Gaziantep Universitesi Sahinbey Arastirma ve Uygulama

location_facility: Oaxaca Site Management Organization S.C.

location_facility: South Valley Imaging Center (Imaging Only)

location_facility: San Antonio Military Medical Center- Department of Radiology

location_facility: Policlinica de Diagnostic Rapid, Hematologie

location_facility: Stauferklinikum Schwaebisch Gmuend, Apotheke

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: SC Ematologia, Fondazione IRCCS Ist Nazionale dei Tumori

location_facility: Charite - Universitaetsmedizin Berlin, Campus Virchow-Klinikum

location_facility: Gen. Hosp. of Athens "Evangelismos-Eye Hosp. - Polikliniki"

location_facility: "LTD ""M. Zodelava's Hematology Centre"""

location_facility: "Dipartimento di Biotecnologie Cellulari ed Ematologia, Universita ""Sapienza""

location_facility: Gemeinschaftspraxis fuer Diagnostische Radiologie und Nuklearmedizin

location_facility: University Hospital Center Zagreb, Department of Nuclear Medicine and Radiation Protection

location_facility: Clinica Ematologica - A.O.U. Ospedali Riuniti di Ancona

location_facility: Torrance Health Association DBA, Torrance Memorial Physician, Network/Cancer Care Associates

location_facility: U.O. Ematologia Universitaria - Dip. Di Oncologia dei Trapianti - AOU Pisana

location_facility: Complejo Hospitalario de Ourense. Hematología

location_facility: "Municipal Institution ""Chernivtsi Regional Clinical Oncology Center"",

location_facility: Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.

location_facility: Klinikum Stuttgart, Klinik fuer Nuklearmedizin

location_facility: Erciyes Universitesi Tip Fakultesi Radyoloji Laboratuvari

location_facility: The Oncology Institute of Hope and Innovation

location_facility: FSBI "Russian Research Centre of Radiology and Surgical Technologies named after academician

location_facility: Hospital universitario Virgen de la Victoria

location_facility: Fundacao do ABC - FMABC/ Faculdade de Medicina ABC ( CEPHO - Centro de Estudos e Pesquisas de

location_facility: Municipal Establishment 'Zaporizhzhia Regional Clinical Oncology Dispensary'

location_facility: SI Republican Research and Practice Centre of oncology and medical radiology n.a N.N Alexandrov

location_facility: Los Angeles Hematology Oncology Medical Group

location_facility: IEP Sao Lucas - Instituto de Ensino e Pesquisa Sao Lucas / HEMOMED - Instituto de Oncologia e

location_facility: Pharmacy Department: Grand Hopital de Charleroi (GHdC) - site Notre-Dame

location_facility: National Hospital Organization Osaka Minami Medical Center

location_facility: Pathology Department, Unique Hospital Multispeciality & Research Institute

location_facility: Hopital Morvan-CHU Brest- Service Hematologie Clinique

location_facility: Seoul National University Bundang Hospital

location_facility: National Hospital Organization Matsumoto Medical Center

location_facility: Onkologiezentrum Thun-Berner Oberland Spital Sts Ag

location_facility: Department of Medical Oncology, University of Pretoria, Steve Biko Academic Hospitals Complex

location_facility: Cancer Center,Northwestern Medicine, West Region

location_facility: Grand Hopital de Charleroi-Site Notre-Dame

location_facility: "Central City Clinical Hospital, City Oncology Center, SHEI ""Uzhhorod National University"", Chair

location_facility: General Hospital of Athens "Evangelismos - Eye Hosp. - Polikliniki"

location_facility: Albert Alberts Stem Cell Transplant Centre

location_facility: Department of Radiology, Ramathibodi Hospital

location_facility: Hospital Clínico Universitario Virgen de la Arrixaca

location_facility: Fundacao Amaral Carvalho / Fundacao Dr. Amaral Carvalho

location_facility: Institutul Oncologic Prof. Dr. Ion Chiricuta, Sectia Oncologie Medicala

location_facility: Unidade Funcional Apoio Diagnostico e terapeutica por Imagem do HC/UFMG - CT Scan

location_facility: Brody School of Medicine at East Carolina University

location_facility: Hospital Universitario Sanitas La Zarzuela

location_facility: Hammoud Hospital, University Medical Center

location_facility: Hospital do Meixoeiro Complejo Hospitalario Universitario de Vigo

location_facility: Ueberoertliche Berufsausuebungsgemeinschaft Drs. med. Helmut Forstbauer

location_facility: Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi

location_facility: Instituto Nacional de Enfermedades Neoplasicas

location_facility: State Healthcare Institution Republican Oncology Dispensary

location_facility: Hospital de Clinicas de Porto Alegre - Centro de Pesquisa Clinica

location_facility: SC Ematologia - SC Ematologia - Arcispedale Santa Maria Nuova - IRCCS

location_facility: Global Cancer Research Institute (GCRI), Inc

location_facility: Centro Universitario de Imagen Diagnostica, Radiologia e Imagen del Hospital Universitario

location_facility: Vely Grupo Medico Quirurgico, S.A. de C.V.

location_facility: High Technology Medical Center, University Clinic

location_facility: FSBI "Russian Research Centre of Radiology and Surgical Technologies n.a. A.M. Granov" of MoH of RF

location_facility: Gen. Hosp. of Athens "Evangelismos-Eye Hosp.-Polikliniki"

location_facility: State Budgetary Institution of Healthcare "Leningrad Regional Clinical Hospital"

location_facility: Apteka Dolnoslaskiego Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku

location_facility: Hacettepe Universitesi Tip Fakultesi Onkoloji Hastanesi

location_facility: Saint Louise Regional Hospital Radiology Department (Radiology Only)

location_facility: IRCSS A.O.U. San Martino - IST - UO Clinica Ematologica

location_facility: Charite - Universitatsmedizin Berlin, Campus Virchow-Klinikum

location_facility: Padiglione 1, Torre delle medicine, 6 piano

location_facility: A.Tsyb Medical Radiological Research Centre -

location_facility: Krankenhaus der Barmherzigen Schwestern Linz

location_facility: Hospital e Maternidade Madre Theodora LTDA

location_facility: Department of Radiology, Curie Manavata Cancer Centre

location_facility: Hospital Clinico Universitario Virgen de la Arrixaca

location_facility: Euromedic Wroclawskie Centrum Medyczne I

location_facility: MI 'City Dnipropetrovsk Multi-field Clin. Hospital #4 of DRC',

