acronym: CASTING

title: An Open-Label Study To Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Multiple Sclerosis Who Have A Suboptimal Response to an Adequate Course of Disease-Modifying Treatment

lead_sponsor: Hoffmann-La Roche

ReferenceCitation: Vermersch P, Oreja-Guevara C, Siva A, Van Wijmeersch B, Wiendl H, Wuerfel J, Buffels R, Kadner K, Kuenzel T, Comi G; CASTING Investigators. Efficacy and safety of ocrelizumab in patients with relapsing-remitting multiple sclerosis with suboptimal response to prior disease-modifying therapies: A primary analysis from the phase 3b CASTING single-arm, open-label trial. Eur J Neurol. 2022 Mar;29(3):790-801. doi: 10.1111/ene.15171. Epub 2021 Nov 25.

location_country:
Denmark
Spain
Ireland
Italy
Estonia
Australia
Finland
Netherlands
Switzerland
United Kingdom
Sweden
France
Turkey
Belgium
Norway
Germany
Czechia

location_facility: AO Ospedali Riuniti Villa Sofia-Cervello;PO Villa Sofia - UO Neurologia - U.O.S. Neuroimmunologia

location_facility: IRCCS Ospedale Casa Sollievo Della Sofferenza; SC Neurologia

location_facility: Länssjukhuset Ryhov; Medicinkliniken / Neurologmottagningen

location_facility: Studienzentrum für Neurologie und Psychiatrie

location_facility: Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften

location_facility: Ospedale Dimiccoli Barletta; Dipartimento Testa-Collo - UO Neurologia

location_facility: Hospital General de Castellon; Servicio de Neurología

location_facility: Hôpital Maison Blanche; Service de Neurologie

location_facility: St. Josef-Hospital, Klinik für Neurologie

location_facility: PANAKEIA - Arzneimittelforschung Leipzig GmbH

location_facility: Fakultni nemocnice Motol; Neurologicka klinika

location_facility: Hopital Gabriel Montpied CHU de Clermont-Ferrand; Service de Neurologie B

location_facility: Ospedale San Salvatore; Clinica Neurologica - Centro Sclerosi Multipla

location_facility: Aarhus Universitetshospital, Neurologisk Afd. F, Skleroseklinikken

location_facility: Hospital Puerta del Mar; Sevicio de Neurologia

location_facility: Policlinico G.B. Rossi; Dip. Scienze Neurologiche Biomediche - Neurologia B - Amb. Sclerosi Multipla

location_facility: IRCCS Ospedale San Raffaele; Neurologia Neurofisiologia Neuroriabilitazione-Centro Sclerosi Multipla

location_facility: AMEOS Klinikum Oldenburg, Klinik für Neurologie und Neurophysiologie

location_facility: Nemocnice Jihlava; NEU-Neurologicke oddeleni

location_facility: Universitaetsklinikum Mainz - PS; Klinik und Poliklinik fuer Neurologie

location_facility: Rigshospitalet Glostrup; Neurologisk Klinik

location_facility: Gemeinschaftspraxis Dr.med. Reinhard Ehret/Dr. med Wolfram von Pannwitz

location_facility: Zuyderland Medisch Centrum - Sittard Geleen

location_facility: Ospedale S.Antonio Abate; Neurologia 2 - Sclerosi Multipla e Recupero Neurologico

location_facility: Klinikum rechts der Isar der TU Muenchen; Neurologische Klinik und Poliklinik im Neuro-Kopf-Zentrum

location_facility: Fondazione Istituto S. Raffaele - Giglio; UO Neurologia

location_facility: Azienda Ospedaliera di Padova; Clinica Neurologica

location_facility: Gemeinschaftspraxis für Neurologie; Dr. Katrin Schulte, Dr. Nils Richter, Dr. Margarete Capito

location_facility: Neurologische Praxisgemeinschaft Hamburger-Straße; Dres. Müller-Habich/Emrich/Vogt

location_facility: Karadeniz Tecnical Uni. Med. Fac.; Neurology

location_facility: Hospital Clinico Universitario de Valencia; Servicio de Neurologia

