title: SERENA-4: A Randomised, Multicentre, Double-Blind, Phase III Study of AZD9833 (an Oral SERD) Plus Palbociclib Versus Anastrozole Plus Palbociclib for the Treatment of Patients With Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease

summary:
The study is intended to show superiority of AZD9833 in combination with palbociclib (a CDK4/6 inhibitor) versus anastrozole (an aromatase inhibitor) and palbociclib as the initial treatment of patients with hormone receptor-positive (ER-positive), human epidermal growth factor 2-negative (HER2-negative) advanced/metastatic breast cancer.

INFORMATION FOR TRIAL PARTICIPANTS

In this trial, the researchers will look at how well camizestrant with palbociclib works, compared with anastrozole with palbociclib, in participants with breast cancer that has either spread into other parts of the body at the time of diagnosis, or has come back after at least 2 years of standard endocrine treatment.

Participants in this trial will have breast cancer that has ER proteins but does not have overexpression of HER2 protein.

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
Japan
Turkey
Chile
Czechia
Canada
France
Portugal
Slovakia
Hungary
Switzerland
United States
India
Belgium
China
Malaysia
Italy
Norway
United Kingdom
Austria
Mexico
Korea, Republic of
Spain
Taiwan
Bulgaria
Russian Federation


study_start_date_type: Actual

intervention_type: Drug

lead_sponsor: Daiichi Sankyo, Inc.

summary: This study will evaluate the efficacy, safety, and pharmacokinetics of DS-1062a versus docetaxel in participants with previously treated advanced or metastatic non-small cell lung cancer (NSCLC) with or without actionable genomic alterations.

sponsor_collaborators:
Daiichi Sankyo, Inc.
AstraZeneca

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

location_facility: Stadtspital Waid ; Triemli, Site Triemli - clinic for Medical oncology & hematology

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: The Catholic University of Korea, Seoul St. Marys Hospital

location_facility: Federal State Budgetary Institution - N.N. Blokhin National Medical Research Center of Oncology

location_facility: MUHC-Glen Site and MUHC Research Institute

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: National Cheng Kung University Hospital NCKUH

location_facility: Orszagos Koranyi TBC es Pulmonologiai Intezet

location_facility: Azienda Ospedaliera Universitaria Policlinico G Rodolico San Marco

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: Chang Gung Memorial Hospital CGMH - Kaohsiung Branch

location_facility: The Center for Cancer and Blood Disorders

location_facility: ASL 3 Genovese Oncologia Medica Villa Scassi

location_facility: CHU de Poitier Pole regional de Cancerologie

location_facility: University Hospitals Cleveland Medical Center

location_facility: Maria Sklodowska-Curie National Research Institute of Oncology

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

location_facility: University Hospital of Nantes - Thoracic Oncology

location_facility: Institutul Oncologic Profesor Doctor Alexandru Trestioreanu

location_facility: Memorial Healthcare System- Memorial Cancer Institute

location_facility: Crown Princess Mary Cancer Centre Westmead Hospital

location_facility: Hospital General Universitario de Valencia

location_facility: Chi Mei Medical Center CMMC - Liouying Branch

location_facility: Hospital Puerte de Hierro de Majadahonda

location_facility: Fondazione IRCCS Istituto Nazionale Tumori

location_facility: Saitama Medical University International Medical Center

location_facility: Azienda Ospedaliero-Universitaria San Luigi Gonzaga

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Instituicao de Fisioterapeutas Ocupacionais

location_facility: Oddział Onkologii Wojewódzki Szpital Specjalistyczny Słupsk

location_facility: Hospital Universitario Jose Eleuterio Gonzalez

location_facility: Kursk Regional Clinical Oncology Dispensary

location_facility: The First Affiliated Hospital of Zhejiang University

location_facility: Seoul National University Bundang Hospital

location_facility: Szpital Specjalistyczny w Prabutach Sp. z o.o.

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

location_facility: Harbin Medical University Cancer Hospital

location_facility: Hospital de Base de Sao Jose do Rio Preto

location_facility: University Health Network - Princess Margaret Hospital

location_facility: OncoCare Cancer Centre - Gleneagles Medical Centre Location

location_facility: Ft. Wayne Medical Oncology and Hematology

location_facility: Tianjin Medical University Cancer Institute and Hospital

location_facility: The Oncology Institute of Hope and Innovation

location_facility: Prince of Wales Hospital / The Chinese University of Hong Kong

location_facility: N.N. Petrov Research Institute of Oncology

location_facility: National Taiwan University Hospital NTUH

location_facility: Azienda Ospedaliero- Universitaria Policlinico S. Orsola-Malpighi

location_facility: Hospital Clinico Universitario Lozano Bleza

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

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde

location_facility: Seoul National University Boramae Medical Center

location_facility: St. Vincents Hospital The Catholic University of Korea

location_facility: Yonsei University Health System - Severance Hospital

location_facility: Kyungpook National University Chilgok Hospital

status: Active, not recruiting

title: Phase 3 Randomized Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer (TROPION-LUNG01)

primary_purpose: Treatment

type: EudraCT Number

source: euctr

enrollment_type: Anticipated

ipd_sharing_description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

design_allocation: Randomized

study_completion_date_type: Anticipated

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Czechia
Canada
France
Hungary
Hong Kong
Switzerland
United States
Romania
Belgium
China
Puerto Rico
Italy
United Kingdom
Singapore
Netherlands
Mexico
Korea, Republic of
Spain
Taiwan
Russian Federation

study_type: Interventional

ipd_sharing: Yes

lead_sponsor_type: industriel

status_simplified: Ongoing


lead_sponsor: Constellation Pharmaceuticals

summary: A Phase 3, randomized, blinded study comparing pelabresib (CPI-0610) and ruxolitinib with placebo and ruxolitinib in myelofibrosis (MF) patients that have not been previously treated with Janus kinase inhibitors (JAKi). Pelabresib is a small molecule inhibitor of bromodomain and extra-terminal (BET) proteins.

ReferenceType: derived

ReferenceCitation: Mascarenhas J, Kremyanskaya M, Patriarca A, Harrison C, Bose P, Rampal RK, Palandri F, Devos T, Passamonti F, Hobbs G, Talpaz M, Vannucchi A, Kiladjian JJ, Verstovsek S, Hoffman R, Salama ME, Chen D, Taverna P, Chang A, Colak G, Klein S, Gupta V. MPN-375 BET Inhibitor Pelabresib (CPI-0610) Combined With Ruxolitinib in Patients With Myelofibrosis - JAK Inhibitor-Naie or With Suboptimal Response to Ruxolitinib - Preliminary Data From the MANIFEST Study. Clin Lymphoma Myeloma Leuk. 2022 Oct;22 Suppl 2:S335-S336. doi: 10.1016/S2152-2650(22)01456-2.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

ReferenceCitation: Harrison CN, Gupta VK, Gerds AT, Rampal R, Verstovsek S, Talpaz M, Kiladjian JJ, Mesa R, Kuykendall AT, Vannucchi AM, Palandri F, Grosicki S, Devos T, Jourdan E, Wondergem MJ, Al-Ali HK, Buxhofer-Ausch V, Alvarez-Larran A, Patriarca A, Kremyanskaya M, Mead AJ, Akhani S, Sheikine Y, Colak G, Mascarenhas J. Phase III MANIFEST-2: pelabresib + ruxolitinib vs placebo + ruxolitinib in JAK inhibitor treatment-naive myelofibrosis. Future Oncol. 2022 Sep;18(27):2987-2997. doi: 10.2217/fon-2022-0484. Epub 2022 Aug 11.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

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

host_type: repository

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

version: acceptedVersion

repositories_concat: LIRIAS (KU Leuven)

unpaywall_oa_status: hybrid

publisher_dissemination: Future Science Ltd

location_facility: Franciscan Health/Indiana blood and Marrow Transplantation

location_facility: Universitätsklinikum Jena, Klinik für Innere Medizin II

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Izmir Ege University Faculty of Medicine Hospital

location_facility: Universitätsklinikum Halle (Saale), Krukenberg-Krebszentrum Halle (KKH)

location_facility: Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust

location_facility: Imperial College Healthcare NHS Trust, Hammersmith Hospital

location_facility: Weill Cornell Medical College- New York Presbyterian Hospital

location_facility: Loyola University - Cardinal Bernardin Cancer Center

location_facility: Norton Cancer Institute, St. Matthews Campus

location_facility: Cha Bundang Medical Center Cha University

location_facility: Ospedale di Circolo e Fondazione Macchi - ASST Sette Laghi

location_facility: General Hospital, School of Medicine National and Kapodistrian University of Athens

location_facility: Mays Cancer Center at UT Health San Antonio MD Anderson

location_facility: London Health Sciences Center - Victoria Hospital

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: Gaziantep University Sahinbey Research and Application Center Hospital

location_facility: CHU DE NIMES _Institut de Cancérologie du Gard

location_facility: LKH - Universitätsklinikum Graz; Abteilung für Hämatologie

location_facility: Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Klinika, Hematologia

location_facility: Center for Blood Disorders and Cellular Therapy, Swedish Cancer Institute

location_facility: The Catholic University Of Korea St. Vincent Hospital

location_facility: Wojewódzki Szpital Specjalistyczny w Bialej Podlaskiej

location_facility: Decatur Memorial Hospital Cancer Care Center of Decatur/Cancer Care Specialists of IL

location_facility: Edirne Trakya University Faculty of Medicine Hospital

location_facility: : Pecs University, 1st Department of Medicine

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

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

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Samsun 19 Mayıs University Health Application Research Hospital

location_facility: Universitätsklinikum Hamburg-Eppendorf (UKE), II. Medizinische Klinik und Poliklinik

location_facility: Azienda Ospedaliera San Gerardo di Monza

location_facility: ICO Badalona - Hospital Universitari Germans Trias i Pujol

location_facility: ICO Girona - Hospital Universitari de Girona

location_facility: Hospital Universitario de Gran Canaria Dr. Negrin

location_facility: Rabin Medical Center - Beilinson Campus,

location_facility: Oxford University Hospitals NHS Foundation Trust, Department of Haematology, Cancer and Haematology Centre, Churchill Hospital

location_facility: Daegu Catholic University Medical Center

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Semmelweis University - Internal Medicine and Oncology Clinic

location_facility: Hospital Universitario Central de Asturias

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers

location_facility: Peninsula Private Hospital Clinical Trials Unit

location_facility: Szabolcs Szatmár Bereg Megyei Kórházak és Egyetemi Oktatókórház; Jósa András Oktatókórház, Hematológia

location_facility: Srinagarind hospital,Khon Kaen University

location_facility: Ankara University Faculty of Medicine Cebeci Research and Application Hospital

location_facility: Dr. Abdurrahman Yurtaslan Oncology Health Application and Research Center

location_facility: IRCCS Istituto Romagnolo per lo studio dei tumori "Dino Amadori"

