title: AdaptResponse Clinical Trial

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

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

repository_institution: UHasselt - Document Server@UHasselt

publisher_dissemination: Wiley

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

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

repository_normalized: HAL

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

sponsor_collaborators: Medtronic Cardiac Rhythm and Heart Failure

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

location_facility: Wake Forest Baptist Health High Point Medical Center

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

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

location_facility: Complexo Hospitalario Universitario de Vigo - Hospital Xeral Cíes

location_facility: Berufsgenossenschaftliche Universitätsklinik Bergmannsheil GmbH

location_facility: Weill Medical College of Cornell University

location_facility: Centre Hospitalier Universitaire de Grenoble-Hopital Albert Michallon

location_facility: CHRU de Montpellier - Hôpital Arnaud de Villeneuve

location_facility: Wojewódzki Szpital Zespolony im. Ludwika Perzyny w Kaliszu

location_facility: Prairie Education and Research Cooperative

location_facility: Universitätsklinikum Jena - Friedrich Schiller Universität

location_facility: Ziekenhuis Oost Limburg - Campus St.-Jan

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

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

location_facility: AdventHealth Cardiovascular Research Institute

location_facility: The University of Vermont Medical Center Inc

location_facility: Azienda Ospedaliera Spedali Civili di Brescia

location_facility: Helse Bergen HF - Haukeland Universitetssjukehus

location_facility: Azienda Ospedaliero-Universitaria di Parma

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

location_facility: University of Minnesota Medical Center Fairview

location_facility: Oklahoma Heart Hospital Research Foundation

location_facility: Keimyung University Dongsan Medical Center

location_facility: Phoenix Cardiovascular Research Group, LLC

location_facility: Medical University of South Carolina (MUSC)

location_facility: Liverpool Heart and Chest Hospital NHS Foundation Trust

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

location_facility: Azienda Ospedaliera Universitaria Integrata Verona

location_facility: King Faisal Specialist Hospital & Research Center

location_facility: Centre Hospitalier Universitaire de Amiens - Hôpital SU

location_facility: Klinikum der Universität München - Campus Großhadern

location_facility: Cardiovascular Research Center of South Florida

location_facility: Almazov National Medical Research Centre

location_facility: University of South Florida Health (USF)

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

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

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

location_facility: National Taiwan University Hospital Hsin Chu Branch

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

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

location_facility: CAMC Health Education & Research Institute Inc

location_facility: Virginia Commonwealth University Health System

location_facility: Universitätsklinikum Schleswig-Holstein - Campus Lübeck

location_facility: Manchester University NHS Foundation Trust - Wythenshawe Hospital

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

location_facility: University of Pittsburgh Medical Center UPMC Presbyterian

location_facility: Washington University School of Medicine

location_facility: Seoul National University Bundang Hospital

location_facility: Wojewódzki Szpital Specjalistyczny im. Stefana Kardynała Wyszyńskiego

location_facility: Hospital Universitario Nuestra Señora de Candelaria

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

location_facility: Cardiology Institute of Northwest Florida

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

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

location_facility: Landeskrankenhaus Innsbruck - Universitätskliniken

location_facility: Massachusetts General Hospital (Boston MA)

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

location_facility: London Health Sciences Centre - University Campus

location_facility: Scripps Green Hospital Scripps Clinic Torrey Pines

location_facility: Stredoslovensky ustav srdcovych a cievnych chorob a.s

location_facility: Saitama Medical Center Jichi Medical University

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

location_facility: Amphia Ziekenhuis - Locatie Molengracht Breda

location_facility: MVZ am Küchwald GmbH ambulantes Herz Zentrum Chemnitz

location_facility: University Hospitals Case Medical Center

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: Hospital Universitario Virgen de las Nieves

location_facility: Golden Jubilee National Hospital - NHS Trust

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

location_facility: North Memorial Heart and Vascular Institute

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied

location_facility: Saint Francis Medical Group Indiana Heart Physician

location_facility: Glacier View Research Institute Cardiology

location_facility: Centennial Heart Cardiovascular Consultants LLC

location_facility: National Cerebral and Cardiovascular Center

intervention_type: Device


study_start_date_type: Actual

acronym: ARAMIS

intervention_type: Drug

lead_sponsor: Bayer

summary: The purpose of this study is to assess the safety and efficacy of BAY1841788 (ODM-201) in patients with non-metastatic castration-resistant prostate cancer.

ReferenceType: derived

ReferenceCitation: Chowdhury S, Oudard S, Uemura H, Joniau S, Dearden L, Capone C, Van Sanden S, Diels J, Hadaschik BA. Apalutamide Compared with Darolutamide for the Treatment of Non-metastatic Castration-Resistant Prostate Cancer: Efficacy and Tolerability in a Matching-Adjusted Indirect Comparison. Adv Ther. 2022 Jan;39(1):518-531. doi: 10.1007/s12325-021-01885-6. Epub 2021 Nov 19.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

license: cc-by

license_normalized: cc-by

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

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

version: acceptedVersion

repositories:
LIRIAS (KU Leuven)
PubMed Central

repositories_concat: LIRIAS (KU Leuven);PubMed Central

unpaywall_oa_status: hybrid

publisher_dissemination: Springer-Nature

ReferenceCitation: Fizazi K, Blue I, Nowak JT. Darolutamide and survival in nonmetastatic, castration-resistant prostate cancer: a patient perspective of the ARAMIS trial. Future Oncol. 2021 May;17(14):1699-1707. doi: 10.2217/fon-2020-1291. Epub 2021 Feb 8. Erratum In: Future Oncol. 2022 Jan;18(2):275.

oa_host_type: publisher

evidence: open (via page says license)

license: cc-by-nd

license_normalized: cc-by-nd

repositories_concat: closed

publisher_dissemination: Future Science Ltd

ReferenceCitation: Fizazi K, Shore N, Tammela TL, Ulys A, Vjaters E, Polyakov S, Jievaltas M, Luz M, Alekseev B, Kuss I, Le Berre MA, Petrenciuc O, Snapir A, Sarapohja T, Smith MR; ARAMIS Investigators. Nonmetastatic, Castration-Resistant Prostate Cancer and Survival with Darolutamide. N Engl J Med. 2020 Sep 10;383(11):1040-1049. doi: 10.1056/NEJMoa2001342.

oa_colors: green other

evidence: open (via free article)

repository_institution: Tampere University - Tampere University Institutional Repository

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Shore N, Zurth C, Fricke R, Gieschen H, Graudenz K, Koskinen M, Ploeger B, Moss J, Prien O, Borghesi G, Petrenciuc O, Tammela TL, Kuss I, Verholen F, Smith MR, Fizazi K. Evaluation of Clinically Relevant Drug-Drug Interactions and Population Pharmacokinetics of Darolutamide in Patients with Nonmetastatic Castration-Resistant Prostate Cancer: Results of Pre-Specified and Post Hoc Analyses of the Phase III ARAMIS Trial. Target Oncol. 2019 Oct;14(5):527-539. doi: 10.1007/s11523-019-00674-0.

repository_institution: PubMed Central - Europe PMC

repositories_concat: PubMed Central;trepo.tuni.fi

ReferenceCitation: Fizazi K, Shore N, Tammela TL, Ulys A, Vjaters E, Polyakov S, Jievaltas M, Luz M, Alekseev B, Kuss I, Kappeler C, Snapir A, Sarapohja T, Smith MR; ARAMIS Investigators. Darolutamide in Nonmetastatic, Castration-Resistant Prostate Cancer. N Engl J Med. 2019 Mar 28;380(13):1235-1246. doi: 10.1056/NEJMoa1815671. Epub 2019 Feb 14. Erratum In: N Engl J Med. 2022 Sep 1;387(9):860.

