acronym: JAVELIN HEAD AND NECK 100

summary: This is a phase 3 randomized, placebo controlled study to evaluate the safety and anti-tumor activity of Avelumab in combination with standard of care chemoradiation (SoC CRT) versus SoC CRT alone in front-line treatment of patients with locally advanced head and neck cancer.

ReferenceCitation: Lee NY, Ferris RL, Psyrri A, Haddad RI, Tahara M, Bourhis J, Harrington K, Chang PM, Lin JC, Razaq MA, Teixeira MM, Lovey J, Chamois J, Rueda A, Hu C, Dunn LA, Dvorkin MV, De Beukelaer S, Pavlov D, Thurm H, Cohen E. Avelumab plus standard-of-care chemoradiotherapy versus chemoradiotherapy alone in patients with locally advanced squamous cell carcinoma of the head and neck: a randomised, double-blind, placebo-controlled, multicentre, phase 3 trial. Lancet Oncol. 2021 Apr;22(4):450-462. doi: 10.1016/S1470-2045(20)30737-3.

location_facility: Helios Klinikum Berlin-Buch, Klinik fur Nuklearmedizin

location_facility: Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: Kansas City VA Radiation Oncology Clinic

location_facility: Istituto Oncologico della Svizzera Italiana IOSI, Ospedale San Giovanni

location_facility: Memorial Sloan Kettering Cancer Center- Bergen

location_facility: University Of Colorado Hospital Cancer Center

location_facility: ICANS - Institut de cancerologie Strasbourg Europe

location_facility: Centrum Onkologii - Instytut im. M. Sklodowskiej - Curie, Klinika Radioterapii i Chemioterapii

location_facility: SBIH "Chelyabinsk Regional Clinical Centre of Oncology and Nuclear Medicine"

location_facility: Instituto Portugues de Oncologia de Coimbra Francisco Gentil, E.P.E.

location_facility: Centre Paul Strauss - Radiologie et medecine nucleaire

location_facility: AULSS 9 - Scaligera Ospedale Mater Salutis

location_facility: Pecsi Tudomanyegyetem, Klinikai Kozpont, Onkoterapias Intezet

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

location_facility: Helios Klinikum Berlin-Buch, Klinik fur Strahlentherapie

location_facility: Klinik fur Radiologie und Nuklearmedizin

location_facility: Memorial Cancer Institute at Memorial Hospital West

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Orszagos Onkologiai Intezet, B Belgyogyaszati Osztaly

location_facility: Cedars Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: University Hospitals Cleveland Medical Center

location_facility: IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)

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

location_facility: SPZOZ Ministerstwa Spraw Wewnetrznych i Administracji z Warminsko-Mazurskim Centrum Onkologii

location_facility: Budgetary Institution of Healthcare of Omsk Region "Clinical Oncology Dispensary"

location_facility: UC San Diego Medical Center- La Jolla (Thornton Hospital)

location_facility: Institut de cancerologie de la Loire Lucien Neuwirth

location_facility: Azienda Ospedaliero-Universitaria di Parma

location_facility: Laura and Isaac Perlmutter Cancer Center at NYU Langone

location_facility: Illawarra Shoalhaven Local Health District

location_facility: Division of Radiation Oncology, Seoul National University Hospital

location_facility: NYU Langone Radiology - Ambulatory Care Center East 41st Street

location_facility: Memorial Sloan Kettering Cancer Center-Basking Ridge

location_facility: Hadassah University Hospital, Department of Oncology

location_facility: Washington University School of Medicine Siteman Cancer Center

location_facility: CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center

location_facility: Memorial Sloan Kettering Cancer Center Westchester

location_facility: Memorial Cancer Institute at Memorial Regional Hospital

location_facility: Department of Radiation Oncology, Ulsan University Hospital

location_facility: Hospital Clinico Universitario Lozano Blesa

location_facility: Division of Radiation Oncology, Asan Medical Center

location_facility: Precision Cancer Research / Gettysburg Cancer Center

location_facility: Istituto Scientifico Romagnolo per lo studio e la cura dei Tumori (I.R.S.T)

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: University of Maryland, Greenebaum Comprehensive Cancer Center

location_facility: Center for Proton Therapy, National Cancer Center

location_facility: Institut Regional du Cancer Montpellier - Val d'Aurelle

location_facility: Cabinet de radiologie Privé - Dr Joseph Mocaer

location_facility: The West Clinic, PC dba West Cancer Center

location_facility: MUSC SCTR Research Nexus Clinical Science Building

location_facility: Barwon Health, University Hospital Geelong

location_facility: Department of Radiation Oncology Methodist Hospital

location_facility: University of Colorado Hospital - Anschutz Outpatient Pavilion

location_facility: SBIH "SPb Clinical Research Centre of Specialized Kinds of Medical Care (Oncology)"

location_facility: Lehigh Valley Health Network Cancer Center Pharmacy

location_facility: University of Missouri- Ellis Fischel Cancer Center

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

location_facility: Fundacion Instituto Valenciano de Oncologia

location_facility: Seoul National University Bundang Hospital

location_facility: Chonnam National University Hwasun Hospital

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

location_facility: Petz Aladar Megyei Oktato Koraz, Onkoradiologiai osztaly

location_facility: University of New Mexico Comprehensive Cancer Center

location_facility: Texas Oncology El Paso Cancer Treatment Center

location_facility: Grand Hopital de Charleroi - Site Notre-Dame

location_facility: Xiangya Hospital Central South University/Oncology Department

location_facility: UCSD Radiation Oncology South Bay, Cancer Treatment Centers

location_facility: Harbin Medical University Cancer Hospital

location_facility: Orszagos Onkologiai Intezet, Sugarterapias Osztaly

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

location_facility: Center for Specific Organ Cancer, National Cancer Center

location_facility: FSBI "National Medical Research Center of Oncology n.a. N.N. Petrov"

location_facility: Kantonsspital Winterthur, Medizinische Onkologie

location_facility: University of Maryland School of Medicine

location_facility: St Luke's Radiation Oncology Network, St Luke's Hospital

location_facility: Centrum Onkologii im. prof. F. Lukaszczyka

location_facility: University Hospital Bristol NHS Foundation Trust

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

location_facility: Chang Gung Memorial Hospital-Linkou Branch

location_facility: SBHI YaR "Regional Clinical Oncology Hospital"

location_facility: The Oncology Institute of Hope and Innovation

location_facility: University of Colorado Hospital - Anschutz Inpatient Pavilion

location_facility: Institut Catala d'Oncologia Badalona, Hospital Germans Trias i Pujol

location_facility: Institut de Cancerologie de l'Ouest (ICO) - Site Paul Papin

location_facility: Specjalistyczny Szpital Onkologiczny NU-MED sp. z o.o.

location_facility: Montefiore-Einstein Center for Cancer Care

location_facility: University of Oklahoma Health Sciences Center- Stephenson Cancer Center

location_facility: The West Clinic PC dba West Cancer Center

location_facility: H. Lee Moffitt Cancer Center and Research Institute

location_facility: Lehigh Valley Health Network-Cedar Crest

location_facility: General Oncology Hospital of Kifissia "Agioi Anargiroi"

location_facility: Szegedi Tudomanyegyetem, Szent-Gyorgyi Albert Klinikai Kozpont

location_facility: Department of Radiation Oncology, CHA Bundang Medical Center, CHA University

location_facility: Chris O'Brien Lifehouse Radiation Oncology Department

location_facility: Shanghai East Hospital/Oncology Department

location_facility: Istituto Nazionale Tumori IRCCS - Fondazione Pascale

location_facility: Cancer Institute Hospital, Japanese Foundation for Cancer Research

location_facility: Hopital Pellegrin - Service de radiologie et d'imagerie

location_facility: UOC Oncologia Medica, AUSL della Romagna -RAVENNA

location_facility: Herbert-Herman Cancer Center, Sparrow Hospital

location_facility: Hospital Clinico Universitario Virgen de la Arrixaca

location_facility: West China Hospital of Sichuan University

location_facility: Klinik fur Strahlentherapie und Radioonkologie

location_facility: City of Hope (City of Hope National Medical Center, City of Hope Medical Center)

location_facility: Helios Klinikum Berlin-Buch, Institut fur Rontgendiagnostik

location_facility: Koo Foundation Sun Yat-Sen Cancer Center

location_facility: Affiliated Tumor Hospital of Guangxi Medical University

location_facility: Memorial Sloan Kettering Cancer Center- Nassau

location_facility: Hopital Franco-Britannique, Institut d'Oncologie Hauts-de-Seine Nord

location_facility: Memorial Sloan Kettering Cancer Center Commack

location_facility: UOC Oncologia Medica, AUSL della Romagna - RAVENNA

location_facility: Memorial Sloan Kettering Cancer Center- Monmouth

location_facility: Cancer Center of Guangzhou Medical University/Oncology Department

location_facility: Guy's and St. Thomas' NHS Foundation Trust

location_facility: Medical University of South Carolina- Hollings Cancer Center

location_facility: Oncology Hematology West, PC dba Nebraska Cancer Specialists

location_facility: Memorial Sloan Kettering Cancer Center: Breast and Imaging Center

status: Terminated

title: A RANDOMIZED DOUBLE-BLIND PHASE 3 STUDY OF AVELUMAB IN COMBINATION WITH STANDARD OF CARE CHEMORADIOTHERAPY (CISPLATIN PLUS DEFINITIVE RADIATION THERAPY) VERSUS STANDARD OF CARE CHEMORADIOTHERAPY IN THE FRONT-LINE TREATMENT OF PATIENTS WITH LOCALLY ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK

location_country:
Germany
Ireland
Poland
Australia
Japan
Canada
France
Portugal
Hungary
Switzerland
United States
Belgium
China
Italy
United Kingdom
Austria
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation
Israel


study_start_date_type: Actual

acronym: SEAL

intervention_type: Drug

lead_sponsor: Karyopharm Therapeutics Inc

summary: This is a randomized, multicenter, double-blind, placebo-controlled, Phase 2-3 study of patients diagnosed with advanced unresectable dedifferentiated liposarcoma. Approximately 342 total patients will be randomized to study treatment (selinexor or placebo).

