acronym: Avelumab in First-Line Gastric Cancer

lead_sponsor: EMD Serono Research & Development Institute, Inc.

summary: The purpose of this study was to demonstrate superiority of treatment with avelumab versus continuation of first-line chemotherapy.

ReferenceCitation: Chang X, Ge X, Zhang Y, Xue X. The current management and biomarkers of immunotherapy in advanced gastric cancer. Medicine (Baltimore). 2022 May 27;101(21):e29304. doi: 10.1097/MD.0000000000029304.

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Moehler M, Dvorkin M, Boku N, Ozguroglu M, Ryu MH, Muntean AS, Lonardi S, Nechaeva M, Bragagnoli AC, Coskun HS, Cubillo Gracian A, Takano T, Wong R, Safran H, Vaccaro GM, Wainberg ZA, Silver MR, Xiong H, Hong J, Taieb J, Bang YJ. Phase III Trial of Avelumab Maintenance After First-Line Induction Chemotherapy Versus Continuation of Chemotherapy in Patients With Gastric Cancers: Results From JAVELIN Gastric 100. J Clin Oncol. 2021 Mar 20;39(9):966-977. doi: 10.1200/JCO.20.00892. Epub 2020 Nov 16.

publisher_dissemination: American Society of Clinical Oncology (ASCO)

location_facility: Trio - Central Coast Medical Oncology Corporation

location_facility: Seconda Università degli Studi di Napoli

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Azienda Socio Sanitaria Territoriale di Cremona (Istituti Ospitalieri di Cremona)

location_facility: Greenville Hospital System University Medical Center (ITOR)

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: Oncosinos - Clínica de Oncologia - Hospital Regina

location_facility: Adana Numune Training and Research Hospital

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: University of Kansas Medical Center Research Institute, Inc.

location_facility: Cotton-O'Neil Clinical Research Center, Hematology and Oncology

location_facility: Hospital de Câncer de Barretos-Fundação Pio XII

location_facility: BHI of Omsk region "Clinical Oncology Dispensary"

location_facility: University of Texas Southwestern Medical Center

location_facility: SBIH " Clinical Oncological Dispensary # 1"

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary"

location_facility: Kyungpook National University Medical Center

location_facility: Hospital Universitario HM Madrid Sanchinarro

location_facility: University of Texas Health Science Center at San Antonio

location_facility: Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj Napoca

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

location_facility: Kagoshima University Medical And Dental Hospital

location_facility: Pavlov First Saint Petersburg State Medical University

location_facility: Saitama Medical University International Medical Center

location_facility: Azienda Ospedaliero-Universitaria Santa Maria della Misericordia

location_facility: Marmara University Pendik Research and Training Hospital

location_facility: SBIH of Stavropol territory "Pyatigorsk Oncological Dispensary"

location_facility: University of Washington - Seattle Cancer Care Alliance

location_facility: SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz

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

location_facility: SPb SBIH "City Clinical Oncological Dispensary"

location_facility: Seoul National University Bundang Hospital

location_facility: Chonnam National University Hwasun Hospital

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: RBIH "Ivanovo Regional Oncological Dispensary"

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

location_facility: Azienda Ospedaliera Universitaria Careggi

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

location_facility: Franciscan St. Francis Health Cancer Center

location_facility: IMV - Instituto De Medicina Vascular Hospital Mae de Deus

location_facility: S.C Centrul de Oncologie Sf. Nectarie S.R.L

location_facility: Konya Necmettin Erbakan University Meram Medical Faculty

location_facility: McGill University - Dept. Oncology Clinical Research Program

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

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

location_facility: Mid Ohio Oncology Hematology, DBA The Mark H. Zangmeister Center

location_facility: ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira

location_facility: CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia

location_facility: Desert Hematology Oncology Medical Group, Inc.

title: A Phase III Open-label, Multicenter Trial of Maintenance Therapy With Avelumab (MSB0010718C) Versus Continuation of First-line Chemotherapy in Subjects With Unresectable, Locally Advanced or Metastatic, Adenocarcinoma of the Stomach, or of the Gastro-esophageal Junction

location_country:
Germany
Italy
Hungary
United Kingdom
Romania
Australia
Brazil
Japan
United States
Korea, Republic of
Spain
Thailand
Turkey
Taiwan
Canada
Russian Federation
France


type: EudraCT Number

title: Secondary Prevention of Cardiovascular Disease in the Elderly Trial

acronym: SECURE

summary: The purpose of this study is to evaluate the efficacy of a polypill strategy containing aspirin (100 mg), ramipril (2.5, 5 or 10 mgs), and atorvastatin (40 mgs) compared with the standard of care (usual care according to the local clinical practices at each participating country) in secondary prevention of major cardiovascular events (cardiovascular death, nonfatal myocardial infarction, nonfatal ischemic stroke, and urgent revascularization) in elderly patients with a recent myocardial infarction.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Castellano JM, Pocock SJ, Bhatt DL, Quesada AJ, Owen R, Fernandez-Ortiz A, Sanchez PL, Marin Ortuno F, Vazquez Rodriguez JM, Domingo-Fernandez A, Lozano I, Roncaglioni MC, Baviera M, Foresta A, Ojeda-Fernandez L, Colivicchi F, Di Fusco SA, Doehner W, Meyer A, Schiele F, Ecarnot F, Linhart A, Lubanda JC, Barczi G, Merkely B, Ponikowski P, Kasprzak M, Fernandez Alvira JM, Andres V, Bueno H, Collier T, Van de Werf F, Perel P, Rodriguez-Manero M, Alonso Garcia A, Proietti M, Schoos MM, Simon T, Fernandez Ferro J, Lopez N, Beghi E, Bejot Y, Vivas D, Cordero A, Ibanez B, Fuster V; SECURE Investigators. Polypill Strategy in Secondary Cardiovascular Prevention. N Engl J Med. 2022 Sep 15;387(11):967-977. doi: 10.1056/NEJMoa2208275. Epub 2022 Aug 26.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free article)

host_type: publisher

license_normalized: no license

version: publishedVersion

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

host_type: repository

repository_institution: London School of Hygiene and Tropical Medicine - LSHTM Research Online

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Buttgereit T, Palmowski A, Forsat N, Boers M, Witham MD, Rodondi N, Moutzouri E, Navidad AJQ, Van't Hof AWJ, van der Worp B, Coll-Planas L, Voshaar M, de Wit M, da Silva J, Stegemann S, Bijlsma JW, Koeller M, Mooijaart S, Kearney PM, Buttgereit F. Barriers and potential solutions in the recruitment and retention of older patients in clinical trials-lessons learned from six large multicentre randomized controlled trials. Age Ageing. 2021 Nov 10;50(6):1988-1996. doi: 10.1093/ageing/afab147.

repository_institution: University of Bern - Bern Open Repository and Information System

repository_institution: Universitätsbibliothek der Freien Universität Berlin - Refubium

repository_institution: University of Twente - University of Twente Research Information

publisher_dissemination: Oxford University Press

lead_sponsor: Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III

collaborators: Centre Hospitalier Universitaire de Besancon

collaborators: Servicio Madrileño de Salud, Madrid, Spain

collaborators: Istituto Di Ricerche Farmacologiche Mario Negri

location_country: Germany Italy Poland Hungary Spain Czechia France

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: Hospital Universitario Reina Sofia de Cordoba

location_facility: Brandenburgklinik Berlin-Brandenburg GmbH, Haus Brandenburg/ Kardiologie

location_facility: Ospedale Bolognini di Seriate - ASST BERGAMO EST

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 7, Śląskiego Uniwersytetu Medycznego w Katowicach, Górnośląskie Centrum Medyczne im. prof. Leszka Gieca

location_facility: Immanuel Klinikum Bernau Herzzentrum Brandenburg

location_facility: Complejo Asistencial Universitario de Leon

location_facility: ASL FG Ospedale "Teresa Masselli Mascia"

location_facility: Ospedale Generale di Zona-Ospedale Valduce

location_facility: Ospedale Ss Giovanni di Dio e Ruggi d'Aragona

location_facility: Specjalistyczny Szpital im. Dra Alfreda Sokołowskiego

location_facility: Gesundheitszentrum Bitterfeld /Wolfen GmbH

location_facility: Hospital Clinic Universitari de Valencia

location_facility: Wojewódzki Szpital Specjalistyczny w Legnicy

location_facility: Hospital Universitario Clinico San Carlos

location_facility: Wojskowy Szpital Kliniczny z Polikliniką SP ZOZ

location_facility: Centre Hospitalier Universitaire de Toulouse

location_facility: Centre Hospitalier Universitaire de Nice

location_facility: AAS3 "Alto Friuli, Collinare, Medio Friuli" Ospedale di San Daniele del Friuli-Tolmezzo sede di S. D. del Friuli

location_facility: Centre hospitalier Universitaire de Bordeaux

location_facility: Samodzielny Publiczny Zespół Opieki Zdrowotnej w Świdnicy

location_facility: Presidio Ospedaliero San Filippo Neri-ASL Roma E

location_facility: Szpital Wielospecjalistyczny im. Dr. Ludwika Błażka w Inowrocławiu

location_facility: ASST di Bergamo Ovest-Ospedale di Treviglio

location_facility: ASST Di Monza-Presidio Ospedaliero di Desio

location_facility: ASST Della Valle Olona-Ospedale di Saronno

location_facility: Centre Hospitalier Régional Universitaire de Besançon

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawła II

location_facility: Centre Hospitalier Universitaire Henri Mondor

location_facility: Centre Hospitalier Universitaire de Caen

location_facility: Centre Hospitalier Universitaire de Lyon

location_facility: Hospital General Universitario de Alicante

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: IRCCS Fondazione S. Maugeri Istit. di Cassano Murge

location_facility: Hospital Universitario y Politécnico de La Fe

location_facility: Centre Hospitalier Universitaire de Dijon

location_facility: Centrum Kardiologiczne "Pro Corde" Sp. z o.o.

location_facility: Centre Hospitalier Régional et Universitaire de Lille

location_facility: ASST Santi Paolo e Carlo-Ospedale San Paolo-Polo Univ.

location_facility: Klinik am See, Rehabilitationszentrum für innere Medizin

location_facility: Fejér Megyei Szent György Egyetemi Kórház

location_facility: Mediclin Reha-Zentrum Spreewald Fachklinik für innere Medizin

location_facility: Complejo Asistencial Universitario de Salamanca

location_facility: Charité - Universitätsmedizin Berlin, Centrum für Schlaganfallforschung (CSB)

location_facility: Hospital Universitario Principe de Asturias

location_facility: Semmelweis Egyetem Városmajori Szív- és Érgyógyászati Klinika

location_facility: Hospital Universitario QuironSalud Madrid

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: Centre Hospitalier Universitaire d'Angers

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Phase III, Double-blind, Randomized Placebo-controlled Study to Evaluate the Effects of Dalcetrapib on Cardiovascular (CV) Risk in a Genetically Defined Population With a Recent Acute Coronary Syndrome (ACS): The Dal-GenE Trial

acronym: dal-GenE

summary: A placebo-controlled, randomized, double-blind, parallel group, phase III multicenter study in subjects recently hospitalized for ACS and with the appropriate genetic profile. Subjects will provide informed consent before any study-specific procedures are performed. Subject enrollment may begin in the hospital and will continue following release from the hospital. Screening procedures may be performed at the time of the index ACS event or anytime thereafter, with the condition that randomization must occur within the mandated window (4-12 weeks after the index event). Subjects will be assessed based on their medical history. Those who are likely to qualify will undergo Genotype Assay testing to evaluate genetic determination for the presence of AA genotype.

study_start_date_type: Actual

primary_purpose: Treatment

ReferenceCitation: Tardif JC, Pfeffer MA, Kouz S, Koenig W, Maggioni AP, McMurray JJV, Mooser V, Waters DD, Gregoire JC, L'Allier PL, Wouter Jukema J, White HD, Heinonen T, Black DM, Laghrissi-Thode F, Levesque S, Guertin MC, Dube MP; dal-GenE Investigators. Pharmacogenetics-guided dalcetrapib therapy after an acute coronary syndrome: the dal-GenE trial. Eur Heart J. 2022 Oct 14;43(39):3947-3956. doi: 10.1093/eurheartj/ehac374. Erratum In: Eur Heart J. 2022 Sep 20;:

oa_host_type: repository

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: Leiden University - Leiden Repository

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

repository_institution: California Digital Library - eScholarship

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

repository_institution: The University of Glasgow - Enlighten: Publications

version: acceptedVersion

unpaywall_oa_status: green

ReferenceCitation: Black DM, Miller M, Heinonen TM, Zhang G. Advancing Beyond Failed High-density Lipoprotein Clinical Trials to Pharmacogenetic Studies of ADCY9 and Cholesterol Ester Transfer Protein Inhibition. J Cardiovasc Pharmacol. 2021 Oct 1;78(4):496-500. doi: 10.1097/FJC.0000000000001093.

oa_host_type: closed

repositories_concat: closed

ReferenceCitation: Tardif JC, Dube MP, Pfeffer MA, Waters DD, Koenig W, Maggioni AP, McMurray JJV, Mooser V, White HD, Heinonen T, Black DM, Guertin MC; dal-GenE Investigators. Study design of Dal-GenE, a pharmacogenetic trial targeting reduction of cardiovascular events with dalcetrapib. Am Heart J. 2020 Apr;222:157-165. doi: 10.1016/j.ahj.2020.01.007. Epub 2020 Jan 17.