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: Azienda Ospedaliera Universitaria Arcispedale Sant'Anna

location_facility: USC Clinical Trials Centre Sunshine Coast Haematology and Oncology Clinic

title: A Phase 3, Randomized, Double-blind, Active-Control Study of Pelabresib (CPI-0610) and Ruxolitinib vs. Placebo and Ruxolitinib in JAKi Treatment Naive MF Patients

enrollment_type: Actual

location_country:
Germany
Poland
Australia
Thailand
Turkey
Czechia
Canada
France
Hungary
Hong Kong
United States
Belgium
Malaysia
Italy
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Greece
Taiwan
Israel

ipd_sharing: No


acronym: STARSCAPE-OLE

lead_sponsor: Hoffmann-La Roche

summary: This study will evaulate the long-term safety, efficacy and pharmacokinetics (PK) of recombinant human pentraxin-2 (rhPTX-2; PRM-151) zinpentraxin alfa, administered by intravenous (IV) infusion to participants with idiopathic pulmonary fibrosis (IPF).

location_facility: Ben-Gurion University of the Negev - Soroka University Medical Center - Pulmonology Institute

location_facility: Tel Aviv Sourasky Medical Center; Department of Neurology

location_facility: Tianjin Medical University General Hospital

location_facility: The Third Xiangya Hospital Of Central South University

location_facility: Az. Osp. Univ. P. Giaccone; UOC di Pneumologia

location_facility: Evang. Lungenklinik Berlin Klinik für Pneumologie

location_facility: Praxis für Pneumologie Dr. Silke Mronga & Dr. Lukas Jerrentrup

location_facility: Centro Medico de Enfermedades Respiratorias (CEMER)

location_facility: University of Cape Town Lung Institute; Lung Clinical Research

location_facility: Florida Lung, Asthma and Sleep Specialists (FLASS) - Celebration

location_facility: National Hospital Organization Kinki-Chuo Chest Medical Center

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Center Hospital of the National Center for Global Health and Medicine

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

location_facility: Oslo University Hospital HF, Rikshospitalet

location_facility: Jefferson University Physicians (JUP) - Jefferson Pulmonary

location_facility: Marmara Universitesi Hastanesi Marmara University Hospital

location_facility: Tokyo Medical Ando Dentaluni Hospital Faculty of Medicine; Surgical Oncology

location_facility: Akdeniz University Faculty of Medicine Department of Pulmonology

location_facility: Ospedale San Giuseppe; U.O. di Pneumologia

location_facility: Hospital Virgen de las Nieves; Servicio de Neumologia

location_facility: University of Louisville Health Sciences Center

location_facility: General Hospital of Thessaloniki G. Papanikolaou

location_facility: Hospital Ramón y Cajal;Servicio de Neumología

location_facility: Sint Antonius Ziekenhuis, locatie Nieuwegein

location_facility: Policlinico Riuniti di Foggia - Department of Medical and Surgical Sciences - University of Foggia

location_facility: University of Padova Ca' Foncello Hospital Immunologic & Respiratory Rare Diseases Center

location_facility: The Catholic University of Korea Yeouido St. Mary's Hospital; Hematology-Oncology

location_facility: Instituto de Medicina Respiratoria, IMeR; Clinic/Outpatient Facility

location_facility: University Of Utah Hosp & Clin; Investigational Pharmacy

location_facility: Lungenklinik Münnerstadt, Thoraxzentrum Bezirk Unterfranken

location_facility: Florida Pulmonary Research Institute, LLC

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

location_facility: Dokuz Eylul University Faculty of Medicine; Chest Diseases

location_facility: Ege Universitesi Tip Fakultesi Hastanesi

location_facility: Hopital Bichat Claude Bernard; Hepatologie Gastro Enterologie

location_facility: University Hospital of Ioannina; Pulmonology Department

location_facility: Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele

location_facility: Kobe City Medical Center General Hospital

location_facility: Uludag Universitesi - Saglik Uygulama ve Arastirrma Merkezi

location_facility: A.O. Univ. Senese Policlinico S. Maria alle Scotte; Dip. Medicina clinica e Scienze Immunologiche

location_facility: Cukurova Universitesi Tip Fakultesi Balcali Hastanesi; Balcali

location_facility: University of Iowa Hospitals and Clinics; Investigational Drug Services

location_facility: National Hospital Organization Himeji Medical Center

location_facility: University of Florida Health Pulmonology - Jacksonville

location_facility: Instituto Medico de la Fundacion Estudios Clinicos

location_facility: Universidad Autonoma de Madrid (UAM) - Hospital Universitario La Paz

location_facility: Ospedale Morgagni Pierantoni; Patologia clinica

location_facility: Beijing Friendship Hospital Affiliated of Capital University of Medical Science

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: Nippon Medical School Musashi Kosugi Hospital

location_facility: Shengjing Hospital of China Medical University

location_facility: The University of Hong Kong; Queen Mary Hospital

location_facility: The First Affiliated Hospital of Zhengzhou University

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

location_facility: Prince of Wales Hospital; Dept. of Medicine & Therapeutics

location_facility: Azienda Ospedale Universita Di Padova; Divisione Clinicizzata Di Nefrologia 1

location_facility: Kanagawa Cardiovascular and Respiratory Center

location_facility: Hospital Universitario de la Princesa; Servicio de Aparato Digestivo

location_facility: Policlinico Tor Vergata - U.O.C. Malattie Apparato Respiratorio

location_facility: Ismett Istituto Mediterraneo Trapianti E Terapie Alta Specializzazione;Pneumologia

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Unidad Médica para la Salud Integral UMSI

location_facility: Thomayerova nemocnice; Lekarna - pavilon H

location_facility: Centro Hospitalar Universitario Lisboa Norte - Hospital Pulido Valente

location_facility: Mersin Universitesi Tip Fakultesi Hastanesi; Tibbi Onkoloji Birimi

location_facility: Advanced Pulmonary & Sleep Research Institute of Florida

location_facility: A.O.U. Sassari; Dip. Medicina Clinica e Sperimentale

location_facility: "General hospital of Chest Diseases ""Sotiria"", 7th Pulmonary Clinic "

location_facility: Helse Bergen HF Haukeland universitetssykehus; Hudavdelingen

location_facility: CHU de Grenoble - Hôpital André Michallon; Pole Pharmacie

location_facility: Krajska nemocnice T. Bati a.s.; Neurologicke oddeleni

location_facility: National Hospital Organization Ibarakihigashi National Hospital; Center for Clinical Research

location_facility: Fakultni Nemocnice; Interni Klinika - odd. Invazivni Kardiologie

location_facility: Fondazione Policlinico Universitario A Gemelli; Servizio di Farmacia

location_facility: Hospital Clinico Universitario Virgen de la Victoria

location_facility: Centre Hospitalier Regional Universitaire de Lille

location_facility: Cliniques Universitaires Saint-Luc; Pharmacy

location_facility: Evangelismos Hospital; Endocrinology, Diabetes & Metabolism

location_facility: University of Texas Medical Branch at Galveston

location_facility: Fundacion Respirar (Centro Medico Dra. De Salvo)

location_facility: Centre Hospitalier Regional Universitaire de Brest - Hopital de la Cavale Blanche

location_facility: Seoul National University Bundang Hospital

location_facility: Investigaciones en Patologias Respiratorias

location_facility: Yedikule Gogus Hastaliklari ve Gogus Cerrahisi Egitim ve Arastirma Hastanesi

location_facility: Koc Universitesi (KU) Tip Fakultesi (Koc University School of Medicine)

location_facility: AOUC Azienda Ospedaliero-Universitaria Careggi; Neurologia 2

location_facility: CHU Dijon Bourgogne Hôpital François Mitterand

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

location_facility: CHVNG/E_Unidade 1; Servico de Pneumologia

location_facility: Thoraxklinik-Heidelberg gGmbH; Apotheke der Thoraxklinik

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Centre Hospitalier Universitaire de Reims; l'Hopital Maison Blanche