ReferenceType: derived

ReferenceCitation: Gounder MM, Razak AA, Somaiah N, Chawla S, Martin-Broto J, Grignani G, Schuetze SM, Vincenzi B, Wagner AJ, Chmielowski B, Jones RL, Riedel RF, Stacchiotti S, Loggers ET, Ganjoo KN, Le Cesne A, Italiano A, Garcia Del Muro X, Burgess M, Piperno-Neumann S, Ryan C, Mulcahy MF, Forscher C, Penel N, Okuno S, Elias A, Hartner L, Philip T, Alcindor T, Kasper B, Reichardt P, Lapeire L, Blay JY, Chevreau C, Valverde Morales CM, Schwartz GK, Chen JL, Deshpande H, Davis EJ, Nicholas G, Groschel S, Hatcher H, Duffaud F, Herraez AC, Beveridge RD, Badalamenti G, Eriksson M, Meyer C, von Mehren M, Van Tine BA, Gotze K, Mazzeo F, Yakobson A, Zick A, Lee A, Gonzalez AE, Napolitano A, Dickson MA, Michel D, Meng C, Li L, Liu J, Ben-Shahar O, Van Domelen DR, Walker CJ, Chang H, Landesman Y, Shah JJ, Shacham S, Kauffman MG, Attia S. Selinexor in Advanced, Metastatic Dedifferentiated Liposarcoma: A Multinational, Randomized, Double-Blind, Placebo-Controlled Trial. J Clin Oncol. 2022 Aug 1;40(22):2479-2490. doi: 10.1200/JCO.21.01829. Epub 2022 Apr 8.

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: Washington University School of Medicine - Digital Commons@Becker

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

repository_institution: Nova Science Publishers, Inc. - Nova Science Publishers

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

version: submittedVersion

unpaywall_oa_status: hybrid

publisher_dissemination: American Society of Clinical Oncology (ASCO)

location_facility: Klinik und Poliklinik für Innere Medizin III, Hämatologie und Onkologie Klinikum rechts der Isar der TU Muenchen

location_facility: U.O.C. Oncologia Medica Oncology Department

location_facility: Technische Universitaet Dresden Med. Fakultaet Carl Gustav Carus Med. Klinik u. Poliklinik I

location_facility: "Germans Trias Pujol" University Hospital

location_facility: Institut Régional du Cancer de Montpellier (ICM)

location_facility: Cross Cancer Center - Alberta Health Services

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: University of Pittsburgh Medical Center (UPMC)

location_facility: National Center for Tumor Diseases, Univeristy Hospital Heidelberg

location_facility: Policlinico Universitario Campus Biomedico

location_facility: Hospital Universitario Clínico San Carlos

location_facility: James Cancer Center, Ohio State University

status: Completed

title: A Phase 2-3, Multicenter, Randomized, Double-blind Study of Selinexor (KPT-330) Versus Placebo in Patients With Advanced Unresectable Dedifferentiated Liposarcoma (DDLS)

primary_purpose: Treatment

type: EudraCT Number

source: euctr

enrollment_type: Actual

design_allocation: Randomized

study_completion_date_type: Actual

location_country:
Germany
Italy
Israel
United Kingdom
Sweden
Belgium
United States
Spain
Canada
France

study_type: Interventional

ipd_sharing: Undecided

lead_sponsor_type: industriel

status_simplified: Completed


acronym: ReTHINK

lead_sponsor: Novartis Pharmaceuticals

summary: Myelofibrosis patients with high molecular risk mutations have an intrinsically aggressive disease with increased risk of leukemic transformation and reduced overall survival. As there are no therapies currently established in the subset of high molecular risk patients with early myelofibrosis, the study aimed to evaluate ruxolitinib in this patient population.

title: A Randomized, Double Blind, Placebo-controlled, Multicenter, Phase III Study Investigating the Efficacy and Safety of Ruxolitinib in Early Myelofibrosis Patients With High Molecular Risk Mutations

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

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

location_country:
Germany
Poland
Australia
Brazil
Japan
Turkey
Canada
France
Portugal
Hungary
Hong Kong
Denmark
Switzerland
Belgium
Italy
Norway
Singapore
United Kingdom
Sweden
Austria
Spain
Greece
Taiwan
Russian Federation
Israel

ipd_sharing: Yes

status_simplified: Unknown


lead_sponsor: Seagen Inc.

summary: This is a randomized, open-label, multicenter, Phase 2 clinical trial designed to evaluate the efficacy and safety of brentuximab vedotin in combination with rituximab and bendamustine for the treatment of patients with relapsed or refractory CD30-positive diffuse large B-cell lymphoma (DLBCL) after failure of second-line salvage therapy or as second-line treatment in patients ineligible for autologous stem cell transplant (ASCT).

location_facility: The Oncology Institute of Hope and Innovation

location_facility: Centre Hospitalier Universitaire de Rennes, Hôpital Pontchaillou

location_facility: Hospital Clinico Universitario Lozano Blesa de Zaragoza

location_facility: University Hospital's Birmingham NHS Foundation trust-Queen Elizabeth Hospital

location_facility: Azienda Ospedaliera Spedali Civili di Brescia

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

location_facility: Centre Hospitalier Universitaire de Nantes (CHU Nantes) - Hotel Dieu

location_facility: Hematology and Oncology Associates of Northern New Jersey, P.A.

location_facility: Centre Hospitalier Universitaire (CHU) de Poitier- Hopital de la Miletrie - Hopital Jean Bernard

location_facility: Centre Hospitalier Regional Universitaire (CHRU) Brest - Hopital Morvan

location_facility: A.O Ospadale Di Circolo E Fondazione Macchi

location_facility: Willamette Valley Cancer Institute and Research Center

location_facility: Greenville Health System Institutional Review Board

location_facility: Oncology and Hematology Associates of Southwest Virginia, Inc.

location_facility: IRCCS Ospedale Casa Sollievo della Sofferenza

title: A Randomized, Open Label, Phase 2 Study of Rituximab and Bendamustine With or Without Brentuximab Vedotin for Relapsed or Refractory CD30-Positive Diffuse Large B-Cell Lymphoma

location_country:
Italy
Poland
United Kingdom
United States
Spain
Czechia
France


title: COMPLEEMENT-1: An Open-label, Multicenter, Phase IIIb Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With Hormone Receptor-positive (HR+) HER2-negative (HER2-) Advanced Breast Cancer (aBC) With no Prior Hormonal Therapy for Advanced Disease

summary: The purpose of this study is to collect additional safety and efficacy data for the combination of ribociclib + letrozole in men and pre/postmenopausal women with HR+HER2- advanced breast cancer and no prior hormonal treatment for advanced disease..

ReferenceCitation: Caputo R, Fabi A, Romagnoli E, Baldini E, Grasso D, Fenderico N, Michelotti A. Ribociclib Plus Letrozole in Italian Male Patients with Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: Case Studies of Phase 3b CompLEEment-1 Trial. Breast Cancer (Dove Med Press). 2022 Oct 18;14:351-362. doi: 10.2147/BCTT.S376902. eCollection 2022.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Informa

ReferenceCitation: Salvador Bofill J, Moreno Anton F, Rodriguez Sanchez CA, Galve Calvo E, Hernando Melia C, Ciruelos Gil EM, Vidal M, Jimenez-Rodriguez B, De la Cruz Merino L, Martinez Janez N, Villanueva Vazquez R, de Toro Salas R, Anton Torres A, Alvarez Lopez IM, Gavila Gregori J, Quiroga Garcia V, Vicente Rubio E, De la Haba-Rodriguez J, Gonzalez-Santiago S, Diaz Fernandez N, Barnadas Molins A, Cantos Sanchez de Ibarguen B, Delgado Mingorance JI, Bellet Ezquerra M, de Casa S, Gimeno A, Martin M. Safety and efficacy of ribociclib plus letrozole in patients with HR+, HER2- advanced breast cancer: Results from the Spanish sub-population of the phase 3b CompLEEment-1 trial. Breast. 2022 Dec;66:77-84. doi: 10.1016/j.breast.2022.09.006. Epub 2022 Sep 28.

oa_host_type: repository

license: cc-by

license_normalized: cc-by

repository_institution: Universitat Autònoma de Barcelona - Dipòsit Digital de Documents de la UAB

repository_institution: Spanish National Research Council (CSIC) - DIGITAL.CSIC

repository_normalized: DIGITAL.CSIC (Spain)

unpaywall_oa_status: green

publisher_dissemination: Elsevier

ReferenceCitation: De Laurentiis M, Caputo R, Mazza M, Mansutti M, Masetti R, Ballatore Z, Torrisi R, Michelotti A, Zambelli A, Ferro A, Generali D, Vici P, Coltelli L, Fabi A, Marchetti P, Ballestrero A, Spazzapan S, Frassoldati A, Sarobba MG, Grasso D, Zamagni C. Safety and Efficacy of Ribociclib in Combination with Letrozole in Patients with HR+, HER2- Advanced Breast Cancer: Results from the Italian Subpopulation of Phase 3b CompLEEment-1 Study. Target Oncol. 2022 Nov;17(6):615-625. doi: 10.1007/s11523-022-00913-x. Epub 2022 Sep 24.

evidence: open (via crossref license)

publisher_dissemination: Springer-Nature

ReferenceCitation: Campone M, De Laurentiis M, Zamagni C, Kudryavcev I, Agterof M, Brown-Glaberman U, Palacova M, Chatterjee S, Menon-Singh L, Wu J, Martin M. Ribociclib plus letrozole in male patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: subgroup analysis of the phase IIIb CompLEEment-1 trial. Breast Cancer Res Treat. 2022 May;193(1):95-103. doi: 10.1007/s10549-022-06543-1. Epub 2022 Feb 25.

oa_host_type: closed

repositories_concat: closed

ReferenceCitation: De Laurentiis M, Borstnar S, Campone M, Warner E, Bofill JS, Jacot W, Dent S, Martin M, Ring A, Cottu P, Lu J, Ciruelos E, Azim HA, Chatterjee S, Zhou K, Wu J, Menon-Singh L, Zamagni C. Full population results from the core phase of CompLEEment-1, a phase 3b study of ribociclib plus letrozole as first-line therapy for advanced breast cancer in an expanded population. Breast Cancer Res Treat. 2021 Oct;189(3):689-699. doi: 10.1007/s10549-021-06334-0. Epub 2021 Aug 19. Erratum In: Breast Cancer Res Treat. 2021 Oct 8;:

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

repositories_concat: PubMed Central;www.repositoriosalud.es

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

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

location_country:
Finland
Poland
Taiwan
Argentina
Thailand
Chile
Czechia
Canada
France
Slovenia
Portugal
Slovakia
Hungary
Hong Kong
Denmark
United States
India
Lebanon
Belgium
Malaysia
Oman
Philippines
Italy
Norway
Singapore
United Kingdom
Sweden
Netherlands
Austria
Mexico
Saudi Arabia
Spain
Greece
Panama
Jordan
Bulgaria
Russian Federation
Israel

location_facility: Greater Baltimore Medical Center Cancer Center Greater Baltimore Medical Ctr

location_facility: California Pacific Medical Center Onc Dept

location_facility: Northwest Medical Specialties Dept.ofNW Med. Specialties

location_facility: Providence Regional Medical Centre of Everett

location_facility: Sarah Cannon at Overland Park Regional Medical Center

location_facility: University Hospitals of Cleveland Seidman Cancer Center Cleveland Medical Center

location_facility: Maryland Oncology Hematology P A Columbia

location_facility: Oklahoma Cancer Specialists and Research Institute SC-2

location_facility: Joliet Oncology-Hematology Associates Presence Cancer Center

location_facility: Summit Cancer Care Summit Cancer Care (SC)

location_facility: University of Kansas Medical Center University of Kansas Med Ctr 9

location_facility: McLeod Center for Cancer Treatment and Research

location_facility: The Christ Hospital Cancer Center Research Program Linder Research Center

location_facility: Millennium Research Clin Develop Millennium Oncology - FL

location_facility: Columbia St Mary s Hospital of Milwaukee St. Mary's Hospital Ozaukee

location_facility: University of California Irvine UC Irvine (11)

location_facility: Alaska Cancer Research and Education Center

location_facility: Medical Faculty Assc Inc Medical Faculty Assc., Inc. (2

location_facility: Comprehensive Cancer Centers of Nevada CCC of Nevada Henderson (4)

location_facility: Carolina Blood and Cancer Care of South Carolina

location_facility: Cheyenne Regional Medical Center Cheyenne Regional Med Ctr (3)

location_facility: Virginia Mason Medical Center-Oncology SC

location_facility: Foundation for Sickle Cell Disease Research

location_facility: John D Archbold Memorial Hospital John D. Archbold Mem Hosp (4)

location_facility: Indian Univ Health Goshen Center forCancer SC

location_facility: Poudre Valley Hospital Poudre Valley Health System

location_facility: Cleveland Clinic Foundation Cleveland Clinic (5)

location_facility: Valley Medical Center Research Valley Medical Center

location_facility: Mid Illinois Hematology Oncology Mid Illinois Hema/Onc (3)

location_facility: Arizona Oncology Associates Arizona Oncology Assoc. (2)

location_facility: Nebraska Cancer Specialists Oncology Hematology West

location_facility: John Ochsner Heart and Vascular Institute Clinical Trials

location_facility: Centura Health Research Center Centura Health Research Center

location_facility: Somerset Hematology Oncology Associates Somerset Hematolgy Onc -MI

location_facility: Watson Clinic Center for Research 1730 Location

location_facility: Stroger Cook County Hospital Division of Hematology & Onc

location_facility: Florida Cancer Research Institute Dept of Oncology


lead_sponsor: Shire

summary: The purpose of this study is to compare the efficacy of maribavir to investigator-assigned anti-Cytomegalovirus (CMV) therapy in CMV viremia clearance in transplant recipients who are refractory or resistant to prior anti-CMV treatment.

ReferenceCitation: Avery RK, Alain S, Alexander BD, Blumberg EA, Chemaly RF, Cordonnier C, Duarte RF, Florescu DF, Kamar N, Kumar D, Maertens J, Marty FM, Papanicolaou GA, Silveira FP, Witzke O, Wu J, Sundberg AK, Fournier M; SOLSTICE Trial Investigators. Maribavir for Refractory Cytomegalovirus Infections With or Without Resistance Post-Transplant: Results From a Phase 3 Randomized Clinical Trial. Clin Infect Dis. 2022 Sep 10;75(4):690-701. doi: 10.1093/cid/ciab988. Erratum In: Clin Infect Dis. 2023 Feb 8;76(3):560.

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories:
LIRIAS (KU Leuven)
PubMed Central

repositories_concat: LIRIAS (KU Leuven);PubMed Central

publisher_dissemination: Oxford University Press

ReferenceCitation: Del Pozo Martin Y. 47th Annual Meeting of the EBMT. Lancet Haematol. 2021 May;8(5):e317-e318. doi: 10.1016/S2352-3026(21)00104-6. Epub 2021 Mar 31. No abstract available.

oa_colors: green other

evidence: open (via free pdf)

unpaywall_oa_status: bronze

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi

location_facility: Hospital Universitario Vall d'Hebrón - PPDS

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: University of Texas Southwestern Medical Center

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: University Hospitals Cleveland Medical Center

location_facility: Medical University of South Carolina - PPDS

location_facility: Azienda Sanitaria Universitaria Integrata di Udine

location_facility: Complejo Asistencial Universitario de Salamanca - H. Clinico

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Beatson West of Scotland Cancer Centre - PPDS

location_facility: Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital

location_facility: University of Utah Health Sciences Center - PPDS

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Royal Liverpool and Broadgreen University Hospitals NHS Trust

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Groupe Hospitalier Necker Enfants Malades

location_facility: Centre Hospitalier Universitaire Sainte-Justine

location_facility: Fondazione Policlinico Universitario A Gemelli

location_facility: New York Presbyterian Hospital - Weill-Cornell

location_facility: Feinberg School of Medicine Northwestern University

location_facility: Cincinnati Children's Hospital Medical Center - PIN

location_facility: Azienda Ospedaliero Universitaria Pisana

title: A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study to Assess the Efficacy and Safety of Maribavir Treatment Compared to Investigator-assigned Treatment in Transplant Recipients With Cytomegalovirus (CMV) Infections That Are Refractory or Resistant to Treatment With Ganciclovir, Valganciclovir, Foscarnet, or Cidofovir

ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

location_country:
Germany
Italy
United Kingdom
Singapore
Denmark
Australia
Switzerland
Austria
Belgium
United States
Spain
Croatia
Canada
France


acronym: GALACTIC-HF

lead_sponsor: Cytokinetics

summary: The purpose of this study is to determine if treatment with omecamtiv mecarbil when added to standard of care is well tolerated and superior to placebo in reducing the risk of cardiovascular death or heart failure events in adults with chronic heart failure with reduced ejection fraction (HFrEF).

ReferenceType: background

ReferenceCitation: Teerlink JR, Diaz R, Felker GM, McMurray JJV, Metra M, Solomon SD, Biering-Sorensen T, Bohm M, Bonderman D, Fang JC, Lanfear DE, Lund M, Momomura SI, O'Meara E, Ponikowski P, Spinar J, Flores-Arredondo JH, Claggett BL, Heitner SB, Kupfer S, Abbasi SA, Malik FI; GALACTIC-HF Investigators. Effect of Ejection Fraction on Clinical Outcomes in Patients Treated With Omecamtiv Mecarbil in GALACTIC-HF. J Am Coll Cardiol. 2021 Jul 13;78(2):97-108. doi: 10.1016/j.jacc.2021.04.065. Epub 2021 May 17.

ReferenceCitation: Solomon SD, Claggett BL, Miao ZM, Diaz R, Felker GM, McMurray JJV, Metra M, Corbalan R, Filippatos G, Goudev AR, Mareev V, Serpytis P, Suter T, Yilmaz MB, Zannad F, Kupfer S, Heitner SB, Malik FI, Teerlink JR. Influence of atrial fibrillation on efficacy and safety of omecamtiv mecarbil in heart failure: the GALACTIC-HF trial. Eur Heart J. 2022 Jun 14;43(23):2212-2220. doi: 10.1093/eurheartj/ehac144. Erratum In: Eur Heart J. 2022 Jun 18;:

oa_host_type: publisher

evidence: open (via free article)

ReferenceCitation: Felker GM, Solomon SD, Claggett B, Diaz R, McMurray JJV, Metra M, Anand I, Crespo-Leiro MG, Dahlstrom U, Goncalvesova E, Howlett JG, MacDonald P, Parkhomenko A, Tomcsanyi J, Abbasi SA, Heitner SB, Hucko T, Kupfer S, Malik FI, Teerlink JR. Assessment of Omecamtiv Mecarbil for the Treatment of Patients With Severe Heart Failure: A Post Hoc Analysis of Data From the GALACTIC-HF Randomized Clinical Trial. JAMA Cardiol. 2022 Jan 1;7(1):26-34. doi: 10.1001/jamacardio.2021.4027.

publisher_dissemination: American Medical Association

ReferenceCitation: Teerlink JR, Diaz R, Felker GM, McMurray JJV, Metra M, Solomon SD, Adams KF, Anand I, Arias-Mendoza A, Biering-Sorensen T, Bohm M, Bonderman D, Cleland JGF, Corbalan R, Crespo-Leiro MG, Dahlstrom U, Echeverria LE, Fang JC, Filippatos G, Fonseca C, Goncalvesova E, Goudev AR, Howlett JG, Lanfear DE, Li J, Lund M, Macdonald P, Mareev V, Momomura SI, O'Meara E, Parkhomenko A, Ponikowski P, Ramires FJA, Serpytis P, Sliwa K, Spinar J, Suter TM, Tomcsanyi J, Vandekerckhove H, Vinereanu D, Voors AA, Yilmaz MB, Zannad F, Sharpsten L, Legg JC, Varin C, Honarpour N, Abbasi SA, Malik FI, Kurtz CE; GALACTIC-HF Investigators. Cardiac Myosin Activation with Omecamtiv Mecarbil in Systolic Heart Failure. N Engl J Med. 2021 Jan 14;384(2):105-116. doi: 10.1056/NEJMoa2025797. Epub 2020 Nov 13.