location_facility: Jüdisches Krankenhaus Berlin; Abteilung fur Neurologie

location_facility: Studienzentrum Nordwest, Dr. med. Joachim Springub / Herr Wolfgang Schwarz

location_facility: Ospedale Binaghi; Centro Sclerosi Multipla

location_facility: Ospedale Bellaria; Istituto delle Scienze Neurologiche - UO RIABILITAZIONE SCLEROSI MULTIPLA

location_facility: Complejo Hospitalario Universitario de Vigo - Xeral Cies; Servicio de Neurologia

location_facility: Odense Universitetshospital, Neurologisk Afdeling N

location_facility: Ospedale Civile di Montichiari; Centro Sclerosi Multipla

location_facility: Hospital Universitario 12 de Octubre; Servicio de Neurologia

location_facility: AO di Perugia - Ospedale S. Maria della Misericordia; Clinica Neurologica

location_facility: Universitätsklinikum Tübingen, Zentrum für Neurologie

location_facility: AOU Policlinico Giaccone; UOC Neurologia e Neurofisiopatologia-Amb Sclerosi Multipla

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Neurología

location_facility: Hospital Universitario la Fe; Servicio de Neurologia

location_facility: A. O. U. Federico II; Dip Neuroscienze, Scienze Riproduttive ed Odontostomatologiche

location_facility: Università degli Studi della Campania Luigi Vanvitelli; Dip. Ass. Integrato Med Int-II Clinica Neur

location_facility: Ospedale SS. Annunziata - Clinica Neurologica - Centro Sclerosi Multipla

location_facility: Mersin University Medical Faculty; Neurology

location_facility: Universitario de La Princesa; Servicio de Neurología

location_facility: CHU de la Timone - Hopital d Adultes; Service de Neurologie

location_facility: Hospital Vall d'Hebron; Servicio de Neurología

location_facility: IRCCS Istituto Neurologico Neuromed; Centro per lo Studio e la Cura della Sclerosi Multipla

location_facility: Hopital Roger Salengro; Service de Neurologie

location_facility: Groupe Hospitalier Pellegrin; Service de neurochirurgie B

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

location_facility: IRCCS Istituto Neurologico C. Mondino-Dip. Neurologia Neuroriabilitazione S.S. Sclerosi Multipla

location_facility: Oberhavel Kliniken GmbH, Klinik Hennigsdorf, Neurologie

location_facility: Hôpital Guillaume et René Laënnec; Service Neurologie

location_facility: Universiätsklinikum Hamburg-Eppendorf , Multiple Sklerose Tagesklinik u. Ambulanz Neurol. Poliklinik

location_facility: Universitaetsklinikum Frankfurt; Klinik für Neurologie

location_facility: Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Neurologia

location_facility: NeuroPoint, Gesellschaft für vorbeugende Gesundheitspflege mbH

location_facility: Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Neurologia

location_facility: Universitaetsklinikum Marburg; Klinik fuer Neurologie

location_facility: Policlinico Universitario A. Gemelli; UOC Neurologia - Centro Sclerosi Multipla

location_facility: Klinikum Augsburg, Neurologische Klinik und klinische Neurophysiologie

location_facility: Hospital Universitario La Paz; Servicio de Neurologia

location_facility: Hacettepe University Medical Faculty; Neurology

location_facility: Fond. Istituto Neurologico C.Besta; UO Neurologia IV - Neuroimmunologia Malattie Neuromuscolari

location_facility: Universitätsklinikum Münster; Klinik und Poliklinik für Neurologie

location_facility: Hospital Universitario Virgen Macarena; Servicio de Neurologia

location_facility: Fakultni nemocnice u sv. Anny; Neurologicka klinika

location_facility: Hôpitaux Universitaires de strasbourg - hôpital civil

location_facility: St. Josefs-Krankenhaus, Klinik für Neurologie

location_facility: Neurologische Klinik, Universitätsklinikum Heidelberg

location_facility: Ruppiner Kliniken, Hochschulklinikum der Medizinischen Hochschule Brandenburg, Klinik für Neurologie