location_facility: Hebei Medical University - The Second Hospital

location_facility: University of Thessaly Faculty of Medicine

location_facility: Markusovszky Egyetemi Oktatokorhaz ; SZEMESZET

location_facility: Istanbul Universitesi Onkoloji Enstitüsü Hastanesi

location_facility: Servie de Pneumologie et centre de Transplantation Pulmonaire

location_facility: Clinica Universidad de Navarra ; Servicio de Farmacia

location_facility: Barzilai Medical Center; Neurology Department

location_facility: University General Hospital of Heraklion

location_facility: The Second Xiangya Hospital of Central South University

location_facility: Seoul National University Hospital (SNUH) - Medical Oncology Center

location_facility: Peking Union Medical College Hospital; Pharmacy

location_facility: Ankara Universitesi Tip Fakultesi Hastaneleri - Cebeci Hastanesi

location_facility: Far Eastern Memorial Hospital; Department of Clinical Pathology

location_facility: Cairns Base Hospital; Cancer Care Centre

location_facility: Buddhist Tzu Chi Dalin General Hospital; Rheumatology

location_facility: "AZIENDA OSPEDALIERA DEI COLLI Monaldi-Cotugno-CTO - Pneumologia "

location_facility: Hospital de Braga; Centro Clínico Académico (Piso 1, Ala E)

location_facility: Dr. Syed Anees Medicine Profession Corporation

location_facility: Eriyes universitesi T?p Fakultesi Hastanesi

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: Centre Hospitalier Universitaire de Rennes

location_facility: Corporació Sanitaria Parc Taulí; Servicio de Neurología

location_facility: Kaohsiung Medical University Hospital; Chung-Ho Memorial Hospital

location_facility: INER- Instituto Nacional de Enfermedades Respiratorias"Ismae

location_facility: Tudogyogyintezet Torokbalint; Onkologiai és Jarobeteg Centrum

location_facility: Fondazione IRCCS Policlinico San Matteo Divisione di EmatologiaDipartimento di Onco-Ematologia

status: Terminated

title: A Phase III Open-label Extension Study to Evaluate Long-term Safety and Efficacy of PRM-151 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

study_completion_date_type: Actual

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Japan
Turkey
Czechia
Canada
France
Portugal
Hungary
Hong Kong
Denmark
United States
Belgium
China
Italy
Norway
Singapore
Netherlands
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Israel

status_simplified: Unknown


lead_sponsor: Merck Sharp & Dohme LLC

summary: This study will evaluate the effect of each dose of MK-3655 versus placebo on the percentage of individuals with NASH resolution without worsening of fibrosis after 52 weeks. The primary hypothesis of the study is that at least 1 dose of MK-3655 is superior to placebo with respect to the percentage of individuals with NASH resolution without worsening of fibrosis after 52 weeks.

location_facility: C.H.U. Nancy Hopital de Brabois ( Site 0803)

location_facility: American Research Corporation at Texas Liver Institute ( Site 2634)

location_facility: Medical Rehabilitation Center ( Site 1904)

location_facility: Hacettepe Uni. Ic Hastaliklari Anabilim Dali, Nefroloji BD ( Site 2403)

location_facility: South Texas Research Institute ( Site 9012)

location_facility: Chongqing Three Gorges Central Hospital ( Site 0618)

location_facility: UCSD - Altman Clinical and Translational Research Institute -UC San Diego NAFLD Research Center ( Si

location_facility: Pusan National University Hospital-Internal Medicine ( Site 2010)

location_facility: Chungang University Hospital ( Site 2007)

location_facility: Bezmialem Vakf Üniversitesi-Gastroenterology ( Site 2402)

location_facility: Azienda Ospedaliera Policlinico Umberto I ( Site 1300)

location_facility: Xinhua Hospital Affiliated to Jiaotong University School of Medicine ( Site 0602)

location_facility: Pan American Center for Oncology Trials ( Site 3102)

location_facility: General Hospital of Ningxia Medical University ( Site 0607)

location_facility: Chang Gung Memorial Hospital - Linkou Branch ( Site 2305)

location_facility: Del Sol Research Management ( Site 2674)

location_facility: Centro de Investigaciones Clinicas Vina del Mar ( Site 0502)

location_facility: The National Diabetes & Obesity Research Institute ( Site 9017)

location_facility: Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital ( Site 1404)

location_facility: Hospital Clinic de Barcelona ( Site 2102)

location_facility: GIRI GI Research Institute - Vancouver ( Site 0404)

location_facility: CHU de Nice Hopital de l Archet II ( Site 0800)

location_facility: Center targetnoy therapy-Gastroenterology ( Site 1918)

location_facility: Nephrology Clinic of Internal and Prof. Diseases n.a.E.M.Tareev ( Site 1906)

location_facility: Adobe Clinical Research, LLC ( Site 2644)

location_facility: McGill University Health Centre ( Site 0400)

location_facility: Shaare Zedek Medical Center ( Site 1205)

location_facility: Hospital Universitario Puerta de Hierro-Majadahonda ( Site 2100)

location_facility: Karolinska Universitetssjukhuset Huddinge ( Site 2900)

location_facility: Clinica de nefrologia urologia y enfermedades cardiovasculares ( Site 0008)

location_facility: Universitaetsklinikum Freiburg ( Site 0446)

location_facility: Hope Clinical Research, Inc. ( Site 2601)

location_facility: Regional Gastroenterology Associates of Lancaster, LTD ( Site 9020)

location_facility: Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 2400)

location_facility: Kansas City Research Institute ( Site 9018)

location_facility: Hospital Británico de Buenos Aires ( Site 0002)

location_facility: NYU Langone Health, New York ( Site 2627)

location_facility: National Taiwan University Hospital ( Site 2301)

location_facility: Texas Clinical Research Institute ( Site 2619)

location_facility: Pontificia Universidad Catolica de Chile ( Site 0501)

location_facility: Fukui-ken Saiseikai Hospital ( Site 1410)

location_facility: Covenant Metabolic Specialists, LLC ( Site 9027)

location_facility: IRCCS Istituto Clinico Humanitas di Rozzano ( Site 1303)

location_facility: Kawasaki Medical School General Medical Center ( Site 1412)

location_facility: Hiroshima University Hospital ( Site 1413)

location_facility: Maccabi Health Services - Ramat Hasharon ( Site 1206)

location_facility: Kagawa Prefectural Central Hospital-liver intemal medicine ( Site 1416)

location_facility: hopital haut leveque chu de bordeaux-Service d'Hépato-gastroentérologie ( Site 0805)

location_facility: Ege University Medical Faculty ( Site 2404)

location_facility: Nara Medical University Hospital ( Site 1407)

location_facility: University Hospital, Kyoto Prefectural University of Medicine ( Site 1405)

location_facility: A.P.H. Paris, Hopital Saint Antoine ( Site 0807)

location_facility: A O U Policlinico di Modena ( Site 1307)

location_facility: Hospital Clinico Universitario de Santiago ( Site 2104)

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 2302)

location_facility: Istanbul Universitesi Tip Fakultesi Hastanesi ( Site 2401)

location_facility: Aichi Medical University Hospital ( Site 1402)

location_facility: Centre Hospitalier et Universitaire Dupuytren ( Site 0810)

location_facility: The Affiliated Hospital of Hangzhou Normal University ( Site 0600)

location_facility: Clinical Trials of Texas, LLC ( Site 2614)

location_facility: Hospital Italiano de Buenos Aires-Hepatology ( Site 0014)

location_facility: Clinical Research Chile SpA ( Site 0506)

location_facility: Inha University Hospital-Gastroenterolgy/Hepatology ( Site 2006)

location_facility: Hanyang University Seoul Hospital ( Site 2002)

location_facility: California Liver Research Institute ( Site 9025)

location_facility: Russian University of People Friendship ( Site 1907)

location_facility: Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0812)

location_facility: Korea University Guro Hospital ( Site 2004)

location_facility: Universitaetsklinikum Leipzig ( Site 0447)

location_facility: City Clinical Hospital named V.M.Buyanova ( Site 1922)

location_facility: Hospital San Juan de Dios de La Serena ( Site 0500)

location_facility: Excel Clinical Research, LLC ( Site 2603)

location_facility: Peak Gastroenterology Associates ( Site 2645)

location_facility: Legacy Clinical Solutions: Tandem Clinical Research, LLC ( Site 2650)

location_facility: Samsung Medical Center-Gastroenterology/Internal Medicine ( Site 2008)

location_facility: Medical Care and Research S.A. de C.V. ( Site 1506)

location_facility: National Cheng Kung University Hospital ( Site 2304)

location_facility: Catalina Research Institute, LLC ( Site 2643)

location_facility: Azienda Ospedaliera Universitaria Integrata Verona ( Site 1301)

location_facility: The Liver Institute at Methodist Dallas Medical Center ( Site 2638)

location_facility: Yokohama City University Hospital ( Site 1411)

location_facility: DHR Health Institute for Research and Development ( Site 9006)

location_facility: Hospital Regional de Concepcion ( Site 0505)

location_facility: Centro de Investigacion Medico Biologica y Terapia Avanzada SC ( Site 1511)

location_facility: Velocity Clinical Research, Panorama City ( Site 9001)

location_facility: CHU Dijon Bourgogne - Hopital F. Mitterrand ( Site 0816)

location_facility: Southeast Clinical Research Center ( Site 9003)

location_facility: Seoul National University Bundang Hospital-Internal Medicine ( Site 2005)

location_facility: Taichung Veterans General Hospital ( Site 2306)

location_facility: Hospital Universitari Vall d Hebron ( Site 2101)

location_facility: Hospital Universitario Marqués de Valdecilla-Gastroenterology and Hepatology ( Site 2106)