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

repository_normalized: HAL

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

repository_institution: Universidade Da Coruña - RUC

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

repository_institution: The University of Glasgow - Enlighten: Publications

version: acceptedVersion

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Teerlink JR, Diaz R, Felker GM, McMurray JJV, Metra M, Solomon SD, Legg JC, Buchele G, Varin C, Kurtz CE, Malik FI, Honarpour N. Omecamtiv Mecarbil in Chronic Heart Failure With Reduced Ejection Fraction: Rationale and Design of GALACTIC-HF. JACC Heart Fail. 2020 Apr;8(4):329-340. doi: 10.1016/j.jchf.2019.12.001. Epub 2020 Feb 6.

title: A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Omecamtiv Mecarbil on Mortality and Morbidity in Subjects With Chronic Heart Failure With Reduced Ejection Fraction (GALACTIC-HF)

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

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Japan
Turkey
Chile
Czechia
Canada
France
Lithuania
Colombia
Portugal
Slovakia
Hungary
Denmark
Switzerland
United States
Ukraine
Romania
Belgium
China
Puerto Rico
Italy
United Kingdom
Netherlands
Austria
Mexico
Spain
Greece
South Africa
Bulgaria
Russian Federation
Sweden


title: An International, Multi-Center, Open-Label, Randomized, Phase III Trial of Sacituzumab Govitecan Versus Treatment of Physician Choice in Patients With Metastatic Triple-Negative Breast Cancer Who Received at Least Two Prior Treatments

acronym: ASCENT

summary: The primary objective of this study is to compare the efficacy of sacituzumab govitecan to the treatment of physician's choice (TPC) as measured by independently-reviewed Independent Review Committee (IRC) progression-free survival (PFS) in participants with locally advanced or metastatic triple-negative breast cancer (TNBC) previously treated with at least two systemic chemotherapy regimens for unresectable, locally advanced or metastatic disease, and without brain metastasis at baseline.

ReferenceCitation: Bardia A, Mayer IA, Vahdat LT, Tolaney SM, Isakoff SJ, Diamond JR, O'Shaughnessy J, Moroose RL, Santin AD, Abramson VG, Shah NC, Rugo HS, Goldenberg DM, Sweidan AM, Iannone R, Washkowitz S, Sharkey RM, Wegener WA, Kalinsky K. Sacituzumab Govitecan-hziy in Refractory Metastatic Triple-Negative Breast Cancer. N Engl J Med. 2019 Feb 21;380(8):741-751. doi: 10.1056/NEJMoa1814213.

ReferenceType: result

ReferenceCitation: Huvitz SA, Tolaney SM, Punie K, et al. 2020 SABCS GS3-06. Biomarker evaluation in the phase 3 ASCENT study of sacituzumab govitecan versus chemotherapy in patients with metastatic triple-negative breast cancer. San Antonio Breast Cancer Symposium; December 8-11, 2020; San Antonio, TX.

ReferenceCitation: Dieras V, Weaver R, Tolaney SM, et al. 2020 SABCS PD13-07. Subgroup analysis of patients with brain metastases from the phase 3 ASCENT study of sacituzumab govitecan versus chemotherapy in metastatic triple-negative breast cancer. San Antonio Breast Cancer Symposium; December 8-11, 2020; San Antonio, TX.

ReferenceCitation: Rugo HS, Tolaney SM, Loirat D, et al. 2020 SABCS PS11-09. Impact of UGT1A1 status on the safety profile of sacituzumab govitecan in the phase 3 ASCENT study in patients with metastatic triple-negative breast cancer. San Antonio Breast Cancer Symposium; December 8-11, 2020; San Antonio, TX.

ReferenceCitation: Bardia A, Tolaney SM, Loirat D, et al. ASCENT: A randomized phase III study of sacituzumab govitecan (SG) vs treatment of physician's choice (TPC) in patients (pts) with previously treated metastatic triple-negative breast cancer (mTNBC). Annals of Oncology (2020) 31 (suppl_4): S1142-S1215. 10.1016/annonc/annonc325

ReferenceCitation: Bardia A, Rugo RS, Horne H, et al. A phase III, randomized trial of sacituzumab govitecan (IMMU-132) vs treatment of physician choice (TPC) for metastatic triple-negative breast cancer (mTNBC). Cancer Res. 2018;78 (4 Supplement): OT2-07-05

ReferenceCitation: O'Shaughnessy J, Brufsky A, Rugo HS, Tolaney SM, Punie K, Sardesai S, Hamilton E, Loirat D, Traina T, Leon-Ferre R, Hurvitz SA, Kalinsky K, Bardia A, Henry S, Mayer I, Zhu Y, Phan S, Cortes J. Analysis of patients without and with an initial triple-negative breast cancer diagnosis in the phase 3 randomized ASCENT study of sacituzumab govitecan in metastatic triple-negative breast cancer. Breast Cancer Res Treat. 2022 Sep;195(2):127-139. doi: 10.1007/s10549-022-06602-7. Epub 2022 May 11.

repository_institution: California Digital Library - eScholarship

repositories_concat: PubMed Central;escholarship.org

repositories_institution: California Digital Library - eScholarship

ReferenceCitation: Bardia A, Hurvitz SA, Rugo HS, Brufsky A, Cortes J, Loibl S, Piccart M, Cowden J, Spears P, Carey LA. A plain language summary of the ASCENT study: Sacituzumab Govitecan for metastatic triple-negative breast cancer. Future Oncol. 2021 Oct 1;17(30):3911-3924. doi: 10.2217/fon-2021-0868. Epub 2021 Sep 1.

license: cc-by-nd

license_normalized: cc-by-nd

publisher_dissemination: Future Science Ltd

ReferenceCitation: Bardia A, Hurvitz SA, Tolaney SM, Loirat D, Punie K, Oliveira M, Brufsky A, Sardesai SD, Kalinsky K, Zelnak AB, Weaver R, Traina T, Dalenc F, Aftimos P, Lynce F, Diab S, Cortes J, O'Shaughnessy J, Dieras V, Ferrario C, Schmid P, Carey LA, Gianni L, Piccart MJ, Loibl S, Goldenberg DM, Hong Q, Olivo MS, Itri LM, Rugo HS; ASCENT Clinical Trial Investigators. Sacituzumab Govitecan in Metastatic Triple-Negative Breast Cancer. N Engl J Med. 2021 Apr 22;384(16):1529-1541. doi: 10.1056/NEJMoa2028485.

repository_institution: University of North Carolina at Chapel Hill - Carolina Digital Repository

ReferenceCitation: McCann KE, Hurvitz SA. Innovations in targeted therapies for triple negative breast cancer. Curr Opin Obstet Gynecol. 2021 Feb 1;33(1):34-47. doi: 10.1097/GCO.0000000000000671.

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Seligson JM, Patron AM, Berger MJ, Harvey RD, Seligson ND. Sacituzumab Govitecan-hziy: An Antibody-Drug Conjugate for the Treatment of Refractory, Metastatic, Triple-Negative Breast Cancer. Ann Pharmacother. 2021 Jul;55(7):921-931. doi: 10.1177/1060028020966548. Epub 2020 Oct 17.

publisher_dissemination: SAGE Publications

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy/

lead_sponsor: Gilead Sciences

location_country:
Germany
United Kingdom
Belgium
United States
Spain
Canada
France

location_facility: Washington University School of Medicine in St. Louis

location_facility: University Cancer & Blood Center, 3320 Old Jefferson Rd

location_facility: North Shore Hematology Oncology Associates., PC, 285 Sills Road Building 16

location_facility: Florida Cancer Specialists & Research Institute, 1201 Fifth Avenue North

location_facility: Hospital Quirón Barcelona, Plaza Alfonso Comín 5

location_facility: Nottingham University Hospitals NHS Trust - City Hospital

location_facility: Florida Cancer Specialists & Research Institute, 601 E. Altamonte Drive

location_facility: West Cancer Center, 7945 Wolf River Blvd

location_facility: Hospital Universitari Arnau de Vilanova de Lleida

location_facility: MidAmerica Division Inc. c/o Menorah Medical Center

location_facility: Florida Cancer Specialists & Research Institute, 8763 River Crossing Blvd

location_facility: Colchester Hospital University NHS Foundation Trust - Colchester General Hospital, Turner Road

location_facility: Rocky Mountain Cancer Centers, 11750 West 2nd Place, Suite 1-100

location_facility: Plymouth Hospitals NHS Trust - Derriford Hospital

location_facility: North Shore Hematology Oncology Associates., PC, 235 North Belle Mead Road

location_facility: UPMC Hillman Cancer Center UPMC Passavant

location_facility: Florida Cancer Specialists & Research Institute, 100 Highland Avenue

location_facility: Baptist Health Medical Group Oncology, LLC

location_facility: The County Hospital, Wye Valley NHS Trust

location_facility: Florida Cancer Specialists & Research Institute, 560 Jackson St

location_facility: Institut Catala d'Oncologia Hospitalet, Avenida Gran Via 199-203

location_facility: Florida Cancer Specialists & Research Institute, 70 W Gore Street

location_facility: University of Chicago Comprehensive Cancer Center at Silver Cross Hospital 1900 Silver Cross Blvd

location_facility: The Royal Free London NHS Foundation Trust - The Royal Free Hospital, Pond Street Oncology & Haematology Clinical Trials Unit Dept. of Academic Oncology

location_facility: Florida Cancer Specialists & Research Institute, 6420 W Newberry Road Est Wing

location_facility: Taunton and Somerset NHS Foundation Trust - Musgrove Park Hospital, Musgrove Park Hospital

location_facility: Cross Cancer Institute, 11560 University Avenue

location_facility: Rocky Mountain Cancer Centers, 8820 Huron Street

location_facility: The Royal Surrey County Hospital NHS Foundation Trust

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

location_facility: Florida Cancer Specialists & Research Institute, 3280 McMullen Booth road

location_facility: Nebraska Cancer Specialists - Midwest Cancer Center - Papillion

location_facility: Mass General - North Shore Cancer Center ( NSCC )

location_facility: Florida Cancer Specialists & Research Institute, 4100 Waterman Way

location_facility: Florida Cancer Specialists & Research Institute - 3730 7th Terrace

location_facility: Hospital de la Santa Creu i Sant Pau, Carrer del Mas Casanovas, 90

location_facility: UCLA Jonsson Comprehensive Cancer Center

location_facility: University of Kansas Cancer Center - The Richard and Annette Bloch Cancer Care Pavilion

location_facility: Florida Cancer Specialists & Research Institute, 1400 US highway 441 N

location_facility: Rocky Mountain Cancer Centers, 1700 South Potomac Street

location_facility: Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus

location_facility: Virginia G. Piper Cancer Center at HonorHealth

location_facility: Institut Régional du Cancer de Montpellier

location_facility: The Arden Cancer Centre- University Hospital Coventry

location_facility: UCLA Jonsson Comprehensive Cancer Center, 625 South Fair Oaks Avenue Suite 320

location_facility: UPMC Hillman Cancer Center Upper Saint Clair

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

location_facility: Southern Cancer Center, 3 Mobile Infirmary Circle

location_facility: Nebraska Cancer Specialists- Midwest Cancer Center- Papillion

location_facility: Rocky Mountain Cancer Centers, 1800 Williams St.