location_facility: MultipEL Studies - Institut für klinische Studien

location_facility: Groupe Hospitalier Pitié- Salpétrière; Service Neurologie

location_facility: Klinikum Grosshadern der LMU; Neuroimmunologie II

location_facility: CHU de Besancon Hopital Jean Minjoz; Service de Neurologie

location_facility: Hospital Universitario Central de Asturias; Servicio de Neurología

location_facility: Azienda Ospedaliera Sant'Andrea; UOC Neurologia

location_facility: Universitätsklinikum Freiburg, Klinik für Neurologie und Neurophysiologie

location_facility: NeuroCentrum Odenwald; Dres. Reifschneider, Unsorg, Ries, Schumann, Hoffmann, Knoblich

location_facility: VFN Praha Poliklinika Rs Centrum - Budova A

location_facility: Marianne-Strauß-Klinik; Behandlung Kempfen für Multip Sklero Kranke gemeinnütz GmbH

location_facility: AOU Senese - Presidio Ospedaliero Le Scotte; UOSA Neurologia Sperimentale

location_facility: Hospital Universitario Virgen de Arrixaca; Servicio de Neurología

location_facility: AOU Policlinico V. Emanuele - P.O G. Rodolico; Clinica Neurologica, Centro Sclerosi Multipla

location_facility: Hospital Universitari de Bellvitge; Servicio de Neurologia

location_facility: East Tallinn Central Hospital; Neurology Department

location_facility: AOU Careggi; Neurologia 1-Dip. Neuroscienze Psicologia Area Farmaco Salute del Bambino(NEUROFARBA)

location_facility: Universitätsklinikum Magdeburg,Otto-von-Guericke-Universität A.ö.R., Klinik für Neurologie

location_facility: Ondokuz Mayis Univ. Med. Fac.; Neurology

location_facility: Henriettenstiftung Hannover; Klinik fuer Neurologie und Klinische Neurophysiologie

location_facility: Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi; Noroloji Anabilim Dali

location_facility: Sykehuset Buskerud HF; Nevrologisk avdeling

location_facility: ASST PAPA GIOVANNI XXIII Neurologia USS Malattie Autoimmuni Centro Sclerosi Multipla

location_facility: Hopital Neurologique et Neurochirurgical Pierre Wertheimer; Service de Neurologie A

location_facility: Universitätsspital Basel Medizin Neurologie; Neurologische Poliklinik

location_facility: PNP Buchholz, Praxis für Neurologie - Psychiatrie, Dres. Dee/Gößling/Hoge

location_facility: Neurologische Gemeinschaftspraxis Kassel und Vellmar, Ch. Lassek, Dres. Ammerbach, Fetzer, M. Fische

location_facility: Kocaeli University Hospital; Department of Neurology

location_facility: AOU Ospedali Riuniti Umberto I-G.M. Lancisi-G. Salesi; SOD Clinica Neurologica-Am.Sclerosi Multipla

location_facility: Charite - Universitatsmedizin Berlin; Klinik fur Neurologie

location_facility: Hospital Quiron de Madrid; Servicio de Neurologia

location_facility: Hospital del Mar; Servicio de Neurologia

location_facility: Fondation Rothschild; Service de Neurologie

location_facility: Royal Devon and Exeter Hospital (Wonford)

location_facility: Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico; UOSD Malattie Neurodegenerative

location_facility: AOUC Azienda Ospedaliero-Universitaria Careggi; Neurologia 2

location_facility: Cork University Hospital; Clinical Research Facility

location_facility: CHU toulouse - Hôpital Purpan; Departement de Neurologie

location_facility: Gesundheitszentrum St. Johannes Hospital; Neurolog. Gemeinschaftspraxis Dres. Schmidt, Neudecker etc

location_facility: Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla

location_facility: Ospedale S.Camillo Forlanini; UOSD Day Hospital Neurologico e Neurochirurgico

summary: The purpose of this prospective, multicenter, open-label, efficacy, and safety study is to assess the efficacy and safety of ocrelizumab in participants with Relapsing Remitting Multiple Sclerosis (RRMS) who have had a suboptimal response to an adequate course of a Disease-Modifying Treatment (DMT). The study will consist of a Screening period (up to 4 weeks), an Open-label treatment period (96 weeks; with last dose administered at Week 72), and a Follow-up period of at least 2 years.


type: EudraCT Number

title: A Randomized, Double-blind Phase 3 Study of Vadastuximab Talirine (SGN-CD33A) Versus Placebo in Combination With Azacitidine or Decitabine in the Treatment of Older Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)

acronym: CASCADE

summary: The purpose of this study in AML patients is to test whether vadastuximab talirine (SGN-CD33A; 33A) combined with either azacitidine or decitabine improves remission rates and extends overall survival as compared to placebo combined with either azacitidine or decitabine.