sponsor_collaborators:
Bayer
Orion Corporation, Orion Pharma

status: Completed

title: A Multinational, Randomised, Double-blind, Placebo-controlled, Phase III Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer

location_country:
Finland
Germany
Poland
Argentina
Australia
Brazil
Japan
Turkey
Czechia
Canada
Serbia
France
Belarus
Lithuania
Colombia
Portugal
Slovakia
Hungary
United States
Latvia
Ukraine
Romania
Belgium
Peru
Estonia
Italy
United Kingdom
Sweden
Austria
Korea, Republic of
Spain
South Africa
Taiwan
Bulgaria
Russian Federation
Israel


title: Prospective, Single Arm, Multi-centre, Observational Registry to Further Validate Safety and Efficacy of the Ultimaster Des System in Unselected Patients Representing Everyday Clinical Practice

acronym: e-Ultimaster

summary: The e-Ultimaster will further validate the safety and efficacy of Ultimaster DES system in unselected patients representing everyday clinical practice. Also the study will assess the impact of non-compliance with dual antiplatelet therapy, one month after stent implementation (frequently observed in every day clinical practice), on stent thrombosis.

status: Unknown status

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ReferenceCitation: Kobo O, Saada M, von Birgelen C, Tonino PAL, Iniguez-Romo A, Frobert O, Halabi M, Oemrawsingh RM, Polad J, IJsselmuiden AJJ, Roffi M, Aminian A, Mamas MA, Roguin A. Impact of multisite artery disease on clinical outcomes after percutaneous coronary intervention: an analysis from the e-Ultimaster registry. Eur Heart J Qual Care Clin Outcomes. 2023 Jun 21;9(4):417-426. doi: 10.1093/ehjqcco/qcac043.

repository_institution: Keele University - Keele Research Repository

repositories_concat: PubMed Central;eprints.keele.ac.uk

publisher_dissemination: Oxford University Press

lead_sponsor: Terumo Europe N.V.

location_country:
Ireland
Poland
Argentina
Japan
Brazil
Kuwait
Thailand
Armenia
Kazakhstan
Vietnam
Chile
Czechia
Serbia
France
Belarus
Lithuania
Colombia
Portugal
Slovakia
Hungary
Switzerland
Morocco
Iceland
Ukraine
Uzbekistan
Indonesia
North Macedonia
India
Romania
Tunisia
Lebanon
Belgium
Malaysia
Oman
Estonia
Egypt
United Kingdom
Sweden
Netherlands
Austria
Mexico
United Arab Emirates
Saudi Arabia
Spain
Bangladesh
South Africa
Jordan
Bulgaria
Georgia
Israel

location_facility: Markusovszky University Teaching Hospital

location_facility: Universitario central de Asturias (Oviedo)

location_facility: Institut Arnault Tzanck St Laurent du Var

location_facility: Hospital Clínico Universitario de Santiago de Compostela

location_facility: Krankenanstalt Rudolfstiftung der Stadt Wien

location_facility: National Institute of Cardiovascular Surgery NAMS

location_facility: City clinic University Multi-Profile Hospital for Acute Care,Sofia

location_facility: Complexo Hospitalario Universitario A Coruña (CHUAC)

location_facility: Le Confluent Nouvelles Cliniques Nantaises

location_facility: National Institute of Surgery and Transplantology NAMS

location_facility: Hospital e Maternidade Dr. Christóvão da Gama

location_facility: Prince Abdullah Bin Abdulaziz Cardiac Center

location_facility: Max Super Speciality Hospital, Saket, Delhi

location_facility: Institute of cardiovascular diseases Vojvodina

location_facility: Szatmar-Szabolcs-Bereg county hospital and university teaching hospital

location_facility: Saiseikai Yokohama City Eastern Hospital

location_facility: Clinica Hospital San Jose de Navojoa SA de CV

location_facility: HRH Princess Maha Chakri Siridhorn Medical Center

location_facility: Hospital General Universitario de Burgos

location_facility: Government institution Regional centre of cardiac and vessel disease

location_facility: NAMS Amosov | Emergency Endovascular Surgery department

location_facility: Polyclinique Bassatine Cite gardin Sfax_Dr. Zeineb Grati Guermazi

location_facility: Groupe Hospitalier de la Rochelle Ré Aunis

location_facility: Hospital Marqués de Valdecilla, Santander

location_facility: HRH Princess Maha Chakri Sirindhorn Medical Center (Nakornayok)

location_facility: Cardiology Clinic, Clinical Centre of Serbia

location_facility: Hopital privé St Martin Pessac (DR Levy)

location_facility: Polyclinique El Bassatine SFAX_Dr. Sami Fourati

location_facility: National Heart Foundation Hospital and Research Institute

location_facility: Hanusch Krankenhaus der Wiener Gebietskrankenkasse

location_facility: Hospital Clínico Lozano Blesa de Zaragoza

location_facility: Polyclinique El Bassatine_Dr. Ridha Ennouri

location_facility: Clinique Générale et Cardiovasculaire de Tunis_Dr. Saloua TRABELSI

location_facility: Dr Hussien Heshmat - As Salam International Hospital

location_facility: Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust

location_facility: H.J. Doshi Ghatkopar Hindusabha Hospital

location_facility: G. Kuppuswamy Naidu Memorial Hospital (GKNM), Coimbatore

location_facility: Clinique Hannibal Lac 2_Dr. Mohamed Drissa

location_facility: Clinique St Augustin Bordeaux-Centre d'exploration-chirurgie

location_facility: Dr JCW Badenhorst - Netcare Unitas Hospital

location_facility: Stredodlovensky Ustav Srdcovych A Cievnych Chorob

location_facility: OLVZ Aalst, Onze Lieve Vrouw Ziekenhuis vzw-Campus Aalst

location_facility: Polyclinique El bassatine_Dr. Mohamed Najeh Abid

location_facility: NAMS Amosov | X-Ray diagnostics and invasive cardiology department

location_facility: Yerevan State medical University Hospital

location_facility: Specialized Cardiology Hospital for Active Treatment

location_facility: National Cardiovascular Center Harapan Kita

location_facility: Instytut Kardiologii im. Prymasa Tysiąclecia Stefana Kardynała Wyszyńskiego

location_facility: Instituto Cardiologico Hospital Campo Grande (Valladolid)

location_facility: Saitama Cardiovascular and Respiratory Center

location_facility: Clinique Générale et Cardiovasculaire de Tunis_Dr. Sami Bouziri

location_facility: S.P.M.C. of Pediatric Cardiology and Cardiac Surgery

location_facility: Szpital Kliniczny Przemienienia Panskiego UM im. K. Marcinkowskiego w Poznaniu

location_facility: Universitario Santa Lucia (Hospital Nostra Señora Rossell) (Cartagena)

location_facility: Landspitali National University hospital

location_facility: Hosp Universitario de Gran Canaria Dr. Negrin

location_facility: Hospital Universitario Lucus Augusti (HULA)

location_facility: National Scientific Medical Research Center JSC

location_facility: Clinical Center of Cardiac Surgery and Transplantation

location_facility: Clinique Général et Cardiovasculaire de Tunis_Dr. Saloua Trabelsi

location_facility: Nottingham University Hospitals - Queen's Medical Centre

location_facility: Medical University Clinic West Kazakhstan

location_facility: Instituto Cardiovascular de Buenos Aires

location_facility: Strazhesko Institute of Cardiology (National Scientific Centre)

location_facility: City General Hospital 8th September Skopje

location_facility: Dr. Wahidin Sudirohusodo General Hospital

lead_sponsor_type: industriel

status_simplified: Unknown


title: A Phase III Randomized, Open-label Study Comparing GSK1120212 to Chemotherapy in Subjects With Advanced or Metastatic BRAF V600E/K Mutation-positive Melanoma

summary: This is a two-arm, open-label, randomized Phase III study comparing single agent GSK1120212 to chemotherapy (either dacarbazine or paclitaxel) in subjects with Stage IIIc or Stage IV malignant cutaneous melanoma. All subjects must have a BRAF mutation-positive tumour sample. Subjects who have received up to one prior regimen of chemotherapy in the advanced or metastatic melanoma setting will be enrolled into the study. Subjects with any prior BRAF or MEK inhibitor use will be excluded. Approximately 297 subjects will be enrolled with 2:1 randomization (198 subjects into the GSK1120212 arm and 99 subjects into the chemotherapy arm). The primary endpoint for the statistical analysis will be a comparison of progression free survival for subjects receiving GSK1120212 compared to chemotherapy. Subjects who have progression on chemotherapy will be offered the option to receive GSK1120212.