location_facility: Complejo Hospitalario Universitario A Coruna

location_facility: Servico de Radiologia do Hospital de Clinicas de Porto Alegre

location_facility: Instituto Portugues de Oncologia do Porto Francisco Gentil E.P.E

location_facility: N.P. Bechtereva Institute of the Human Brain of the Russian Academy of Sciences

location_facility: Fukuoka Wajiro PET Diagnostic Imaging Clinic

location_facility: National Hospital Organization Kumamoto Medical Center

location_facility: Ematologia e Centro Trapianti - AZ Osp. Ospedali Riuniti Marche Nord (AORMN) - Presidio S. Salvatore

location_facility: "State Budget Healthcare Institution ""Chelyabinsk Regional Clinical Center of Oncology

location_facility: Adnan Menderes University Medical Faculty

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Rocky Mountain Cancer Center-Lakewood (Laboratory)

location_facility: FSBI "Russian Research Centre of Radiology and Surgical Technologies

location_facility: InsCer - Instituto do Cerebro do Rio Grande do Sul - PUCRS

location_facility: Integra Gurses Teshis Tedavi ve Saglik Hizmetleri A.S.

location_facility: Erciyes Universitesi Tip Fakultesi Nukleer Tip Laboratuvari

location_facility: Charite - Universitatsmedizin Berlin - Campus Benjamin Franklin

location_facility: Rocky Mountain Cancer Centers (RMCC) - Lakewood - St Anthony

location_facility: Hospital Santa Izabel / Santa Casa de Misericordia da Bahia

location_facility: Hospital Universitario Sanitas La Moraleja

location_facility: Yakima Valley Memorial Hospital/North Star Lodge Cancer Center

location_facility: Southend University Hospital NHS Foundation Trust

location_facility: Comprehensive Cancer Center at Desert Regional Medical Center


ReferenceCitation: Swain SM, Ewer MS, Viale G, Delaloge S, Ferrero JM, Verrill M, Colomer R, Vieira C, Werner TL, Douthwaite H, Bradley D, Waldron-Lynch M, Kiermaier A, Eng-Wong J, Dang C; BERENICE Study Group. Pertuzumab, trastuzumab, and standard anthracycline- and taxane-based chemotherapy for the neoadjuvant treatment of patients with HER2-positive localized breast cancer (BERENICE): a phase II, open-label, multicenter, multinational cardiac safety study. Ann Oncol. 2018 Mar 1;29(3):646-653. doi: 10.1093/annonc/mdx773.

family: Swain

full_name: S.M. Swain

family: Ewer

full_name: M.S. Ewer

family: Viale

full_name: G. Viale

given: G.

family: Delaloge

full_name: S. Delaloge

given: S.

family: Ferrero

full_name: J.-M. Ferrero

family: Verrill

full_name: M. Verrill

given: M.

family: Colomer

full_name: R. Colomer

given: R.

family: Vieira

full_name: C. Vieira

given: C.

family: Werner

full_name: T.L. Werner

family: Douthwaite

full_name: H. Douthwaite

given: H.

family: Bradley

full_name: D. Bradley

given: D.

family: Waldron-Lynch

full_name: M. Waldron-Lynch

family: Kiermaier

full_name: A. Kiermaier

given: A.

family: Eng-Wong

full_name: J. Eng-Wong

given: J.

family: Dang

full_name: C. Dang

journal_name: Annals of Oncology

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

design_allocation: Non-Randomized

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
Mexico
Spain
Germany
France
Poland
Norway
Portugal
Denmark
United States
United Kingdom
Canada

acronym: BERENICE

location_facility: Centre Antoine Lacassagne; Hopital De Jour A2

location_facility: Herlev Hospital; Afdeling for Kræftbehandling

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: Centre Oscar Lambret; Cancerologie Gynecologique

location_facility: Guys & St Thomas Hospital; Department of Oncology

location_facility: Royal Marsden Hospital - Fulham; Oncology Department

location_facility: A.O. Città della Salute e della Scienza - Presidio Molinette; divisione oncologia medica

location_facility: Allina Health, Virginia Piper Cancer Institute

location_facility: Ospedale Santa Maria Annunziata; Oncologia

location_facility: Royal Marsden Hospital; Dept of Medical Oncology

location_facility: Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Oncologia

location_facility: Hospital Beatriz Angelo; Departamento de Oncologia

location_facility: Mount Sinai Beth Israel Comprehensive Cancer Center

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Policlinico Umberto i di Roma; dip. Scienze Radiologiche, Oncologiche, Anatomopatologiche

location_facility: Ruppiner Kliniken, Klinik fuer Gynaekologie und Geburtshilfe

location_facility: Royal United Hospital; Oncology Department

location_facility: Freeman Hospital; Northern Centre For Cancer Care

location_facility: MedStar Georgetown University Hospital (Lombardi Comprehensive Cancer Center)

location_facility: Churchill Hospital; Oxford Cancer and Haematology Centre

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Universitätsklinikum "Carl Gustav Carus"; Frauenheilkunde und Geburtshilfe

location_facility: University of South Alabama; Mitchell Cancer Institute

location_facility: Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej

location_facility: Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy)

location_facility: Cite de La Sante de Laval; Hemato-Oncologie

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

location_facility: Northwest Georgia Oncology Centers PC - Marietta

location_facility: Klinikum rechts der Isar der TU München; Klinik und Poliklinik für Frauenheilkunde

location_facility: Hospital Universitario Reina Sofia; Servicio de Oncologia

location_facility: Casa Di Cura Di Alta Specialita La Maddalena; Dept. Oncologico Di Iii Livello

location_facility: Regional Cancer Care Associates LLC - Morristown

location_facility: Hospital Universitario Virgen Macarena; Servicio de Oncologia

location_facility: Centro Clinico Champalimaud; Oncologia Medica

location_facility: Washington Cancer Institute at MedStar Washington Hospital Center.