location_facility: Florida Cancer Specialists & Research Institute, 1037 State Road 7 Bldg B

location_facility: Allegheny-Singer Research Institute, 320 East North Avenue

location_facility: The Mid Yorkshire Hospitals NHS Trust - Pinderfields Hospital

location_facility: University of California, San Francisco (UCSF) - Innovation, Technology & Alliances, 1600 Divisadero Street

location_facility: Rocky Mountain Cancer Centers, 3676 Parker Blvd., Suite 350

location_facility: Nebraska Cancer Specialists - Midwest Cancer Center - Paillion

location_facility: UCLA Jonsson Comprehensive Cancer Center, 2020 Santa Monica Boulevard

location_facility: Sarah Cannon Cancer Institute/Tennessee Oncology

location_facility: Vanderbilt Breast Cancer Center at One Hundred Oaks 719 Thompson Lane, Suite 25000

location_facility: UCLA Jonsson Comprehensive Cancer Center, 1411 S. Garfield Ave Suite 200

location_facility: Orland Park - UCMC Center for Advanced Care 14290 South LaGrange Rd

location_facility: Tennessee Oncology - Chattanooga Oncology & Hematology Associates

location_facility: Southern Cancer Center, 6701 Airport Blvd., Bldg B, Terace Level

location_facility: Florida Cancer Specialists & Research Institute, 224 Memorial medical Parway

location_facility: Florida Cancer Specialists & Research Institute, 521 N. Lecanto Highway

location_facility: University of Colorado Hospital - Anschutz Cancer Pavilion, 1665 Aurora Court

location_facility: Florida Cancer Specialists & Research Institute, 2100 Glenwood Drive

location_facility: Texas Oncology- Medical City Dallas Building D

location_facility: Florida Cancer Specialists & Research Institute, 403 S. King Ave

location_facility: UCLA Jonsson Comprehensive Cancer Center, 200 UCLA Medical Plaza

location_facility: Centre de Lutte Contre le Cancer - Institut de Cancerologie de l'Ouest - Paul Papin

location_facility: Queen Elizabeth II Health Sciences Centre

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

location_facility: Florida Cancer Specialists & Research Institute, 765 Image Way

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

location_facility: Florida Cancer Specialists & Research Institute, 1630 SE 18th ST

location_facility: Souther Cancer Center, 3719 Dauphin St., 5 Floor

location_facility: Rocky Mountain Cancer Centers, 22 West Dry Creek Circle

location_facility: Institut für Versorgungsforschung in der Onkologie

location_facility: Rocky Mountain Cancer Centers, 10103 Ridge Gate Parkway, Suite G-01

location_facility: The Ohio State University Wexner Medical Center, 1145 Olentangy River Road

location_facility: Jewish General Hospital, 3755 Côte-Sainte-Catherine

location_facility: Rocky Mountain Cancer Centers, 4700 E. Hale Parkway, Suite 400

location_facility: Florida Cancer Specialists & Research Institute1309 N Flagler Dr

location_facility: Rocky Mountain Cancer Centers, 4715 Arapahoe Ave

location_facility: Southern Cancer Center, 29653 Anchor Cross Blvd

location_facility: Georgetown Lombardi Comprehensive Cancer Center

location_facility: Florida Cancer Specialists & Research Institute, 7154 Medical Center Drive

location_facility: Beth Israel Deaconess Medical Center (BIDMC)

location_facility: County Durham and Darlington NHS Foundation Trust - University Hospital of North Durham

location_facility: Rocky Mountain Cancer Centers, 2030 W Mountain View Avenue, Ste. 210

location_facility: Praxis für interdisziplinäre Onkologie & Hämatologie GbR

location_facility: UPMC Hillman Cancer Center Mountainview Arnold Palmer Pavilion

location_facility: University of Chicago Medical Center 5841 S. Maryland Ave

location_facility: Henry-Joyce Cancer Clinic 1301 Medical Center Drive 1903 The Vanderbilt Clinic Nashville, TN 37232

location_facility: Praxis für Hämatologie und Internistische Onkologie

location_facility: Florida Cancer Specialists & Research Institute - 325 Clyde Morris

location_facility: UCLA Jonsson Comprehensive Cancer Center, 201. S. Buena Vista St Suite 200

location_facility: The Ohio State University Wexner Medical Center, 460 W 10th Ave

location_facility: Rocky Mountain Cancer Centers, 499 E Hampden Ave Suite 450

location_facility: Rocky Mountain Cancer Centers, 2312 N. Nevada Avenue, Suite 400

location_facility: Houston Methodist Hospital - 6565 Fannin St

location_facility: Florida Cancer Specialists & Research Institute, 3402 W Dr. Martin Luther King Jr Boulevard

location_facility: Rocky Mountain Cancer Centers, 9397 Crown Crest Blvd., Suite 421


acronym: Project blue

lead_sponsor: EMD Serono Research & Development Institute, Inc.

summary: This study looked at how effective the study drug (tepotinib) was at stopping the growth and spread of lung cancer. This study also measures a number of other things including safety of the study drug and the side effects, how body processes the study drug, or how the study drug affects your quality of life. The study also has an optional pharmacogenetic research part. Pharmacogenetic research is an important way to try to understand the role of genetics in human disease and how genes impact the effectiveness of drugs, because differences in genes can change the way a person responds to a particular drug.

ReferenceCitation: Paik PK, Felip E, Veillon R, Sakai H, Cortot AB, Garassino MC, Mazieres J, Viteri S, Senellart H, Van Meerbeeck J, Raskin J, Reinmuth N, Conte P, Kowalski D, Cho BC, Patel JD, Horn L, Griesinger F, Han JY, Kim YC, Chang GC, Tsai CL, Yang JC, Chen YM, Smit EF, van der Wekken AJ, Kato T, Juraeva D, Stroh C, Bruns R, Straub J, Johne A, Scheele J, Heymach JV, Le X. Tepotinib in Non-Small-Cell Lung Cancer with MET Exon 14 Skipping Mutations. N Engl J Med. 2020 Sep 3;383(10):931-943. doi: 10.1056/NEJMoa2004407. Epub 2020 May 29.

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

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

ReferenceCitation: Xiong W, Hietala SF, Nyberg J, Papasouliotis O, Johne A, Berghoff K, Goteti K, Dong J, Girard P, Venkatakrishnan K, Strotmann R. Exposure-response analyses for the MET inhibitor tepotinib including patients in the pivotal VISION trial: support for dosage recommendations. Cancer Chemother Pharmacol. 2022 Jul;90(1):53-69. doi: 10.1007/s00280-022-04441-3. Epub 2022 Jun 30.

ReferenceCitation: Xiong W, Papasouliotis O, Jonsson EN, Strotmann R, Girard P. Population pharmacokinetic analysis of tepotinib, an oral MET kinase inhibitor, including data from the VISION study. Cancer Chemother Pharmacol. 2022 May;89(5):655-669. doi: 10.1007/s00280-022-04423-5. Epub 2022 Apr 6.

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: Seconda Università degli Studi di Napoli

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku - Dept of Pulmonology & Tuberculosis

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Centre Hospitalier Départemental Les Oudairies

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Universitaetsspital Zuerich - Klinik fuer Onkologie

location_facility: Charite Universitaetsmedizin Berlin - Campus Charite Mitte

location_facility: For Recruiting Locations in the United States, please Contact U.S. Medical Information

location_facility: Universitaetsklinikum Carl Gustav Carus TU Dresden

location_facility: Centrum Pulmonologii i Torakochirurgii w Bystrej

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

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: For Recruiting Locations outside US, please Contact Merck KGaA Communication Center

location_facility: Hackensack University Medical Center PARTNER

location_facility: Groupe Hospitalier Sud - Hôpital Haut-Lévêque

location_facility: Kyungpook National University Medical Center

location_facility: Hospital Universitario HM Madrid Sanchinarro

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

location_facility: Dr n med. Slawomir Mandziuk Specjalistyczna Praktyka Lekarska

location_facility: California Cancer Associates for Research & Excellence, Inc.

location_facility: Hospital de Especialidades de Jerez de la Frontera - Servicio de Oncologia

location_facility: Universitair Medisch Centrum Groningen (UMCG) - Parent

location_facility: Somerset Hematology Oncology Associates - Somerville Location

location_facility: Hospital Clinico Universitario Virgen de la Victoria

location_facility: Affiliated Tumor Hospital of Harbin Medical University

location_facility: Staedtisches Klinikum Dresden Standort Dresden-Friedrichstadt

location_facility: Hospital General Universitario Santa Lucia

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

location_facility: Centrum Onkologii-Instytut im. M. Sklodowskiej Curie

location_facility: Seoul National University Bundang Hospital

location_facility: Chonnam National University Hwasun Hospital

location_facility: Hospital Universitario Nuestra Señora de Valme

location_facility: LKH - Universitätsklinikum der PMU Salzburg - Innere Med III/Hämatologie und Onkologie

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Wenatchee Valley Medical Center Oncology

location_facility: Anhui Provincial Cancer Hospital aka West Branch of Anhui Province Hospital

location_facility: Wenatchee Valley Hospital & Clinics - ATTN: Jay Johnson

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Memorial Sloan Kettering Cancer Center - Commack