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: KT Flaherty, C Robert, P Hersey, P Nathan, C Garbe, M Milhem, L Demidov, J Hassel, P Rutkowski, P Mohr, R Dummer, U Trefzer, JMG Larkin, J Utikal, B Dreno, M Nyakas, MR Middleton, JC Becker, M Casey, LJ Sherman, FS Wu, D Ouellet, AM Martin, K Patel, & D S. MEK inhibition improves survival in Melanoma with activating BRAF Mutations. [N Engl J Med]. 2012;367:107-14.

ReferenceType: result

ReferenceCitation: Flaherty KT, Robert C, Hersey P, Nathan P, Garbe C, Milhem M, Demidov LV, Hassel JC, Rutkowski P, Mohr P, Dummer R, Trefzer U, Larkin JM, Utikal J, Dreno B, Nyakas M, Middleton MR, Becker JC, Casey M, Sherman LJ, Wu FS, Ouellet D, Martin AM, Patel K, Schadendorf D; METRIC Study Group. Improved survival with MEK inhibition in BRAF-mutated melanoma. N Engl J Med. 2012 Jul 12;367(2):107-14. doi: 10.1056/NEJMoa1203421. Epub 2012 Jun 4.

ReferenceCitation: Robert C, Flaherty K, Nathan P, Hersey P, Garbe C, Milhem M, Demidov L, Mohr P, Hassel JC, Rutkowski P, Dummer R, Utikal J, Kiecker F, Larkin J, D'Amelio A Jr, Mookerjee B, Schadendorf D. Five-year outcomes from a phase 3 METRIC study in patients with BRAF V600 E/K-mutant advanced or metastatic melanoma. Eur J Cancer. 2019 Mar;109:61-69. doi: 10.1016/j.ejca.2018.12.015. Epub 2019 Jan 25.

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 - Diderot

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - UFC - Université de Franche-Comté

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

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

repositories_concat: HAL

publisher_dissemination: Elsevier

ReferenceCitation: Latimer NR, Bell H, Abrams KR, Amonkar MM, Casey M. Adjusting for treatment switching in the METRIC study shows further improved overall survival with trametinib compared with chemotherapy. Cancer Med. 2016 May;5(5):806-15. doi: 10.1002/cam4.643. Epub 2016 Jan 27.

oa_colors: green gold

evidence: oa journal (via doaj)

repository_institution: University of Illinois at Chicago - INDIGO

repository_institution: University of Leicester - Leicester Research Archive

unpaywall_oa_status: gold

ReferenceCitation: Santiago-Walker A, Gagnon R, Mazumdar J, Casey M, Long GV, Schadendorf D, Flaherty K, Kefford R, Hauschild A, Hwu P, Haney P, O'Hagan A, Carver J, Goodman V, Legos J, Martin AM. Correlation of BRAF Mutation Status in Circulating-Free DNA and Tumor and Association with Clinical Outcome across Four BRAFi and MEKi Clinical Trials. Clin Cancer Res. 2016 Feb 1;22(3):567-74. doi: 10.1158/1078-0432.CCR-15-0321. Epub 2015 Oct 7.

oa_host_type: repository

evidence: oa repository (via page says license)

version: submittedVersion

publisher_dissemination: American Association for Cancer Research

ReferenceCitation: Schadendorf D, Amonkar MM, Milhem M, Grotzinger K, Demidov LV, Rutkowski P, Garbe C, Dummer R, Hassel JC, Wolter P, Mohr P, Trefzer U, Lefeuvre-Plesse C, Rutten A, Steven N, Ullenhag G, Sherman L, Wu FS, Patel K, Casey M, Robert C. Functional and symptom impact of trametinib versus chemotherapy in BRAF V600E advanced or metastatic melanoma: quality-of-life analyses of the METRIC study. Ann Oncol. 2014 Mar;25(3):700-706. doi: 10.1093/annonc/mdt580. Epub 2014 Feb 6.

repository_institution: University of Zurich - Zurich Open Repository and Archive

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Czechia
Canada
France
Switzerland
United States
Ukraine
Belgium
Italy
Norway
United Kingdom
Austria
Greece
Russian Federation
Sweden


title: A Phase III, 52 Week, Randomized, Double-blind, 3-arm Parallel Group Study, Comparing the Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination FF/UMEC/VI With the Fixed Dose Dual Combinations of FF/VI and UMEC/VI, All Administered Once-daily in the Morning Via a Dry Powder Inhaler in Subjects With Chronic Obstructive Pulmonary Disease

summary: The study evaluates the efficacy of fluticasone furoate/umeclidinium bromide/vilanterol (FF/UMEC/VI) to reduce the annual rate of moderate and severe exacerbations compared with dual therapy of FF/VI or UMEC/VI in subjects with COPD. Published studies which assessed the use of an 'open' triple therapy (use of Inhaled Corticosteroid [ICS]/ Long-acting Muscarinic Receptor Antagonists [LAMA])/ Long Acting Beta-Agonist [LABA] delivered via multiple inhalers) in moderate-severe COPD patients, reported improvements in lung function, Health Related Quality of Life (HRQoL), hospitalization rates and rescue medication use, compared to dual therapy (ICS/LABA) or LAMA alone. These studies have also shown similar safety profile with dual or monotherapy doses for periods of up to one year. Given the clinical experience with FF, UMEC and VI, and that the associated risks with these compounds are anticipated from their known pharmacology, the potential benefit of a new therapy option in patients with moderate to severe COPD supports the further development of the closed triple combination (delivered via one inhaler). In the current study subjects meeting all inclusion/exclusion criteria will complete 2-week run-in period; 52 week treatment period and a 1-week safety follow-up period. Eligible subjects will be randomized to one of the following double-blind treatment groups FF/UMEC/VI 100 micrograms (mcg)/62.5 mcg/25 mcg once daily (QD), FF/VI 100 mcg/25 mcg QD, or UMEC/VI 62.5 mcg/25 mcg QD

ReferenceCitation: Dransfield MT, Criner GJ, Halpin DMG, Han MK, Hartley B, Kalhan R, Lange P, Lipson DA, Martinez FJ, Midwinter D, Singh D, Wise R, Kunisaki KM. Time-Dependent Risk of Cardiovascular Events Following an Exacerbation in Patients With Chronic Obstructive Pulmonary Disease: Post Hoc Analysis From the IMPACT Trial. J Am Heart Assoc. 2022 Sep 20;11(18):e024350. doi: 10.1161/JAHA.121.024350. Epub 2022 Sep 14.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: University of Exeter - Open Research Exeter

repositories_concat: PubMed Central;ore.exeter.ac.uk

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Thomashow B, Stiegler M, Criner GJ, Dransfield MT, Halpin DMG, Han MK, Lange P, Martinez FJ, Midwinter D, Singh D, Tabberer M, Wise RA, Lipson DA, Jones P. Higher COPD Assessment Test Score Associated With Greater Exacerbations Risk: A Post Hoc Analysis of the IMPACT Trial. Chronic Obstr Pulm Dis. 2022 Jan 27;9(1):68-79. doi: 10.15326/jcopdf.2021.0259.

evidence: open (via free pdf)

repositories_concat: PubMed Central

publisher_dissemination: COPD Foundation

ReferenceCitation: Bafadhel M, Barnes N, Bourke SC, Compton C, Criner GJ, Dransfield MT, Halpin DMG, Han MK, Hartley B, Jones CE, Lange P, Lettis S, Lipson DA, Lomas DA, Martin N, Martinez FJ, Wise R, Singh D. A single blood eosinophil count measurement is as good as two for prediction of ICS treatment response in the IMPACT trial. Eur Respir J. 2021 Sep 23;58(3):2004522. doi: 10.1183/13993003.04522-2020. Print 2021 Sep. No abstract available.