location_facility: University of Utah; Huntsman Cancer Hospital

location_facility: Institut Gustave Roussy; Departement Oncologie Medicale

location_facility: Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii

location_facility: Hospital Universitario de la Princesa; Servicio de Oncologia

location_facility: Hospital de Santa Maria; Servico de Oncologia Medica

location_facility: Peterborough City Hospital, Edith Cavell Campus; Oncology Department

location_facility: Ospedale Della Misericordia; U.O. Di Medicina Ia - Oncologia Medica

location_facility: Asl Le-Ospedale "Vito Fazzi";U.O. Oncologia

location_facility: Centro de Diagnóstico y Tratamiento Integral de Mama, Hospital San José Tec de Monterrey

location_facility: Haukeland Universitetssjukehus; Klinisk forskningspost

location_facility: Centro Oncológico Gallego José Antonio Quiroga y Piñeiro, Servicio de Oncologia

location_facility: Oslo universitetssykehus HF, Ullevål, Kreftsenteret

location_facility: Centre D'Oncologie de Gentilly; Oncology

location_facility: Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii

location_facility: Wielkopolskie Centrum Onkologii; im. Marii Skłodowskiej-Curie

title: A Multicenter, Multinational, Phase II Study to Evaluate Perjeta in Combination With Herceptin and Standard Neoadjuvant Anthracycline-Based Chemotherapy in Patients With HER2-Positive, Locally Advanced, Inflammatory, or Early-Stage Breast Cancer

summary: This multicenter, non-randomized, open-label, phase 2 study is designed to evaluate the safety and efficacy of pertuzumab (Perjeta) in combination with trastuzumab (Herceptin) and anthracycline-based chemotherapy as neoadjuvant treatment in participants with HER2-positive locally advanced, inflammatory, or early-stage breast cancer. Each investigator will choose a treatment regimen (A or B) for all of their participants to follow. Treatment regimen A (for Cohort A) will include dose-dense doxorubicin and cyclophosphamide (ddAC), followed by paclitaxel, with pertuzumab and trastuzumab given from the start of paclitaxel. Treatment regimen B (for Cohort B) will include 5-fluorouracil, epirubicin, and cyclophosphamide (FEC), followed by docetaxel, with pertuzumab and trastuzumab given from the start of docetaxel. Participants in both cohorts will subsequently undergo surgical treatment and then resume pertuzumab and trastuzumab treatment.


ReferenceCitation: Hurvitz SA, Martin M, Jung KH, Huang CS, Harbeck N, Valero V, Stroyakovskiy D, Wildiers H, Campone M, Boileau JF, Fasching PA, Afenjar K, Spera G, Lopez-Valverde V, Song C, Trask P, Boulet T, Sparano JA, Symmans WF, Thompson AM, Slamon D. Neoadjuvant Trastuzumab Emtansine and Pertuzumab in Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer: Three-Year Outcomes From the Phase III KRISTINE Study. J Clin Oncol. 2019 Sep 1;37(25):2206-2216. doi: 10.1200/JCO.19.00882. Epub 2019 Jun 3.

name: University of California, Los Angeles, Los Angeles, CA

family: Hurvitz

full_name: Sara A. Hurvitz

given: Sara A.

name: Universidad Complutense, CUBERONC, GEICAM, Madrid, Spain

family: Martin

full_name: Miguel Martin

given: Miguel

name: Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea

family: Jung

full_name: Kyung Hae Jung

given: Kyung Hae

name: National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Republic of China

family: Huang

full_name: Chiun-Sheng Huang

given: Chiun-Sheng

family: Harbeck

full_name: Nadia Harbeck

given: Nadia

name: The University of Texas MD Anderson Cancer Center, Houston, TX

family: Valero

full_name: Vicente Valero

given: Vicente

name: Moscow City Oncology Hospital 62, Moscow, Russia

family: Stroyakovskiy

full_name: Daniil Stroyakovskiy

given: Daniil

name: University Hospitals Leuven, Leuven, Belgium

family: Wildiers

full_name: Hans Wildiers

given: Hans

name: Centre René Gauducheau, Saint-Herblain, France

family: Campone

full_name: Mario Campone

given: Mario

name: McGill University, Jewish General Hospital Segal Cancer Centre, Montréal, Québec, Canada

family: Boileau

full_name: Jean-François Boileau

given: Jean-François

name: University Hospital Erlangen, Friedrich-Alexander-University Erlangen-Nuremberg, Erlangen, Germany

family: Fasching

full_name: Peter A. Fasching

given: Peter A.

name: Translational Research in Oncology, Paris, France

family: Afenjar

full_name: Karen Afenjar

given: Karen

name: Translational Research in Oncology, Montevideo, Uruguay

family: Spera

full_name: Gonzalo Spera

given: Gonzalo

name: PAREXEL International GmbH, Berlin, Germany

family: Lopez-Valverde

full_name: Vanesa Lopez-Valverde

given: Vanesa

family: Song

full_name: Chunyan Song

given: Chunyan

family: Trask

full_name: Peter Trask

given: Peter

family: Boulet

full_name: Thomas Boulet

given: Thomas

name: Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY

family: Sparano

full_name: Joseph A. Sparano

given: Joseph A.

family: Symmans

full_name: W. Fraser Symmans

given: W. Fraser

family: Thompson

full_name: Alastair M. Thompson

given: Alastair M.

family: Slamon

full_name: Dennis Slamon

given: Dennis

journal_name: Journal of Clinical Oncology

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: University of California - eScholarship University of California

repository_normalized: California Digital Library - eScholarship

publisher: American Society of Clinical Oncology (ASCO)

title: Neoadjuvant Trastuzumab Emtansine and Pertuzumab in Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: Three-Year Outcomes From the Phase III KRISTINE Study

ReferenceCitation: Hurvitz SA, Martin M, Symmans WF, Jung KH, Huang CS, Thompson AM, Harbeck N, Valero V, Stroyakovskiy D, Wildiers H, Campone M, Boileau JF, Beckmann MW, Afenjar K, Fresco R, Helms HJ, Xu J, Lin YG, Sparano J, Slamon D. Neoadjuvant trastuzumab, pertuzumab, and chemotherapy versus trastuzumab emtansine plus pertuzumab in patients with HER2-positive breast cancer (KRISTINE): a randomised, open-label, multicentre, phase 3 trial. Lancet Oncol. 2018 Jan;19(1):115-126. doi: 10.1016/S1470-2045(17)30716-7. Epub 2017 Nov 23.

location_country:
United States
Germany
France
Belgium
Russian Federation
Spain
Canada
Korea, Republic of
Taiwan
Ukraine

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Hospital Nuestra Señora de Sonsoles; servicio de Oncologia

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: State Inst. Of Healthcare Orenburg Regional Clinical Oncology Dis

location_facility: Saint-Petersburg City Clinical Oncology Dispensary

location_facility: Comprehensive Cancer Centers of Nevada - Henderson

location_facility: Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology

location_facility: Cross Cancer Institute ; Dept of Medical Oncology

location_facility: S.I. Russian Oncological Research Center n.a. N.N. Blokhin

location_facility: Hospital Quiron de Madrid; Servicio de Oncologia

location_facility: Hospital Universitario Miguel Servet; Servicio Oncologia

location_facility: Seoul National University Bundang Hospital

location_facility: Centro Integral Oncologico Clara Campal (CIOCC); Dirección Médica