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

location_facility: Istituto Nazionale per la Ricerca sul Cancro di Genova

location_facility: Inselspital - Universitaetsspital Bern - Klinik und Poliklinik für Medizinische Onkologie

location_facility: Regional Cancer Care Associates East Brunswick

location_facility: Shanghai Cancer Hospital, Fudan University

location_facility: Memorial Sloan Kettering Cancer Center, West Harrison Regional Outpatient Pavilion

location_facility: The Affiliated Cancer Hospital of Xinjiang Medical university

location_facility: NZOZ Olsztynski Osr. Onkologiczny "Kopernik" Sp.z o.o

status: Active, not recruiting

title: A Phase II Single-arm Trial to Investigate Tepotinib in Advanced (Locally Advanced or Metastatic) Non-small Cell Lung Cancer With METex14 Skipping Alterations or MET Amplification (VISION)

ipd_sharing_description: We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21

study_completion_date_type: Anticipated

location_country:
Germany
Italy
Poland
Israel
Japan
Netherlands
Austria
Belgium
Switzerland
United States
China
Korea, Republic of
Spain
Taiwan
France

status_simplified: Ongoing


title: An International Survey on Aminoglycoside Practices in Critically Ill Patients: AMINO III Survey

summary: This is an international observational cohort study on current aminoglycoside practices in intensive care units. Clinical and demographic data, dosing and therapeutic drug monitoring data will be collected during the first week of aminoglycoside (tobramycin, amikacin or gentamicin) administration in different countries over a year. A minimum of ten consecutive patients will be enrolled at each site.

study_type: Observational

time_perspective: Prospective

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_country:
United Kingdom
Australia
Greece
Chile
France

location_facility: University Critical Care Department Aghioi Anargyroi Hospital

location_facility: Centre Hospitalier de Toulon, Hopital Sainte Musse

location_facility: Centre Hospitalier La Rochelle-Hopital Saint Louis

intervention_type: Other

lead_sponsor_type: academique


summary:
This study aimed to determine the efficacy and safety of QAW039 150 mg and QAW039 450 mg, compared with placebo, when added to GINA (Global Initiative for Asthma) steps 4 and 5 standard-of- care (SoC) asthma therapy (GINA 2016) in the following two populations:

patient with inadequately controlled severe asthma and high eosinophil counts at baseline (eosinophil count at Visit 1 ≥250 cells/ µl) (sub-population)
patients with inadequately controlled severe asthma (overall study population)

Inadequate control is defined as partly controlled or uncontrolled asthma (GINA 2016).

ReferenceCitation: Brightling CE, Gaga M, Inoue H, Li J, Maspero J, Wenzel S, Maitra S, Lawrence D, Brockhaus F, Lehmann T, Brindicci C, Knorr B, Bleecker ER. Effectiveness of fevipiprant in reducing exacerbations in patients with severe asthma (LUSTER-1 and LUSTER-2): two phase 3 randomised controlled trials. Lancet Respir Med. 2021 Jan;9(1):43-56. doi: 10.1016/S2213-2600(20)30412-4. Epub 2020 Sep 24.

title: A 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of QAW039 When Added to Existing Asthma Therapy in Patients With Uncontrolled Severe Asthma.

location_country:
Finland
Germany
Ireland
Poland
Argentina
Australia
Brazil
Vietnam
France
Lithuania
Hungary
Denmark
Switzerland
United States
Latvia
Iceland
Romania
Belgium
China
Estonia
Philippines
Guatemala
United Kingdom
Singapore
Austria
Spain
Greece


title: A Randomized, Multicenter, Double-Blind, Phase 3 Study of Nivolumab, Nivolumab in Combination With Ipilimumab, or Placebo as Maintenance Therapy in Subjects With Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) After Completion of Platinum-based First Line Chemotherapy (CheckMate 451: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 451)

acronym: CheckMate 451

summary: In this study, all patients must have already completed first-line chemotherapy to treat extensive-stage disease small cell lung cancer. The purpose of this study is to show that nivolumab, or nivolumab plus ipilimumab followed by nivolumab by itself, will prolong overall survival when administered as consolidation treatment in patients that are stable or responding after chemotherapy. Patients receiving treatment will be compared with patients taking placebo.

ReferenceCitation: Kang YK, Reck M, Nghiem P, Feng Y, Plautz G, Kim HR, Owonikoko TK, Boku N, Chen LT, Lei M, Chang H, Lin WH, Roy A, Bello A, Sheng J. Assessment of hyperprogression versus the natural course of disease development with nivolumab with or without ipilimumab versus placebo in phase III, randomized, controlled trials. J Immunother Cancer. 2022 Apr;10(4):e004273. doi: 10.1136/jitc-2021-004273.

repository_institution: Yonsei University Medical Library - YUHSpace

repositories_concat: PubMed Central;ir.ymlib.yonsei.ac.kr

publisher_dissemination: British Medical Journal

ReferenceCitation: Owonikoko TK, Park K, Govindan R, Ready N, Reck M, Peters S, Dakhil SR, Navarro A, Rodriguez-Cid J, Schenker M, Lee JS, Gutierrez V, Percent I, Morgensztern D, Barrios CH, Greillier L, Baka S, Patel M, Lin WH, Selvaggi G, Baudelet C, Baden J, Pandya D, Doshi P, Kim HR. Nivolumab and Ipilimumab as Maintenance Therapy in Extensive-Disease Small-Cell Lung Cancer: CheckMate 451. J Clin Oncol. 2021 Apr 20;39(12):1349-1359. doi: 10.1200/JCO.20.02212. Epub 2021 Mar 8.

repository_institution: Université de Lausanne - SERVAL

lead_sponsor: Bristol-Myers Squibb

sponsor_collaborators:
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd

location_country:
Finland
Germany
Ireland
Poland
Argentina
Australia
Brazil
Japan
Canada
France
Colombia
Hong Kong
Switzerland
United States
Romania
Belgium
China
Peru
Italy
United Kingdom
Singapore
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Russian Federation
Israel

location_facility:
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Princess Alexandra Hospital
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Interbalkan European Medical Center
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Local Institution - 0093
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acronym: EMERGE

lead_sponsor: Biogen

summary: The primary objective of the study is to evaluate the efficacy of monthly doses of aducanumab in slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score as compared with placebo in participants with early AD. Secondary objectives are to assess the effect of monthly doses of aducanumab as compared with placebo on clinical progression as measured by Mini-Mental State Examination (MMSE), AD Assessment Scale-Cognitive Subscale (13 items) [ADAS-Cog 13], and AD Cooperative Study-Activities of Daily Living Inventory (Mild Cognitive Impairment version) [ADCS-ADL-MCI].

ReferenceCitation: Salloway S, Chalkias S, Barkhof F, Burkett P, Barakos J, Purcell D, Suhy J, Forrestal F, Tian Y, Umans K, Wang G, Singhal P, Budd Haeberlein S, Smirnakis K. Amyloid-Related Imaging Abnormalities in 2 Phase 3 Studies Evaluating Aducanumab in Patients With Early Alzheimer Disease. JAMA Neurol. 2022 Jan 1;79(1):13-21. doi: 10.1001/jamaneurol.2021.4161.

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories:
PubMed Central
UCL Discovery

repositories_concat: PubMed Central;UCL Discovery

location_facility: University of Utah Health Sciences Center

location_facility: Centre de Recherche Clinique du Gérontopôle - Cité de la Santé

location_facility: Cleveland Clinic Lou Ruvo Center for Brain Health

location_facility: Centre Neurologique & de Réadaptation Fonctionnelle

location_facility: Klinikum rechts der Isar der TU Muenchen

location_facility: University of California San Diego Medical Center

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Zentrum f. Neurologisch- Psychiatrische Studien und Begutachtung

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie

location_facility: Research Center for Clinical Studies, Inc.

location_facility: Emory University Cognitive Neurology Clinic & ADRC

location_facility: SPZOZ Centralny Szpital Kliniczny UM w Lodzi

location_facility: Sahlgrenska Universitetssjukhuset, Mölndal Sjukhus

location_facility: Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

location_facility: Medical Research Health and Education Foundation, Inc

location_facility: Josephson, Wallack, Munshower Neurology, PC

location_facility: NZOZ "SENIOR" Poradnia Psychogeriatryczna

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

location_facility: ISPG - Institut fuer Studien zur Psychischen Gesundheit

location_facility: Umberto I Pol. di Roma-Università di Roma La Sapienza

location_facility: Schwerpunktpraxis fuer Neurologie, Psychiatrie und Klinische Studien

location_facility: True North Clinical Research - Halifax Inc.

location_facility: True North Clinical Research Kentville, Inc

location_facility: Weill Cornell Medical College-New York Presbyterian Hospital

location_facility: Lehigh Center for Clinical Research, LLC

location_facility: The Methodist Hospital Research Institute

location_facility: NZOZ "NEURO-KARD", "Ilkowski i Partnerzy" Sp. Partn. Lek.

location_facility: Centrum Diagnostyczno - Terapeutyczne "MEDICUS" Sp.z o.o.

location_facility: Universitären Psychiatrischen Kliniken Basel (UPK)

location_facility: Institut fuer Regenerative Medizin (IREM) der Universitaet Zuerich, Zentrum fuer Praevention und Demenztherapie

location_facility: Fondazione IRCCS Istituto Neurologico Carlo Besta

location_facility: Associated Neurologists of Southern Connecticut, PC

location_facility: Clinical Neuroscience Research Association, Inc

location_facility: Institut fuer Schlaganfall- und Demenzforschung (ISD)

title: A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Aducanumab (BIIB037) in Subjects With Early Alzheimer's Disease

location_country:
Finland
Germany
Italy
Poland
Japan
Sweden
Netherlands
Switzerland
Belgium
United States
Spain
Canada
France


acronym: ARASENS

lead_sponsor: Bayer

summary: The purpose of the study is to assess the efficacy and safety of BAY1841788 (darolutamide (ODM-201)) in combination with standard androgen deprivation therapy (ADT) and docetaxel in patients with metastatic hormone sensitive prostate cancer.

ReferenceCitation: Smith MR, Hussain M, Saad F, Fizazi K, Sternberg CN, Crawford D, Manarite J, Muslin D, Farrington T, Tombal B. Darolutamide and survival in metastatic, hormone-sensitive prostate cancer: a patient and caregiver perspective and plain language summary of the ARASENS trial. Future Oncol. 2022 Jul;18(21):2585-2597. doi: 10.2217/fon-2022-0433. Epub 2022 Jun 3.