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: Technische Universität München - mediaTUM Gesamtbestand

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

ipd_sharing: No

lead_sponsor: DalCor Pharmaceuticals

collaborators: The Montreal Health Innovations Coordinating Center (MHICC)

location_country:
Finland
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Turkey
Chile
Czechia
Canada
France
Portugal
Slovakia
Hungary
Denmark
Switzerland
United States
Romania
Belgium
Puerto Rico
Italy
United Kingdom
Sweden
Netherlands
Austria
United Arab Emirates
Spain
South Africa
Bulgaria
Russian Federation
Israel

location_facility:
Research Site
Institut de Cardiologie de Montreal


acronym: CONFIDENCE

lead_sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

summary: The primary objective of this study is to compare patient medication satisfaction as measured by the Medication Satisfaction Questionnaire (MSQ) scores between the Copaxone 40 mg/mL three time a week (TIW) group and the Copaxone 20 mg/mL once daily (QD) group over 6 months of treatment.

ReferenceCitation: Cutter G, Veneziano A, Grinspan A, Al-Banna M, Boyko A, Zakharova M, Maida E, Pasic MB, Gandhi SK, Everts R, Cordioli C, Rossi S. Higher satisfaction and adherence with glatiramer acetate 40 mg/mL TIW vs 20 mg/mL QD in RRMS. Mult Scler Relat Disord. 2019 Aug;33:13-21. doi: 10.1016/j.msard.2019.04.036. Epub 2019 May 9.

repository_institution: INFN Catania - INFM-OAR

repository_normalized: Zenodo

repositories_concat: Zenodo

location_facility:
Teva Investigational Site 35209
Teva Investigational Site 13479
Teva Investigational Site 32605
Teva Investigational Site 50378
Teva Investigational Site 13471
Teva Investigational Site 40015
Teva Investigational Site 50387
Teva Investigational Site 50391
Teva Investigational Site 13476
Teva Investigational Site 82050
Teva Investigational Site 30164
Teva Investigational Site 50374
Teva Investigational Site 50392
Teva Investigational Site 30166
Teva Investigational Site 35201
Teva Investigational Site 60034
Teva Investigational Site 31177
Teva Investigational Site 50375
Teva Investigational Site 31180
Teva Investigational Site 31182
Teva Investigational Site 53350
Teva Investigational Site 82051
Teva Investigational Site 82049
Teva Investigational Site 35211
Teva Investigational Site 50376
Teva Investigational Site 13472
Teva Investigational Site 60036
Teva Investigational Site 35210
Teva Investigational Site 31178
Teva Investigational Site 53349
Teva Investigational Site 53348
Teva Investigational Site 32606
Teva Investigational Site 35202
Teva Investigational Site 53353
Teva Investigational Site 53346
Teva Investigational Site 32604
Teva Investigational Site 32602
Teva Investigational Site 53356
Teva Investigational Site 33040
Teva Investigational Site 53352
Teva Investigational Site 13481
Teva Investigational Site 35204
Teva Investigational Site 35214
Teva Investigational Site 35213
Teva Investigational Site 35203
Teva Investigational Site 30161
Teva Investigational Site 13480
Teva Investigational Site 30163
Teva Investigational Site 21095
Teva Investigational Site 30165
Teva Investigational Site 31179
Teva Investigational Site 50373
Teva Investigational Site 44029
Teva Investigational Site 13487
Teva Investigational Site 31181
Teva Investigational Site 82052
Teva Investigational Site 30167
Teva Investigational Site 40014
Teva Investigational Site 60037
Teva Investigational Site 35207
Teva Investigational Site 35205
Teva Investigational Site 53347
Teva Investigational Site 13483
Teva Investigational Site 13478
Teva Investigational Site 60035
Teva Investigational Site 13473
Teva Investigational Site 53354
Teva Investigational Site 13477
Teva Investigational Site 35208
Teva Investigational Site 21097
Teva Investigational Site 13470
Teva Investigational Site 37063
Teva Investigational Site 53345
Teva Investigational Site 21098
Teva Investigational Site 13485
Teva Investigational Site 37066
Teva Investigational Site 50372
Teva Investigational Site 20062
Teva Investigational Site 50377
Teva Investigational Site 60040
Teva Investigational Site 31184
Teva Investigational Site 35206
Teva Investigational Site 50389
Teva Investigational Site 30169
Teva Investigational Site 60039
Teva Investigational Site 32603
Teva Investigational Site 13524
Teva Investigational Site 53355
Teva Investigational Site 50390
Teva Investigational Site 13482
Teva Investigational Site 35212
Teva Investigational Site 30162
Teva Investigational Site 20061
Teva Investigational Site 21096
Teva Investigational Site 20063
Teva Investigational Site 13475
Teva Investigational Site 53351

title: CONFIDENCE: A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) Treated With Subcutaneous Injections of Copaxone(R) (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily

source: euctr

location_country:
Finland
Germany
Ireland
Italy
Poland
Argentina
Austria
Belgium
Mexico
United States
Spain
Turkey
Croatia
Puerto Rico
Russian Federation
France


acronym: CARD

lead_sponsor: Sanofi

summary:
Primary Objective:

To compare the radiographic progression-free survival (rPFS) (using Response Evaluation Criteria in Solid Tumors [RECIST] 1.1 for tumor lesions and Prostate Cancer Working Group 2 (PCWG2) criteria for bone scan lesions or death due to any cause) with chemotherapy (cabazitaxel plus prednisone, Arm A) versus Androgen Receptor (AR)-targeted therapy (enzalutamide or abiraterone acetate plus prednisone, Arm B) in mCRPC participants who have been treated with docetaxel and who had disease progression while receiving AR-targeted therapy within 12 months of AR treatment initiation (less than or equal to [<=]12 months, either before or after docetaxel).

Secondary Objective:

To compare efficacy for:
Prostate-specific antigen (PSA) response rate and time to PSA progression (TTPP).
Progression-free survival (PFS).
Overall survival (OS).
Tumor response rate and duration of tumor response.
Pain response and time to pain progression.
Symptomatic skeletal event (SSE) rate and time to occurrence of any SSE.
Health status and Health-related Quality of Life (HRQOL).
To evaluate the correlation of a signature of resistance to AR-targeted agents with clinical outcome via the analysis of circulating tumor cell (CTC) phenotypes as well as expression and localization of proteins including AR isoforms in CTCs.
To evaluate safety in the 2 treatment arms.

ReferenceCitation: de Wit R, Wulfing C, Castellano D, Kramer G, Eymard JC, Sternberg CN, Fizazi K, Tombal B, Bamias A, Carles J, Iacovelli R, Melichar B, Sverrisdottir A, Theodore C, Feyerabend S, Helissey C, Foster MC, Ozatilgan A, Geffriaud-Ricouard C, de Bono J. Baseline neutrophil-to-lymphocyte ratio as a predictive and prognostic biomarker in patients with metastatic castration-resistant prostate cancer treated with cabazitaxel versus abiraterone or enzalutamide in the CARD study. ESMO Open. 2021 Oct;6(5):100241. doi: 10.1016/j.esmoop.2021.100241. Epub 2021 Aug 24.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repository_institution: Erasmus University Rotterdam - EUR Research Repository

repositories_concat: PubMed Central;pure.eur.nl

unpaywall_oa_status: gold

ReferenceCitation: Sternberg CN, Castellano D, de Bono J, Fizazi K, Tombal B, Wulfing C, Kramer G, Eymard JC, Bamias A, Carles J, Iacovelli R, Melichar B, Sverrisdottir A, Theodore C, Feyerabend S, Helissey C, Poole EM, Ozatilgan A, Geffriaud-Ricouard C, de Wit R. Efficacy and Safety of Cabazitaxel Versus Abiraterone or Enzalutamide in Older Patients with Metastatic Castration-resistant Prostate Cancer in the CARD Study. Eur Urol. 2021 Oct;80(4):497-506. doi: 10.1016/j.eururo.2021.06.021. Epub 2021 Jul 15.

ReferenceCitation: Fizazi K, Kramer G, Eymard JC, Sternberg CN, de Bono J, Castellano D, Tombal B, Wulfing C, Liontos M, Carles J, Iacovelli R, Melichar B, Sverrisdottir A, Theodore C, Feyerabend S, Helissey C, Oudard S, Facchini G, Poole EM, Ozatilgan A, Geffriaud-Ricouard C, Bensfia S, de Wit R. Quality of life in patients with metastatic prostate cancer following treatment with cabazitaxel versus abiraterone or enzalutamide (CARD): an analysis of a randomised, multicentre, open-label, phase 4 study. Lancet Oncol. 2020 Nov;21(11):1513-1525. doi: 10.1016/S1470-2045(20)30449-6. Epub 2020 Sep 11.

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

repository_normalized: HAL

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

repositories_concat: HAL

ReferenceCitation: de Wit R, de Bono J, Sternberg CN, Fizazi K, Tombal B, Wulfing C, Kramer G, Eymard JC, Bamias A, Carles J, Iacovelli R, Melichar B, Sverrisdottir A, Theodore C, Feyerabend S, Helissey C, Ozatilgan A, Geffriaud-Ricouard C, Castellano D; CARD Investigators. Cabazitaxel versus Abiraterone or Enzalutamide in Metastatic Prostate Cancer. N Engl J Med. 2019 Dec 26;381(26):2506-2518. doi: 10.1056/NEJMoa1911206. Epub 2019 Sep 30.

repository_institution: Ghent University - Ghent University Academic Bibliography

repository_institution: Radboud University - Radboud Repository

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

location_facility:
Investigational Site Number 276025
Investigational Site Number 250007
Investigational Site Number 276028
Investigational Site Number 826001
Investigational Site Number 056013
Investigational Site Number 250002
Investigational Site Number 056006
Investigational Site Number 276022
Investigational Site Number 300001
Investigational Site Number 724002
Investigational Site Number 380009
Investigational Site Number 578002
Investigational Site Number 276023
Investigational Site Number 250004
Investigational Site Number 250010
Investigational Site Number 203001
Investigational Site Number 250008
Investigational Site Number 276003
Investigational Site Number 352001
Investigational Site Number 276010
Investigational Site Number 250013
Investigational Site Number 056007
Investigational Site Number 203005
Investigational Site Number 300004
Investigational Site Number 250006
Investigational Site Number 372003
Investigational Site Number 276002
Investigational Site Number 724004
Investigational Site Number 528005
Investigational Site Number 276006
Investigational Site Number 276018
Investigational Site Number 250014
Investigational Site Number 250001
Investigational Site Number 380008
Investigational Site Number 380001
Investigational Site Number 040002
Investigational Site Number 250005
Investigational Site Number 276026
Investigational Site Number 372001
Investigational Site Number 380004
Investigational Site Number 528002
Investigational Site Number 276008
Investigational Site Number 724001
Investigational Site Number 528003
Investigational Site Number 250009
Investigational Site Number 056005
Investigational Site Number 250016
Investigational Site Number 040003
Investigational Site Number 276007
Investigational Site Number 528004
Investigational Site Number 203002
Investigational Site Number 578001
Investigational Site Number 300005
Investigational Site Number 276011
Investigational Site Number 203003
Investigational Site Number 250011
Investigational Site Number 276004
Investigational Site Number 040004
Investigational Site Number 724003
Investigational Site Number 380002
Investigational Site Number 380006
Investigational Site Number 380005
Investigational Site Number 250018
Investigational Site Number 056001
Investigational Site Number 056003

title: A Randomized, Open Label, Multicenter Study of Cabazitaxel Versus an Androgen Receptor (AR)-Targeted Agent (Abiraterone or Enzalutamide) in mCRPC Patients Previously Treated With Docetaxel and Who Rapidly Failed a Prior AR-targeted Agent (CARD)

type: Other Identifier

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

location_country:
Germany
Ireland
Italy
Norway
United Kingdom
Netherlands
Austria
Belgium
Spain
Greece
Czechia
Iceland
France


lead_sponsor: Hoffmann-La Roche

summary: This Phase III, open-label, randomized, multicenter study is to evaluate the efficacy and safety of adjuvant treatment with atezolizumab compared with observation in participants with muscle-invasive UC who are at high risk for recurrence following resection. Eligible participants were randomized by a 1:1 ratio into atezolizumab group or control group.