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories_concat: UCL Discovery

publisher_dissemination: European Respiratory Society

ReferenceCitation: Singh D, Criner GJ, Dransfield MT, Halpin DMG, Han MK, Lange P, Lettis S, Lipson DA, Mannino D, Martin N, Martinez FJ, Miller BE, Wise R, Zhu CQ, Lomas D. InforMing the PAthway of COPD Treatment (IMPACT) trial: fibrinogen levels predict risk of moderate or severe exacerbations. Respir Res. 2021 Apr 28;22(1):130. doi: 10.1186/s12931-021-01706-y.

repository_institution: University of Kentucky - UKnowledge

repositories:
PubMed Central
UCL Discovery
uknowledge.uky.edu

ReferenceCitation: Halpin DMG, Criner GJ, Dransfield MT, Han MK, Hartley B, Harvey C, Jones CE, Kato M, Lange P, Lettis S, Lomas DA, Martinez FJ, Martin N, Singh D, Wise R, Zheng J, Lipson DA. Triple Versus Dual Combination Therapy in Chronic Obstructive Pulmonary Disease in Asian Countries: Analysis of the IMPACT Trial. Pulm Ther. 2021 Jun;7(1):101-118. doi: 10.1007/s41030-020-00136-3. Epub 2020 Nov 17.

repositories:
PubMed Central
UCL Discovery
deepblue.lib.umich.edu

ReferenceCitation: Bourdin A, Criner G, Devouassoux G, Dransfield M, Halpin DMG, Han MK, Jones CE, Kalhan R, Lange P, Lettis S, Lipson DA, Lomas DA, Echave-Sustaeta Maria-Tome JM, Martin N, Martinez FJ, Quasny H, Sail L, Siler TM, Singh D, Thomashow B, Watz H, Wise R, Hanania NA. InforMing the PAthway of COPD Treatment (IMPACT Trial) Single-Inhaler Triple Therapy (Fluticasone Furoate/Umeclidinium/Vilanterol) Versus Fluticasone Furoate/Vilanterol and Umeclidinium/Vilanterol in Patients With COPD: Analysis of the Western Europe and North America Regions. Chronic Obstr Pulm Dis. 2021 Jan;8(1):76-90. doi: 10.15326/jcopdf.2020.0158.

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

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

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

ReferenceCitation: Zheng J, Zhong N, Wang C, Wei LP, Zhou XD, Zhao L, Dong Yuan Y, He B, Wu B, Du X, Song J, Lipson DA. Single inhaler triple therapy (FF/UMEC/VI) versus FF/VI and UMEC/VI in patients with COPD: subgroup analysis of the China cohort in the IMPACT trial. Curr Med Res Opin. 2021 Jan;37(1):145-155. doi: 10.1080/03007995.2020.1844646. Epub 2020 Dec 7.

ReferenceCitation: Marin JM, Mateos L, Roldan J, Echave-Sustaeta JM, Pascual-Guardia S, Pardo MV, Velasco B, Jones CE, Kilbride S, Lipson DA. Efficacy of FF/UMEC/VI compared with FF/VI and UMEC/VI in patients with COPD: subgroup analysis of the Spain cohort in IMPACT. Ther Adv Respir Dis. 2020 Jan-Dec;14:1753466620963021. doi: 10.1177/1753466620963021.

repository_institution: Universitat Pompeu Fabra - Repositori digital de la UPF

repository_institution: University of Zaragoza Repository - Zaguan

ReferenceCitation: Hanania NA, Mannino DM, Criner GJ, Dransfield MT, Han MK, Jones CE, Kilbride S, Lomas DA, Martin N, Martinez FJ, Singh D, Wise RA, Halpin DMG, Lima R, Lipson DA. Effect of Age on the Efficacy and Safety of Once-Daily Single-Inhaler Triple-Therapy Fluticasone Furoate/Umeclidinium/Vilanterol in Patients With COPD: A Post Hoc Analysis of the Informing the Pathway of COPD Treatment Trial. Chest. 2021 Mar;159(3):985-995. doi: 10.1016/j.chest.2020.09.253. Epub 2020 Oct 5.

ReferenceCitation: Tabberer M, Jones CE, Kilbride S, Halpin DMG, Lomas DA, Pascoe S, Singh D, Wise RA, Criner GJ, Lange P, Dransfield MT, Han MK, Martinez FJ, Kaisermann MC, Lipson DA. Single-Inhaler Triple Therapy and Health-Related Quality of Life in COPD: The IMPACT Study. Adv Ther. 2020 Sep;37(9):3775-3790. doi: 10.1007/s12325-020-01409-8. Epub 2020 Jul 9. Erratum In: Adv Ther. 2022 Mar;39(3):1446.

ReferenceCitation: Han MK, Criner GJ, Dransfield MT, Halpin DMG, Jones CE, Kilbride S, Lange P, Lettis S, Lipson DA, Lomas DA, Martin N, Wise RA, Singh D, Martinez FJ. The Effect of Inhaled Corticosteroid Withdrawal and Baseline Inhaled Treatment on Exacerbations in the IMPACT Study. A Randomized, Double-Blind, Multicenter Clinical Trial. Am J Respir Crit Care Med. 2020 Nov 1;202(9):1237-1243. doi: 10.1164/rccm.201912-2478OC.

ReferenceCitation: Day NC, Kumar S, Criner G, Dransfield M, Halpin DMG, Han MK, Jones CE, Kaisermann MC, Kilbride S, Lange P, Lomas DA, Martin N, Martinez FJ, Singh D, Wise R, Lipson DA. Single-inhaler triple therapy fluticasone furoate/umeclidinium/vilanterol versus fluticasone furoate/vilanterol and umeclidinium/vilanterol in patients with COPD: results on cardiovascular safety from the IMPACT trial. Respir Res. 2020 Jun 5;21(1):139. doi: 10.1186/s12931-020-01398-w.

repository_institution: University of Copenhagen - Research at the University of Copenhagen

repositories:
PubMed Central
Pure (Denmark)
UCL Discovery
deepblue.lib.umich.edu

repositories_concat: PubMed Central;Pure (Denmark);UCL Discovery;deepblue.lib.umich.edu

ReferenceCitation: Bogart MR, Hopson SD, Shih HC, Stanford RH, Coutinho AD. COPD exacerbation costs in the IMPACT study: a within-trial analysis. Am J Manag Care. 2020 May 1;26(5):e150-e154. doi: 10.37765/ajmc.2020.43157.

publisher_dissemination: Managed Care and Healthcare Communications, LLC

ReferenceCitation: Halpin DMG, Dransfield MT, Han MK, Jones CE, Kilbride S, Lange P, Lipson DA, Lomas DA, Martinez FJ, Pascoe S, Singh D, Wise R, Criner GJ. The effect of exacerbation history on outcomes in the IMPACT trial. Eur Respir J. 2020 May 21;55(5):1901921. doi: 10.1183/13993003.01921-2019. Print 2020 May. Erratum In: Eur Respir J. 2020 Jun 18;55(6):

ReferenceCitation: Lipson DA, Crim C, Criner GJ, Day NC, Dransfield MT, Halpin DMG, Han MK, Jones CE, Kilbride S, Lange P, Lomas DA, Lettis S, Manchester P, Martin N, Midwinter D, Morris A, Pascoe SJ, Singh D, Wise RA, Martinez FJ. Reduction in All-Cause Mortality with Fluticasone Furoate/Umeclidinium/Vilanterol in Patients with Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2020 Jun 15;201(12):1508-1516. doi: 10.1164/rccm.201911-2207OC.