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Seagen Inc.

location_country:
Poland
Taiwan
Luxembourg
Spain
Italy
Austria
Australia
United Kingdom
Hungary
Korea, Republic of
United States
France
Israel
Belgium
Germany
Czechia

location_facility: Soroka Medical Center, Dept. of Oncology

location_facility: Washington University School of Medicine

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Chonnam National University Hwasun Hospital

location_facility: Università degli Studi di Roma "La Sapienza, Policlinico Umberto I

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny

location_facility: County Durham and Darlington NHS Foundation Trust

location_facility: Az Sint-Jane Brugge - Oostende Av - Campus Sint-Jan

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Centre Hospitalier Universitaire de Rennes, Hopital Pontchaillou

location_facility: Intermountain Blood and Marrow Transplant/Acute Leukemia Program

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Azienda Ospedaliera Ospedali Riuniti Marche Nord

location_facility: Debreceni Egyetem Orvos Ã©s Egeszsegtudomanyi Centrum, III. sz. Belgyogyaszati Klinika

location_facility: MD Anderson Cancer Center / University of Texas

location_facility: Florida Cancer Specialists - South Region

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Hopital Saint-Louis / Service d'Hematologie

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikat Kozpont

location_facility: James P. Wilmot Cancer Center / University of Rochester Medical Center

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Fakultni nemocnice Hradec Kralove-oddeleni klinicke hematologie

location_facility: Shands Cancer Center / University of Florida

location_facility: Texas Oncology - San Antonio Medical Center

location_facility: Bacs-Kiskun Megyei Korhaz Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Oktato Korhaza

location_facility: Centre Hospitalier Universitaire Nantes-Hotel Dieu

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Centre Hospitalier Luxembourg - CHL Centre

location_facility: Centre Hospitalier Universitaire Hopital Avicenne

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Hospital Universitario de Girona Doctor Josep Trueta

location_facility: Medical University of South Carolina/Hollings Cancer Center

location_facility: University Hospitals of North Midlands NHS Trust

location_facility: Centre Hospitalier Universitaire de Poitiers

location_facility: Azienda Ospedaliero-Univesitaria San Luigi Gonzaga

location_facility: LSU Health Sciences Center / Feist Weiller Cancer Center

location_facility: Hopital d'Instruction des Armees - Percy

location_facility: Keimyung University Dongsan Medical Center

location_facility: Ziekenhuis Netwerk Antwerpen Campus Stuivenberg

location_facility: Virginia Commonwealth University Medical Center

location_facility: Center Hospitalier Universitaire d' Angers

location_facility: LKH Salzburg, Universitatsklinikum der PMU

location_facility: University of Arkansas for Medical Sciences

location_facility: Florida Cancer Specialists - North Region

location_facility: Florida Center for Cellular Therapy / Blood and Marrow Transplant Center

location_facility: Centre Hospitalier Universitaire Sart Tilman Liege

location_facility: Centre Hospitalier Universitaire (CHU) De Limoges - Hopital Dupuytren

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust

location_facility: Cliniques Universitaires UCL de Mont-Goddine

location_facility: Centre Hospitalier Victor Dupouy d'Argenteuil

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Unknown


title: A Phase 3, Long-term Active Treatment Extension Study of Mongersen (GED-0301) in Subjects With Crohn's Disease

summary:
The purpose of this study is to assess long-term safety data of GED-0301 for a period of up to 208 weeks in adult subjects (i.e., ≥ 18 years of age) who participated in the core Phase 3 GED-0301-CD-002 and GED-0301-CD-003 studies and adolescent subjects (i.e., 12 to 17 years of age) who participated in the core Phase 3 GED-0301-CD-003 study. Although all subjects will receive active treatment, this study is double-blinded for the entire 208 weeks for the purpose of preserving the blind of the subject's treatment allocation in the initial, core Phase 3 GED-0301 study.