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Oncologia

location_facility: Regional Oncology Hospital Of Kursk; Chemotherapy

location_facility: Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery

location_facility: St. Jude Heritage Healthcare; Virgiia K.Crosson Can Ctr

location_facility: CHU de Québec - Hôpital du Saint-Sacrement / ONCOLOGY

location_facility: Mackay Memorial Hospital; Dept of Surgery

location_facility: Roper Bon Secours St. Francis Cancer Center

location_facility: Railway Clinical Hospital on Saratov - 2 Station Oao "Rzhd"

location_facility: Hospital Universitari de Lleida Arnau de Vilanova

location_facility: IInstituto Oncologico de San Sebastian, Oncologikoa; Servicio de Oncologia

location_facility: McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology

location_facility: Hospital Clinico Universitario de Valencia

title: A Randomized, Multicenter, Open-Label, Two-Arm, Phase III Neoadjuvant Study Evaluating Trastuzumab Emtansine Plus Pertuzumab Compared With Chemotherapy Plus Trastuzumab and Pertuzumab for Patients With HER2-Positive Breast Cancer

summary:
This is a randomized, multicenter, open-label, two-arm study in treatment-naive participants with operable, locally advanced, or inflammatory, centrally-assessed HER2-positive early breast cancer (EBC) whose primary tumors were greater than or equal to (>/=) 2 centimeters (cm). The study was designed to evaluate the efficacy and safety of trastuzumab emtansine + pertuzumab (experimental arm; T-DM1 + P) versus chemotherapy, trastuzumab + pertuzumab (control arm; TCH + P). The study comprised a neoadjuvant treatment period, followed by surgery, and an adjuvant treatment period.

Treatment can be stopped due to disease recurrence, unacceptable toxicity, withdrawal of consent, or study termination.


ReferenceCitation: Chuah C, Koh LP, Numbenjapon T, Zang DY, Ong KH, Do YR, Ohkura M, Ono C, Viqueira A, Cortes JE, Brümmendorf TH. Efficacy and safety of bosutinib versus imatinib for newly diagnosed chronic myeloid leukemia in the Asian subpopulation of the phase 3 BFORE trial. Int J Hematol. 2021 Jul;114(1):65-78. doi: 10.1007/s12185-021-03144-4. Epub 2021 Apr 13.

family: Chuah

full_name: Charles Chuah

given: Charles

family: Koh

full_name: Liang Piu Koh

given: Liang Piu

family: Numbenjapon

full_name: Tontanai Numbenjapon

given: Tontanai

family: Zang

full_name: Dae Young Zang

given: Dae Young

family: Ong

full_name: Kiat Hoe Ong

given: Kiat Hoe

family: Do

full_name: Young Rok Do

given: Young Rok

family: Ohkura

full_name: Masayuki Ohkura

given: Masayuki

family: Ono

full_name: Chiho Ono

given: Chiho

family: Viqueira

full_name: Andrea Viqueira

given: Andrea

family: Cortes

full_name: Jorge E. Cortes

given: Jorge E.

family: Brümmendorf

full_name: Tim H. Brümmendorf

given: Tim H.

journal_name: International Journal of Hematology

ReferenceCitation: Cortes JE, Gambacorti-Passerini C, Deininger MW, Mauro MJ, Chuah C, Kim DW, Dyagil I, Glushko N, Milojkovic D, le Coutre P, Garcia-Gutierrez V, Reilly L, Jeynes-Ellis A, Leip E, Bardy-Bouxin N, Hochhaus A, Brümmendorf TH. Bosutinib Versus Imatinib for Newly Diagnosed Chronic Myeloid Leukemia: Results From the Randomized BFORE Trial. J Clin Oncol. 2018 Jan 20;36(3):231-237. doi: 10.1200/JCO.2017.74.7162. Epub 2017 Nov 1.

name: Jorge E. Cortes, University of Texas MD Anderson Cancer Center, Houston, TX; Carlo Gambacorti-Passerini, University of Milano-Bicocca, Monza, Italy; Michael W. Deininger, University of Utah, Salt Lake City, UT; Michael J. Mauro, Memorial Sloan Kettering Cancer Center, New York, NY; Charles Chuah, Singapore General Hospital, Duke-National University of Singapore Medical School, Singapore, Singapore; Dong-Wook Kim, Seoul St Mary’s Hospital, The Catholic University of Korea, Seoul, South Korea; Irina Dyagil...

family: Gambacorti-Passerini

full_name: Carlo Gambacorti-Passerini

given: Carlo

family: Deininger

full_name: Michael W. Deininger

given: Michael W.

family: Mauro

full_name: Michael J. Mauro

given: Michael J.

family: Kim

full_name: Dong-Wook Kim

given: Dong-Wook

family: Dyagil

full_name: Irina Dyagil

given: Irina

family: Glushko

full_name: Nataliia Glushko

given: Nataliia

family: Milojkovic

full_name: Dragana Milojkovic

given: Dragana

family: le Coutre

full_name: Philipp le Coutre

given: Philipp

family: Garcia-Gutierrez

full_name: Valentin Garcia-Gutierrez

given: Valentin

family: Reilly

publisher_dissemination: American Society of Clinical Oncology (ASCO)

publisher_group: American Society of Clinical Oncology (ASCO)

publisher_normalized: American Society of Clinical Oncology (ASCO)

location_country:
Finland
Belgium
Australia
Denmark
Taiwan
Ukraine
France
Poland
Thailand
Slovakia
Norway
Canada
Korea, Republic of
South Africa
Sweden
Netherlands
Singapore
Hungary
United States
Germany
United Kingdom
Italy
Mexico
Czechia
Israel
Spain

location_facility: Saint Alphonsus Regional Medical Center, Cancer Care Center

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Kyiv City Clinical Hospital #9, Hematology department #1,

location_facility: Azienda Ospedaliero Universitaria Careggi

location_facility: NYU Winthrop Hospital - Pharmacy Department

location_facility: Universitätsklinikum Hamburg-Eppendorf, Onkologisches Zentrum

location_facility: Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Hematologii

location_facility: North Mississippi Medical Center Hematology and Oncology Clinic

location_facility: Department of Haematology The Royal Hallamshire Hospital

location_facility: MUSC University of South Carolina, Investigational Drug Services

location_facility: State Institution "Institute of Blood Pathology and Transfusion Medicine NAMS of Ukraine"

location_facility: USC Ematologia, A. O. Papa Giovanni XXIII

location_facility: University of Rochester Investigational Drug Pharmacy

location_facility: Jász-Nagykun-Szolnok Megyei Hetényi, Géza Kórház-Rendelőintézet

location_facility: MI "Cherkasy Regional Oncological Dispensary " of Cherkasy Regional Council

location_facility: Klinika Hematologii i Transplantologii Uniwersyteckie Centrum Kliniczne

location_facility: Indiana Blood and Marrow Transplantation

location_facility: Saint Alphonsus Caldwell Cancer Care Center

location_facility: HSHS St. Vincent Hospital Regional Cancer Center at HSHS St. Vincent Hospital

location_facility: Hospital Angeles del Pedregal (S.A. de C.V.)