ReferenceCitation: Ismaila AS, Risebrough N, Schroeder M, Shah D, Martin A, Goodall EC, Ndirangu K, Criner G, Dransfield M, Halpin DM, Han MK, Lomas DA. Cost-Effectiveness Of Once-Daily Single-Inhaler Triple Therapy In COPD: The IMPACT Trial. Int J Chron Obstruct Pulmon Dis. 2019 Nov 29;14:2681-2695. doi: 10.2147/COPD.S216072. eCollection 2019.

repository_institution: Royal Devon and Exeter - Royal Devon and Exeter Research Repository

ReferenceCitation: Mehta R, Farrell C, Hayes S, Birk R, Okour M, Lipson DA. Population Pharmacokinetic Analysis of Fluticasone Furoate/Umeclidinium Bromide/Vilanterol in Patients with Chronic Obstructive Pulmonary Disease. Clin Pharmacokinet. 2020 Jan;59(1):67-79. doi: 10.1007/s40262-019-00794-w.

ReferenceCitation: Pascoe S, Barnes N, Brusselle G, Compton C, Criner GJ, Dransfield MT, Halpin DMG, Han MK, Hartley B, Lange P, Lettis S, Lipson DA, Lomas DA, Martinez FJ, Papi A, Roche N, van der Valk RJP, Wise R, Singh D. Blood eosinophils and treatment response with triple and dual combination therapy in chronic obstructive pulmonary disease: analysis of the IMPACT trial. Lancet Respir Med. 2019 Sep;7(9):745-756. doi: 10.1016/S2213-2600(19)30190-0. Epub 2019 Jul 4. Erratum In: Lancet Respir Med. 2021 Dec;9(12):e114.

ReferenceCitation: Lipson DA, Barnhart F, Brealey N, Brooks J, Criner GJ, Day NC, Dransfield MT, Halpin DMG, Han MK, Jones CE, Kilbride S, Lange P, Lomas DA, Martinez FJ, Singh D, Tabberer M, Wise RA, Pascoe SJ; IMPACT Investigators. Once-Daily Single-Inhaler Triple versus Dual Therapy in Patients with COPD. N Engl J Med. 2018 May 3;378(18):1671-1680. doi: 10.1056/NEJMoa1713901. Epub 2018 Apr 18.

repository_institution: The University of Manchester - Research Explorer

ReferenceCitation: Pascoe SJ, Lipson DA, Locantore N, Barnacle H, Brealey N, Mohindra R, Dransfield MT, Pavord I, Barnes N. A phase III randomised controlled trial of single-dose triple therapy in COPD: the IMPACT protocol. Eur Respir J. 2016 Aug;48(2):320-30. doi: 10.1183/13993003.02165-2015. Epub 2016 Jul 13.

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

location_country:
Finland
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Japan
Thailand
Vietnam
Turkey
Chile
Czechia
Canada
France
Colombia
Hong Kong
Denmark
United States
Ukraine
Romania
Belgium
China
Peru
Puerto Rico
Philippines
Norway
Singapore
United Kingdom
Sweden
Netherlands
Austria
Korea, Republic of
Spain
South Africa
Russian Federation
Israel


type: EudraCT Number

type: Other Grant/Funding Number

type: Registry Identifier

title: A Randomised, Open-label Phase III Trial Evaluating the Addition of Denosumab to Standard First-line Anticancer Treatment in Advanced NSCLC

acronym: SPLENDOUR

summary: The purpose of this study is to investigate how well the standard treatment (platinum-based doublet chemotherapy) in combination with denosumab works compared with the standard treatment alone in patients with a type of lung cancer called "non small cell lung cancer" (NSCLC) that has spread to other parts of the body.

ReferenceCitation: Rosen LS, Gordon D, Tchekmedyian NS, Yanagihara R, Hirsh V, Krzakowski M, Pawlicki M, De Souza P, Zheng M, Urbanowitz G, Reitsma D, Seaman J. Long-term efficacy and safety of zoledronic acid in the treatment of skeletal metastases in patients with nonsmall cell lung carcinoma and other solid tumors: a randomized, Phase III, double-blind, placebo-controlled trial. Cancer. 2004 Jun 15;100(12):2613-21. doi: 10.1002/cncr.20308.

ReferenceCitation: Tsuya A, Kurata T, Tamura K, Fukuoka M. Skeletal metastases in non-small cell lung cancer: a retrospective study. Lung Cancer. 2007 Aug;57(2):229-32. doi: 10.1016/j.lungcan.2007.03.013. Epub 2007 Apr 23.

ReferenceCitation: Henry DH, Costa L, Goldwasser F, Hirsh V, Hungria V, Prausova J, Scagliotti GV, Sleeboom H, Spencer A, Vadhan-Raj S, von Moos R, Willenbacher W, Woll PJ, Wang J, Jiang Q, Jun S, Dansey R, Yeh H. Randomized, double-blind study of denosumab versus zoledronic acid in the treatment of bone metastases in patients with advanced cancer (excluding breast and prostate cancer) or multiple myeloma. J Clin Oncol. 2011 Mar 20;29(9):1125-32. doi: 10.1200/JCO.2010.31.3304. Epub 2011 Feb 22.

ReferenceCitation: Tan W, Zhang W, Strasner A, Grivennikov S, Cheng JQ, Hoffman RM, Karin M. Tumour-infiltrating regulatory T cells stimulate mammary cancer metastasis through RANKL-RANK signalling. Nature. 2011 Feb 24;470(7335):548-53. doi: 10.1038/nature09707. Epub 2011 Feb 16.

ReferenceCitation: Scagliotti GV, Hirsh V, Siena S, Henry DH, Woll PJ, Manegold C, Solal-Celigny P, Rodriguez G, Krzakowski M, Mehta ND, Lipton L, Garcia-Saenz JA, Pereira JR, Prabhash K, Ciuleanu TE, Kanarev V, Wang H, Balakumaran A, Jacobs I. Overall survival improvement in patients with lung cancer and bone metastases treated with denosumab versus zoledronic acid: subgroup analysis from a randomized phase 3 study. J Thorac Oncol. 2012 Dec;7(12):1823-1829. doi: 10.1097/JTO.0b013e31826aec2b.

ipd_sharing: No

lead_sponsor: ETOP IBCSG Partners Foundation

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

location_country:
Germany
Ireland
Italy
Poland
Slovenia
United Kingdom
Switzerland
Austria
Belgium
Spain
France

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Centre Hospitalier Intercommunal Creteil

location_facility: Centre Hospitalier Regional De La Citadelle

location_facility: Centre hospitalier universitaire d'Angers

location_facility: Institut Català d'Oncologia - L'Hospitalet

location_facility: IRCCS Azienda Ospedaliera Universitaria San Martino

location_facility: Hôpitale de la Cavale Blanche - CHRU de BREST

location_facility: Assistance Publique-Hôitaux de Marseille

location_facility: ASKLEPIOS - Fachkliniken München - Gauting

status_simplified: Completed


type: Other Identifier

title: Efficacy and Safety of Semaglutide Once Weekly Versus Insulin Glargine Once Daily as Add on to Metformin With or Without Sulphonylurea in Insulin-naïve Subjects With Type 2 Diabetes

acronym: SUSTAIN™ 4

summary: This trial is conducted in Africa, North and South America, Asia and Europe. The purpose of the trial is to compare the effect of once-weekly dosing of two dose levels of semaglutide versus insulin glargine once-daily on glycaemic control after 30 weeks of treatment in insulin-naïve subjects with type 2 diabetes.