ReferenceCitation: Smith MR, Hussain M, Saad F, Fizazi K, Sternberg CN, Crawford ED, Kopyltsov E, Park CH, Alekseev B, Montesa-Pino A, Ye D, Parnis F, Cruz F, Tammela TLJ, Suzuki H, Utriainen T, Fu C, Uemura M, Mendez-Vidal MJ, Maughan BL, Joensuu H, Thiele S, Li R, Kuss I, Tombal B; ARASENS Trial Investigators. Darolutamide and Survival in Metastatic, Hormone-Sensitive Prostate Cancer. N Engl J Med. 2022 Mar 24;386(12):1132-1142. doi: 10.1056/NEJMoa2119115. Epub 2022 Feb 17.

repository_institution: Ghent University - Ghent University Academic Bibliography

sponsor_collaborators:
Bayer
Orion Corporation, Orion Pharma

title: A Randomized, Double-blind, Placebo Controlled Phase III Study of Darolutamide (ODM-201) Versus Placebo in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Patients With Metastatic Hormone Sensitive Prostate Cancer

ipd_sharing_description:
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

location_country:
Finland
Germany
Poland
Australia
Brazil
Japan
Czechia
Canada
France
United States
Belgium
China
Italy
United Kingdom
Sweden
Netherlands
Mexico
Korea, Republic of
Spain
Taiwan
Bulgaria
Russian Federation
Israel


title: An Open-label, Prospective, Non-randomized, Multicenter Study to Evaluate Clear Skin Effect on Health Related Quality of Life Outcomes at 16 and 52 Weeks in Patients With Moderate to Severe Plaque Psoriasis Treated With Secukinumab 300 mg s.c. With or Without Previous Exposure to Systemic Therapy.

acronym: PROSE

summary: Study of effects of secukinumab 300 mg s.c. on quality of life (QoL) in psoriasis in patients with or without prior exposure to systemic therapy.

primary_purpose: Other

ReferenceCitation: Merola JF, McInnes IB, Deodhar AA, Dey AK, Adamstein NH, Quebe-Fehling E, Aassi M, Peine M, Mehta NN. Effect of Secukinumab on Traditional Cardiovascular Risk Factors and Inflammatory Biomarkers: Post Hoc Analyses of Pooled Data Across Three Indications. Rheumatol Ther. 2022 Jun;9(3):935-955. doi: 10.1007/s40744-022-00434-z. Epub 2022 Mar 19.

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

repositories_institution: The University of Glasgow - Enlighten: Publications

ReferenceCitation: da Silva N, Sommer R, Ortmann CE, Jagiello P, Bachhuber T, Augustin M. Secukinumab effects on disease burden, patient needs and benefits, and treatment satisfaction in patients with plaque psoriasis across European regions: patient perspective data from the PROSE study. J Eur Acad Dermatol Venereol. 2021 Nov;35(11):2241-2249. doi: 10.1111/jdv.17525. Epub 2021 Jul 31.

publisher_dissemination: Wiley

location_country:
Germany
Italy
Lithuania
Poland
Portugal
Slovakia
Israel
United Kingdom
Romania
Belgium
Latvia
Spain
Greece
Czechia
Bulgaria
Estonia
France


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Nonalcoholic Steatohepatitis (NASH) and Fibrosis

acronym: RESOLVE-IT

summary: The primary objectives of this study are to evaluate the effect of Elafibranor treatment compared to placebo on 1) histological improvement and 2) all-cause mortality and liver-related outcomes in patients with nonalcoholic steatohepatitis (NASH) and fibrosis.

lead_sponsor: Genfit

location_country:
Finland
Germany
Argentina
Australia
Turkey
Chile
Czechia
Canada
France
Colombia
Portugal
Denmark
Switzerland
United States
Romania
Belgium
Puerto Rico
Italy
United Kingdom
Netherlands
Mexico
Spain
South Africa
Russian Federation
Sweden

location_facility: Centro de Investigación y Prevención Cardiovascular SA (CIPREC)

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: I. M. Sechenov - First Moscow State Medical University

location_facility: South Florida Center of Gastroenterology, PA

location_facility: Plymouth Hospitals NHS Trust - Derriford Hospital

location_facility: Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino - Ospedale Molinette

location_facility: Centro de Estudios Clinicos Barros Luco SPA (Patients seen, Fibroscan stored and Drug Shipment)

location_facility: Campus Hospital Universitario Virgen del Rocío - Instituto de Biomedicina de Sevilla (IBIS)

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: Henry Ford Health System, Division of Gastroenterology & Hepatology

location_facility: Guy's and St Thomas' NHS Foundation Trust - St Thomas' Hospital

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital

location_facility: St George's University Hospitals NHS Foundation Trust - St George's Hospital

location_facility: Spitalul Clinic Judetean de Urgenta "Pius Brinzeu" Timisoara

location_facility: Centre Hospitalier Universitaire Vaudois (CHUV)

location_facility: University of Massachusetts Memorial Medical Center

location_facility: Banner University Medical Center Phoenix

location_facility: Florida Digestive Health Specialists, LLP

location_facility: The University of Chicago Medical Center

location_facility: Hull and East Yorkshire Hospitals NHS Trust - Hull Royal Infirmary

location_facility: University of California, San Diego Airway Research and Clinical Trials Center

location_facility: University of Calgary, Cumming School of Medicine

location_facility: Frimley Park Hospital NHS Foundation Trust

location_facility: Beth Israel Deaconess Medical Center (BIDMC)

location_facility: University of Mississippi Medical Center

location_facility: University of Kentucky Chandler Medical Center

location_facility: Nottingham University Hospitals NHS FoundationTrust - Queen's Medical Centre

location_facility: Caparra Internal Medicine Research Center

location_facility: Centro De Hepatologia Ciudad de La Plata

location_facility: The Ohio State University Wexner Medical Center

location_facility: University at Buffalo, Clinical and Translational Research Center

location_facility: Marmara Üniversitesi Eğitim ve Araştırma Hastanesi

location_facility: The University of Arizona College of Medicine Liver Research Institute

location_facility: University of Louisville Medical / Dental Complex

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi

location_facility: St. Luke's Liver Transplant & Specialist

location_facility: Centro Hospita de Tras-os-Montes e Alto Douro, EPE

location_facility: Medical University of South Carolina (MUSC)

location_facility: Universitätsklinikum Frankfurt - Goethe Universität

location_facility: Queen Elizabeth II Health Sciences Centre, Nova Scotia Health Authority

location_facility: University of California, San Francisco, Medical Center at Parnassus

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Veterans Affairs Greater Los Angeles Healthcare System

location_facility: University of Cincinnati Physicians Company , LLC

location_facility: Sutter West Bay Hospitals dba California Pacific Medical Center

location_facility: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

location_facility: University of California, Davis Medical Center

location_facility: Hospital Universitario San Vicente de Paul Fundación

location_facility: New York-Presbyterian Hospital - Columbia University Medical Center

location_facility: Complexo Hospitalario Universitario de Pontevedra

location_facility: St Petersburg State Budgetary Healthcare Institution City Clinical Hospital N°31

location_facility: Centro Hospitalar de São João, EPE - Hospital de São João

location_facility: University of California, San Francisco, Fresno Community Regional Medical Center

location_facility: Atlantic Gastroenterology Associates, LLC

location_facility: Portsmouth Hospitals NHS Trust - Queen Alexandra Hospital

location_facility: Saint Louis University School of Medicine

location_facility: Centro de Investigación Clínica del Pacífico, S.A de C.V.

location_facility: Bart Health NHS Trust- Royal London Hospital

location_facility: Carolinas Center for Liver Disease, Carolinas HealthCare System/Atrium Health

location_facility: Weill Medical College of Cornell University

location_facility: Bon Secours Liver Institute of Virginia - Newport News

location_facility: Kaiser Permanente Shady Grove Medical Center

location_facility: Centro Hospitalar Lisboa Central, EPE - Hospital Santo António dos Capuchos

location_facility: Loma Linda University Medical Center - Transplantation Insitute

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

location_facility: Digestive Health Specialists of the Southeast

location_facility: Vancouver General Hospital (VGH) - Gordon and Leslie Diamond Health Care Centre

location_facility: University Hospitals Cleveland Medical Center

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

location_facility: New York University Langone Medical Center

location_facility: Solano&Terront Servicios Médicos LTDA - Unidad Integral de Endocrinologia UNIENDO

location_facility: Military medical academy n. a. S.M. Kirov

location_facility: University of Miami - Schiff Center for Liver Diseases

location_facility: Veterans Affaires Greater Los Angeles Healthcare System, West LA VA Medical Center

location_facility: Institutul National de Boli Infectioase "Prof. Dr. Matei Bals"

location_facility: The Royal Free London NHS Foundation Trust - The Royal Free Hospital

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

location_facility: Gastrointestinal Biosciences Clinical Trials LLC

location_facility: SC Cabinet Particular Policlinic Algomed SRL

location_facility: University Hospitals Birmingham NHS foundation Trust

location_facility: Instituto de Investigaciones Clinicas San Nicolas SRL

location_facility: Northwestern Memorial Hospital - Arkes Family Pavilion

location_facility: Rutgers, Robert Wood Johnson Medical School

location_facility: Gastrointestinal Specialists of Georgia, PC

location_facility: Bon Secours Liver Institute of Virginia - Richmond

location_facility: Ospedale Casa Sollievo della Sofferenza I.R.C.C.S.

location_facility: Centre Hospitalier de Wallonie Picardie (CHWAPI)

location_facility: Walter Reed National Military Medical Center

location_facility: Gastrointestinal Associates & Endoscopy Center

location_facility: Kaiser Permanente Springfield Medical Center

location_facility: Gastroenterologie am Bayerischen Platz/ Gastro-Studien

location_facility: University of Miami - Miller School of Medicine

location_facility: Fundación Cardio Infantil - Instituto de Cardiología

location_facility: Yale University School of Medicine, Section of Digestive Diseases

location_facility: Centro Hospitalar e Universitário de Coimbra, EPE - Hospitais da Universidade de Coimbra

location_facility: Sağlık Bilimleri Üniversitesi Ümraniye Eğitim ve Araştırma Hastanesi

location_facility: Inova Fairfax Medical Campus - Center for Liver Disease

location_facility: FSBRI "Federal Research Center of nutrition and biotechnology

location_facility: M. F. Vladimirsky - Clinical Research Institution of Moscow Region

location_facility: Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Baylor All Saints Medical Center - Baylor Research Institute

location_facility: Swedish Organ Transplant and Liver Center

location_facility: Gastroenterology Consultants of San Antonio

location_facility: Fundacion Hospitalaria San Vicente de Paul


type: Other Identifier

title: A Randomized, Open-label, Phase 3 Study in Subjects With Relapsed and Refractory Multiple Myeloma Receiving Carfilzomib in Combination With Dexamethasone, Comparing Once-weekly Versus Twice-weekly Carfilzomib Dosing

acronym: ARROW

summary: The purpose of the study is to compare the progression-free survival (PFS) of once-weekly carfilzomib dosing in combination with dexamethasone to twice-weekly carfilzomib dosing in combination with dexamethasone in adults with relapsed and refractory multiple myeloma, previously treated with bortezomib and an immunomodulatory agent (IMiD).