The GED-0301-CD-003 trial was not initiated; see detailed description.

study_start_date_type: Actual

lead_sponsor: Celgene

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Romania
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Israel
Turkey
Norway
Sweden
Slovakia
Canada
Switzerland
Hungary
Germany
Bulgaria
Denmark
Greece
Latvia
Korea, Republic of
France
Netherlands

location_facility: LKH - Universitätsklinikum der PMU Salzburg

location_facility: University General Hospital of Alexandroupolis

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Istanbul University Cerrahpasa Medical Faculty Hospital

location_facility: CHA Bundang Medical Center CHA University

location_facility: RCI Chernivtsi Regional Clinical Hospital Dept of Surgery Bukovinian SMU

location_facility: Universitaetsklinikum Carl Gustav Carus TU Dresden

location_facility: Nottingham University Hospitals Queens Medical Centre

location_facility: Groupe Hospitalier Sud Hopital Haut Leveque USN

location_facility: Fakultna nemocnica s poliklinikou F. D. Roosevelta

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: SPZOZ Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej - Centralny Szpital Weteranow

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej POLIMEDICA

location_facility: FSBI Scientific Research Institute of Physyology and Basic Medicine under the SB of RAMS

location_facility: CI Zaporizhzhia Regional Clinical Hospital of ZRC

location_facility: Medizinisches Zentrum Klinikum Lueneburg

location_facility: Universitaetsklinikum Schleswig Holstein Campus Kiel

location_facility: Azienda Ospedaliera Universitaria Policlinico G Martino

location_facility: Texas Digestive Disease Consultants - Dallas

location_facility: NonState Healthcare Institution Central Clinical Hospital, Samara station JSC Russian Railways

location_facility: Staedtisches Klinikum Braunschweig gGmbH Standort Salzdahlumer

location_facility: London Health Science Center U. Hospital

location_facility: Texas Digestive Disease Consultants - Southlake

location_facility: Gastroeneterologicka ambulancia MUDr. Peter Hegyi s.r.o.

location_facility: Atlanta Gastroenterology Associates, LLC

location_facility: Crohn-Colitis Zentrum Bern Gemeinschaftspraxis Balsiger Seibold und Partner

location_facility: Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH

location_facility: Treatment-Diagnostic Center of Private Enterprise of PMF Atsynus

location_facility: Hospital da Senhora da Oliveira Guimaraes

location_facility: Marmara University Pendik Training and Research Hospital

location_facility: University of Texas Health Science Center at Houston

location_facility: SBEIHPE Novosibirsk State Medical University

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Kocaeli Derince Training and Research Hospital

location_facility: Szent Pantaleon Korhaz Rendelointezet Dunaujvaros

location_facility: IRCCS Ospedale Casa Sollievo della Sofferenza

location_facility: McMaster University Health Sciences Center

location_facility: Yeditepe University Medical School Hospital

location_facility: Charite Universitaetsmedizin Berlin Campus Benjamin Franklin

location_facility: SEIHPE Rostov State Medical University of MoH of RF

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata

location_facility: Centre de sante et de services sociaux Champlain Charles Le Moyne

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: University of Washington School of Medicine

location_facility: Fondazione IRCCS CA Granda Ospedale Maggiore Policlinico

location_facility: Pauls Stradins Clinical University Hospital

location_facility: Clinical Research Institute of Michigan, LLC

location_facility: Seoul National University Bundang Hospital

location_facility: SBHI of NN region RCH of NN n.a. N.A.Semashko

location_facility: Haydarpasa Numune Training and Research Hospital

location_facility: Tel Aviv Sourasky Medical Center Department of Hematology

location_facility: Via Christi Research a division of Via Christi Hospitals Wichita Inc

location_facility: SI Republican Clinical Hospital of the MOHU Dept of Gastroenterology O.O.Bogomolets NMU

location_facility: McGill University Health Centre Glen Site Royal Victoria Hospital