ReferenceCitation: Rodbard HW, Bellary S, Hramiak I, Seino Y, Silver R, Damgaard LH, Nayak G, Zacho J, Aroda VR. GREATER COMBINED REDUCTIONS IN HbA1C >/=1.0% AND WEIGHT >/=5.0% WITH SEMAGLUTIDE VERSUS COMPARATORS IN TYPE 2 DIABETES. Endocr Pract. 2019 Jun;25(6):589-597. doi: 10.4158/EP-2018-0444. Epub 2019 Mar 13.

ReferenceCitation: Aroda VR, Bain SC, Cariou B, Piletic M, Rose L, Axelsen M, Rowe E, DeVries JH. Efficacy and safety of once-weekly semaglutide versus once-daily insulin glargine as add-on to metformin (with or without sulfonylureas) in insulin-naive patients with type 2 diabetes (SUSTAIN 4): a randomised, open-label, parallel-group, multicentre, multinational, phase 3a trial. Lancet Diabetes Endocrinol. 2017 May;5(5):355-366. doi: 10.1016/S2213-8587(17)30085-2. Epub 2017 Mar 23.

repository_institution: Swansea University - Cronfa

unpaywall_oa_status: green

ReferenceCitation: Kapitza C, Dahl K, Jacobsen JB, Axelsen MB, Flint A. Effects of semaglutide on beta cell function and glycaemic control in participants with type 2 diabetes: a randomised, double-blind, placebo-controlled trial. Diabetologia. 2017 Aug;60(8):1390-1399. doi: 10.1007/s00125-017-4289-0. Epub 2017 May 19.

repository_institution: PubMed Central - Europe PMC

ReferenceCitation: Warren M, Chaykin L, Trachtenbarg D, Nayak G, Wijayasinghe N, Cariou B. Semaglutide as a therapeutic option for elderly patients with type 2 diabetes: Pooled analysis of the SUSTAIN 1-5 trials. Diabetes Obes Metab. 2018 Sep;20(9):2291-2297. doi: 10.1111/dom.13331. Epub 2018 Jun 7.

ReferenceCitation: Ahren B, Atkin SL, Charpentier G, Warren ML, Wilding JPH, Birch S, Holst AG, Leiter LA. Semaglutide induces weight loss in subjects with type 2 diabetes regardless of baseline BMI or gastrointestinal adverse events in the SUSTAIN 1 to 5 trials. Diabetes Obes Metab. 2018 Sep;20(9):2210-2219. doi: 10.1111/dom.13353. Epub 2018 Jun 12.

ReferenceCitation: DeVries JH, Desouza C, Bellary S, Unger J, Hansen OKH, Zacho J, Woo V. Achieving glycaemic control without weight gain, hypoglycaemia, or gastrointestinal adverse events in type 2 diabetes in the SUSTAIN clinical trial programme. Diabetes Obes Metab. 2018 Oct;20(10):2426-2434. doi: 10.1111/dom.13396. Epub 2018 Jul 9.

repository_institution: Aston University - Aston Publications Explorer

ReferenceCitation: Aroda VR, Ahmann A, Cariou B, Chow F, Davies MJ, Jodar E, Mehta R, Woo V, Lingvay I. Comparative efficacy, safety, and cardiovascular outcomes with once-weekly subcutaneous semaglutide in the treatment of type 2 diabetes: Insights from the SUSTAIN 1-7 trials. Diabetes Metab. 2019 Oct;45(5):409-418. doi: 10.1016/j.diabet.2018.12.001. Epub 2019 Jan 4.

repository_institution: La Trobe University - OPAL (Open@LaTrobe)

repositories_institution: University of Leicester - Leicester Research Archive

ReferenceCitation: Husain M, Bain SC, Holst AG, Mark T, Rasmussen S, Lingvay I. Effects of semaglutide on risk of cardiovascular events across a continuum of cardiovascular risk: combined post hoc analysis of the SUSTAIN and PIONEER trials. Cardiovasc Diabetol. 2020 Sep 30;19(1):156. doi: 10.1186/s12933-020-01106-4.

repositories:
PubMed Central
cronfa.swan.ac.uk
localhost

repositories_institution:
Swansea University - Cronfa
University of Toronto - TSpace

ReferenceCitation: Capehorn M, Ghani Y, Hindsberger C, Johansen P, Jodar E. Once-Weekly Semaglutide Reduces HbA1c and Body Weight in Patients with Type 2 Diabetes Regardless of Background Common OAD: a Subgroup Analysis from SUSTAIN 2-4 and 10. Diabetes Ther. 2020 May;11(5):1061-1075. doi: 10.1007/s13300-020-00796-z. Epub 2020 Mar 19.

ReferenceCitation: Husain M, Bain SC, Jeppesen OK, Lingvay I, Sorrig R, Treppendahl MB, Vilsboll T. Semaglutide (SUSTAIN and PIONEER) reduces cardiovascular events in type 2 diabetes across varying cardiovascular risk. Diabetes Obes Metab. 2020 Mar;22(3):442-451. doi: 10.1111/dom.13955. Epub 2020 Feb 5.

repositories_institution:
PubMed Central - Europe PMC
Swansea University - Cronfa

ReferenceCitation: DeSouza C, Cariou B, Garg S, Lausvig N, Navarria A, Fonseca V. Efficacy and Safety of Semaglutide for Type 2 Diabetes by Race and Ethnicity: A Post Hoc Analysis of the SUSTAIN Trials. J Clin Endocrinol Metab. 2020 Feb 1;105(2):dgz072. doi: 10.1210/clinem/dgz072.

repository_institution: CERN European Organization for Nuclear Research - Zenodo

ReferenceCitation: Jendle J, Birkenfeld AL, Polonsky WH, Silver R, Uusinarkaus K, Hansen T, Hakan-Bloch J, Tadayon S, Davies MJ. Improved treatment satisfaction in patients with type 2 diabetes treated with once-weekly semaglutide in the SUSTAIN trials. Diabetes Obes Metab. 2019 Oct;21(10):2315-2326. doi: 10.1111/dom.13816. Epub 2019 Jul 12.

location_country:
Germany
Slovenia
North Macedonia
India
Slovakia
United Kingdom
Argentina
Romania
Netherlands
Mexico
United States
South Africa
Croatia
Puerto Rico
France


title: A Phase III Multicenter, International, Randomized, Double-blind, Placebo-controlled Study of Doxorubicin Plus Palifosfamide-tris vs. Doxorubicin Plus Placebo in Patients With Front-line Metastatic Soft Tissue Sarcoma.

acronym: PICASSO III

summary: This is an international, randomized, double-blind, placebo-controlled trial to evaluate the clinical efficacy of palifosfamide-tris administered with doxorubicin in combination, compared with doxorubicin administered with placebo in front-line patients diagnosed with metastatic soft tissue sarcoma (STS).