location_facility: Floridian Clinical Research, LLC ( Site 2656)

location_facility: The First People's Hospital of Foshan-Infection Department ( Site 0612)

location_facility: Indago Research and Health Center Inc ( Site 2610)

location_facility: Genoma Research Group, Inc. ( Site 2669)

location_facility: Klinical Investigations Group ( Site 3100)

location_facility: Kagoshima University Hospital ( Site 1418)

location_facility: Hospital Kuala Lumpur-Gastroenterology Department ( Site 2701)

location_facility: Auckland Clinical Studies Limited ( Site 1600)

location_facility: Royal Prince Alfred Hospital ( Site 0102)

location_facility: Beijing YouAn Hospital, Capital Medical University ( Site 0605)

location_facility: Sweet Hope Research Specialty Inc ( Site 2660)

location_facility: Baylor College of Medicine - Advanced Liver Therapies ( Site 2670)

location_facility: Ruane Clinical Research Group, Inc ( Site 9014)

location_facility: Hospital Universitario Virgen del Rocio ( Site 2105)

location_facility: Velocity Clinical Research, Huntington Park ( Site 9022)

location_facility: Scientific research center ECO-security ( Site 1920)

location_facility: Hippokration University Hopsital-4th Department of Internal Medicine ( Site 3300)

location_facility: North Florida South Georgia Veterans Health System ( Site 2613)

location_facility: Fundacion Santa Fe de Bogota ( Site 0705)

location_facility: Centro de Investigacion y Gastroenterologia SC ( Site 1503)

location_facility: University Health Network - Toronto General Hospital ( Site 0401)

location_facility: Velocity Clinical Research, Westlake ( Site 9013)

location_facility: Velocity Clinical Research, Syracuse ( Site 9016)

location_facility: SPb State Budgetary Institution Health Care City Policlinic 17 ( Site 1910)

location_facility: Hospital Universitario Austral ( Site 0003)

location_facility: Medica Sur-Clinica de Enfermedades Digestivas y Obesidad ( Site 1515)

location_facility: Ankara University Cebeci Research and Application Hospital ( Site 2406)

location_facility: Virginia Commonwealth University Health System ( Site 2657)

location_facility: Ocean Blue Medical Research Center Inc ( Site 2667)

location_facility: Velocity Clinical Research, Santa Ana ( Site 9002)

location_facility: Universitätsklinikum Frankfurt-Medizinische Klinik 1 ( Site 0445)

location_facility: Glenny Corp. S.A.-CLINICAL RESEARCH ( Site 0013)

location_facility: Hospital Provincial del Centenario ( Site 0007)

location_facility: Regional Gastroenterology Associates of Lancaster, LTD ( Site 9004)

location_facility: Instituto de Investigaciones Clínicas Mar del Plata ( Site 0010)

location_facility: Shinyurigaoka General Hospital ( Site 1420)

location_facility: Gazi University Medical Faculty ( Site 2405)

location_facility: Osaka Metropolitan University Hospital ( Site 1415)

location_facility: Chung Shan Medical University Hospital ( Site 2307)

location_facility: Seoul National University Hospital ( Site 2003)

location_facility: The Crofoot Research Center, Inc. ( Site 2611)

location_facility: Kanazawa University Hospital ( Site 1419)

location_facility: Centro de Investigacion Medica de Occidente S.C. ( Site 1514)

location_facility: Johannes Gutenberg Universitat Mainz ( Site 0442)

location_facility: Hopital de la Pitie Salpetriere ( Site 0813)

location_facility: Charite Universitaetsmedizin Berlin ( Site 0443)

location_facility: Arkansas Gastroenterology - North Little Rock ( Site 9015)

title: A Phase 2b Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-3655 in Individuals With Pre-cirrhotic Nonalcoholic Steatohepatitis.

type: Other Identifier

type: Registry Identifier

location_country:
Germany
New Zealand
Argentina
Australia
Japan
Turkey
Chile
Canada
France
Colombia
Hong Kong
United States
China
Malaysia
Puerto Rico
Italy
Sweden
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation
Israel


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare the Efficacy and Safety of Sotatercept Versus Placebo When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH

summary: The objectives of this study are to evaluate the efficacy and safety of sotatercept (MK-7962) treatment (plus background pulmonary arterial hypertension (PAH) therapy) versus placebo (plus background PAH therapy) at 24 weeks in adults with PAH. The primary hypothesis of the study is that the participants receiving sotatercept will have improved 6-minute walk distance (6MWD) at 24 weeks compared to participants receiving placebo.

status: Completed

ReferenceType: result

ReferenceCitation: Hoeper MM, Badesch DB, Ghofrani HA, Gibbs JSR, Gomberg-Maitland M, McLaughlin VV, Preston IR, Souza R, Waxman AB, Grunig E, Kopec G, Meyer G, Olsson KM, Rosenkranz S, Xu Y, Miller B, Fowler M, Butler J, Koglin J, de Oliveira Pena J, Humbert M; STELLAR Trial Investigators. Phase 3 Trial of Sotatercept for Treatment of Pulmonary Arterial Hypertension. N Engl J Med. 2023 Apr 20;388(16):1478-1490. doi: 10.1056/NEJMoa2213558. Epub 2023 Mar 6.

publisher_dissemination: Massachusetts Medical Society

lead_sponsor: Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Czechia
Canada
Serbia
France
Switzerland
United States
Belgium
Italy
United Kingdom
Sweden
Netherlands
Mexico
Korea, Republic of
Spain
Israel

location_facility: Hospital Universitario Marques de Valdecilla (Site 1601)

location_facility: Waikato District Health Board (Site 2702)

location_facility: Gachon University Gil Medical Center (Site 3103)

location_facility: Statcare Pulmonary Consultants - Knoxville (Site 1031)

location_facility: University of Washington Medical Center - Montlake (Site 1067)

location_facility: Universitaetsklinik Regensburg (Site 1503)

location_facility: Vseobecna fakultni nemocnice v Praze ( Site 2201_

location_facility: Hospital Universitari Vall d'Hebron (Site 1605)

location_facility: DRK Kliniken Berlin Westend ( Site 1507)

location_facility: The Ohio State University Wexner Medical Center (Site 1032)

location_facility: Hospital Clinic de Barcelona (Site 1602)

location_facility: Uniklinik Köln, Institut für Kliniche Chemie ( Site 1511)

location_facility: Universita "La Sapienza" Policlinico Umberto I (Site 2402)

location_facility: CHU de Grenoble - Hopital Michallon ( Site 1303)

location_facility: Institute of Cardiovascular Diseases Dedinje (Site 2903)

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku (Site 2803)

location_facility: Royal Free London NHS Foundation Trust (Site 1202)

location_facility: University of Cincinnati Medical Center (Site 1035)

location_facility: UPMC Presbyterian. UPMC Presbyterian Hospital (Site 1059)

location_facility: Centre Hospitalier Universitaire de Saint-Etienne ( Site 1302)

location_facility: Renown Institute for Heart & Vascular Health (Site 1055)

location_facility: University of Colorado Hospital (Site 1013)

location_facility: Lady Davis Carmel Medical Center (Site 1705)

location_facility: CHI St. Luke's Health Baylor College of Medicine Medical Center (Site 1044)

location_facility: Hopital Arnaud de Villeneuve ( Site 1301)

location_facility: Operadora de Hospitales Angeles. S.A. de C.V. -Sucursal Lomas (Site 2501)

location_facility: Medical University of South Carolina - PPDS (Site 1003)

location_facility: Medizinische Hochschule Hannover (Site 1505)

location_facility: Universitaetsklinikum Carl Gustav Carus der TU Dresden (Site 1501)

location_facility: Severance Hospital Yonsei University Health System - PPDS (Site 3101)

location_facility: Hopitaux Universitaires de Strasbourg ( Site 1307)

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawla II (Site 2801)

location_facility: New York Presbyterian Hospital (Site 1046)

location_facility: Vanderbilt University Medical Center (Site 1027)

location_facility: Institut Klinicke a Experimentalni Mediciny ( Site 2202)

location_facility: Norton Pulmonary Specialists (Site 1066)

location_facility: Golden Jubilee National Hospital (Site 1204)

location_facility: Hospital Universitario Austral ( Site 1901)

location_facility: Hospital Universitario Puerta de Hierro-Majadahonda (Site 1604)

location_facility: CHRU Brest - Hopital Cavale Blanche (Site 1314)

location_facility: Sahlgrenska Universitets Sjukhuset (Site 3201)

location_facility: Hopitaux Universitaires de Geneve HUG (Site 3302)

location_facility: Royal Prince Alfred Hospital ( Site 1106)

location_facility: University Clinical Center Nis (Site 2904)