ReferenceCitation: Bellmunt J, Hussain M, Gschwend JE, Albers P, Oudard S, Castellano D, Daneshmand S, Nishiyama H, Majchrowicz M, Degaonkar V, Shi Y, Mariathasan S, Grivas P, Drakaki A, O'Donnell PH, Rosenberg JE, Geynisman DM, Petrylak DP, Hoffman-Censits J, Bedke J, Kalebasty AR, Zakharia Y, van der Heijden MS, Sternberg CN, Davarpanah NN, Powles T; IMvigor010 Study Group. Adjuvant atezolizumab versus observation in muscle-invasive urothelial carcinoma (IMvigor010): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2021 Apr;22(4):525-537. doi: 10.1016/S1470-2045(21)00004-8. Epub 2021 Mar 12.

repository_institution: PubMed Central - Europe PMC

repository_institution: Universitat Pompeu Fabra - Repositori digital de la UPF

repositories_concat: PubMed Central;repositori.upf.edu

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

location_facility: Universitätsmedizin Rostock, Urologische Klinik und Poliklinik

location_facility: Huashan Hospital Affiliated to Fudan University

location_facility: CI Dnipropetrovsk CMCH #4 MA of MOHU Ch of Oncology and MR

location_facility: SBEI of HPE ?Bashkir State Medical University? of MoH RF

location_facility: Baylor College of Medicine; Gastroenterology

location_facility: Academ Ziekenhuis Groningen; Medical Oncology

location_facility: Friendship Hospital, Capital Medical University

location_facility: Barts Health NHS Trust - St Bartholomew's Hospital

location_facility: Campus Charitè Mitte Charité Centrum 10. Klinik f.Urologie

location_facility: The Ohio State University Wexner Medical Center

location_facility: Institut Mutualiste Montsouris; Oncologie

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

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Fairview Hospital; Cleveland Clinic Cancer Center

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: Chaim Sheba Medical Center; Oncology Dept

location_facility: Taichung Veterans General Hospital; Division of Urology

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Royal Brisbane & Women's Hosp; Cancer Care Serv

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

location_facility: Institut Sainte Catherine;Recherche Clinique

location_facility: Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval Department of Urology #4

location_facility: Hiroshima City Hiroshima Citizens Hospital; Urology

location_facility: Szpital Kliniczny Dzieci?tka Jezus; Oddzia? Urologii

location_facility: Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: University Hospitals Bristol NHS Foundation Trust

location_facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica

location_facility: Centre Francois Baclesse; Recherche Clinique

location_facility: Irccs Ospedale San Raffaele;Oncologia Medica

location_facility: Sverdlovsk Regional Oncology Dispensary; Chemotherapy

location_facility: Diakonie-Klinikum Stuttgart; Urologische Klinik

location_facility: Alexandras General Hospital of Athens; Oncology Department

location_facility: Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia

location_facility: Universitätsklinikum Düsseldorf; Urologische Klinik

location_facility: Irccs Istituto Europeo Di Oncologia (IEO); Cure Mediche

location_facility: Clinic for Urology; Clinical Hospital Center "Dragisa Misovic-Dedinje"

location_facility: Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

location_facility: National Cancer Center Hospital; Urology

location_facility: University of Chicago; Hematology/Oncology

location_facility: Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica

location_facility: A.O. UNIVERSITARIA S. LUIGI GONZAGA; Oncologia Medica

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: HonorHealth Research Institute - Pima - Virginia G. Piper Cancer Care Network

location_facility: Hirosaki University School of Medicine & Hospital; Urology

location_facility: Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia

location_facility: University of Texas Health Science Center at San Antonio

location_facility: University Hospital Motol; Department of Urology

location_facility: Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica

location_facility: Hopital Cochin; Unite Fonctionnelle D Oncologie

location_facility: Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology

location_facility: Saint Barnabas Medical Center Cancer Center

location_facility: University Hospital of Patras Medical Oncology

location_facility: Abramson Cancer Center; Univ of Pennsylvania

location_facility: Saitama Medical University International Medical Center

location_facility: Szpital Kliniczny im. Heliodora ?wi?cickiego UM w Poznaniu; Oddzia? Chemioterapii

location_facility: Hospital de Donostia; Servicio de Oncologia Medica

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

location_facility: Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology

location_facility: Helsinki University Central Hospital; Urology Clinics

location_facility: Hadassah Ein Karem Hospital; Oncology Dept

location_facility: University of Iowa Hospital & Clinic; Division of Hematology/Oncology

location_facility: Kimmel Cancer Center Thomas Jefferson University

location_facility: Universitätsklinikum der Ruhr-Universität Bochum, Marien-Hospital Herne, Urologische Klinik

location_facility: Augusta-Kranken-Anstalt gGmbH; Klinik für Hämatologie, Onkologie & Palliativmedizin

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: Centre D'Oncologie de Gentilly; Oncology

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

location_facility: Laura and ISAAC Perlmutter Cancer Center at NYU Langone.

location_facility: SpecjalistycznySzpital Miejski w Toruniu; Oddzia? Urologii Ogólnej i Onkologicznej

location_facility: P.A. Herzen Oncological Inst. ; Oncology

location_facility: The Ottawa Hospital Cancer Centre; Oncology

location_facility: Azienda Ospedaliera S. Maria - Terni; Oncologia

location_facility: Turku University Central Hospital; Urology clinic

location_facility: National Taiwan University Hospital, Department of Urology

location_facility: The Cancer Institute Hospital, JFCR; Urology

location_facility: Hospital Clinico San Carlos; Servicio de Oncologia

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Albert B. Chandler Medical Center; University of Kentucky

location_facility: The Second Affiliated Hospital, Sun Yat-sen University

location_facility: Cross Cancer Institute ; Dept of Medical Oncology

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Austin and Repatriation Medical Centre; Cancer Services

location_facility: Az. Osp. Cardarelli; Divisione Di Oncologia

location_facility: Iwate Medical University Hospital; Urology

location_facility: GU "Institution of urology of Academy Medical science of Ukraine"

location_facility: Instituto Valenciano Oncologia; Oncologia Medica

location_facility: Wake Forest University Baptist Medical Center

location_facility: Tampere University Hospital; Dept Of Urology

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego; Oddzial Urologii i Onkologii

location_facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

location_facility: ISTITUTO NAZIONALE TUMORI IRCCS FONDAZIONE G. PASCALE; Dipartimento Uro-Ginecologico

location_facility: Northwestern University Feinberg School Of Medicine

location_facility: Hopital Europeen Georges Pompidou; Service D'Oncologie Medicale

location_facility: VU MEDISCH CENTRUM; Dept. of Medical Oncology

location_facility: Clinical Center of Serbia; Clinic of Urology

location_facility: Universitätsklinikum Ulm; Klinik für Urologie

location_facility: UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie

location_facility: Universitätsklinikum Tübingen; Klinik für Urologie

location_facility: Medizinische Fakultät Mannheim, Universitätsklinikum Mannheim, Klinik für Urologie

location_facility: Hospital Clinic de Barcelona. Unidad de Nuevas Terapias;Oncology Department

location_facility: Rambam Health Care Campus; Oncology - Hafia

status: Terminated

title: A Phase III, Open-Label, Multicenter, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) Versus Observation as Adjuvant Therapy in Patients With High-Risk Muscle-Invasive Urothelial Carcinoma After Surgical Resection

location_country:
Finland
Germany
Poland
Australia
Japan
Turkey
Czechia
Canada
Serbia
France
Switzerland
United States
Ukraine
Belgium
China
Italy
United Kingdom
Netherlands
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation
Israel

status_simplified: Unknown


lead_sponsor: Novartis Pharmaceuticals

summary: The main aim of this study was to evaluate the efficacy and safety of adding ribociclib to fulvestrant in men and postmenopausal women with hormone receptor positive (HR+), HER2-negative advanced breast cancer.

ReferenceCitation: Burris HA, Chan A, Bardia A, Thaddeus Beck J, Sohn J, Neven P, Tripathy D, Im SA, Chia S, Esteva FJ, Hart L, Zarate JP, Ridolfi A, Lorenc KR, Yardley DA. Safety and impact of dose reductions on efficacy in the randomised MONALEESA-2, -3 and -7 trials in hormone receptor-positive, HER2-negative advanced breast cancer. Br J Cancer. 2021 Aug;125(5):679-686. doi: 10.1038/s41416-021-01415-9. Epub 2021 Jun 22.

evidence: open (via free pdf)

repositories_concat: PubMed Central

publisher_dissemination: Springer-Nature

ReferenceCitation: Slamon DJ, Neven P, Chia S, Jerusalem G, De Laurentiis M, Im S, Petrakova K, Valeria Bianchi G, Martin M, Nusch A, Sonke GS, De la Cruz-Merino L, Beck JT, Ji Y, Wang C, Deore U, Chakravartty A, Zarate JP, Taran T, Fasching PA. Ribociclib plus fulvestrant for postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer in the phase III randomized MONALEESA-3 trial: updated overall survival. Ann Oncol. 2021 Aug;32(8):1015-1024. doi: 10.1016/j.annonc.2021.05.353. Epub 2021 Jun 5. Erratum In: Ann Oncol. 2021 Oct;32(10):1307.

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repository_institution: University of Liège - Open Repository and Bibliography

repository_institution: Universidad de Sevilla - idUS

ReferenceCitation: Prat A, Chaudhury A, Solovieff N, Pare L, Martinez D, Chic N, Martinez-Saez O, Braso-Maristany F, Lteif A, Taran T, Babbar N, Su F. Correlative Biomarker Analysis of Intrinsic Subtypes and Efficacy Across the MONALEESA Phase III Studies. J Clin Oncol. 2021 May 1;39(13):1458-1467. doi: 10.1200/JCO.20.02977. Epub 2021 Mar 26. Erratum In: J Clin Oncol. 2021 Nov 1;39(31):3525. J Clin Oncol. 2023 Apr 20;41(12):2299-2301.

evidence: open (via page says license)

ReferenceCitation: Slamon DJ, Neven P, Chia S, Fasching PA, De Laurentiis M, Im SA, Petrakova K, Bianchi GV, Esteva FJ, Martin M, Nusch A, Sonke GS, De la Cruz-Merino L, Beck JT, Pivot X, Sondhi M, Wang Y, Chakravartty A, Rodriguez-Lorenc K, Taran T, Jerusalem G. Overall Survival with Ribociclib plus Fulvestrant in Advanced Breast Cancer. N Engl J Med. 2020 Feb 6;382(6):514-524. doi: 10.1056/NEJMoa1911149. Epub 2019 Dec 11.

repositories_concat: LIRIAS (KU Leuven)

ReferenceCitation: Yardley DA. MONALEESA clinical program: a review of ribociclib use in different clinical settings. Future Oncol. 2019 Aug;15(23):2673-2686. doi: 10.2217/fon-2019-0130. Epub 2019 Jul 15.