location_facility: Institut de Cancérologie du Gard - Hématologie Clinique

location_facility: Division of Hematology, Department of Internal Medicine, Maharaj Nakorn Chiang Mai Hospital

location_facility: Debreceni Egyetem Klinikai Központ, Belgyógyászati Inézet Hematológiai Tanszék

location_facility: Horizon Health Network - The Moncton Hospital

location_facility: Azienda Ospedaliero-Universitaria "Policlinico - Vittorio Emanuele" - P.O. G. Rodolico

location_facility: St. John Hospital&Medical Center-Van Elslander Cancer Center

location_facility: St George Hospital - Hematology Department

location_facility: Department of Medical Oncology, University of Pretoria and Steve Biko

location_facility: Charité, CVK, Med. Klinik m.S Hämatologie und Onkologie

location_facility: Universytet Medyczny im. Piastów Śląskich we Wrocławiu Katedra i

location_facility: NYU Winthrop Hospital - Oncology / Hematology department

location_facility: Schwerpunktpraxis für Hämatologie und Onkologie

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopole

location_facility: National University Hospital, Main Building

location_facility: Hospital (Universitari(o)) Germans Trias i Pujol

location_facility: Winship Cancer Institute, Emory University

location_facility: IRCCS - AOU San Martino_IST, Ematologia 1

location_facility: Universitätsklinikum Freiburg, Klinik für Innere Medizin I

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Regional Clinical Hospital in Ivano-Frankivsk, Hematology Department

location_facility: Haukeland University Hospital Department of Hematology

location_facility: Department of Haematology at UZ Leuven (7 th Floor)

location_facility: Seoul St. Mary's Hospital of the Catholic University of Korea

location_facility: State Institution "National research center for radiation medicine of NAMS of Ukraine",

location_facility: Cancer Center of Acadiana at Lafayette General Medical Center

location_facility: Froedtert Hospital and the Medical College of Wisconsin

location_facility: Khmelnytskyi Regional Hospital, Hematology Department

location_facility: Wojewódzki Szpital Specjalistyczny im M. Kopernika, Klinika Hematologii Uniwersytetu Medycznego

location_facility: The University of Texas, MD Anderson Cancer Center

location_facility: PHARMACY Department Franciscan St. Francis Health ATTN:Jill Leslie, Pharm D

location_facility: Unità di Ricerca Clinica, U.O. Ematologia Adulti

location_facility: Cancer & Haematology Centre, Churchill Hospital

location_facility: HSHS St. Vincent Hospital Regional Cancer Center at HSHS St. Mary's Hospital Medical Center

location_facility: Universitätsklinikum Jena, Klinik für Innere Medizin II

location_facility: Petz Aladár Megyei OktatóKórház, II. Belgyógyászati Osztály és Haematológiai Részleg

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Hematology Div. Davidoff Cancer Center, Rabin Medical Center

location_facility: John H. Stroger, Jr. Hospital of Cook County

location_facility: Pr Mauricette Michallet Centre Hospitalier Lyon Sud

location_facility: Catherine Lewis Centre, Hammersmith Hospital

location_facility: University of Massachusetts Memorial Medical Center, ONC/Research Pharmacy

location_facility: Division of Hematology, Department of Medicine, Faculty of Medicine Siriraj Hospital

location_facility: Univerzitná Nemocnica Bratislava-Nemocnica sv. Cyrila a Metoda

location_facility: A.O.U. Policlinico Università degli Studi di Napoli "Federico II"

location_facility: SPSK, Klinika Hematoonkologii i Transplantacji Szpiku w Lublinie

location_facility: Szegedi Tudományegyetem, AOK, Szent-Györgyi Albert Klinikai Központ, II. sz.

location_facility: private Practice of Dr. Viviane Dubruille

location_facility: transplantation department of hemotology and transplantology division within Clinical Radiology

location_facility: Samodzielny Publiczny Szpital Kliniczny im. A Mielęckiego, ŚUM w Katowicach

location_facility: SPZOZ ZSM w Chorzowie Oddzial Hematologiczny

location_facility: Hematology Department, Rambam Medical Centre

location_facility: private Practice of Pr Philippe Rousselot

location_facility: St. Joseph Mercy Hospital - Inpatient Pharmacy

title: A MULTICENTER PHASE 3 RANDOMIZED, OPEN-LABEL STUDY OF BOSUTINIB VERSUS IMATINIB IN ADULT PATIENTS WITH NEWLY DIAGNOSED CHRONIC PHASE CHRONIC MYELOGENOUS LEUKEMIA

summary: Phase 3, 2-arm, randomized, open label trial. Patients will be randomized to receive bosutinib or imatinib for the duration of the study.


title: A 52-week Treatment, Multi-center, Randomized, Double-blind, Double Dummy, Parallel-group, Active Controlled Study to Compare the Effect of QVA149 (Indacaterol Maleate / Glycopyrronium Bromide) With Salmeterol/Fluticasone on the Rate of Exacerbations in Subjects With Moderate to Very Severe COPD. (FLAME).

summary: This study will assess the efficacy, safety and tolerability of QVA149 in patients with moderate to very severe COPD.