ReferenceCitation: Ryan CW, Merimsky O, Agulnik M, Blay JY, Schuetze SM, Van Tine BA, Jones RL, Elias AD, Choy E, Alcindor T, Keedy VL, Reed DR, Taub RN, Italiano A, Garcia Del Muro X, Judson IR, Buck JY, Lebel F, Lewis JJ, Maki RG, Schoffski P. PICASSO III: A Phase III, Placebo-Controlled Study of Doxorubicin With or Without Palifosfamide in Patients With Metastatic Soft Tissue Sarcoma. J Clin Oncol. 2016 Nov 10;34(32):3898-3905. doi: 10.1200/JCO.2016.67.6684. Epub 2016 Sep 30.

oa_host_type: closed

publisher_dissemination: American Society of Clinical Oncology (ASCO)

lead_sponsor: Alaunos Therapeutics

location_country:
Germany
Poland
Argentina
Australia
Brazil
Chile
Canada
France
Colombia
United States
India
Romania
Belgium
Italy
Guatemala
United Kingdom
Singapore
Spain
Panama
Russian Federation
Israel

location_facility: University of Washington/Seattle Cancer Care Alliance

location_facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre

location_facility: Institution name: Hospital de Câncer de Barretos - Fundação PIOXII

location_facility: University of Arkansas for Medical Sciences

location_facility: The Ohio State University Medical Center

location_facility: Washington University School of Medicine

location_facility: The Royal Marsden NHS Foundation Trust Sarcoma

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


lead_sponsor: Boehringer Ingelheim

summary: This study will investigate the efficacy and safety of the BI 10773 in type 2 diabetic patients with renal impairment in order to provide these data for approval for BI 10773 as an antidiabetic agent by regulatory authorities.

ReferenceCitation: Tuttle KR, Levin A, Nangaku M, Kadowaki T, Agarwal R, Hauske SJ, Elsasser A, Ritter I, Steubl D, Wanner C, Wheeler DC. Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. Diabetes Care. 2022 Jun 2;45(6):1445-1452. doi: 10.2337/dc21-2034.

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

repository_institution: University of Illinois at Chicago - INDIGO

repositories_institution: University College London - UCL Discovery

repositories_institution: University of Illinois at Chicago - INDIGO

publisher_dissemination: American Diabetes Association

ReferenceCitation: Cherney D, Lund SS, Perkins BA, Groop PH, Cooper ME, Kaspers S, Pfarr E, Woerle HJ, von Eynatten M. The effect of sodium glucose cotransporter 2 inhibition with empagliflozin on microalbuminuria and macroalbuminuria in patients with type 2 diabetes. Diabetologia. 2016 Sep;59(9):1860-70. doi: 10.1007/s00125-016-4008-2. Epub 2016 Jun 17.

ReferenceCitation: Barnett AH, Mithal A, Manassie J, Jones R, Rattunde H, Woerle HJ, Broedl UC; EMPA-REG RENAL trial investigators. Efficacy and safety of empagliflozin added to existing antidiabetes treatment in patients with type 2 diabetes and chronic kidney disease: a randomised, double-blind, placebo-controlled trial. Lancet Diabetes Endocrinol. 2014 May;2(5):369-84. doi: 10.1016/S2213-8587(13)70208-0. Epub 2014 Jan 24.

sponsor_collaborators:
Boehringer Ingelheim
Eli Lilly and Company

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location_facility: 1245.36.44023 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.63009 Boehringer Ingelheim Investigational Site

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location_facility: 1245.36.35004 Boehringer Ingelheim Investigational Site

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location_facility: 1245.36.10013 Boehringer Ingelheim Investigational Site

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location_facility: 1245.36.63008 Boehringer Ingelheim Investigational Site

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location_facility: 1245.36.31012 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.91205 Boehringer Ingelheim Investigational Site

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location_facility: 1245.36.10005 Boehringer Ingelheim Investigational Site

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location_facility: 1245.36.74012 Boehringer Ingelheim Investigational Site

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location_facility: 1245.36.91207 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.91213 Boehringer Ingelheim Investigational Site

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location_facility: 1245.36.48001 Boehringer Ingelheim Investigational Site

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location_facility: 1245.36.48004 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.63010 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.10017 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.10008 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.33001 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.33040 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.74013 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.48007 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.33038 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.63007 Boehringer Ingelheim Investigational Site

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location_facility: 1245.36.60001 Boehringer Ingelheim Investigational Site

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location_facility: 1245.36.44013 Boehringer Ingelheim Investigational Site

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location_facility: 1245.36.35001 Boehringer Ingelheim Investigational Site

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location_facility: 1245.36.33041 Boehringer Ingelheim Investigational Site

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title: A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group, Efficacy and Safety Study of BI 10773 (10 mg and 25 mg Administered Once Daily) as Add on to Pre-existing Antidiabetic Therapy Over 52 Weeks in Patients With Type 2 Diabetes Mellitus and Renal Impairment and Insufficient Glycaemic Control

source: euctr

location_country:
Poland
Russian Federation
India
Portugal
Slovakia
United Kingdom
Hong Kong
Netherlands
United States
Spain
Malaysia
South Africa
Canada
Philippines
France


title: Phase 3, Randomized, Open-label Study Of The Efficacy And Safety Of Crizotinib Versus Pemetrexed/Cisplatin Or Pemetrexed/Carboplatin In Previously Untreated Patients With Non-squamous Carcinoma Of The Lung Harboring A Translocation Or Inversion Event Involving The Anaplastic Lymphoma Kinase (Alk) Gene Locus.

acronym: PROFILE 1014

summary: This study will evaluate the anti-cancer effects of crizotinib when compared with standard chemotherapy in patients with ALK positive lung cancer.

ReferenceCitation: Camidge DR, Kim EE, Usari T, Polli A, Lewis I, Wilner KD. Renal Effects of Crizotinib in Patients With ALK-Positive Advanced NSCLC. J Thorac Oncol. 2019 Jun;14(6):1077-1085. doi: 10.1016/j.jtho.2019.02.015. Epub 2019 Feb 26.

ReferenceCitation: Wilner KD, Usari T, Polli A, Kim EE. Comparison of cardiovascular effects of crizotinib and chemotherapy in ALK-positive advanced non-small-cell lung cancer. Future Oncol. 2019 Apr;15(10):1097-1103. doi: 10.2217/fon-2018-0869. Epub 2019 Jan 17.

ReferenceCitation: Solomon BJ, Kim DW, Wu YL, Nakagawa K, Mekhail T, Felip E, Cappuzzo F, Paolini J, Usari T, Tang Y, Wilner KD, Blackhall F, Mok TS. Final Overall Survival Analysis From a Study Comparing First-Line Crizotinib Versus Chemotherapy in ALK-Mutation-Positive Non-Small-Cell Lung Cancer. J Clin Oncol. 2018 Aug 1;36(22):2251-2258. doi: 10.1200/JCO.2017.77.4794. Epub 2018 May 16.

ReferenceCitation: Yoneda KY, Scranton JR, Cadogan MA, Tassell V, Nadanaciva S, Wilner KD, Stollenwerk NS. Interstitial Lung Disease Associated With Crizotinib in Patients With Advanced Non-Small Cell Lung Cancer: Independent Review of Four PROFILE Trials. Clin Lung Cancer. 2017 Sep;18(5):472-479. doi: 10.1016/j.cllc.2017.03.004. Epub 2017 Mar 14.

ReferenceCitation: Solomon BJ, Cappuzzo F, Felip E, Blackhall FH, Costa DB, Kim DW, Nakagawa K, Wu YL, Mekhail T, Paolini J, Tursi J, Usari T, Wilner KD, Selaru P, Mok TS. Intracranial Efficacy of Crizotinib Versus Chemotherapy in Patients With Advanced ALK-Positive Non-Small-Cell Lung Cancer: Results From PROFILE 1014. J Clin Oncol. 2016 Aug 20;34(24):2858-65. doi: 10.1200/JCO.2015.63.5888. Epub 2016 Mar 28.

ReferenceCitation: Solomon BJ, Mok T, Kim DW, Wu YL, Nakagawa K, Mekhail T, Felip E, Cappuzzo F, Paolini J, Usari T, Iyer S, Reisman A, Wilner KD, Tursi J, Blackhall F; PROFILE 1014 Investigators. First-line crizotinib versus chemotherapy in ALK-positive lung cancer. N Engl J Med. 2014 Dec 4;371(23):2167-77. doi: 10.1056/NEJMoa1408440. Erratum In: N Engl J Med. 2015 Oct 15;373(16):1582.