oa_host_type: publisher

publisher_dissemination: Future Science Ltd

ReferenceCitation: Slamon DJ, Neven P, Chia S, Fasching PA, De Laurentiis M, Im SA, Petrakova K, Bianchi GV, Esteva FJ, Martin M, Nusch A, Sonke GS, De la Cruz-Merino L, Beck JT, Pivot X, Vidam G, Wang Y, Rodriguez Lorenc K, Miller M, Taran T, Jerusalem G. Phase III Randomized Study of Ribociclib and Fulvestrant in Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: MONALEESA-3. J Clin Oncol. 2018 Aug 20;36(24):2465-2472. doi: 10.1200/JCO.2018.78.9909. Epub 2018 Jun 3.

location_facility: Central Coast Medical Oncology Corporation SC

location_facility: University of New Mexico Cancer Center SC

location_facility: Providence Regional Cancer Partnership .

location_facility: NYU Langone Med Center CV Research NYU Langone Medical Center

location_facility: Moanalua Medical Center. Attn: Oncology Dept SC

location_facility: UF Health Cancer Center at Orlando Health

location_facility: Ironwood Cancer and Research Centers SC-2

location_facility: Northern Utah Cancer Associates CFTY720DUS01

location_facility: Virginia Mason Medical Center-Oncology SC

location_facility: Oncology Specialists, SC Advocate Medical Group-Niles

location_facility: Penn State University Milton S Hershey Medical Center SC

location_facility: Florida Cancer Research Institute Dept of Oncology

title: A Randomized Double-blind, Placebo-controlled Study of Ribociclib in Combination With Fulvestrant for the Treatment of Men and Postmenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer Who Have Received no or Only One Line of Prior Endocrine Treatment

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

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

location_country:
Germany
Poland
Australia
Thailand
Turkey
Czechia
Canada
France
Colombia
Portugal
Hungary
Denmark
Switzerland
United States
Lebanon
Belgium
Malaysia
Italy
Norway
Singapore
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Jordan
Bulgaria
Russian Federation
Sweden

ipd_sharing: Yes


acronym: MetaPHer

summary: This is an open-label, single-arm, multicenter, Phase IIIb study to evaluate the safety and tolerability of Herceptin SC in combination with Perjeta IV plus docetaxel in female patients with HER2-positive metastatic or locally recurrent breast cancer. Enrolled patients are to receive study medication until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end, whichever occurs first. The anticipated time on study treatment is approximately 24 months. The target sample size is 400.

ReferenceCitation: Kuemmel S, Tondini CA, Abraham J, Nowecki Z, Itrych B, Hitre E, Karaszewska B, Juarez-Ramiro A, Morales-Vasquez F, Perez-Garcia JM, Cardona-Huerta S, Monturus E, Sequi M, Restuccia E, Benyunes M, Martin M. Subcutaneous trastuzumab with pertuzumab and docetaxel in HER2-positive metastatic breast cancer: Final analysis of MetaPHER, a phase IIIb single-arm safety study. Breast Cancer Res Treat. 2021 Jun;187(2):467-476. doi: 10.1007/s10549-021-06145-3. Epub 2021 Mar 21.

evidence: oa repository (via free pdf)

repository_normalized: Research Square

version: submittedVersion

repositories:
PubMed Central
Research Square

repositories_concat: PubMed Central;Research Square

location_facility: Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie; Klinika Onkologiczna

location_facility: Centre Hospitalier Regional Metz-Thionville - Hopital de Mercy

location_facility: Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli

location_facility: Centro Hospitalar de Lisboa Norte, EPE - Hospital Santa Maria

location_facility: Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele

location_facility: Guys and St Thomas NHS Foundation Trust, Guys Hospital

location_facility: University Multiprofile Hospital for Active Treatment Sveti Georgi EAD

location_facility: Azienda Ospedaliera Santa Maria di Terni

location_facility: Specialized Hospital for Active Treatment of Oncological Diseases - Sofia District EOOD

location_facility: Hopital Saint Joseph; Service de Rhumatologie

location_facility: Szent Margit Hospital; Dept. of Oncology

location_facility: Complexo Hospitalario Universitario de Santiago (CHUS) - Hospital Clinico Universitario

location_facility: Szpital Kliniczny; Przemienienia Panskiego;Uniwersytetu Medyczny im.; Karola Marcinkowskiego w Pozna

location_facility: "Azienda Ospedaliera Universitaria Integrata Verona Ospedale Borgo Trento"

location_facility: Superare Centro de Infusion S.A. de C.V.

location_facility: Ospedale Santo Stefano, Azienda USL Centro Prato

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Azienda Ospedaliero - Universitaria di Modena Policlinico

location_facility: Multiprofile Hospital for Active Treatment Central Onco Hospital OOD

location_facility: Azienda Ospedaliero-Universitaria di Ferrara, Arcispedale Sant'Anna

location_facility: Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe

location_facility: Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely

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

location_facility: Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház

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

location_facility: Onkologische Schwerpunktpraxis Dr. Joerg Schilling

location_facility: Instituto Portugues Oncologia de Coimbra Francisco Gentil, EPE

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Azienda Ospedaliera Universitaria Careggi

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

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Centre Hospitalier de Mont de Marsan - Hopital Layne

location_facility: Fundacion Instituto Valenciano de Oncologia (IVO)

location_facility: Pole Sante Republique; Pharmacie Oncologique

location_facility: Multiprofile Hospital For Active Treatment Dr. Tota Venkova JSC

location_facility: Praxis für Interdisziplinäre Onkologie und Hämatologie GbR

location_facility: Johanniter-Krankenhaus Genthin - Stendal GmbH; Gynäkologie und gynäkologische Onkologie

location_facility: Bialostockie Centrum Onkologii im. Marii Sklodowskiej - Curie

location_facility: Groupe Hospitalier Mutualiste de Grenoble

location_facility: Medipole De Savoie; Departement Oncologie

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

location_facility: Samodzielny Publiczny Zakład Opieki Zdrowotnej MSW z W-MCO w Olsztynie

location_facility: Specialized Hospital for Active Cancer Treatment, Dr. Mark Antonov Markov - Varna Ltd

location_facility: Azienda Ospedaliera di Reggio Emilia - Arcispedale Santa Maria Nuova

location_facility: Samodzielny Publiczny Zakład Opieki Zdrowotnej Opolskie Centrum Onkologii

location_facility: Universitatsklinikum Schleswig-Holstein; Klinik fuer Innere Medizin I

location_facility: Portsmouth Hospitals NHS Trust - Queen Alexandra Hospital

title: A MULTICENTER, OPEN-LABEL, SINGLE-ARM SAFETY STUDY OF HERCEPTIN® SC IN COMBINATION WITH PERJETA® AND DOCETAXEL IN TREATMENT OF PATIENTS WITH HER2−POSITIVE ADVANCED BREAST CANCER (METASTATIC OR LOCALLY RECURRENT)

location_country:
Germany
Italy
Poland
Portugal
Hungary
United Kingdom
Mexico
Belgium
Spain
Bulgaria
Canada
France


title: A Phase 2 Randomised, Double-blind, Placebo-controlled, Single-dose, Dose-ranging Study of the Efficacy and Safety of MEDI4893, a Human Monoclonal Antibody Against Staphylococcus Aureus Alpha Toxin in Mechanically Ventilated Adult Subjects.

acronym: SAATELLITE

summary: Clinical trial looking at safety and efficacy of MEDI4893 in prevention of pneumonia caused by Staphylococcus aureus in high-risk patients

ReferenceCitation: Francois B, Jafri HS, Chastre J, Sanchez-Garcia M, Eggimann P, Dequin PF, Huberlant V, Vina Soria L, Boulain T, Bretonniere C, Pugin J, Trenado J, Hernandez Padilla AC, Ali O, Shoemaker K, Ren P, Coenjaerts FE, Ruzin A, Barraud O, Timbermont L, Lammens C, Pierre V, Wu Y, Vignaud J, Colbert S, Bellamy T, Esser MT, Dubovsky F, Bonten MJ, Goossens H, Laterre PF; COMBACTE Consortium and the SAATELLITE Study Group. Efficacy and safety of suvratoxumab for prevention of Staphylococcus aureus ventilator-associated pneumonia (SAATELLITE): a multicentre, randomised, double-blind, placebo-controlled, parallel-group, phase 2 pilot trial. Lancet Infect Dis. 2021 Sep;21(9):1313-1323. doi: 10.1016/S1473-3099(20)30995-6. Epub 2021 Apr 21.

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

repository_normalized: irua

repositories_concat: irua

ReferenceCitation: Yu XQ, Robbie GJ, Wu Y, Esser MT, Jensen K, Schwartz HI, Bellamy T, Hernandez-Illas M, Jafri HS. Safety, Tolerability, and Pharmacokinetics of MEDI4893, an Investigational, Extended-Half-Life, Anti-Staphylococcus aureus Alpha-Toxin Human Monoclonal Antibody, in Healthy Adults. Antimicrob Agents Chemother. 2016 Dec 27;61(1):e01020-16. doi: 10.1128/AAC.01020-16. Print 2017 Jan.

publisher_dissemination: American Society for Microbiology

lead_sponsor: MedImmune LLC

collaborators: Innovative Medicines Initiative and COMBACTE-NET

collaborators: Antibacterial Resistance Leadership Group

collaborators: National Institute of Allergy and Infectious Diseases (NIAID)

location_country:
Germany
Portugal
Hungary
Switzerland
Belgium
United States
Spain
Greece
Czechia
France


acronym: MODUL

summary: This randomized, multi-center, active-controlled, open-label, parallel-group study will investigate the efficacy and safety of biomarker-driven maintenance treatment for first-line mCRC. Participants with mCRC are eligible for entry and cannot have received any prior chemotherapy in the metastatic setting. The entire study duration is anticipated to be approximately 7.5 years.

location_facility: Institut Hospitalier Franco-Britannique; Cancerologie

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Hospital Universitario Miguel Servet; Servicio Oncologia

location_facility: Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie

location_facility: Sygehus Syd Roskilde; Onkologisk/haematologisk ambulatorium

location_facility: Universitätsklinikum Magdeburg Klinik für Gastroenterologie und Hepatologie

location_facility: Narodny Onkologicky Ustav; Oddelenie klinickej onkologie E

location_facility: Castle Hill Hospital; The Queens Centre for Oncology and Haematology

location_facility: Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1

location_facility: Royal Marsden Hospital; Dept. of Medicine

location_facility: Krankenhaus Nordwest; Klinik f. Onkologie und Hämatologie

location_facility: Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

location_facility: MVZ für Hämatologie, Onkologie, Strahlentherapie und Palliativmedizin -; Klinik Dr. Hancken

location_facility: Istanbul Uni Capa Medical Faculty; Inst. of Oncology

location_facility: Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia

location_facility: Faculdade de Medicina de Sao Jose do Rio Preto - FAMERP*X*

location_facility: Herlev Hospital; Afdeling for Kræftbehandling

location_facility: Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia

location_facility: Hospital Universitario Reina Sofia; Servicio de Oncologia

location_facility: BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie

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

location_facility: Klinikum Magdeburg gGmbH Klinik für Allgemein- und Viszeralchirurgie

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

location_facility: Karolinska Hospital; Oncology - Radiumhemmet

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

location_facility: Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii

location_facility: Istituto Regina Elena; Oncologia Medica A

location_facility: Hospital Universitario Puerta de Hierro; Servicio de Oncologia

location_facility: Guys and St Thomas NHS Foundation Trust, Guys Hospital

location_facility: Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department

location_facility: A.O.U.I. VERONA-OSPEDALE POLICLINICO G.B. ROSSI BORGO ROMA;ONCOLOGIA MEDICA-d.U.

location_facility: Catharina ZKHS; Inwendige Geneeskunde Afd.