ReferenceCitation: Mackay AJ, Kostikas K, Roche N, Frent SM, Olsson P, Pfister P, Gupta P, Patalano F, Banerji D, Wedzicha JA. Impact of baseline symptoms and health status on COPD exacerbations in the FLAME study. Respir Res. 2020 Apr 22;21(1):93. doi: 10.1186/s12931-020-01354-8.

family: Mackay

full_name: Alexander J. Mackay

given: Alexander J.

family: Kostikas

full_name: Konstantinos Kostikas

given: Konstantinos

family: Roche

full_name: Nicolas Roche

given: Nicolas

family: Frent

full_name: Stefan-Marian Frent

given: Stefan-Marian

family: Olsson

full_name: Petter Olsson

given: Petter

family: Pfister

full_name: Pascal Pfister

given: Pascal

family: Gupta

full_name: Pritam Gupta

given: Pritam

family: Patalano

full_name: Francesco Patalano

given: Francesco

family: Banerji

full_name: Donald Banerji

given: Donald

family: Wedzicha

full_name: Jadwiga A. Wedzicha

given: Jadwiga A.

currency_apc_doaj: GBP

journal_name: Respiratory Research

license: cc-by

license_normalized: cc-by

ReferenceCitation: Wedzicha JA, Singh D, Tsiligianni I, Jenkins C, Fucile S, Fogel R, Shen S, Goyal P, Mezzi K, Kostikas K. Treatment response to indacaterol/glycopyrronium versus salmeterol/fluticasone in exacerbating COPD patients by gender: a post-hoc analysis in the FLAME study. Respir Res. 2019 Jan 8;20(1):4. doi: 10.1186/s12931-019-0972-7.

family: Singh

full_name: Dave Singh

given: Dave

family: Tsiligianni

full_name: Ioanna Tsiligianni

given: Ioanna

family: Jenkins

full_name: Christine Jenkins

given: Christine

family: Fucile

full_name: Sebastian Fucile

given: Sebastian

repositories_institution:
Imperial College London - Spiral
PubMed Central - Europe PMC

ReferenceCitation: Frent SM, Chapman KR, Larbig M, Mackay A, Fogel R, Gutzwiller FS, Shen S, Patalano F, Banerji D, Kostikas K, Wedzicha JA. Capturing Exacerbations of Chronic Obstructive Pulmonary Disease with EXACT. A Subanalysis of FLAME. Am J Respir Crit Care Med. 2019 Jan 1;199(1):43-51. doi: 10.1164/rccm.201801-0038OC.

name: Department of Pulmonology, University of Medicine and Pharmacy Timisoara, Timisoara, Romania

name: European Respiratory Society Fellow at Novartis Pharma AG, Basel, Switzerland

name: Department of Medicine, Asthma and Airway Centre, University Health Network, University of Toronto, Toronto, Ontario, Canada

name: National Heart and Lung Institute, Imperial College London, London, United Kingdom

name: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey; and

journal_name: American Journal of Respiratory and Critical Care Medicine

ReferenceCitation: Anzueto AR, Kostikas K, Mezzi K, Shen S, Larbig M, Patalano F, Fogel R, Banerji D, Wedzicha JA. Indacaterol/glycopyrronium versus salmeterol/fluticasone in the prevention of clinically important deterioration in COPD: results from the FLAME study. Respir Res. 2018 Jun 20;19(1):121. doi: 10.1186/s12931-018-0830-z.

ReferenceCitation: Roche N, Chapman KR, Vogelmeier CF, Herth FJF, Thach C, Fogel R, Olsson P, Patalano F, Banerji D, Wedzicha JA. Blood Eosinophils and Response to Maintenance Chronic Obstructive Pulmonary Disease Treatment. Data from the FLAME Trial. Am J Respir Crit Care Med. 2017 May 1;195(9):1189-1197. doi: 10.1164/rccm.201701-0193OC.

name: Service de Pneumologie AP-HP, University Paris Descartes (EA2511), Paris, France

name: Asthma and Airway Centre, University Health Network and University of Toronto, Toronto, Ontario, Canada

name: Department of Medicine, Pulmonary and Critical Care Medicine, University Medical Center Giessen and Marburg, Philipps-Universität Marburg, Marburg, Germany

name: Department of Pneumology and Critical Care Medicine, Thoraxklinik, University of Heidelberg and Translational Lung Research Center Heidelberg, German Center for Lung Research, Heidelberg, Germany

name: Novartis Pharma AG, Basel, Switzerland; and

ReferenceCitation: Wedzicha JA, Banerji D, Chapman KR, Vestbo J, Roche N, Ayers RT, Thach C, Fogel R, Patalano F, Vogelmeier CF; FLAME Investigators. Indacaterol-Glycopyrronium versus Salmeterol-Fluticasone for COPD. N Engl J Med. 2016 Jun 9;374(23):2222-34. doi: 10.1056/NEJMoa1516385. Epub 2016 May 15.

repository_institution: The University of Manchester - Research Explorer

title: Indacaterol–Glycopyrronium versus Salmeterol–Fluticasone for COPD

location_country:
Guatemala
Finland
Greece
Romania
Belgium
Russian Federation
Denmark
Czech Republic
Taiwan
Iceland
India
Croatia
France
Japan
Lithuania
Poland
Norway
Slovakia
Argentina
Thailand
Canada
Korea, Republic of
Turkey
Colombia
South Africa
Chile
Sweden
Hong Kong
Netherlands
Philippines
Bulgaria
Hungary
China
Portugal
Germany
United Kingdom
Italy
Austria
Serbia
Mexico
Spain
Estonia
Latvia


title: A Randomized Controlled Phase 3 Study of Oral Pacritinib Versus Best Available Therapy in Patients With Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis

summary: Phase 3, randomized, controlled study to evaluate the safety and efficacy of oral pacritinib compared to Best Available Therapy (BAT) in patients with primary or secondary myelofibrosis.

ReferenceType: background

ReferenceCitation: Mesa RA, Vannucchi AM, Mead A, Egyed M, Szoke A, Suvorov A, Jakucs J, Perkins A, Prasad R, Mayer J, Demeter J, Ganly P, Singer JW, Zhou H, Dean JP, Te Boekhorst PA, Nangalia J, Kiladjian JJ, Harrison CN. Pacritinib versus best available therapy for the treatment of myelofibrosis irrespective of baseline cytopenias (PERSIST-1): an international, randomised, phase 3 trial. Lancet Haematol. 2017 May;4(5):e225-e236. doi: 10.1016/S2352-3026(17)30027-3. Epub 2017 Mar 20.

ReferenceCitation: Tremblay D, Mesa R, Scott B, Buckley S, Roman-Torres K, Verstovsek S, Mascarenhas J. Pacritinib demonstrates spleen volume reduction in patients with myelofibrosis independent of JAK2V617F allele burden. Blood Adv. 2020 Dec 8;4(23):5929-5935. doi: 10.1182/bloodadvances.2020002970.

lead_sponsor: CTI BioPharma

location_country:
Italy
Netherlands
Germany
France
Czechia
Hungary
Belgium
Australia
New Zealand
Russian Federation
United States
United Kingdom

location_facility:
CTI Investigational Site 36007
CTI Investigational Site 64002
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title: Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study of Idalopirdine in Patients With Mild-moderate Alzheimer's Disease Treated With Donepezil

acronym: STARBEAM

summary: To establish efficacy of Idalopirdine as adjunctive therapy to donepezil for symptomatic treatment of patients with mild-to-moderate Alzheimer's disease (AD).