location_facility: Gastroenterology Associates of Western Michigan PLC

location_facility: Toronto Digestive Disease Associates Inc

location_facility: Praxis fuer Gastroenterologie Dr Ehehal Dr Helmstaedter

location_facility: Ternopil City Communal Emergency Medical Care Hospital

location_facility: Istanbul Medeniyet Uni Goztepe Training&Res Hosp

location_facility: Ukrainian-German Antiulcer Gastroenterological Center BYK-Kyiv LLC

location_facility: Indywidualna Praktyka Lekarska Maciej Zymla

location_facility: KH der Barmherzigen Brüder St.Veit an der Glan

location_facility: Klinikum Mannheim GmbH Universitaetsklinikum

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant Orsola Malpighi

intervention_type: Other


ipd_sharing: Yes

status: Completed

title: A Phase 3, Global, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 8 Weeks and Sofosbuvir/Velpatasvir for 12 Weeks in Subjects With Chronic Genotype 3 HCV Infection and Cirrhosis

lead_sponsor: Gilead Sciences

source: euctr

publications_result: Foster GR, Thompson AJ, Ruane PJ, Borgia SM, Dore G, Workowski K, et al. A Randomized Phase 3 Trial of Sofosbuvir/Velpatasvir/Voxilaprevir for 8 Weeks and Sofosbuvir/Velpatasvir for 12 Weeks for Patients with Genotype 3 HCV Infection and Cirrhosis: The POLARIS-3 Study [Abstract 258]. J Hepatology 2016;63 (1S):135A

ReferenceType: result

ReferenceCitation: Jacobson IM, Lawitz E, Gane EJ, Willems BE, Ruane PJ, Nahass RG, Borgia SM, Shafran SD, Workowski KA, Pearlman B, Hyland RH, Stamm LM, Svarovskaia E, Dvory-Sobol H, Zhu Y, Subramanian GM, Brainard DM, McHutchison JG, Bräu N, Berg T, Agarwal K, Bhandari BR, Davis M, Feld JJ, Dore GJ, Stedman CAM, Thompson AJ, Asselah T, Roberts SK, Foster GR. Efficacy of 8 Weeks of Sofosbuvir, Velpatasvir, and Voxilaprevir in Patients With Chronic HCV Infection: 2 Phase 3 Randomized Trials. Gastroenterology. 2017 Jul;153(1):113-122. doi: 10.1053/j.gastro.2017.03.047. Epub 2017 Apr 5.

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.gilead.com/about/ethics-and-code-of-conduct/policies.

location_country:
United Kingdom
Australia
New Zealand
Canada
Puerto Rico
United States
France
Germany

summary: The primary objective of this study is to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC) for 8 weeks and of treatment with sofosbuvir/velpatasvir (SOF/VEL) FDC for 12 weeks in participants naive to direct-acting antivirals (DAA) with chronic genotype 3 hepatitis C virus (HCV) infection and cirrhosis.

status_simplified: Completed


type: Other Identifier

title: Efficacy and Long-term Safety of Oral Semaglutide Versus Sitagliptin in Subjects With Type 2 Diabetes

acronym: PIONEER 3

summary: This trial is conducted globally. The aim of the trial is to investigate efficacy and long-term safety of oral semaglutide versus sitagliptin in subjects with type 2 diabetes.

ReferenceCitation: Rosenstock J, Allison D, Birkenfeld AL, Blicher TM, Deenadayalan S, Jacobsen JB, Serusclat P, Violante R, Watada H, Davies M; PIONEER 3 Investigators. Effect of Additional Oral Semaglutide vs Sitagliptin on Glycated Hemoglobin in Adults With Type 2 Diabetes Uncontrolled With Metformin Alone or With Sulfonylurea: The PIONEER 3 Randomized Clinical Trial. JAMA. 2019 Apr 16;321(15):1466-1480. doi: 10.1001/jama.2019.2942.