location_facility: Hospital de Santa Maria; Servico de Oncologia Medica

location_facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica

location_facility: Klinik Fulda, Medizinisches Versorgungszentrum Osthessen GmbH

location_facility: Hopital Saint Antoine; Oncologie Medicale

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

location_facility: Aberdeen Royal Infirmary; Medical Oncology Dept

location_facility: Hospital de Gastroenterologia Dr. Bonorino Udaondo ; Servicio de Oncología

location_facility: Ch De Montbeliard;Chir Generale Digestive

location_facility: Ege Uni Medical Faculty Hospital; Oncology Dept

location_facility: Instituto de Ensino e Pesquisa Sao Lucas - IEP

location_facility: Southampton General Hospital; Medical Oncology

location_facility: Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie; Klinika Gastroenterologii Onkologicznej

location_facility: Euromedical General Clinic of Thessaloniki; Oncology Department

location_facility: Hospital Universitario la Fe; Servicio de Oncologia

location_facility: Humanitas Gavazzeni;U.O. Oncologia Medica

location_facility: Kliniken Maria Hilf GmbH, Krankenhaus St. Franziskus

location_facility: Agioi Anargyroi; 3Rd Dept. of Medical Oncology

location_facility: University Hospital of Patras Medical Oncology

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

location_facility: Hospital de Donostia; Servicio de Oncologia Medica

location_facility: Hospital da Cidade de Passo Fundo; Centro de Pesquisa em Oncologia

location_facility: PIOH PD Dr. R. Schnell - Dr. H. Schulz - Dr. M. Hellmann

location_facility: University Clinical Center of the Republic of Srpska

location_facility: Regionshospitalet Herning; Onkologisk afdeling

location_facility: Chu Estaing; Chir Generale Digestive A Et B

location_facility: Acibadem University School of Medicine, Adana Hospital; General Surgery

location_facility: Uni Hospital of Ioannina; Oncology Dept.

location_facility: Klinik der Ruhr-Uni Bochum; Marien-Hospital Herne

location_facility: Universitätsklinikum Hamburg-Eppendorf, Onkologisches Zentrum, Studienzentrale der II. Med. Klinik

location_facility: Hospital de Navarra; Servicio de Oncologia

location_facility: Institut Gustave Roussy; Departement Oncologie Medicale

location_facility: Christie Hospital Nhs Trust; Medical Oncology

location_facility: Centro Oncologico Riojano Integral (CORI)

location_facility: Hämatologisch-onkologische Praxis Dr. med. - Heinrich, - Bangerter

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

location_facility: DRK Kliniken Berlin Köpenick Darmzentrum

location_facility: Krankenhaus Barmherziger Brüder; Klinik für Internistische Onkologie / Hämatologie

location_facility: Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Oncologia

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Russian Oncology Research Center n.a. N.N. Blokhin Dpt of Clinical Pharmacology and Chemotherapy

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Prima

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Hospital General Univ. de Alicante; Servicio de Oncologia

location_facility: Odense Universitetshospital, Onkologisk Afdeling R

location_facility: Deventer Ziekenhuis; Interne Geneeskunde

location_facility: Hopital Claude Huriez; Medecine Interne Oncologie

location_facility: Hospital General Universitario de Elche; Servicio de Oncologia

location_facility: Städt. Klinikum München GmbH Klinikum Neuperlach Klinik f.Hämatologie u.Onkologie

location_facility: IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia

location_facility: Hospital Universitario Marques de Valdecilla; Servicio de Oncologia

location_facility: Albert Schweitzer Ziekenhuis - loc Dordrecht

location_facility: Studienzentrum Onkologie Ravensburg; Onkologie Ravensburg

location_facility: Hospital General Universitario de Valencia; Servicio de oncologia

location_facility: Hospital Clinico Universitario Lozano Blesa; Servicio de Oncologia

location_facility: Chu La Miletrie; Gastro Enterologie Endoscopies

location_facility: SLK-Kliniken Heilbronn GmbH; Klinik für Innere Medizin III; Schwerpunkt Häma./Onko./Palliativm.

location_facility: Ijsselland Ziekenhuis; Inwendige Geneeskunde

location_facility: Klinikum Wetzlar-Braunfels, Klinik für Hämatologie/Onkologie und Palliativmedizin

location_facility: Hopital Rangueil; Gastro Enterologie Et Nutrition

location_facility: Medizinische Hochschule; Zentrum Innere Medizin; Abt. Hämatologie u. Onkologie

location_facility: Hopital Augustin Morvan; Federation De Cancerologie

location_facility: Univ General Hosp Heraklion; Medical Oncology

location_facility: Gemeinschaftspraxis für Hämatologie und Onkologie

location_facility: Complejo Hospitalario de Orense; Servicio de Oncologia

location_facility: Hospital Regional Universitario Carlos Haya; Servicio de Oncologia

location_facility: Skånes University Hospital, Skånes Department of Onclology

location_facility: Instituto Nacional de Cancerologia; Oncology

location_facility: Institute for Oncology and Radiology of Serbia; Medical Oncology

location_facility: Gemeinschaftspraxis für Hämatologie und Onkologie PD Dr. Bauer, Dr. Kremers

location_facility: Hospital Univ. Central de Asturias; Servicio de Oncologia

location_facility: Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

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

location_facility: Bashkirian Republican Clinical Oncology Dispensary

location_facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1

location_facility: Marmara Uni Faculty of Medicine; Medical Oncology

title: A Multi-Centre Randomised Clinical Trial of Biomarker-Driven Maintenance Treatment for First-Line Metastatic Colorectal Cancer (MODUL)

location_country:
Germany
Poland
Argentina
Brazil
Bosnia and Herzegovina
Turkey
Serbia
France
Slovenia
Portugal
Slovakia
Denmark
Belgium
Egypt
Italy
United Kingdom
Netherlands
Mexico
Korea, Republic of
Spain
Greece
Russian Federation
Sweden


title: A Phase II, Open-Label, Multicenter Trial to Investigate the Clinical Activity and Safety of Avelumab (MSB0010718C) in Subjects With Merkel Cell Carcinoma

summary: This is a multicenter, international, single-arm, open-label, Phase 2 trial to evaluate the efficacy and safety of avelumab in participants with metastatic Merkel cell carcinoma (MCC).

design_allocation: Non-Randomized

ReferenceType: result

ReferenceCitation: Kaufman HL, Russell J, Hamid O, Bhatia S, Terheyden P, D'Angelo SP, Shih KC, Lebbe C, Linette GP, Milella M, Brownell I, Lewis KD, Lorch JH, Chin K, Mahnke L, von Heydebreck A, Cuillerot JM, Nghiem P. Avelumab in patients with chemotherapy-refractory metastatic Merkel cell carcinoma: a multicentre, single-group, open-label, phase 2 trial. Lancet Oncol. 2016 Oct;17(10):1374-1385. doi: 10.1016/S1470-2045(16)30364-3. Epub 2016 Sep 1.

ReferenceCitation: Kaufman HL, Russell JS, Hamid O, Bhatia S, Terheyden P, D'Angelo SP, Shih KC, Lebbe C, Milella M, Brownell I, Lewis KD, Lorch JH, von Heydebreck A, Hennessy M, Nghiem P. Updated efficacy of avelumab in patients with previously treated metastatic Merkel cell carcinoma after >/=1 year of follow-up: JAVELIN Merkel 200, a phase 2 clinical trial. J Immunother Cancer. 2018 Jan 19;6(1):7. doi: 10.1186/s40425-017-0310-x.

publisher_dissemination: British Medical Journal

ReferenceCitation: D'Angelo SP, Russell J, Lebbe C, Chmielowski B, Gambichler T, Grob JJ, Kiecker F, Rabinowits G, Terheyden P, Zwiener I, Bajars M, Hennessy M, Kaufman HL. Efficacy and Safety of First-line Avelumab Treatment in Patients With Stage IV Metastatic Merkel Cell Carcinoma: A Preplanned Interim Analysis of a Clinical Trial. JAMA Oncol. 2018 Sep 1;4(9):e180077. doi: 10.1001/jamaoncol.2018.0077. Epub 2018 Sep 13.

publisher_dissemination: American Medical Association

ReferenceCitation: D'Angelo SP, Bhatia S, Brohl AS, Hamid O, Mehnert JM, Terheyden P, Shih KC, Brownell I, Lebbe C, Lewis KD, Linette GP, Milella M, Georges S, Shah P, Ellers-Lenz B, Bajars M, Guzel G, Nghiem PT. Avelumab in patients with previously treated metastatic Merkel cell carcinoma: long-term data and biomarker analyses from the single-arm phase 2 JAVELIN Merkel 200 trial. J Immunother Cancer. 2020 May;8(1):e000674. doi: 10.1136/jitc-2020-000674.

ReferenceCitation: Lambert J, Marrel A, D'Angelo SP, Burgess MA, Chmielowski B, Fazio N, Gambichler T, Grob JJ, Lebbe C, Robert C, Russell J, Guzel G, Bharmal M. Patient Experiences with Avelumab in Treatment-Naive Metastatic Merkel Cell Carcinoma: Longitudinal Qualitative Interview Findings from JAVELIN Merkel 200, a Registrational Clinical Trial. Patient. 2020 Aug;13(4):457-467. doi: 10.1007/s40271-020-00428-5.

ReferenceCitation: Kaufman HL, Dias Barbosa C, Guillemin I, Lambert J, Mahnke L, Bharmal M. Living with Merkel Cell Carcinoma (MCC): Development of a Conceptual Model of MCC Based on Patient Experiences. Patient. 2018 Aug;11(4):439-449. doi: 10.1007/s40271-018-0301-0.

ReferenceCitation: Bharmal M, Fofana F, Barbosa CD, Williams P, Mahnke L, Marrel A, Schlichting M. Psychometric properties of the FACT-M questionnaire in patients with Merkel cell carcinoma. Health Qual Life Outcomes. 2017 Dec 22;15(1):247. doi: 10.1186/s12955-017-0815-5. Erratum In: Health Qual Life Outcomes. 2019 Mar 27;17(1):52.

ReferenceCitation: Kelly K, Manitz J, Patel MR, D'Angelo SP, Apolo AB, Rajan A, Kasturi V, Speit I, Bajars M, Warth J, Gulley JL. Efficacy and immune-related adverse event associations in avelumab-treated patients. J Immunother Cancer. 2020 Nov;8(2):e001427. doi: 10.1136/jitc-2020-001427.

ReferenceCitation: Bharmal M, Nolte S, Lebbe C, Mortier L, Brohl AS, Fazio N, Grob JJ, Pusceddu S, Hanna GJ, Hassel JC, Kiecker F, Ellers-Lenz B, Bajars M, Guzel G, Nghiem P, Hunger M, Schlichting M, Henry-Szatkowski M, D'Angelo SP. Health-related quality of life trajectory of treatment-naive patients with Merkel cell carcinoma receiving avelumab. Future Oncol. 2020 Sep;16(27):2089-2099. doi: 10.2217/fon-2020-0426. Epub 2020 Sep 17.

ReferenceCitation: Grisic AM, Xiong W, Tanneau L, Jonsson S, Friberg LE, Karlsson MO, Dai H, Zheng J, Girard P, Khandelwal A. Model-Based Characterization of the Bidirectional Interaction Between Pharmacokinetics and Tumor Growth Dynamics in Patients with Metastatic Merkel Cell Carcinoma Treated with Avelumab. Clin Cancer Res. 2022 Apr 1;28(7):1363-1371. doi: 10.1158/1078-0432.CCR-21-2662.

repository_institution: Uppsala University - Uppsala University Publications

publisher_dissemination: American Association for Cancer Research

ReferenceCitation: D'Angelo SP, Lebbe C, Mortier L, Brohl AS, Fazio N, Grob JJ, Prinzi N, Hanna GJ, Hassel JC, Kiecker F, Georges S, Ellers-Lenz B, Shah P, Guzel G, Nghiem P. First-line avelumab in a cohort of 116 patients with metastatic Merkel cell carcinoma (JAVELIN Merkel 200): primary and biomarker analyses of a phase II study. J Immunother Cancer. 2021 Jul;9(7):e002646. doi: 10.1136/jitc-2021-002646.

ReferenceCitation: Bharmal M, Nolte S, Henry-Szatkowski M, Hennessy M, Schlichting M. Update on the psychometric properties and minimal important difference (MID) thresholds of the FACT-M questionnaire for use in treatment-naive and previously treated patients with metastatic Merkel cell carcinoma. Health Qual Life Outcomes. 2020 May 19;18(1):145. doi: 10.1186/s12955-020-01402-3.

ReferenceCitation: Bullement A, Willis A, Amin A, Schlichting M, Hatswell AJ, Bharmal M. Evaluation of survival extrapolation in immuno-oncology using multiple pre-planned data cuts: learnings to aid in model selection. BMC Med Res Methodol. 2020 May 6;20(1):103. doi: 10.1186/s12874-020-00997-x.

repository_institution: University College London - UCL Discovery

repositories:
PubMed Central
UCL Discovery
eprints.whiterose.ac.uk

ReferenceCitation: Novakovic AM, Wilkins JJ, Dai H, Wade JR, Neuteboom B, Brar S, Bello CL, Girard P, Khandelwal A. Changing Body Weight-Based Dosing to a Flat Dose for Avelumab in Metastatic Merkel Cell and Advanced Urothelial Carcinoma. Clin Pharmacol Ther. 2020 Mar;107(3):588-596. doi: 10.1002/cpt.1645. Epub 2019 Nov 18.