ReferenceCitation: Ballard C, Atri A, Boneva N, Cummings JL, Frölich L, Molinuevo JL, Tariot PN, Raket LL. Enrichment factors for clinical trials in mild-to-moderate Alzheimer's disease. Alzheimers Dement (N Y). 2019 May 20;5:164-174. doi: 10.1016/j.trci.2019.04.001. eCollection 2019.

name: University of Exeter Medical SchoolExeterUK

family: Ballard

full_name: Clive Ballard

given: Clive

name: Banner Sun Health Research InstituteSun CityAZUSA

name: Brigham and Women's Hospital and Harvard Medical SchoolBostonMAUSA

family: Atri

full_name: Alireza Atri

given: Alireza

family: Boneva

full_name: Neli Boneva

given: Neli

name: Cleveland Clinic Lou Ruvo Center for Brain HealthLas VegasNVUSA

family: Cummings

full_name: Jeffrey L. Cummings

given: Jeffrey L.

name: Central Institute of Mental HealthMedical Faculty MannheimUniversity of HeidelbergHeidelbergGermany

family: Frölich

full_name: Lutz Frölich

given: Lutz

name: Alzheimer's Disease and Other Cognitive Disorders Unit, IDIBAPSHospital Clinic i UniversitariBarcelonaSpain

name: Barcelonaβeta Brain Research CenterPasqual Maragall FoundationBarcelonaSpain

family: Molinuevo

full_name: José Luis Molinuevo

given: José Luis

family: Tariot

full_name: Pierre N. Tariot

given: Pierre N.

family: Raket

full_name: Lars Lau Raket

given: Lars Lau

currency_apc_doaj: USD

journal_name: Alzheimer's & Dementia: Translational Research & Clinical Interventions

title: Enrichment factors for clinical trials in mild‐to‐moderate Alzheimer's disease

ReferenceCitation: Cummings JL, Atri A, Ballard C, Boneva N, Frölich L, Molinuevo JL, Raket LL, Tariot PN. Insights into globalization: comparison of patient characteristics and disease progression among geographic regions in a multinational Alzheimer's disease clinical program. Alzheimers Res Ther. 2018 Nov 24;10(1):116. doi: 10.1186/s13195-018-0443-2.

repository_institution: Heidelberg University - heiDOK - The Heidelberg Document Repository

title: Insights into globalization: comparison of patient characteristics and disease progression among geographic regions in a multinational Alzheimer’s disease clinical program

ReferenceCitation: Atri A, Frölich L, Ballard C, Tariot PN, Molinuevo JL, Boneva N, Windfeld K, Raket LL, Cummings JL. Effect of Idalopirdine as Adjunct to Cholinesterase Inhibitors on Change in Cognition in Patients With Alzheimer Disease: Three Randomized Clinical Trials. JAMA. 2018 Jan 9;319(2):130-142. doi: 10.1001/jama.2017.20373.

name: Ray Dolby Brain Health Center, California Pacific Medical Center, San Francisco

name: Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts

name: Central Institute of Mental Health, Medical Faculty Mannheim, University of Heidelberg, Heidelberg, Germany

name: University of Exeter Medical School, Exeter, England

name: Banner Alzheimer’s Institute, Phoenix, Arizona

name: Alzheimer’s Disease and Other Cognitive Disorders Unit, IDIBAPS, Hospital Clinic i Universitari, Barcelona, Spain

name: Barcelonaβeta Brain Research Centre, Pasqual Maragall Foundation, Barcelona, Spain

name: Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas, Nevada

location_country:
Italy
Brazil
United States
Finland
Croatia
Czechia
France
Israel
Lithuania
Poland
Hungary
Argentina
Ireland
Portugal
Estonia
Canada
United Kingdom
Korea, Republic of
Taiwan


title: SUNRISE: A Phase III, Randomized, Double-Blind, Placebo-Controlled Multicenter Trial of Bavituximab Plus Docetaxel Versus Docetaxel Alone in Patients With Previously Treated Stage IIIb/IV Non-Squamous Non Small-Cell Lung Cancer

acronym: SUNRISE

summary: The primary purpose of this research study is to see whether adding bavituximab (an investigational drug) to the standard chemotherapy drug docetaxel, will improve the results of the treatment for non-small-cell lung cancer.

enrollment_type: Anticipated

ReferenceCitation: Gerber DE, Horn L, Boyer M, Sanborn R, Natale R, Palmero R, Bidoli P, Bondarenko I, Germonpre P, Ghizdavescu D, Kotsakis A, Lena H, Losonczy G, Park K, Su WC, Tang M, Lai J, Kallinteris NL, Shan JS, Reck M, Spigel DR. Randomized phase III study of docetaxel plus bavituximab in previously treated advanced non-squamous non-small-cell lung cancer. Ann Oncol. 2018 Jul 1;29(7):1548-1553. doi: 10.1093/annonc/mdy177.

family: Gerber

full_name: D.E. Gerber

family: Horn

full_name: L. Horn

given: L.

family: Boyer

full_name: M. Boyer

given: M.

family: Sanborn

full_name: R. Sanborn

given: R.

family: Natale

full_name: R. Natale

family: Palmero

full_name: R. Palmero

family: Bidoli

full_name: P. Bidoli

given: P.

family: Bondarenko

full_name: I. Bondarenko

given: I.

family: Germonpre

full_name: P. Germonpre

family: Ghizdavescu

full_name: D. Ghizdavescu

given: D.

family: Kotsakis

full_name: A. Kotsakis

given: A.

family: Lena

full_name: H. Lena

given: H.

family: Losonczy

full_name: G. Losonczy

given: G.

family: Park

full_name: K. Park

given: K.

family: Su

full_name: W -C Su

given: W -C

family: Tang

full_name: M. Tang

family: Lai

full_name: J. Lai

given: J.