ReferenceCitation: Araki E, Terauchi Y, Watada H, Deenadayalan S, Christiansen E, Horio H, Kadowaki T. Efficacy and safety of oral semaglutide in Japanese patients with type 2 diabetes: A post hoc subgroup analysis of the PIONEER 1, 3, 4 and 8 trials. Diabetes Obes Metab. 2021 Dec;23(12):2785-2794. doi: 10.1111/dom.14536. Epub 2021 Sep 27.

ReferenceCitation: Eliasson B, Ericsson Å, Fridhammar A, Nilsson A, Persson S, Chubb B. Long-Term Cost Effectiveness of Oral Semaglutide Versus Empagliflozin and Sitagliptin for the Treatment of Type 2 Diabetes in the Swedish Setting. Pharmacoecon Open. 2022 May;6(3):343-354. doi: 10.1007/s41669-021-00317-z. Epub 2022 Jan 21.

ReferenceCitation: Aroda VR, Bauer R, Christiansen E, Haluzík M, Kallenbach K, Montanya E, Rosenstock J, Meier JJ. Efficacy and safety of oral semaglutide by subgroups of patient characteristics in the PIONEER phase 3 programme. Diabetes Obes Metab. 2022 Jul;24(7):1338-1350. doi: 10.1111/dom.14710. Epub 2022 May 9.

ReferenceType: derived

ReferenceCitation: Pratley RE, Crowley MJ, Gislum M, Hertz CL, Jensen TB, Khunti K, Mosenzon O, Buse JB. Oral Semaglutide Reduces HbA(1c) and Body Weight in Patients with Type 2 Diabetes Regardless of Background Glucose-Lowering Medication: PIONEER Subgroup Analyses. Diabetes Ther. 2021 Apr;12(4):1099-1116. doi: 10.1007/s13300-020-00994-9. Epub 2021 Mar 4.

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

ReferenceCitation: Thethi TK, Pratley R, Meier JJ. Efficacy, safety and cardiovascular outcomes of once-daily oral semaglutide in patients with type 2 diabetes: The PIONEER programme. Diabetes Obes Metab. 2020 Aug;22(8):1263-1277. doi: 10.1111/dom.14054. Epub 2020 May 13. Review.

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

ipd_sharing_description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

lead_sponsor: Novo Nordisk A/S

location_country:
Brazil
Romania
United Kingdom
Russian Federation
Argentina
Ukraine
United States
France
India
Israel
Mexico
Japan
Germany
South Africa
Turkey


ipd_sharing: No

acronym: FIGARO-DKD

title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Event-driven Phase 3 Study to Investigate Efficacy and Safety of Finerenone on the Reduction of Cardiovascular Morbidity and Mortality in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease in Addition to Standard of Care.

lead_sponsor: Bayer

ReferenceCitation: Ruilope LM, Agarwal R, Anker SD, Bakris GL, Filippatos G, Nowack C, Kolkhof P, Joseph A, Mentenich N, Pitt B; FIGARO-DKD study investigators. Design and Baseline Characteristics of the Finerenone in Reducing Cardiovascular Mortality and Morbidity in Diabetic Kidney Disease Trial. Am J Nephrol. 2019;50(5):345-356. doi: 10.1159/000503712. Epub 2019 Oct 30.

ReferenceCitation: Pitt B, Filippatos G, Agarwal R, Anker SD, Bakris GL, Rossing P, Joseph A, Kolkhof P, Nowack C, Schloemer P, Ruilope LM; FIGARO-DKD Investigators. Cardiovascular Events with Finerenone in Kidney Disease and Type 2 Diabetes. N Engl J Med. 2021 Dec 9;385(24):2252-2263. doi: 10.1056/NEJMoa2110956. Epub 2021 Aug 28.

ReferenceCitation: Filippatos G, Anker SD, Pitt B, Rossing P, Joseph A, Kolkhof P, Lambelet M, Lawatscheck R, Bakris GL, Ruilope LM, Agarwal R. Finerenone and Heart Failure Outcomes by Kidney Function/Albuminuria in Chronic Kidney Disease and Diabetes. JACC Heart Fail. 2022 Nov;10(11):860-870. doi: 10.1016/j.jchf.2022.07.013. Epub 2022 Oct 12.