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

repository_institution: University of Turin - Institutional Research Information System University of Turin

repository_institution: University of Liège - ORBi - Open Repository and Bibliography of the University of Liège

ReferenceCitation: Ou SH. Crizotinib: a drug that crystallizes a unique molecular subset of non-small-cell lung cancer. Expert Rev Anticancer Ther. 2012 Feb;12(2):151-62. doi: 10.1586/era.11.186.

lead_sponsor: Pfizer

location_country:
Finland
Germany
Ireland
Australia
Brazil
Japan
Luxembourg
Chile
Canada
France
Portugal
Hong Kong
Switzerland
United States
Ukraine
India
Belgium
China
Peru
Italy
Norway
Singapore
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
South Africa
Taiwan
Russian Federation

location_facility: IRCCS -Arcispedale S. Maria Nuova Tecnologie Avanzate e Modelli Assistenziali in Oncologia

location_facility: Centre Hospitalier Universitaire de Liege

location_facility: Samsung Medical Center, Sungkyunkwan Univ. School of Medicine

location_facility: Institut Jules Bordet, Centre des Tumeurs de l'ULB

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

location_facility: Oncology Center, Guangdong General Hospital

location_facility: Centro Hospitalar e Universitario de Coimbra - Hospital Geral

location_facility: Department of Pulmonary Diseases AZ Delta

location_facility: Thoraxklinik am Universitaetsklinikum Heidelberg

location_facility: Oncologia Medica, Azienda Ospedaliero- Universitaria di Parma

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

location_facility: Tata Memorial Centre, Tata Memorial Hospital,

location_facility: Karmanos Cancer Institute at Farmington Hills

location_facility: The Christie Hospital NHS Foundation Trust, Department of Medical Oncology

location_facility: UT Southwestern University Hospital - William P. Clements, Jr.

location_facility: APHM - Hopital Nord / Service d'Oncologie Multidisciplinaire et Innovations Thérapeutiques

location_facility: Istituto Regina Elena, Struttura Complessa Oncologia Medica A

location_facility: UT Southwestern Medical Center - Simmons Cancer Center Pharmacy

location_facility: National Hospital Organization Yamaguchi-Ube Medical Center

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Samara Regional Clinical Oncology Dispensary

location_facility: Clinica Anglo Americana/Centro de Investigacion Oncologia CAA

location_facility: Lynn Cancer Institute Center for Hematology Oncology

location_facility: McGill University Health Centre (MUHC), Glen Site, Cedars Cancer Centre

location_facility: Union Hospital, Tongji Medical College of Huazhong University of Science & Technology/Cancer Center

location_facility: Azienda Ospedaliero-Universitaria "Mater Domini"

location_facility: Hematology-Oncology Associates of Northern New Jersey

location_facility: Ospedale Niguarda Ca'Granda, Divisione Oncologia Medica Falck

location_facility: The Gujarat Cancer & Research Institute (M.P Shah Cancer Hospital),

location_facility: SC Oncologia Medica, Ospedale Santa Maria della Misericordia

location_facility: Institut universitaire de cardiologie et de pneumologie de Quebec (IUCPQ)

location_facility: First Saint-Petersburg State Medical University n.a. I.P. Pavlov

location_facility: UT Southwestern University Hospital - Zale Lipshy

location_facility: Fondazione IRCCS Istituto Nazionale Tumori, Struttura Complessa di Medicina Oncologica 1

location_facility: Universitair Ziekenhuis Gent (U.Z. Gent)

location_facility: Struttura Operativa Complessa Oncologia Medica A Centro di Riferimento Oncologico

location_facility: Unità Operativa di Oncologia Medica Azienda USL Città di Bologna

location_facility: Department of Oncology and Medical Radiology, SI "DMA of MOH, Ukraine

location_facility: Kyiv City Clinical Oncologic Center/Department of Chemotherapy

location_facility: Kanagawa Cardiovascular and Respiratory Center

location_facility: Farmacia Istituto Europeo di Oncologia IRCCS, U.O. Farmacia

location_facility: Unità Operativa di Farmacia - Campus Salvatore venuta

location_facility: Hospital Clinico Universitario Lozano Blesa

location_facility: Russian Scientific Center of Radiology and Surgical Technologies

location_facility: Nouvel Hopital Civil - HSU - Pôle de Pathologie Thoracique - Service de Pneumologie

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Ospedale Civile Azienda USL Toscana Nord Ovest

location_facility: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

location_facility: Loma Linda University Cancer Center (LLUCC)-Schuman Pavilion

location_facility: Universitair Ziekenhuis Brussel / Medische Oncologie

location_facility: Research Pharmacy, Georgetown University Medical Center

location_facility: UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz

location_facility: Russian Oncological Research Center N.N. Blokhin

location_facility: R.S. McLaughlin Durham Regional Cancer Centre

location_facility: Unità Operativa Farmacia Ospedaliera PO di Livorno

location_facility: Lviv State Oncologic Regional Treatment and Diagnostic Center

location_facility: Hospital Universitario Virgen de La Victoria

location_facility: Satakunnan keskussairaala/Keuhkosairauksien osasto A4

location_facility: Hopital Arnaud de Villeneuve / CHU de Montpellier

location_facility: Chang Gung Medical Foundation, Kaohsiung Branch

location_facility: Chang Gung Medical Foundation, LinKou Branch

location_facility: Hospital Clinico Universidad de Chile, Seccion de Oncologia

location_facility: Helsingin yliopistollinen keskussairaala, Meilahden kolmiosairaala,Keuhkosairauksien poliklinikka

location_facility: Azienda Ospedaliera San Camillo Forlanini-Padiglione Flaiani

location_facility: Centro Hospitalar de Lisboa Norte - Hospital Pulido Valente

location_facility: Taichung Veterans General Hospital, Comprehensive Cancer Center

location_facility: Peter MacCallum Cancer Centre, Department of Haematology and Medical Oncology

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Unita Operativa, Oncologia Medica, Istituto di Medicina Interna e Geriatria

location_facility: Grand Hopital de Charleroi -Site Notre Dame

location_facility: Rondebosch Oncology Centre, Rondebosch Medical Centre

location_facility: Department of Clinical Oncology, Queen Elizabeth Hospital

location_facility: Hospital Universitario Insular de Gran Canaria

location_facility: Academisch Ziekenhuis Maastricht / afdeling longziekten en tuberculose

location_facility: Oncology Department, West China Hospital of Sichuan University

location_facility: Shanghai Chest Hospital/Department of Pulmonary Medicine

location_facility: Oslo universitetssykehus HF - Radiumhospitalet

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: Peninsula & South Eastern Haematology and Oncology Group

location_facility: S.C. Farmacia Ospedaliera , Azienda Ospedaliero Universitaria San Luigi Gonzaga

location_facility: City Multiple-Discipline Clinical Hospital #4

location_facility: Washington University Center for Advanced Medicine Infusion Center Pharmacy

location_facility: Kyushu University Hospital Respiratory Medicine

location_facility: Instituto Português de Oncologia de Lisboa, Prof. Francisco Gentil E.P.E.

location_facility: City Multiple-Discipline Clinical Hospital #4,

location_facility: Charite - Universitaetsmedizin Berlin, Campus Mitte

location_facility: NSLIJ Health System/Monter Cancer Center

location_facility: Fundacao Pio XII Hospital de Cancer de Barretos

location_facility: National Hospital organization Kyushu Cancer Center

location_facility: Azienda Ospedaliera Universitaria San Luigi Gonzaga

location_facility: University of Wisconsin Hospital and Clinics

location_facility: Shanghai Pulmonary Hospital/Dept. of Oncology

location_facility: Indiana University Melvin and Bren Simon Cancer Center

location_facility: Mount Vernon Hospital, Mount Vernon Cancer Centre

location_facility: NHS Greater Glasgow and Clyde Health Board, Beatson West of Scotland Cancer Centre,