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alegre ( Site 1805)

location_facility: The George Washington University Medical Faculty Associates (Site 1025)

location_facility: The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital (Site 1001)

location_facility: Instituto de Investigaciones Clinicas Quilmes ( Site 1903)

location_facility: Hospital Universitario Marques de Valdecilla (Site 1603)

location_facility: Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina (Site 2802)

location_facility: Hospital Provincial Dr. Jose M. Cullen ( Site 1902)

location_facility: CHU Nantes - Hopital Laennec (Site 1309)

location_facility: Universitaetsklinikum Giessen und Marburg GmbH ( Site 1512)

location_facility: Seoul National University Hospital (Site 3102)

location_facility: Arizona Pulmonary Specialists (Site 1010)

location_facility: Unidad de Investigacion Clinica en Medicina, S.C. (Site 2505)

location_facility: Oregon Health and Science University (Site 1054)

location_facility: Duke University Medical Center (Site 1026)

location_facility: Stanford University Medical Center (Site 1024)

location_facility: University of Otago, Wellington (Site 2701)

location_facility: Hospital Clinico Universitario de Salamanca (Site 1608)

location_facility: Washington University School of Medicine (Site 1022)

location_facility: University of Kansas Medical Center (Site 1020)

location_facility: University of California - Davis Medical Center (Site 1064)

location_facility: C.H.U. de Nancy. Hopital de Brabois Adultes ( Site 1308)

location_facility: University of Ottawa Heart Institute ( Site 2104)

location_facility: University of California San Diego Medical Center (Site 1002)

location_facility: CHU de Toulouse - Hopital Larrey ( Site 1315)

location_facility: Brigham and Women's Hospital (Site 1014)

location_facility: Instituto do Coracao - HC FMUSP ( Site 1803)

location_facility: Imperial College Healthcare NHS Trust (Site 1203)

location_facility: Hospital Universitario Ramon y Cajal (Site 1609)

location_facility: Thoraxklinik-Heidelberg gGmbH (Site 1509)

location_facility: University Of Alberta Hospital ( Site 2101)

location_facility: Maastricht University Medical Center (Site 2603)

location_facility: Centre Hospitalier Universitaire de Bicetre ( Site 1304)

location_facility: Saint Vincents Hospital Sydney ( Site 1102)

location_facility: University Hospitals Cleveland Medical Center (Site 1005)

status_simplified: Completed


title: A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment Naïve Patients With Mayo Stage IIIb AL Amyloidosis

summary:
AL (or light chain) amyloidosis begins in the bone marrow where abnormal proteins misfold and create free light chains that cannot be broken down. These free light chains bind together to form amyloid fibrils that build up in the extracellular space of organs, affecting the kidneys, heart, liver, spleen, nervous system and digestive tract.

The primary purpose of this study is to determine whether CAEL-101, a monoclonal antibody that removes AL amyloid deposits from tissues and organs, improves overall survival and it is safe and well tolerated in patients with stage IIIb AL amyloidosis.

ipd_sharing_description: Each patient will be assigned a unique identifier after signing the Informed Consent Form (ICF). Patient numbers will not be reassigned. Any patient records or datasets transferred to the Sponsor must contain only the unique identifier and must not include patient names or any information which would make the patient identifiable. Patients will be informed that their personal study-related data will be used by the Sponsor in accordance with local data protection laws and that their medical records may be examined by representatives of the Sponsor, Institutional Review Board (IRB)/Independent Ethics Committee (IEC) members and by inspectors from regulatory authorities. Study monitors will inspect all documents and records that are required to be maintained by the Investigator for this study.

lead_sponsor: Alexion Pharmaceuticals, Inc.

location_country:
Germany
Poland
Australia
Brazil
Japan
Czechia
Canada
France
Switzerland
United States
Belgium
China
Italy
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Greece
Russian Federation
Israel

location_facility:
Clincal Trial Site
Clinical Trial Site
Clinical Trail Site


title: Personalized Therapy Study - Intrinsic Antitachycardia Pacing Post-Approval Study (iATP PAS)

summary:
Medtronic is sponsoring the Intrinsic Antitachycardia Pacing Post-Approval Study (iATP PAS) to further confirm safety and effectiveness of ventricular iATP therapy in routine clinical practice, following commercial release of iATP-capable devices.

The iATP PAS is conducted within Medtronic's Product Surveillance Registry platform (NCT01524276).

status: Recruiting

study_type: Observational

time_perspective: Prospective

lead_sponsor: Medtronic

location_country:
Italy
Portugal
Slovakia
United Kingdom
Switzerland
United States
Spain
Greece
France

location_facility: Hospital de Santa Maria-Centro HospitalarLisboa Norte, EPE

location_facility: University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital

location_facility: New York-Presbyterian Hospital/Weill Cornell Medical Center

location_facility: Complejo Hospitalario Universitario de Santiago de Compostela

location_facility: Générale de Santé - Hôpital Privé Saint Martin

location_facility: Imperial College Healthcare NHS Trust Hammersmith Hospital

location_facility: Presidio Ospedaliero Centrale - SS.Annunziata

location_facility: Azienda ospedaleria Santa Maria dellaMisericordia di Udine

location_facility: Azienda Sanitaria Provinciale di Cosenza"Ospedale di Castrovillari"

location_facility: NewYork-Presbyterian/Columbia University Irving Medical Center

location_facility: North Memorial Health Heart & Vascular Center

location_facility: CHU de Caen - Hôpital Côte de Nacre - Centre Esquirol

location_facility: Hospital da Senhora da Oliveira -Guimarães

location_facility: Azienda Ospedaliera ospedale Niguarada ca Granda

location_facility: Cardiology Associates of Northeast Arkansas

location_facility: Liverpool Heart and Chest Hospital NHS Foundation Trust

location_facility: UPMC Heart and Vascular Institute at UPMC Hamot

location_facility: Cardiovascular Consultants Medical Group (Van Nuys CA)

location_facility: Blackpool, Fylde and Wyre Hospitals NHSFoundation Trust - Blackpool Victoria Hospital

location_facility: Centre Hospitalier Universitaire Saint Étienne

location_facility: Cardiovascular Institute of Northwest Florida

location_facility: Texas Cardiac Arrhythmia Research Foundation

location_facility: Heart Rhythm Consultants P.A. (Sarasota Memorial Research)

location_facility: Washington University School of Medicine

location_facility: Hospital Universitario Nuestra Señora de Candelaria

location_facility: The James Cook University Hospital - SouthTees Hospitals NHS

location_facility: Hospital Universitario Clínico San Cecilio

location_facility: Národný ústav srdcových a cievnych chorôb, a.s. (NUSCH, a.s.)

location_facility: Sheffield Vascular Institute, Sheffield TeachingHospitals NHS - Northern Genera

location_facility: Brigham and Women's Hospital (Boston MA)

location_facility: Hospital Universitario Virgen de las Nieves

location_facility: Consultants in Cardiology (Fort Worth TX)

location_facility: Summa Center for Clinical Trials-Northeast Ohio Cardiovascular Specialists

location_facility: Hospital Clínico Universitario de Valladolid

location_facility: Centro Hospitalar Universitário de SãoJoão Alameda

location_facility: Centre hospitalier de la région d'Annecy

location_facility: Central Manchester University Hospitals NHS - mancester Royal Infirmary

intervention_type: Device


title: Personalized Therapy Study - Heart Failure Risk Status (TriageHF) Post Approval Study

summary: Medtronic is sponsoring the HFRS PAS to evaluate the HFRS feature (TriageHF) when used in routine clinical practice following commercial release. The HFRS PAS is conducted within Medtronic's Product Surveillance Registry (PSR) platform.

location_facility: Sheffield Vascular Institute, Sheffield Teaching Hospitals NHS - Northern General

location_facility: University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital

location_facility: Cardiovascular Consultants Medical Group

location_facility: Národný ústav srdcových a cievnych chorôb, a.s. (NÚSCH, a.s.)

location_facility: Central Manchester University Hospitals NHS - Manchester Royal Infirmary

location_facility: Hospital da Senhora da Oliveira - Guimarães

location_facility: New York-Presbyterian Hospital/Weill-Cornell Medical Center

location_facility: Complejo Hospitalario Universitario de Santiago de Compostela

location_facility: Générale de Santé - Hôpital Privé Saint Martin

location_facility: Azienda Sanitaria Provinciale di Cosenza "Ospedale di Castrovillari"

location_facility: Imperial College Healthcare NHS Trust - Hammersmith Hospital

location_facility: NewYork-Presbyterian/Columbia University Irving Medical Center

location_facility: CHU de Caen - Hôpital Côte de Nacre - Centre Esquirol

location_facility: Azienda ospedaleria Santa Maria della Misericordia di Udine

location_facility: Centro Hospitalar Universitário de São João

location_facility: Cardiology Associates of Northeast Arkansas

location_facility: Blackpool, Fylde and Wyre Hospitals NHS Foundation Trust - Blackpool Victoria Hospital

location_facility: Liverpool Heart and Chest Hospital NHS Foundation Trust

location_facility: UPMC Heart and Vascular Institute at UPMC Hamot

location_facility: Azienda Ospedaliera Ospedale Niguarda Ca Granda

location_facility: Cardiovascular Institute of Northwest Florida

location_facility: Presidio Ospedaliero Centrale - SS. Annunziata

location_facility: The James Cook University Hospital - South Tees Hospitals NHS

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

location_facility: North Memorial Heart and Vascular Institute

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

intervention_type: Other


acronym: MARIPOSA

lead_sponsor: Janssen Research & Development, LLC

summary: The purpose of this study is to assess the efficacy of the amivantamab and lazertinib combination, compared with osimertinib, in participants with epidermal growth factor receptor (EGFR) mutation (Exon 19 deletions [Exon 19del] or Exon 21 L858R substitution) positive, locally advanced or metastatic non-small cell lung cancer (NSCLC).