ReferenceCitation: Moreau P, Mateos MV, Berenson JR, Weisel K, Lazzaro A, Song K, Dimopoulos MA, Huang M, Zahlten-Kumeli A, Stewart AK. Once weekly versus twice weekly carfilzomib dosing in patients with relapsed and refractory multiple myeloma (A.R.R.O.W.): interim analysis results of a randomised, phase 3 study. Lancet Oncol. 2018 Jul;19(7):953-964. doi: 10.1016/S1470-2045(18)30354-1. Epub 2018 Jun 1. Erratum In: Lancet Oncol. 2018 Aug;19(8):e382.

ReferenceCitation: Facon T, Niesvizky R, Mateos MV, Siegel D, Rosenbaum C, Bringhen S, Weisel K, Ho PJ, Ludwig H, Kumar S, Wang K, Obreja M, Yang Z, Klippel Z, Mezzi K, Goldrick A, Tekle C, Dimopoulos MA. Efficacy and safety of carfilzomib-based regimens in frail patients with relapsed and/or refractory multiple myeloma. Blood Adv. 2020 Nov 10;4(21):5449-5459. doi: 10.1182/bloodadvances.2020001965.

ReferenceCitation: Dimopoulos MA, Niesvizky R, Weisel K, Siegel DS, Hajek R, Mateos MV, Cavo M, Huang M, Zahlten-Kumeli A, Moreau P. Once- versus twice-weekly carfilzomib in relapsed and refractory multiple myeloma by select patient characteristics: phase 3 A.R.R.O.W. study subgroup analysis. Blood Cancer J. 2020 Mar 9;10(3):35. doi: 10.1038/s41408-020-0300-y.

ReferenceCitation: Moreau P, Stewart KA, Dimopoulos M, Siegel D, Facon T, Berenson J, Raje N, Berdeja JG, Orlowski RZ, Yang H, Ma H, Klippel Z, Zahlten-Kumeli A, Mezzi K, Iskander K, Mateos MV. Once-weekly (70 mg/m2 ) vs twice-weekly (56 mg/m2 ) dosing of carfilzomib in patients with relapsed or refractory multiple myeloma: A post hoc analysis of the ENDEAVOR, A.R.R.O.W., and CHAMPION-1 trials. Cancer Med. 2020 May;9(9):2989-2996. doi: 10.1002/cam4.2945. Epub 2020 Feb 28.

ReferenceCitation: Moreau P, Kumar S, Boccia R, Iida S, Goldschmidt H, Cocks K, Trigg A, Zahlten-Kumeli A, Yucel E, Panjabi SS, Dimopoulos M. Convenience, satisfaction, health-related quality of life of once-weekly 70 mg/m2 vs. twice-weekly 27 mg/m2 carfilzomib (randomized A.R.R.O.W. study). Leukemia. 2019 Dec;33(12):2934-2946. doi: 10.1038/s41375-019-0480-2. Epub 2019 May 15.

ReferenceCitation: Kumar SK, Majer I, Panjabi S, Medhekar R, Campioni M, Dimopoulos MA. Cost-effectiveness of once weekly carfilzomib 70 mg/m2 plus dexamethasone in patients with relapsed and refractory multiple myeloma in the United States. Expert Rev Hematol. 2020 Jun;13(6):687-696. doi: 10.1080/17474086.2020.1746639. Epub 2020 Apr 6.

ReferenceCitation: Dimopoulos MA, Moreau P, Iida S, Huang SY, Takezako N, Chng WJ, Zahlten-Kumeli A, Sersch MA, Li J, Huang M, Lee JH. Outcomes for Asian patients with multiple myeloma receiving once- or twice-weekly carfilzomib-based therapy: a subgroup analysis of the randomized phase 3 ENDEAVOR and A.R.R.O.W. Trials. Int J Hematol. 2019 Oct;110(4):466-473. doi: 10.1007/s12185-019-02704-z. Epub 2019 Aug 6.

lead_sponsor: Amgen

location_country:
Finland
Germany
Poland
New Zealand
Australia
Japan
Czechia
Canada
France
Hungary
Denmark
United States
Romania
Belgium
Italy
Norway
United Kingdom
Spain
Greece
Sweden

location_facility: John Theurer Cancer Center at Hackensack University Medical Center


title: A Multicenter, Prospective Epidemiologic Study of the Progression of Geographic Atrophy Secondary to Age-Related Macular Degeneration

summary: This study seeks to better characterize relationships between visual function and the progression (worsening) of geographic atrophy (GA) due to age-related macular degeneration (AMD). The study also will generate new information on the relationship between genetics and GA progression. This is a global, prospective, multicenter, epidemiologic study enrolling 200 participants with GA secondary to AMD. The study visits are scheduled to occur every 6 months. The anticipated duration of the study is up to 60 months.

lead_sponsor: Hoffmann-La Roche

location_country:
Germany
Italy
Poland
Hungary
Argentina
United Kingdom
Australia
Brazil
United States
Spain
Canada
France

location_facility: ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco)

location_facility: Hospital Universitari de Bellvitge; Servicio de Oftalmologia

location_facility: Centres Ophtalmologique St Exupéry; Ophtalmologie

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: University Health Network Toronto Western Hospital

location_facility: Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika

location_facility: Moorfields Eye Hospital NHS Foundation Trust

location_facility: Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont, Szemeszet KR

location_facility: Semmelweis Egyetem AOK, Szemeszeti Klinika

location_facility: SP ZOZ Szpital Uniwersytecki w Krakowie Oddział Kliniczny Okulistyki i Onkologii Okulistycznej

location_facility: Clinica Universitaria de Navarra; Servicio de Oftalmologia

location_facility: CHU Poitiers - CHR La Miletrie; Ophtalmologie

location_facility: Universitätsklinikum Regensburg, Klinik & Poliklinik für Augenheilkunde

location_facility: Hopital de la croix rousse; Ophtalmologie

location_facility: Fondazione Ptv Policlinico Tor Vergata Di Roma;U.O.S.D. Patologie Renitiche

location_facility: Centre Paradis Monticelli; Ophtalmologie

location_facility: Gabinet Okulistyczny Prof Edward Wylegala

location_facility: Szpital Specjalistyczny nr 1; Oddzial Okulistyki

location_facility: Centre Odeon; Exploration Ophtalmologique


acronym: PORTICO

lead_sponsor: Actelion

summary: 24-week study to evaluate the efficacy and safety of macitentan for the treatment of portopulmonary hypertension.

ReferenceCitation: Raevens S, Fallon MB. PORTICO: First Randomized Controlled Trial of Vasomodulator Therapy in Portopulmonary Hypertension. Hepatology. 2020 May;71(5):1870-1872. doi: 10.1002/hep.31166. No abstract available.

ReferenceCitation: Sitbon O, Bosch J, Cottreel E, Csonka D, de Groote P, Hoeper MM, Kim NH, Martin N, Savale L, Krowka M. Macitentan for the treatment of portopulmonary hypertension (PORTICO): a multicentre, randomised, double-blind, placebo-controlled, phase 4 trial. Lancet Respir Med. 2019 Jul;7(7):594-604. doi: 10.1016/S2213-2600(19)30091-8. Epub 2019 Jun 6.

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 - Inria

repositories_concat: HAL

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

location_facility: University of Texas Southwestern Medical Center Division of NeuroCritical Care 75390-8550

location_facility: Universitätsklinikum Leipzig, Department Innere Medizin, Abteilung Pneumologie

location_facility: University of Florida College of Medicine

location_facility: University of New Mexico Health Science Center

location_facility: CHU Côte de Nacre, Service de Pneumologie

location_facility: The Royal Free Hospital/ Cardiology Department

location_facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo (HC-FMUSP)

location_facility: IKEM (Institut klinické a experimentální medicíny, Institute for Clinical and Experimental Medicine)

location_facility: Hôpital cardiologique, Service de cardiologie 59037 Lille Cedex"

location_facility: Cleveland Clinic - Department of Cardiovascular Medicine

location_facility: Hospital Clinico i Provincial Servicio de Neumología

location_facility: CHRU de Grenoble, Hôpital Albert Michallon

location_facility: Hôpital Kremlin Bicêtre Service de Pneumologie

location_facility: University of Colorado Health Sciences Center Aurora

location_facility: University of Florida - Divison of Pulmonary Critical Care & Sleep

location_facility: Thoraxklinik des Universitätsklinikums Heidelberg Zentrum für pulmonale Hypertonie Studienkoordination

location_facility: Hôpital Cardiologique et Pneumologique Louis Pradel 69677 Bron cedex"

location_facility: CHU Toulouse - Hôpital Larrey Hôpital de Jour et Semaine

location_facility: Medizinische Hochschule Hannover, Abteilung Pneumologie

location_facility: Universitätsklinikum Giessen und Marburg GmbH Justus-Liebig Universität Giessen 35392

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital

location_facility: Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden

location_facility: Lékařská fakulta a Všeobecná fakultní nemocnice v Praze, II. Interní klinika kardiologie a angiologie U

location_facility: Hôpital Pontchaillou - CHU Rennes Service de Cardiologie et des Maladies Vasculaires Rennes Cedex 9 35033"

location_facility: Servico de Hipertensao Pulmonar - Complexo Hospitalar Santa Casa Irmandade Santa de Misericordia de Porto Alegre

title: A Randomized, Double-blind, Placebo-controlled, Prospective, Multicenter, Parallel Group Study to Assess the Safety and Efficacy of Macitentan in Patients With Portopulmonary Hypertension

location_country:
Germany
United Kingdom
Brazil
United States
Spain
Czechia
France