family: Kallinteris

full_name: N.L. Kallinteris

family: Shan

full_name: J.S. Shan

family: Reck

full_name: M. Reck

family: Spigel

full_name: D.R. Spigel

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

location_country:
Italy
Germany
France
Greece
Romania
Hungary
Belgium
Australia
Russian Federation
Spain
United States
Korea, Republic of
Taiwan
Ukraine

location_facility: Peregrine Pharmaceuticals Investigational Site


title: A Phase II, Randomized, Double-Blind, Placebo Controlled, Multicenter Trial to Assess the Oral Corticosteroid-Sparing Effect of Lebrikizumab in Patients With Severe Corticosteroid Dependent Asthma

summary: This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy of lebrikizumab compared with placebo, as measured by the ability of participants to achieve lower daily doses of OCS, among those with severe corticosteroid-dependent asthma. Prednisone/prednisolone will be the OCS therapy prescribed. Participants will be randomized to receive lebrikizumab or matching placebo for 44 weeks in a double-blind, placebo-controlled (DBPC) period. Those who complete the 44-week period may continue into a 32-week active treatment extension (ATE) period, during which all participants will receive lebrikizumab treatment. Following completion of the ATE period, participants who have both tolerated and derived benefit from treatment with lebrikizumab may continue their lebrikizumab treatment into a long-term extension (LTE) period. Participants will transition to 24 weeks of safety follow-up upon discontinuation of study drug.

location_country:
United States
United Kingdom
Mexico
Netherlands
Spain
France
Czechia
Poland
Slovakia
Belgium
Australia
New Zealand
Puerto Rico
Denmark
Canada
Slovenia

location_facility: Sheffield Clinical Research Facility; National Institute for Health Research

location_facility: Spaarne Ziekenhuis Hoofddorp; Long Geneeskunde

location_facility: Complejo Hospitalario Universitario de Santiago; Servicio de Neumología

location_facility: Princess Alexandra Hospital, Department of Respiratory and Sleep Medicine

location_facility: Glenfield Hospital; Respiratory -Allergy Unit

location_facility: Royal Brompton Hospital; Respiratory Department

location_facility: Medical Research Inst. of New Zealand; Respiratory

location_facility: Instituto Jalisciense de Investigacion Clinica S.A. de C.V.

location_facility: San Juan Bautista School of Medicine-Clinical Research Unit

location_facility: St Bartholomew's Hospital (Barts); Respiratory Department

location_facility: Derriford Hospital; The Lind Research Department

location_facility: Nouvel Hôpital Civil; Pôle de Pathologie Thoracique

location_facility: Specjalistyczny Osrodek Alergologiczno-Internistyczny ALL-MED

location_facility: SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi

location_facility: CHU Nantes - Hôpital Laennec; Service de Pneumologie

location_facility: University Clinic of Pulmonary and Allergic Diseases Golnik

location_facility: Wythenshawe Hospital; North West Lung Research Centre

location_facility: Hospital Clinico Universitario de Salamanca; Servicio de Neumologia

location_facility: Belfast City Hospital; Respiratory Department

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej PROFILAKTYKA Wladyslaw Pierzchala

location_facility: New Lister Buliding, Level 1; Clinical Research Facility

location_facility: Clinical Trials Unit, Bay of Plenty District Health Board

location_facility: Southampton General Hospital; Respiratory Department

location_facility: Academisch Medisch Centrum; Afdeling Longziekten, F5-258

location_facility: Antonius Ziekenhuis; Dept of Lung Diseases

location_facility: Hopital Bichat Claude Bernard ; Service de Pneumologie

location_facility: Centro Investigacion Medico Biologica y Terapia Avanzada

location_facility: Klinika Chorób Wewnetrznych i Alergologii MSW

location_facility: Monash Medical Centre; Respiratory and Sleep Medicine

location_facility: EMC Instytut Medyczny SA; Przychodnia przy ulicy Łowieckiej

location_facility: Freeman Hospital; Respiratory Department

location_facility: Heartlands Hospital; Respiratory Department

location_facility: Allergy & Asthma Care Center of Southern California

location_facility: Gartnavel General Hospital; Respiratory Department

location_facility: CHU de Grenoble - Hôpital André Michallon


status: Recruiting

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

location_country: Italy Austria Netherlands France Greece Hungary Belgium Germany

location_facility: Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet

location_facility: Athens University - Attikon University General Hospital

location_facility: Universitaetsklinikum Jena-Radiation Therapy and Radiooncology Clinic

location_facility: Spaarne Gasthuis - Vrije Universiteit Medisch Centrum

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: University Medical Center Groningen (UMCG)

location_facility: CHU de Bordeaux - Groupe Hospitalier Saint-André - Hopital Saint-Andre

location_facility: Institut de Cancerologie de l'Ouest (ICO) - Centre Rene Gauducheau

location_facility: Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin

location_facility: Assistance Publique - Hopitaux de Paris - Hopital Tenon

location_facility: Institut Universitaire du Cancer de Toulouse (IUCT) Oncopole - Institut Claudius Regaud

location_facility: Azienda Provinciale per i Servizi Sanitari - Ospedale Santa Chiara

location_facility: Medical University Vienna - General Hospital AKH

location_facility: Radboud University Medical Center Nijmegen

study_completion_date_type: Anticipated

title: A Randomized Phase II Study to Evaluate the Efficacy and Safety of Chemotherapy (CT) vs Androgen Deprivation Therapy (ADT) in Patients With Recurrent and/or Metastatic, Androgen Receptor (AR) Expressing, Salivary Gland Cancer (SGCs)

summary:
Salivary Gland (SG) Cancers are a rare and heterogeneous group of tumors, usually approached by multidisciplinary teams in high specialized centers. Until today no standard of care exists to treat these cancers. The identification of a target, the androgen receptor, in SG tumors has allowed for new treatment strategies options for this rare group of diseases. As a matter of fact, strong positivity for androgen expression has been found in salivary duct carcinoma and adenocarcinomas. The purpose of this study is therefore to evaluate the efficacy and safety of chemotherapy versus androgen deprivation therapy (ADT) in patients with recurrent and/or metastatic AR expressing SGCs.

The study will include two cohorts of patients: Cohort A, which comprises chemo-naïve patients, and Cohort B, which comprises pretreated patients.

status_simplified: Ongoing


lead_sponsor: Bayer

location_country:
Italy
United States
Brazil
Spain
Germany
France
Japan
Israel
Belgium
Australia
China
Canada
United Kingdom
Portugal

acronym: COAST

location_facility: Fujian Medical University Union Hospital

title: A Randomized, Double-blind, Placebo-controlled Phase-III Study of Adjuvant Regorafenib Versus Placebo for Patients With Stage IV Colorectal Cancer After Curative Treatment of Liver Metastases

summary: To evaluate and compare the efficacy and safety of regorafenib versus placebo in subjects with colorectal cancer (CRC) after curative resection of liver metastasis and completion of all planned chemotherapy.