ReferenceCitation: Cho BC, Felip E, Hayashi H, Thomas M, Lu S, Besse B, Sun T, Martinez M, Sethi SN, Shreeve SM, Spira AI. MARIPOSA: phase 3 study of first-line amivantamab + lazertinib versus osimertinib in EGFR-mutant non-small-cell lung cancer. Future Oncol. 2022 Feb;18(6):639-647. doi: 10.2217/fon-2021-0923. Epub 2021 Dec 16.

location_facility: Hospital Evangélico de Cachoeiro de Itapemirim

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

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Tianjin Medical University General Hospital

location_facility: Private Specialist Hospitals - MedPolonia

location_facility: CHU de Grenoble - Hopital Albert Michallon

location_facility: Taipei Medical University Shuang Ho Hospital

location_facility: Azienda Ospedaliero Univ. Policlinico Gaspare Rodolico

location_facility: TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology

location_facility: Irmandade Santa Casa de Misericordia de Porto Alegre

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Krasnoyarsk Regional Oncology Dispensary

location_facility: Ministerio da Saude - Instituto Nacional do Cancer

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

location_facility: National Hospital Organization Tokyo Medical Center

location_facility: Grand Hopital de Charleroi, site Notre Dame

location_facility: National Hospital Organization Himeji Medical Center

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

location_facility: National Hospital Organization Osaka Toneyama Medical Center

location_facility: Uniao Brasileira de Educaçao e Assistencia-Hospital Sao Lucas da PUCRS

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi Ic Hastaliklari Anabilim Dali Medikal Onkoloji Bd

location_facility: Municipal Oncology Centre of Uzhgorod Central Municipal Clinical Hospitlal

location_facility: Shengjing Hospital of China Medical University

location_facility: Städtisches Krankenhaus Martha-Maria Halle-Dölau gGmbH

location_facility: Oncosite - Centro de Pesquisa Clínica em Oncologia Ltda

location_facility: The First Affiliated Hospital of Wenzhou Medical University

location_facility: Orszagos Koranyi Tbc es Pulmonologiai Intezet

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

location_facility: Ruijin Hospital, Shanghai Jiao Tong University

location_facility: National Hospital Organization Shibukawa Medical Center

location_facility: Başkent University Medical Faculty Adana Application and Research Center

location_facility: Centro Hospitalar Universitario do Porto, EPE

location_facility: Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz

location_facility: UPCO Unidade de Pesquisa Clinica em Oncologia

location_facility: Robert-Bosch-Krankenhaus - Klinik Schillerhoehe

location_facility: Nizhny Novgorod Regional Oncological Dispensary

location_facility: Asklepios Klinik Gauting GmbH - Asklepios Fachkliniken München-Gauting

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

location_facility: Mexico Centre for Clinical Research, S.A. de C.V.

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: National Hospital Organization Iwakuni Clinical Center

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

location_facility: Oncology Medical Clinics AV Medical group

location_facility: Tambov Regional Oncology Clinical Dispansary

location_facility: Ospedale San Giuseppe Moscati di Avellino

location_facility: Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo

location_facility: National Hospital Organization Yamaguchi Ube Medical Center

location_facility: Washington University School of Medicine

location_facility: Cancer Hospital of Xinjiang Medical University

location_facility: Seoul National University Bundang Hospital

location_facility: Centrum Onkologii im. Prof. F. Lukaszczyka

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

location_facility: Centro Hospitalar Lisboa Norte EPE - Hospital Pulido Valente

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

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

location_facility: Thoraxklinik am Universitätsklinikum Heidelberg

location_facility: IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado

location_facility: Willamette Valley Cancer Institute and Research Center

location_facility: Pan American Center for Oncology Trials LLC

location_facility: Yaroslavl Regional Clinical Oncology Hospital

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

location_facility: The First People's Hospital Of Changzhou

location_facility: Second Affiliated Hospital, School of Medicine, Zhejiang University

location_facility: Hospital Privado Centro Medico de Cordoba

location_facility: Phramongkutklao Hospital and Medical College

location_facility: Songklanagarind Hospital, Prince of Songkla University

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

location_facility: Centro Oncologico Riojano Integral (Cori)

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde

location_facility: Harbin medical university cancer hospital

location_facility: Beijing Chest hospital, Capital medical university

location_facility: Necmettin Erbakan University Meram Medical Faculty

location_facility: The Second Affiliated Hospital of Zhejiang University College of Medicine

location_facility: CIMOVA, Morals Vargas Centro de Investigación SC

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

location_facility: Beijing Friendship Hospital Capital Medical University

location_facility: N.N. Petrov Research Institute Of Oncology

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Medical Center 'Ok Clinic' of LLC 'International Institute of Clinical Studies'

location_facility: Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie

title: A Phase 3, Randomized Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib Versus Lazertinib as First-Line Treatment in Patients With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer.

ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical- trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) project site at yoda.yale.edu

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Thailand
Turkey
Canada
France
Portugal
Hungary
United States
Ukraine
India
Belgium
China
Malaysia
Puerto Rico
Italy
United Kingdom
Netherlands
Mexico
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel


acronym: PERSEUS

lead_sponsor: Sanofi

summary:
Primary Objective:

To determine the efficacy of SAR442168 compared to placebo in delaying disability progression in primary progressive multiple sclerosis (PPMS)

Secondary Objectives:

To evaluate efficacy of SAR442168 compared to placebo on clinical endpoints, magnetic resonance imaging (MRI) lesions, cognitive performance, physical function, and quality of life To evaluate safety and tolerability of SAR442168 To evaluate population pharmacokinetics (PK) of SAR442168 in PPMS and its relationship to efficacy and safety To evaluate pharmacodynamics of SAR442168

location_facility: Tufts Medical Center Site Number : 8400072

location_facility: University of Florida, Fixel Center for Neurology Site Number : 8400159

location_facility: Jefferson Neurology Associates Site Number : 8400016

location_facility: University of Colorado Site Number : 8400012

location_facility: Wheaton Franciscan Healthcare Site Number : 8400022

location_facility: Neurology Associates, PA Site Number : 8400004

location_facility: Sharlin Health & Neurology Site Number : 8400093

location_facility: The Memorial Hospital Site Number : 8400033

location_facility: College Park Family Care Center Site Number : 8400044

location_facility: Providence Multiple Sclerosis Center Site Number : 8400020

location_facility: Mt Olympus Medical Research Site Number : 8400163

location_facility: Medical College of Wisconsin Site Number : 8400028

location_facility: Novant Health Multiple Sclerosis Care Center - South Park Site Number : 8400120

location_facility: Prairie Education and Research Cooperative Site Number : 8400071

location_facility: University of New Mexico Site Number : 8400032

location_facility: University of Massachusetts Site Number : 8400014

location_facility: Meridian Clinical Research, LLC Site Number : 8400005

location_facility: Mountain View Clinical Research Site Number : 8400024

location_facility: The Ohio State University Wexner Medical Center Site Number : 8400150

location_facility: University of Kentucky Site Number : 8400106

location_facility: Atrium Health Wake Forest Baptist Site Number : 8400116

location_facility: Advanced Neuroscience Center Site Number : 8400035

location_facility: Advanced Neurosciences Research Site Number : 8400025

location_facility: Neurology Center of San Antonio Site Number : 8400036

location_facility: Multiple Sclerosis Center Site Number : 8400143

location_facility: Consultants In Neurology Site Number : 8400011

location_facility: Wayne State University Site Number : 8400046

location_facility: SC3 Research - Pasadena Site Number : 8400070

location_facility: UC San Diego ACTRI Site Number : 8400101

location_facility: Saint Luke's Hospital Site Number : 8400153

location_facility: South Florida Neurology Associates Site Number : 8400029

location_facility: University of South Florida Site Number : 8400006

location_facility: The Boster Center for Multiple Sclerosis Site Number : 8400147

location_facility: Duke Neurological Disorders Clinic Site Number : 8400098

location_facility: Hackensack University Hospital Site Number : 8400047

location_facility: University Of Nebraska Site Number : 8400129

location_facility: Icahn School of Medicine at Mount Sinai (Department of Endoc Site Number : 8400038

location_facility: Velocity Clinical Research Site Number : 8400003

location_facility: International Neurorehabilitation Institute Site Number : 8400034

location_facility: Michigan Institute For Neurological Disorders Site Number : 8400058

location_facility: Ochsner Baptist Clinical Trials Unit (CTU) Site Number : 8400107

location_facility: Methodist Hospital Site Number : 8400164

location_facility: University of San Francisco, Sandler Neurosciences Center Site Number : 8400137

location_facility: Hawaii Pacific Neuroscience Site Number : 8400103

location_facility: Neurology Associates of Stony Brook Site Number : 8400042

location_facility: Multiple Sclerosis Center of California Site Number : 8400135

location_facility: Collaborative Neuroscience Research Site Number : 8400045

title: A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing SAR442168 to Placebo in Participants With Primary Progressive Multiple Sclerosis (PERSEUS)

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
Poland
Argentina
Australia
Japan
Turkey
Croatia
Chile
Czechia
Canada
Serbia
France
Belarus
Colombia
Portugal
Hungary
Denmark
United States
Latvia
Ukraine
India
Romania
Belgium
China
Peru
Estonia
Italy
Norway
Singapore
United Kingdom
Sweden
Netherlands
Austria
Mexico
Spain
Greece
South Africa
Bulgaria
Georgia
Russian Federation
Israel


title: A Phase 3 Multicenter, Randomized, Double Masked, Sham- Controlled Clinical Trial to Assess the Safety and Efficacy of Intravitreal Administration of Zimura (Complement C5 Inhibitor) in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration

summary: The objectives of this study are to evaluate the safety and efficacy of Zimura (avacincaptad pegol) intravitreal administration in patients with geographic atrophy secondary to age-related macular degeneration (AMD)

lead_sponsor: IVERIC bio, Inc.