ReferenceCitation: Bharmal M, Guillemin I, Marrel A, Arnould B, Lambert J, Hennessy M, Fofana F. How to address the challenges of evaluating treatment benefits-risks in rare diseases? A convergent mixed methods approach applied within a Merkel cell carcinoma phase 2 clinical trial. Orphanet J Rare Dis. 2018 Jun 18;13(1):95. doi: 10.1186/s13023-018-0835-1.

ipd_sharing_description: Per company policy, following approval of a new product or a new indication for an approved product in both the EU and the US, EMD Serono will share study protocols, anonymized patient level and study level data and redacted clinical study reports from clinical trials in patients with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website https://www.emdgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html

sponsor_collaborators: EMD Serono Research & Development Institute, Inc.

location_country:
Germany
Italy
Australia
Japan
United States
Spain
France

location_facility: Istituto Nazionale Tumori Regina Elena IRCCS

location_facility: Hôpital Ambroise Paré - Boulogne-Billancourt

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia

location_facility: Universitaetsklinikum Schleswig Holstein - Campus Luebeck

location_facility: The Angeles Clinic and Research Institute - West LA

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet

location_facility: University of Washington - Seattle Cancer Care Alliance

location_facility: Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

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

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

location_facility: Charite Universitaetsmedizin Berlin - Campus Charite Mitte

location_facility: Washington University School of Medicine

location_facility: Peggy & Charles Stephenson Oklahoma Cancer Center

location_facility: Groupe Hospitalier Saint André - Hôpital Saint André

location_facility: Universitaetsklinikum Carl Gustav Carus TU Dresden

location_facility: Istituto Nazionale Tumori Fondazione G.Pascale

location_facility: Hospital General Universitario de Valencia

location_facility: Fondazione del Piemonte per l'Oncologia IRCC Candiolo

location_facility: Universitaetsklinikum Schleswig-Holstein - Klinik fuer Allgemeine Innere Medizin


title: A Phase III, Randomised, Double-blind, Placebo-controlled, Multi-centre, International Study of MEDI4736 as Sequential Therapy in Patients With Locally Advanced, Unresectable Non-Small Cell Lung Cancer (Stage III) Who Have Not Progressed Following Definitive, Platinum-based, Concurrent Chemoradiation Therapy (PACIFIC)

acronym: PACIFIC

summary: A Global Study to Assess the Effects of MEDI4736 following concurrent chemoradiation in Patients with Stage III Unresectable Non-Small Cell Lung Cancer.

ReferenceCitation: Senan S, Ozguroglu M, Daniel D, Villegas A, Vicente D, Murakami S, Hui R, Faivre-Finn C, Paz-Ares L, Wu YL, Mann H, Dennis PA, Antonia SJ. Outcomes with durvalumab after chemoradiotherapy in stage IIIA-N2 non-small-cell lung cancer: an exploratory analysis from the PACIFIC trial. ESMO Open. 2022 Apr;7(2):100410. doi: 10.1016/j.esmoop.2022.100410. Epub 2022 Mar 2.

repositories_concat: PubMed Central;www.repositoriosalud.es

ReferenceCitation: Naidoo J, Vansteenkiste JF, Faivre-Finn C, Ozguroglu M, Murakami S, Hui R, Quantin X, Broadhurst H, Newton M, Thiyagarajah P, Antonia SJ. Characterizing immune-mediated adverse events with durvalumab in patients with unresectable stage III NSCLC: A post-hoc analysis of the PACIFIC trial. Lung Cancer. 2022 Apr;166:84-93. doi: 10.1016/j.lungcan.2022.02.003. Epub 2022 Feb 9.

ReferenceCitation: Spigel DR, Faivre-Finn C, Gray JE, Vicente D, Planchard D, Paz-Ares L, Vansteenkiste JF, Garassino MC, Hui R, Quantin X, Rimner A, Wu YL, Ozguroglu M, Lee KH, Kato T, de Wit M, Kurata T, Reck M, Cho BC, Senan S, Naidoo J, Mann H, Newton M, Thiyagarajah P, Antonia SJ. Five-Year Survival Outcomes From the PACIFIC Trial: Durvalumab After Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer. J Clin Oncol. 2022 Apr 20;40(12):1301-1311. doi: 10.1200/JCO.21.01308. Epub 2022 Feb 2. Erratum In: J Clin Oncol. 2022 Jun 10;40(17):1965.

repository_institution: Yonsei University Medical Library - YUHSpace

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

ReferenceCitation: Ouwens M, Darilay A, Zhang Y, Mukhopadhyay P, Mann H, Ryan J, Dennis PA. Assessing the Influence of Subsequent Immunotherapy on Overall Survival in Patients with Unresectable Stage III Non-Small Cell Lung Cancer from the PACIFIC Study. Curr Ther Res Clin Exp. 2021 Aug 12;95:100640. doi: 10.1016/j.curtheres.2021.100640. eCollection 2021.

ReferenceCitation: Socinski MA, Ozguroglu M, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Gray JE, Park K, Vincent M, Mann H, Newton M, Dennis PA, Antonia SJ. Durvalumab After Concurrent Chemoradiotherapy in Elderly Patients With Unresectable Stage III Non-Small-Cell Lung Cancer (PACIFIC). Clin Lung Cancer. 2021 Nov;22(6):549-561. doi: 10.1016/j.cllc.2021.05.009. Epub 2021 Jun 12.

ReferenceCitation: Garassino MC, Paz-Ares L, Hui R, Faivre-Finn C, Spira A, Planchard D, Ozguroglu M, Daniel D, Vicente D, Murakami S, Langer C, Senan S, Spigel D, Ryden A, Zhang Y, O'Brien C, Dennis PA, Antonia SJ. Patient-reported outcomes with durvalumab by PD-L1 expression and prior chemoradiotherapy-related variables in unresectable stage III non-small-cell lung cancer. Future Oncol. 2021 Apr;17(10):1165-1184. doi: 10.2217/fon-2020-1102. Epub 2021 Feb 15.

ReferenceCitation: Mehra R, Yong C, Seal B, van Keep M, Raad A, Zhang Y. Cost-Effectiveness of Durvalumab After Chemoradiotherapy in Unresectable Stage III NSCLC: A US Healthcare Perspective. J Natl Compr Canc Netw. 2021 Feb 2;19(2):153-162. doi: 10.6004/jnccn.2020.7621. Print 2021 Feb.

ReferenceCitation: Faivre-Finn C, Vicente D, Kurata T, Planchard D, Paz-Ares L, Vansteenkiste JF, Spigel DR, Garassino MC, Reck M, Senan S, Naidoo J, Rimner A, Wu YL, Gray JE, Ozguroglu M, Lee KH, Cho BC, Kato T, de Wit M, Newton M, Wang L, Thiyagarajah P, Antonia SJ. Four-Year Survival With Durvalumab After Chemoradiotherapy in Stage III NSCLC-an Update From the PACIFIC Trial. J Thorac Oncol. 2021 May;16(5):860-867. doi: 10.1016/j.jtho.2020.12.015. Epub 2021 Jan 19.

ReferenceCitation: Faivre-Finn C, Spigel DR, Senan S, Langer C, Perez BA, Ozguroglu M, Daniel D, Villegas A, Vicente D, Hui R, Murakami S, Paz-Ares L, Broadhurst H, Wadsworth C, Dennis PA, Antonia SJ. Impact of prior chemoradiotherapy-related variables on outcomes with durvalumab in unresectable Stage III NSCLC (PACIFIC). Lung Cancer. 2021 Jan;151:30-38. doi: 10.1016/j.lungcan.2020.11.024. Epub 2020 Nov 26.

ReferenceCitation: Paz-Ares L, Spira A, Raben D, Planchard D, Cho BC, Ozguroglu M, Daniel D, Villegas A, Vicente D, Hui R, Murakami S, Spigel D, Senan S, Langer CJ, Perez BA, Boothman AM, Broadhurst H, Wadsworth C, Dennis PA, Antonia SJ, Faivre-Finn C. Outcomes with durvalumab by tumour PD-L1 expression in unresectable, stage III non-small-cell lung cancer in the PACIFIC trial. Ann Oncol. 2020 Jun;31(6):798-806. doi: 10.1016/j.annonc.2020.03.287. Epub 2020 Mar 21.

ReferenceCitation: Gray JE, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Kurata T, Chiappori A, Lee KH, Cho BC, Planchard D, Paz-Ares L, Faivre-Finn C, Vansteenkiste JF, Spigel DR, Wadsworth C, Taboada M, Dennis PA, Ozguroglu M, Antonia SJ. Three-Year Overall Survival with Durvalumab after Chemoradiotherapy in Stage III NSCLC-Update from PACIFIC. J Thorac Oncol. 2020 Feb;15(2):288-293. doi: 10.1016/j.jtho.2019.10.002. Epub 2019 Oct 14.

ReferenceCitation: Hui R, Ozguroglu M, Villegas A, Daniel D, Vicente D, Murakami S, Yokoi T, Chiappori A, Lee KH, de Wit M, Cho BC, Gray JE, Ryden A, Viviers L, Poole L, Zhang Y, Dennis PA, Antonia SJ. Patient-reported outcomes with durvalumab after chemoradiotherapy in stage III, unresectable non-small-cell lung cancer (PACIFIC): a randomised, controlled, phase 3 study. Lancet Oncol. 2019 Dec;20(12):1670-1680. doi: 10.1016/S1470-2045(19)30519-4. Epub 2019 Oct 7.

ReferenceCitation: Antonia SJ, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Kurata T, Chiappori A, Lee KH, de Wit M, Cho BC, Bourhaba M, Quantin X, Tokito T, Mekhail T, Planchard D, Kim YC, Karapetis CS, Hiret S, Ostoros G, Kubota K, Gray JE, Paz-Ares L, de Castro Carpeno J, Faivre-Finn C, Reck M, Vansteenkiste J, Spigel DR, Wadsworth C, Melillo G, Taboada M, Dennis PA, Ozguroglu M; PACIFIC Investigators. Overall Survival with Durvalumab after Chemoradiotherapy in Stage III NSCLC. N Engl J Med. 2018 Dec 13;379(24):2342-2350. doi: 10.1056/NEJMoa1809697. Epub 2018 Sep 25.

repository_institution: The University of Manchester - Research Explorer

ReferenceCitation: Antonia SJ, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Yokoi T, Chiappori A, Lee KH, de Wit M, Cho BC, Bourhaba M, Quantin X, Tokito T, Mekhail T, Planchard D, Kim YC, Karapetis CS, Hiret S, Ostoros G, Kubota K, Gray JE, Paz-Ares L, de Castro Carpeno J, Wadsworth C, Melillo G, Jiang H, Huang Y, Dennis PA, Ozguroglu M; PACIFIC Investigators. Durvalumab after Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer. N Engl J Med. 2017 Nov 16;377(20):1919-1929. doi: 10.1056/NEJMoa1709937. Epub 2017 Sep 8.

repositories_institution: University of Liège - Open Repository and Bibliography

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

location_country:
Germany
Poland
Australia
Japan
Thailand
Vietnam
Turkey
Chile
Canada
France
Slovakia
Hungary
United States
Belgium
Peru
Italy
United Kingdom
Singapore
Netherlands
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Israel


title: A Multicentre, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase III Efficacy and Safety Study of Benralizumab (MEDI-563) Added to High-dose Inhaled Corticosteroid Plus Long-acting β2 Agonist in Patients With Uncontrolled Asthma

summary: The purpose of this study is to determine whether Benralizumab reduces the number of asthma exacerbations in patients who remain uncontrolled on high doses of ICS-LABA.