location_country:
Germany
Poland
Argentina
Australia
Brazil
Croatia
Czechia
Canada
France
Colombia
Hungary
United States
Latvia
Belgium
Estonia
Italy
United Kingdom
Austria
Spain
Israel

location_facility: Retina and Vitreous Center of Southern Oregon

location_facility: Centro Medico Micro Diagnostico y Microcirugla Ocular

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Centro de Diagnóstico y Cirugía Ocular "Oftalmólogos Especialistas"

location_facility: Nuovo Arcispedale Sant' Anna (A.O.U. di Ferrara)

location_facility: Ophthalmic Consultants of the Capital Region

location_facility: Universitätsklinikum Hamburg Eppendorf Klinik und Poliklinik für Augenheilkunde Studienzentrum

location_facility: Retina Consultants of Southern California

location_facility: Hospital Clínico Universitario "Lozano Blesa"

location_facility: Pauls Stradinis Clinical University Hospital

location_facility: Semmelweis University, Dept of Ophthalmology

location_facility: Instituto Clinico Quirurgico de Oftalmologia

location_facility: Southern California Desert Retina Consultants

location_facility: Fundacion OJlalmologica Nacional - FUNDONAL

location_facility: Centre Ophtalmologique d'Imagerie et de Laser

location_facility: Azienda Sanitaria Universitaria Integrata

location_facility: Azienda Ospedaliera di Padova Unità Operativa Complessa di Clinica Oculistica

location_facility: Centro de Ensino e Pesquisa do Instituto da Visao (CEPIV)

location_facility: Retina Vitreous Surgeons of Central New York, PC

location_facility: Medizinische Universitaet Innsbruck - Universitaetsklinik fuer Augenheilkunde und Optometrie

location_facility: Retina Consultants of Southern Colorado, P.C.

location_facility: Retina-Vitreous Associates Medical Group

location_facility: Centro Privado de Oftalmologia - OFTAR Mendoza SRL

location_facility: Vitreous Retina Macula Consultants of New York (VRMNY)

location_facility: Ospedale Clinicizzato Universita di Chieti "Ss Annunziata"

location_facility: Medizinische Universitaet Graz - Augenklinik

location_facility: University of Utah, John A. Moran Eye Center

location_facility: University Retina and Macula Associates, PC

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Szabolcs-Szatmar-Bereg County Hospital and University Teaching Hospital

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego

location_facility: University of Miami-Bascom Palmer Eye Institute

location_facility: Retina Research Institute at New England Retinal Consultants

location_facility: Northern California Retina Vitreous Associates

location_facility: Centre d'exploration ophtalmologique de l'Odeon

location_facility: Klinika Okulistyczna OFT ALMIKA Sp. z o. o.

location_facility: Canadian Centre for Advanced Eye Therapeutics Inc.

location_facility: Scheie Eye Institute, University of Pennsylvania

location_facility: Hull University Teaching Hospitals NHS Trust

location_facility: Department of Ophthalmology, Rabin Medical Center

location_facility: AOU Universita degli Studi della Campania Luigi Vanvitelli UOC Oculistica

location_facility: Debrecen University Clinical Center, Dept of Ophthalmology

location_facility: Jules Stein Eye Institute/David Geffen School of Medicine


title: A Global Multicenter Randomized Placebo-Controlled Phase 3 Trial To Compare The Efficacy And Safety Of Fruquintinib Plus Best Supportive Care To Placebo Plus Best Supportive Care In Patients With Refractory Metastatic Colorectal Cancer

summary: This is a global, randomized, double-blind, placebo-controlled, multicenter phase 3 clinical trial to compare the efficacy and safety of fruquintinib plus best supportive care (BSC) versus placebo plus BSC in participants with refractory metastatic colorectal cancer (mCRC). 691 participants were randomized to one of the following treatment arms in a 2:1 ratio, fruquintinib plus BSC or placebo plus BSC.

ReferenceCitation: Dasari A, Sobrero A, Yao J, Yoshino T, Schelman W, Yang Z, Chien C, Kania M, Tabernero J, Eng C. FRESCO-2: a global Phase III study investigating the efficacy and safety of fruquintinib in metastatic colorectal cancer. Future Oncol. 2021 Aug;17(24):3151-3162. doi: 10.2217/fon-2021-0202. Epub 2021 May 17.

oa_host_type: publisher

lead_sponsor: Hutchison Medipharma Limited

location_country:
Germany
Italy
Poland
Hungary
United Kingdom
Australia
Japan
Austria
Belgium
United States
Spain
Czechia
Estonia
France

location_facility: Sarah Cannon Research Institute-S-Ft. Myers (FCS South)

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: University of Louisville - James Brown Cancer Center

location_facility: Zala Megyei Szent Rafael Korhaz, Onkologiai Osztaly, F epulet 3. em.

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Sarah Cannon Research-E-WPB (Florida Cancer Specialists-FCS East)

location_facility: Asklepios Tumorzentrum Hamburg AK Altona

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

location_facility: East Tallinn Central Hospital Centre of Oncology

location_facility: Zentrum für Hämatologie und Onkologie MVZ GmbH

location_facility: Wiener Gesundheitsverbund - Klinik Ottakring

location_facility: The George Washington University Medical Center

location_facility: XCancer / New Mexico Oncology & Hematology Consultants

location_facility: Ordensklinikum Linz Barmherzige Schwestern

location_facility: Sarah Cannon Research Institute-N-St Pete (FCS North)

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Institut de cancerologie Strasbourg-Europe

location_facility: Masaryk Memorial Cancer Institute, Hematoonkologie

location_facility: Institut fr Klinisch Onkologische ForschungKrankenhaus Nordwest GmbH

location_facility: Onze-Lieve-Vrouwziekenhuis OLV - Campus Aalst

location_facility: Vseobecna Fakultni Nemocnice VFN, Onkologicka Klinika

location_facility: Hospital Regional Universitario Carlos Haya

location_facility: Hospital ClÃ-nico Universitario de Santiago-CHUS

location_facility: Del-Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet, Szent Laszlo Korhaz

location_facility: Ospedale San Bortolo Azienda ULSS8 Berica - Distretto Est

location_facility: CHU de Lige - Domaine Universitaire du Sart Tilman

location_facility: Hospital General Universitario Gregorio Maranon HGUGM

location_facility: Hospital Universitario Central de Asturias

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Bialostockie Centrum Onkologii im. Marii Skodowskiej-Curie

location_facility: Centre Hospitalier Universitaire CHU de Rennes - Hopital de Pontchaillou

location_facility: Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

location_facility: City of Hope Comprehensive Cancer Center

location_facility: Tartu University Hospital Clinic of Haematology and Oncology

location_facility: Universitaetsmedizin Mannheim- III. Medizinische Klinik

location_facility: Bekes Megyei Kozponti Korhaz, Pandy Kalman Tagkorhaz, Megyei Onkologiai Kozpont

location_facility: Medical College of Wisconsin/ Froedtert Hospital

location_facility: Sarah Cannon Research Institute-Pan-Tallahassee (FCS Panhandle)

location_facility: Integrated Clinical Oncology Network Pty Ltd (Icon)

location_facility: St. Marianna University School of Medicine Hospital

location_facility: Fakultni nemocnice Olomouc, Onkologicka klinika

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz, Klinikai Onkologiai Osztaly

location_facility: Sihtasutus Pohja-Eesti Regionaalhaigla (PERH) (North Estonia Medical Centre)

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: M Sklodowska Curie Memorial Cancer Center, Klinika Gastroenterologii Onkologicznej

location_facility: Haematologisch-Onkologische Praxis Hamburg Eppendorf


title: ENHANCE: A Randomized, Double-blind, Multicenter Study Comparing Magrolimab in Combination With Azacitidine Versus Azacitidine Plus Placebo in Treatment-naïve Patients With Higher Risk Myelodysplastic Syndrome

acronym: ENHANCE

summary: The primary objective of this study is to evaluate the efficacy of magrolimab in combination with azacitidine compared to that of azacitidine plus placebo in previously untreated participants with intermediate/high/very high risk myelodysplastic syndrome (MDS) by Revised International Prognostic Scoring System (IPSS-R) as measured by complete remission (CR) and overall survival (OS).

lead_sponsor: Gilead Sciences

location_country:
Finland
Germany
Poland
New Zealand
Australia
Turkey
Czechia
Canada
France
Portugal
Hungary
Hong Kong
Switzerland
United States
Belgium
Italy
Norway
United Kingdom
Netherlands
Austria
Spain

location_facility: Fakultni nemocnice Ostrava, Klinika hemato-onkologicka

location_facility: Istituto Oncologico Della Svizzera Italiana- IOSI, EOC, Clinica di Ematologia

location_facility: U.O di Ematologia, Ospedale San Gerardo- ASST Monza

location_facility: Columbia University Medical Center - Herbert Irving Pavilion

location_facility: Centro Hospitalar Universitario Sao Joao. E.P.E

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: Petz Aladar Egyetemi Oktato Korhaz II. Belgyogyaszat - Hematologial Osztaly

location_facility: U.O Ematologica- ASST degli Spedali Civili di Brescia

location_facility: OSI Araba, Hospital Universitario de Alava, Hospital Txagorritxu