ReferenceCitation: Menzies-Gow A, Hoyte FL, Price DB, Cohen D, Barker P, Kreindler J, Jison M, Brooks CL, Papeleu P, Katial R. Clinical Remission in Severe Asthma: A Pooled Post Hoc Analysis of the Patient Journey with Benralizumab. Adv Ther. 2022 May;39(5):2065-2084. doi: 10.1007/s12325-022-02098-1. Epub 2022 Mar 14.

repository_institution: Aberdeen University - Aberdeen University Research Archive

repositories_concat: PubMed Central;aura.abdn.ac.uk

ReferenceCitation: Lugogo NL, Kreindler JL, Martin UJ, Cook B, Hirsch I, Trudo FJ. Blood eosinophil count group shifts and kinetics in severe eosinophilic asthma. Ann Allergy Asthma Immunol. 2020 Aug;125(2):171-176. doi: 10.1016/j.anai.2020.04.011. Epub 2020 Apr 22.

ReferenceCitation: Jackson DJ, Humbert M, Hirsch I, Newbold P, Garcia Gil E. Ability of Serum IgE Concentration to Predict Exacerbation Risk and Benralizumab Efficacy for Patients with Severe Eosinophilic Asthma. Adv Ther. 2020 Feb;37(2):718-729. doi: 10.1007/s12325-019-01191-2. Epub 2019 Dec 14.

ReferenceCitation: Chipps BE, Hirsch I, Trudo F, Alacqua M, Zangrilli JG. Benralizumab efficacy for patients with fixed airflow obstruction and severe, uncontrolled eosinophilic asthma. Ann Allergy Asthma Immunol. 2020 Jan;124(1):79-86. doi: 10.1016/j.anai.2019.10.006. Epub 2019 Oct 15.

ReferenceCitation: Chupp G, Lugogo NL, Kline JN, Ferguson GT, Hirsch I, Goldman M, Zangrilli JG, Trudo F. Rapid onset of effect of benralizumab on morning peak expiratory flow in severe, uncontrolled asthma. Ann Allergy Asthma Immunol. 2019 May;122(5):478-485. doi: 10.1016/j.anai.2019.02.016. Epub 2019 Feb 23.

ReferenceCitation: Bleecker ER, Wechsler ME, FitzGerald JM, Menzies-Gow A, Wu Y, Hirsch I, Goldman M, Newbold P, Zangrilli JG. Baseline patient factors impact on the clinical efficacy of benralizumab for severe asthma. Eur Respir J. 2018 Oct 18;52(4):1800936. doi: 10.1183/13993003.00936-2018. Print 2018 Oct.

ReferenceCitation: DuBuske L, Newbold P, Wu Y, Trudo F. Seasonal variability of exacerbations of severe, uncontrolled eosinophilic asthma and clinical benefits of benralizumab. Allergy Asthma Proc. 2018 Sep 4;39(5):345-349. doi: 10.2500/aap.2018.39.4162. Epub 2018 Aug 4.

ReferenceCitation: Chipps BE, Newbold P, Hirsch I, Trudo F, Goldman M. Benralizumab efficacy by atopy status and serum immunoglobulin E for patients with severe, uncontrolled asthma. Ann Allergy Asthma Immunol. 2018 May;120(5):504-511.e4. doi: 10.1016/j.anai.2018.01.030. Epub 2018 Feb 1.

ReferenceCitation: Bleecker ER, FitzGerald JM, Chanez P, Papi A, Weinstein SF, Barker P, Sproule S, Gilmartin G, Aurivillius M, Werkstrom V, Goldman M; SIROCCO study investigators. Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting beta2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016 Oct 29;388(10056):2115-2127. doi: 10.1016/S0140-6736(16)31324-1. Epub 2016 Sep 5.

location_country:
France
Italy
Poland
United Kingdom
Australia
Brazil
Mexico
United States
Korea, Republic of
Spain
Vietnam
South Africa
Turkey
Peru
Bulgaria
Russian Federation
Czech Republic


title: A Multicenter, Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients (NYHA Class II-IV) With Preserved Ejection Fraction (PARAGON-HF)

acronym: PARAGON-HF

summary: The purpose of this study was to evaluate the effect of LCZ696 compared to valsartan in the reduction of cardiovascular death and heart failure(HF) hospitalizations in patients with HF with preserved ejection fraction.

ReferenceCitation: Butt JH, Dewan P, Jhund PS, Anand IS, Atar D, Ge J, Desai AS, Echeverria LE, Kober L, Lam CSP, Maggioni AP, Martinez F, Packer M, Rouleau JL, Sim D, Van Veldhuisen DJ, Vrtovec B, Zannad F, Zile MR, Gong J, Lefkowitz MP, Rizkala AR, Solomon SD, McMurray JJV. Sacubitril/Valsartan and Frailty in Patients With Heart Failure and Preserved Ejection Fraction. J Am Coll Cardiol. 2022 Sep 20;80(12):1130-1143. doi: 10.1016/j.jacc.2022.06.037. Epub 2022 Aug 29.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

repository_institution: University of Oslo - Duo Research Archive

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

repository_institution: The University of Glasgow - Enlighten: Publications

repositories_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

ReferenceCitation: Wijkman MO, Claggett B, Vaduganathan M, Cunningham JW, Rorth R, Jackson A, Packer M, Zile M, Rouleau J, Swedberg K, Lefkowitz M, Shah SJ, Pfeffer MA, McMurray JJV, Solomon SD. Effects of sacubitril/valsartan on glycemia in patients with diabetes and heart failure: the PARAGON-HF and PARADIGM-HF trials. Cardiovasc Diabetol. 2022 Jun 18;21(1):110. doi: 10.1186/s12933-022-01545-1.

repository_institution: Linkoping University - DiVA

ReferenceCitation: Vaduganathan M, Claggett BL, Inciardi RM, Fonarow GC, McMurray JJV, Solomon SD. Estimating the Benefits of Combination Medical Therapy in Heart Failure With Mildly Reduced and Preserved Ejection Fraction. Circulation. 2022 Jun 7;145(23):1741-1743. doi: 10.1161/CIRCULATIONAHA.121.058929. Epub 2022 May 23. No abstract available.

ReferenceCitation: Vaduganathan M, Claggett BL, McMurray JJV, Solomon SD. Health Status Trajectories Before and After Hospitalization for Heart Failure. Circulation. 2022 Jun 21;145(25):1872-1874. doi: 10.1161/CIRCULATIONAHA.122.059282. Epub 2022 May 21. No abstract available.

ReferenceCitation: Cikes M, Planinc I, Claggett B, Cunningham J, Milicic D, Sweitzer N, Senni M, Gori M, Linssen G, Shah SJ, Packer M, Pfeffer M, Zile MR, Anand I, Chiang LM, Lam CSP, Redfield M, Desai AS, McMurray JJV, Solomon SD. Atrial Fibrillation in Heart Failure With Preserved Ejection Fraction: The PARAGON-HF Trial. JACC Heart Fail. 2022 May;10(5):336-346. doi: 10.1016/j.jchf.2022.01.018. Epub 2022 Apr 6.

ReferenceCitation: Jackson AM, Rorth R, Liu J, Kristensen SL, Anand IS, Claggett BL, Cleland JGF, Chopra VK, Desai AS, Ge J, Gong J, Lam CSP, Lefkowitz MP, Maggioni AP, Martinez F, Packer M, Pfeffer MA, Pieske B, Redfield MM, Rizkala AR, Rouleau JL, Seferovic PM, Tromp J, Van Veldhuisen DJ, Yilmaz MB, Zannad F, Zile MR, Kober L, Petrie MC, Jhund PS, Solomon SD, McMurray JJV; PARAGON-HF Committees and Investigators. Diabetes and pre-diabetes in patients with heart failure and preserved ejection fraction. Eur J Heart Fail. 2022 Mar;24(3):497-509. doi: 10.1002/ejhf.2403. Epub 2022 Jan 4.

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

ReferenceCitation: Desai AS, Vaduganathan M, Cleland JG, Claggett BL, Barkoudah E, Finn P, McCausland FR, Yilmaz MB, Lefkowitz M, Shi V, Pfeffer MA, McMurray JJV, Solomon SD. Mode of Death in Patients With Heart Failure and Preserved Ejection Fraction: Insights From PARAGON-HF Trial. Circ Heart Fail. 2021 Dec;14(12):e008597. doi: 10.1161/CIRCHEARTFAILURE.121.008597. Epub 2021 Nov 22.

ReferenceCitation: Mooney L, Hawkins NM, Jhund PS, Redfield MM, Vaduganathan M, Desai AS, Rouleau JL, Minamisawa M, Shah AM, Lefkowitz MP, Zile MR, Van Veldhuisen DJ, Pfeffer MA, Anand IS, Maggioni AP, Senni M, Claggett BL, Solomon SD, McMurray JJV. Impact of Chronic Obstructive Pulmonary Disease in Patients With Heart Failure With Preserved Ejection Fraction: Insights From PARAGON-HF. J Am Heart Assoc. 2021 Dec 7;10(23):e021494. doi: 10.1161/JAHA.121.021494. Epub 2021 Nov 19.

ReferenceCitation: Jackson AM, Jhund PS, Anand IS, Dungen HD, Lam CSP, Lefkowitz MP, Linssen G, Lund LH, Maggioni AP, Pfeffer MA, Rouleau JL, Saraiva JFK, Senni M, Vardeny O, Wijkman MO, Yilmaz MB, Saito Y, Zile MR, Solomon SD, McMurray JJV. Sacubitril-valsartan as a treatment for apparent resistant hypertension in patients with heart failure and preserved ejection fraction. Eur Heart J. 2021 Sep 21;42(36):3741-3752. doi: 10.1093/eurheartj/ehab499.

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

ReferenceCitation: Felker GM, Butler J, Januzzi JL Jr, Desai AS, McMurray JJV, Solomon SD. Probabilistic Readjudication of Heart Failure Hospitalization Events in the PARAGON-HF Study. Circulation. 2021 Jun 8;143(23):2316-2318. doi: 10.1161/CIRCULATIONAHA.121.054496. Epub 2021 Jun 7. No abstract available.

ReferenceCitation: Selvaraj S, Claggett BL, Packer M, Zannad F, Anand IS, Pieske B, Zhao Z, Shi VC, Lefkowitz MP, McMurray JJV, Solomon SD. Effects of Sacubitril/Valsartan on Serum Lipids in Heart Failure With Preserved Ejection Fraction. J Am Heart Assoc. 2021 Sep 7;10(17):e022069. doi: 10.1161/JAHA.121.022069. Epub 2021 May 16.

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

ReferenceCitation: Shen L, Jhund PS, Anand IS, Bhatt AS, Desai AS, Maggioni AP, Martinez FA, Pfeffer MA, Rizkala AR, Rouleau JL, Swedberg K, Vaduganathan M, Vardeny O, van Veldhuisen DJ, Zannad F, Zile MR, Packer M, Solomon SD, McMurray JJV. Incidence and Outcomes of Pneumonia in Patients With Heart Failure. J Am Coll Cardiol. 2021 Apr 27;77(16):1961-1973. doi: 10.1016/j.jacc.2021.03.001.

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

ReferenceCitation: Tromp J, Claggett BL, Liu J, Jackson AM, Jhund PS, Kober L, Widimsky J, Boytsov SA, Chopra VK, Anand IS, Ge J, Chen CH, Maggioni AP, Martinez F, Packer M, Pfeffer MA, Pieske B, Redfield MM, Rouleau JL, Van Veldhuisen DJ, Zannad F, Zile MR, Rizkala AR, Inubushi-Molessa A, Lefkowitz MP, Shi VC, McMurray JJV, Solomon SD, Lam CSP; PARAGON-HF Investigators. Global Differences in Heart Failure With Preserved Ejection Fraction: The PARAGON-HF Trial. Circ Heart Fail. 2021 Apr;14(4):e007901. doi: 10.1161/CIRCHEARTFAILURE.120.007901. Epub 2021 Apr 19.

ReferenceCitation: Vaduganathan M, Cunningham JW, Claggett BL, Causland FM, Barkoudah E, Finn P, Zannad F, Pfeffer MA, Rizkala AR, Sabarwal S, McMurray JJV, Solomon S, Desai AS. Worsening Heart Failure Episodes Outside a Hospital Setting in Heart Failure With Preserved Ejection Fraction: The PARAGON-HF Trial. JACC Heart Fail. 2021 May;9(5):374-382. doi: 10.1016/j.jchf.2021.01.014. Epub 2021 Apr 7.

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

ReferenceCitation: Gronda E, Vanoli E, Iacoviello M. The PARAGON-HF trial: the sacubitril/valsartan in heart failure with preserved ejection fraction. Eur Heart J Suppl. 2020 Nov 18;22(Suppl L):L77-L81. doi: 10.1093/eurheartj/suaa140. eCollection 2020 Nov.

ReferenceCitation: Jering K, Claggett B, Redfield MM, Shah SJ, Anand IS, Martinez F, Sabarwal SV, Seferovic PM, Kerr Saraiva JF, Katova T, Lefkowitz MP, Pfeffer MA, McMurray JJV, Solomon SD. Burden of Heart Failure Signs and Symptoms, Prognosis, and Response to Therapy: The PARAGON-HF Trial. JACC Heart Fail. 2021 May;9(5):386-397. doi: 10.1016/j.jchf.2021.01.011. Epub 2021 Mar 10.

ReferenceCitation: Jering KS, Zannad F, Claggett B, Mc Causland FR, Ferreira JP, Desai A, Barkoudah E, McMurray JJV, Pfeffer MA, Solomon SD. Cardiovascular and Renal Outcomes of Mineralocorticoid Receptor Antagonist Use in PARAGON-HF. JACC Heart Fail. 2021 Jan;9(1):13-24. doi: 10.1016/j.jchf.2020.08.014. Epub 2020 Nov 11.

ReferenceCitation: Mc Causland FR, Lefkowitz MP, Claggett B, Anavekar NS, Senni M, Gori M, Jhund PS, McGrath MM, Packer M, Shi V, Van Veldhuisen DJ, Zannad F, Comin-Colet J, Pfeffer MA, McMurray JJV, Solomon SD. Angiotensin-Neprilysin Inhibition and Renal Outcomes in Heart Failure With Preserved Ejection Fraction. Circulation. 2020 Sep 29;142(13):1236-1245. doi: 10.1161/CIRCULATIONAHA.120.047643. Epub 2020 Aug 17.

ReferenceCitation: Cunningham JW, Claggett BL, O'Meara E, Prescott MF, Pfeffer MA, Shah SJ, Redfield MM, Zannad F, Chiang LM, Rizkala AR, Shi VC, Lefkowitz MP, Rouleau J, McMurray JJV, Solomon SD, Zile MR. Effect of Sacubitril/Valsartan on Biomarkers of Extracellular Matrix Regulation in Patients With HFpEF. J Am Coll Cardiol. 2020 Aug 4;76(5):503-514. doi: 10.1016/j.jacc.2020.05.072.

ReferenceCitation: Cunningham JW, Vaduganathan M, Claggett BL, Zile MR, Anand IS, Packer M, Zannad F, Lam CSP, Janssens S, Jhund PS, Kober L, Rouleau J, Shah SJ, Chopra VK, Shi VC, Lefkowitz MP, Prescott MF, Pfeffer MA, McMurray JJV, Solomon SD. Effects of Sacubitril/Valsartan on N-Terminal Pro-B-Type Natriuretic Peptide in Heart Failure With Preserved Ejection Fraction. JACC Heart Fail. 2020 May;8(5):372-381. doi: 10.1016/j.jchf.2020.03.002. Epub 2020 Mar 30.

ReferenceCitation: Selvaraj S, Claggett BL, Bohm M, Anker SD, Vaduganathan M, Zannad F, Pieske B, Lam CSP, Anand IS, Shi VC, Lefkowitz MP, McMurray JJV, Solomon SD. Systolic Blood Pressure in Heart Failure With Preserved Ejection Fraction Treated With Sacubitril/Valsartan. J Am Coll Cardiol. 2020 Apr 14;75(14):1644-1656. doi: 10.1016/j.jacc.2020.02.009. Epub 2020 Mar 16.

ReferenceCitation: Shah AM, Cikes M, Prasad N, Li G, Getchevski S, Claggett B, Rizkala A, Lukashevich I, O'Meara E, Ryan JJ, Shah SJ, Mullens W, Zile MR, Lam CSP, McMurray JJV, Solomon SD; PARAGON-HF Investigators. Echocardiographic Features of Patients With Heart Failure and Preserved Left Ventricular Ejection Fraction. J Am Coll Cardiol. 2019 Dec 10;74(23):2858-2873. doi: 10.1016/j.jacc.2019.09.063.

ReferenceCitation: Solomon SD, Vaduganathan M, L Claggett B, Packer M, Zile M, Swedberg K, Rouleau J, A Pfeffer M, Desai A, Lund LH, Kober L, Anand I, Sweitzer N, Linssen G, Merkely B, Luis Arango J, Vinereanu D, Chen CH, Senni M, Sibulo A, Boytsov S, Shi V, Rizkala A, Lefkowitz M, McMurray JJV. Sacubitril/Valsartan Across the Spectrum of Ejection Fraction in Heart Failure. Circulation. 2020 Feb 4;141(5):352-361. doi: 10.1161/CIRCULATIONAHA.119.044586. Epub 2019 Nov 17.

ReferenceCitation: McMurray JJV, Jackson AM, Lam CSP, Redfield MM, Anand IS, Ge J, Lefkowitz MP, Maggioni AP, Martinez F, Packer M, Pfeffer MA, Pieske B, Rizkala AR, Sabarwal SV, Shah AM, Shah SJ, Shi VC, van Veldhuisen DJ, Zannad F, Zile MR, Cikes M, Goncalvesova E, Katova T, Kosztin A, Lelonek M, Sweitzer N, Vardeny O, Claggett B, Jhund PS, Solomon SD. Effects of Sacubitril-Valsartan Versus Valsartan in Women Compared With Men With Heart Failure and Preserved Ejection Fraction: Insights From PARAGON-HF. Circulation. 2020 Feb 4;141(5):338-351. doi: 10.1161/CIRCULATIONAHA.119.044491. Epub 2019 Nov 17.

ReferenceCitation: Vaduganathan M, Claggett BL, Desai AS, Anker SD, Perrone SV, Janssens S, Milicic D, Arango JL, Packer M, Shi VC, Lefkowitz MP, McMurray JJV, Solomon SD. Prior Heart Failure Hospitalization, Clinical Outcomes, and Response to Sacubitril/Valsartan Compared With Valsartan in HFpEF. J Am Coll Cardiol. 2020 Jan 28;75(3):245-254. doi: 10.1016/j.jacc.2019.11.003. Epub 2019 Nov 11.

ReferenceCitation: Solomon SD, McMurray JJV, Anand IS, Ge J, Lam CSP, Maggioni AP, Martinez F, Packer M, Pfeffer MA, Pieske B, Redfield MM, Rouleau JL, van Veldhuisen DJ, Zannad F, Zile MR, Desai AS, Claggett B, Jhund PS, Boytsov SA, Comin-Colet J, Cleland J, Dungen HD, Goncalvesova E, Katova T, Kerr Saraiva JF, Lelonek M, Merkely B, Senni M, Shah SJ, Zhou J, Rizkala AR, Gong J, Shi VC, Lefkowitz MP; PARAGON-HF Investigators and Committees. Angiotensin-Neprilysin Inhibition in Heart Failure with Preserved Ejection Fraction. N Engl J Med. 2019 Oct 24;381(17):1609-1620. doi: 10.1056/NEJMoa1908655. Epub 2019 Sep 1.

repository_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

repository_institution: University of Zurich - Zurich Open Repository and Archive

ReferenceCitation: Chandra A, Vaduganathan M, Lewis EF, Claggett BL, Rizkala AR, Wang W, Lefkowitz MP, Shi VC, Anand IS, Ge J, Lam CSP, Maggioni AP, Martinez F, Packer M, Pfeffer MA, Pieske B, Redfield MM, Rouleau JL, Van Veldhuisen DJ, Zannad F, Zile MR, McMurray JJV, Solomon SD; PARAGON-HF Investigators. Health-Related Quality of Life in Heart Failure With Preserved Ejection Fraction: The PARAGON-HF Trial. JACC Heart Fail. 2019 Oct;7(10):862-874. doi: 10.1016/j.jchf.2019.05.015. Epub 2019 Jul 10.

ReferenceCitation: Solomon SD, Rizkala AR, Lefkowitz MP, Shi VC, Gong J, Anavekar N, Anker SD, Arango JL, Arenas JL, Atar D, Ben-Gal T, Boytsov SA, Chen CH, Chopra VK, Cleland J, Comin-Colet J, Duengen HD, Echeverria Correa LE, Filippatos G, Flammer AJ, Galinier M, Godoy A, Goncalvesova E, Janssens S, Katova T, Kober L, Lelonek M, Linssen G, Lund LH, O'Meara E, Merkely B, Milicic D, Oh BH, Perrone SV, Ranjith N, Saito Y, Saraiva JF, Shah S, Seferovic PM, Senni M, Sibulo AS Jr, Sim D, Sweitzer NK, Taurio J, Vinereanu D, Vrtovec B, Widimsky J Jr, Yilmaz MB, Zhou J, Zweiker R, Anand IS, Ge J, Lam CSP, Maggioni AP, Martinez F, Packer M, Pfeffer MA, Pieske B, Redfield MM, Rouleau JL, Van Veldhuisen DJ, Zannad F, Zile MR, McMurray JJV. Baseline Characteristics of Patients With Heart Failure and Preserved Ejection Fraction in the PARAGON-HF Trial. Circ Heart Fail. 2018 Jul;11(7):e004962. doi: 10.1161/CIRCHEARTFAILURE.118.004962.

ReferenceCitation: Mutze T, Glimm E, Schmidli H, Friede T. Group sequential designs with robust semiparametric recurrent event models. Stat Methods Med Res. 2019 Aug;28(8):2385-2403. doi: 10.1177/0962280218780538. Epub 2018 Jun 11.

repository_institution: Georg-August-Universität Göttingen - GoeScholar  The Publication Server of the Georg-August-Universität Göttingen

ReferenceCitation: Solomon SD, Rizkala AR, Gong J, Wang W, Anand IS, Ge J, Lam CSP, Maggioni AP, Martinez F, Packer M, Pfeffer MA, Pieske B, Redfield MM, Rouleau JL, Van Veldhuisen DJ, Zannad F, Zile MR, Desai AS, Shi VC, Lefkowitz MP, McMurray JJV. Angiotensin Receptor Neprilysin Inhibition in Heart Failure With Preserved Ejection Fraction: Rationale and Design of the PARAGON-HF Trial. JACC Heart Fail. 2017 Jul;5(7):471-482. doi: 10.1016/j.jchf.2017.04.013. Epub 2017 Jun 26.

ReferenceCitation: Rossi A, Gheorghiade M, Triposkiadis F, Solomon SD, Pieske B, Butler J. Left atrium in heart failure with preserved ejection fraction: structure, function, and significance. Circ Heart Fail. 2014 Nov;7(6):1042-9. doi: 10.1161/CIRCHEARTFAILURE.114.001276. No abstract available.

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

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

location_country:
Finland
Germany
Poland
Argentina
Australia
Brazil
Japan
Turkey
Croatia
Czechia
Canada
Serbia
France
Slovenia
Colombia
Slovakia
Hungary
Denmark
Switzerland
United States
India
Romania
Belgium
China
Peru
Philippines
Italy
Guatemala
Norway
Singapore
United Kingdom
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Bulgaria
Russian Federation
Israel


title: An Open-label, Multi-centre, Multi-national Post-marketing Non-interventional Prospective Study Evaluating Retention Rate, Seizure Control and Tolerability of Eslicarbazepine Acetate (ESL) as Adjunctive Treatment to One Baseline Antiepileptic Drug in Adult Patients With Partial-Onset Seizures With or Without Secondary Generalisation

summary: This was a Non-interventional Prospective Study. Centres enrolled adult patients with partial-onset seizures with or without secondary generalisation for whom the clinician had decided to initiate Eslicarbazepine Acetate (ESL) as an adjunctive therapy prior to the decision to take part in this study. Patients enrolled into the study were not sufficiently controlled with one drug licensed for the use as monotherapy in partial-onset seizures. Patients were seen at baseline and then during normal clinical visits at intervals. Patients in this study were assessed for efficacy and tolerability at baseline and then at least 3 and 6 months after the baseline.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Eisai Inc.

location_country:
Ireland
Germany
Norway
United Kingdom
Denmark
Sweden
Czech Republic
France