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

location_facility: Centro Hospitalar Vila Nova de Gaia/Espinho

location_facility: University of Miami Hospital and Clinics / Sylvester Comprehensive Cancer Center

location_facility: Robert-Bosch-Krankenhaus, GmBH, Hamatologie, Onkologie und Palliativmedizin

location_facility: Institut Catala d'Oncologia, Hospital Duran i Reynals

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: SC Ematologica, ASST Sette Laghi, Ospedale di Circolo e Fondazione Macchi

location_facility: Hanusch kranhenkaus, 3. Medizinische Abteilung

location_facility: University of Minnesota Medical Center, Fairview

location_facility: Centro Clinico Academico de Braga, Hospital de Braga, E.P.E

location_facility: The Ohio State University Wexner Medical Center / James Cancer Hospital

location_facility: CHU de Poitiers - Hopital de la Miletrie

location_facility: University of North Carolina at Chapel Hill

location_facility: University of Oklahoma Health Sciences Center

location_facility: Thomas Jefferson University, Sidney Kimmel Cancer Center; Clinical Research Organization

location_facility: U.O.C Ematologia - Dipartimento di Medicina Interna, Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico

location_facility: Fakultni nemocnice Olomouc, Hemato-onkologicka klinika

location_facility: Kent and Canterbury Hospital- East Kent Hospitals University NHS Foundation Trust

location_facility: University of Maryland, Greenebaum Comprehensive Cancer Center

location_facility: Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Hospital Regional Universitario de Malaga

location_facility: Azienda Ospedaliera Ospedali Riuniti Marche Nord

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

location_facility: Oregon Health & Science University Pharmacy Services

location_facility: Barwon Health, University Hospital Geelong

location_facility: Complejo Asistencial Universitario de Salamanca- Hospital Clinico Universitario de Salamanca

location_facility: Marien hospital, klinik fur onkologie, hamatologie und palliavmedizin

location_facility: SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz

location_facility: Area Sanitaria de Santiago de Compostela y Barbanza. Complejo Hospitalario Universitario de SantiagoD

location_facility: Huntsman Cancer Institute/University of Utah

location_facility: SC di Oncoematologia - Azienda Ospedaliera Santa Maria

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Hospital Clinico Universitario de Valencia

location_facility: The Chinese University of Hong Kong, Prince of Wales Hospital

location_facility: The University of Chicago Medical Center

location_facility: SC Ematologica- Azienda Ospedaliera Nazionale SS. Antonio e Biagio e C. Arrigo

location_facility: Washington University School of Medicine - Siteman Cancer Center

location_facility: University of California, Davis Comprehensive Cancer Center

location_facility: Universitaetsspital Zurich - Klinik fur Medizinische Onkologie und Hematologie

location_facility: Hospital Universitario Quironsalud Madrid. Servico de Hematologica y Hemoterapia

location_facility: Haukeland Universitetssjukehus, seksjon for blodsjukdommar- klinisk studieteam

location_facility: University of Arkansas for Medical Sciences IRB

location_facility: Centro Hospitalar Universitario Sao Joao

location_facility: Universitatsmedizin der Johannes Gutenberg Universitat Mainz, III. Medizinische Klinik und Poliklinik

location_facility: Semmelweis Egyetem Belgyógyászati és Hematológiai Kilnika

location_facility: Hospital of the University of Pennsylvania

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie, Oddzial Kliniczny Hematologii

location_facility: Tekirdag Namik Kemal Universitesi Tip Fakultesi

location_facility: S. C. Ematologia Azienda Ospedaliero - Universitaria Maggiore Della Carita

location_facility: Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE

location_facility: Hospital Universitario La Paz, Edificio General, 6 Planta. Despacho de Hematologia

location_facility: Dokuz Eylul Universitesi Tip Fakultesi Onkoloji Enstitusu

location_facility: Ankara Universitesi Tip Fakultesi Cebeci Hastanesi

location_facility: Froedtert Hospital & the Medical College of Wisconsin

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

location_facility: Weill Cornell Medicine-New York Presbyterian Hospital

location_facility: University of Kansas Clinical Research Center


acronym: AcceleRET-Lung

summary: This is an international, randomized, open-label, Phase 3 study designed to evaluate whether the potent and selective RET inhibitor, pralsetinib, improves outcomes when compared to a platinum chemotherapy-based regimen chosen by the Investigator from a list of standard of care treatments, as measured primarily by progression free survival (PFS), for participants with RET fusion-positive metastatic NSCLC who have not previously received systemic anticancer therapy for metastatic disease. Participants who have centrally confirmed progressive disease on the control arm have the option to crossover to pralsetinib.

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Vitebsk Regional Clinical Oncology Dispensary

location_facility: Auckland City Hospital, Cancer and Blood Research

location_facility: Adana Baskent University Hospital; Medical Oncology

location_facility: National Hospital Organization Yamaguchi - Ube Medical Center

location_facility: Hôpital Louis Pradel, Hospices Civils de Lyon

location_facility: Oslo universitetssykehus HF, Ullevål, Kreftsenteret

location_facility: Hopital Bichat Claude Bernard; Oncologie Serv.

location_facility: Hosp Clinico Univ Lozano Blesa; División De Oncología Médica

location_facility: Karolinska Universitetssjukhuset, Solna; Kliniska prövningsenheten Z:4:01

location_facility: Klinikum der Universität München; Campus Großhadern; Med. Klinik und Poliklinik V

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: AZ. Ospedaliera San Giovanni - Addolorata

location_facility: Rigshospitalet, Onkologisk Klinik; Klinisk Forskningsenhed

location_facility: Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Ospedale Provinciale Santa Maria Delle Croci; Oncologia Medica

location_facility: Hospital Universitario Puerta de Hierro; Servicio de Oncologia

location_facility: IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II

location_facility: Complejo Hospitalario Universitario A Coruña

location_facility: Azienda Ospedaliera Universitaria Pisana - Ospedale Cisanello; Dipartimento Cardio Toraco Vascolare

location_facility: Hôpital Ambroise Paré - Boulogne-Billancourt

location_facility: Institut universitaire de cardiologie et de pneumologie de Québec (Hôpital Laval)

location_facility: National Hospital Organization Himeji Medical Center

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

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

location_facility: Medipol Mega Üniversite Hastanesi Göztepe

location_facility: A.O.U. INTEGRATA DI VERONA-Ospedale Civile Maggiore Borgo Trento; U.O.C. Oncologia

location_facility: Pius-Hospital; Klinik fuer Haematologie und Onkologie

location_facility: Universitätsklinikum Carl Gustav Carus, Medizinische Klinik I, Pneumologie MK1-A13

location_facility: Sourasky / Ichilov Hospital; Dept. of Oncology

location_facility: Hospital Garcia de Orta; Servico de Pneumologia

location_facility: State Inst N.N. Alexandrov Republican Scientific & Practical Centre of Oncology & Medical Radiology

location_facility: Royal Marsden Hospital; Dept of Medical Oncology

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

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: CHRU Lille Service de Pneumologie et Oncologie Thoracique

location_facility: CI of Kherson Regional Council Kherson Regional Oncology Dispensary

location_facility: Hospital Regional Universitario de Malaga

location_facility: Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad; Klinika Nowot.Pluca i Klatki Piers

location_facility: Institut Jules Bordet; Pulmonary Oncology

location_facility: Helsinki University Central Hospital; Dept of Oncology

location_facility: Institut Gustave Roussy; Departement Oncologie Medicale

location_facility: Fundación CENIT para la Investigación en Neurociencias

location_facility: Royal North Shore Hospital; Department of Medical Oncology

location_facility: Christie Hospital Nhs Trust; Medical Oncology

location_facility: Centro Oncologico Riojano Integral (CORI)

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Millennium Research & Clinical Development

location_facility: COI Centro Oncologico Internacional SAPI de CV

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Leopoldina-Krankenhaus Medizinische Klinik II

location_facility: University of Maryland Marlene and Stewart Greenebaum Cancer Center

location_facility: Hopital de Pontchaillou; Service de Pneumologie

location_facility: Guys & St Thomas Hospital; Department of Oncology

location_facility: Medical Park Seyhan Hospital; Oncology Department

location_facility: Klinik Schillerhöhe; Pneumologische Onkologie

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

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

location_facility: Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale

location_facility: University College Hospital; Department of Oncology

location_facility: MI Zaporizhzhia Regional Clinical Oncological Dispensary Zaporizhzhia SMU Ch of Oncology

location_facility: Hospital Universitario Marques de Valdecilla; Servicio de Oncologia

location_facility: Shaare Zedek Medical Center; Oncology Dept

location_facility: Hospital General Universitario de Valencia; Servicio de oncologia

location_facility: IRCCS Giovanni Paolo II Istituto Oncologico

location_facility: Hospital de Braga; Serviço de Pneumologia

location_facility: University of Texas Health Science Center

location_facility: Sylvester Comprehensive Cancer Center; University of Miami School of Medicine

location_facility: Institut Paoli Calmettes; Oncologie Medicale

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

location_facility: Ivano-Frankivsk Regional Oncology Center

location_facility: Leicester Royal Infirmary; Dept. of Medical Oncology

location_facility: Hemato Oncología de Panamá Especializada

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

location_facility: CHU de Toulouse - Hôpital Larrey; Service de pneumologie et oncologie pneumologique

location_facility: Università degli Studi della Campania Luigi Vanvitelli

title: A Phase III, Randomized, Open-Label Study of Pralsetinib Versus Standard of Care for First-Line Treatment of RET Fusion-Positive, Metastatic Non-Small Cell Lung Cancer

location_country:
Finland
Germany
Ireland
Poland
New Zealand
Argentina
Australia
Brazil
Costa Rica
Japan
Turkey
Canada
France
Belarus
Portugal
Denmark
Switzerland
United States
Ukraine
Belgium
Italy
Norway
United Kingdom
Sweden
Netherlands
Mexico
Korea, Republic of
Spain
Panama
Israel