ReferenceCitation: Pitt B, Agarwal R, Anker SD, Ruilope LM, Rossing P, Ahlers C, Brinker M, Joseph A, Lambelet M, Lawatscheck R, Filippatos GS; FIDELIO-DKD and FIGARO-DKD Investigators. Association of Finerenone Use With Reduction in Treatment-Emergent Pneumonia and COVID-19 Adverse Events Among Patients With Type 2 Diabetes and Chronic Kidney Disease: A FIDELITY Pooled Secondary Analysis. JAMA Netw Open. 2022 Oct 3;5(10):e2236123. doi: 10.1001/jamanetworkopen.2022.36123.

ReferenceCitation: Filippatos G, Anker SD, Agarwal R, Ruilope LM, Rossing P, Bakris GL, Tasto C, Joseph A, Kolkhof P, Lage A, Pitt B; FIGARO-DKD Investigators. Finerenone Reduces Risk of Incident Heart Failure in Patients With Chronic Kidney Disease and Type 2 Diabetes: Analyses From the FIGARO-DKD Trial. Circulation. 2022 Feb 8;145(6):437-447. doi: 10.1161/CIRCULATIONAHA.121.057983. Epub 2021 Nov 13.

ReferenceCitation: Erraez S, López-Mesa M, Gómez-Fernández P. [Mineralcorticoid receptor blockers in chronic kidney disease]. Nefrologia (Engl Ed). 2021 May-Jun;41(3):258-275. doi: 10.1016/j.nefro.2020.10.001. Epub 2020 Dec 24. Review. English, Spanish.

ReferenceCitation: Agarwal R, Anker SD, Bakris G, Filippatos G, Pitt B, Rossing P, Ruilope L, Gebel M, Kolkhof P, Nowack C, Joseph A; FIDELIO-DKD and FIGARO-DKD Investigators. Investigating new treatment opportunities for patients with chronic kidney disease in type 2 diabetes: the role of finerenone. Nephrol Dial Transplant. 2022 May 25;37(6):1014-1023. doi: 10.1093/ndt/gfaa294.

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, time point and process of data access. As such, Bayer commits to sharing upon request from qualified researcher's 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.clinicalstudydatarequest.com 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 Study sponsors section of the portal.

location_country:
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
Belgium
Japan
Philippines
Romania
South Africa
Czechia
Poland
Hong Kong
Portugal
Austria
Australia
Russian Federation
Argentina
Puerto Rico
Israel
Turkey
Mexico
Norway
Malaysia
Singapore
Sweden
Slovakia
Brazil
Canada
Switzerland
Hungary
China
Germany
Bulgaria
Denmark
Taiwan
Greece
Ireland
New Zealand
Finland
Thailand
Vietnam
Korea, Republic of
France
Chile
Colombia
Netherlands

summary: The purpose of this study was to evaluate whether oral finerenone (study drug), in addition to standard daily therapy, is effective and safe in treating patients with type 2 diabetes mellitus and diabetic kidney disease, when compared to a placebo.


title: A Phase I, Open-label, Multiple-ascending Dose Trial to Investigate the Safety, Tolerability, PK, Biological and Clinical Activity of MSB0011359C in Subjects With Metastatic or Locally Advanced Solid Tumors and Expansion to Selected Indications

summary: The main purpose of this Phase I study is to test MSB0011359C (M7824) at different dose levels to see if it is safe and well tolerated when given once every 2 weeks. Phase I means the study drug has not previously been given to humans or has only been given to a limited number of people, although it has been extensively studied in animals. Based on this information, it is hoped to find out which dose could be best for the treatment of patients. There are two parts of this research study: a dose-escalation part and an expansion part. Dose escalation means that the first people taking part in the study will receive low doses of the study drug, and as more people take part, the additional participants will receive a higher dose. This is done to find the safest dose for the study drug. Expansion means that after the dose-escalation part of the study has looked at the safety and effectiveness of different doses, many more people will be invited to take part in the study and will receive the study drug at the safest dose. Additional purposes of the study are to find out whether the study drug has anti-cancer effects and how the study drug is processed by the body.

ReferenceCitation: Strauss J, Gatti-Mays ME, Cho BC, Hill A, Salas S, McClay E, Redman JM, Sater HA, Donahue RN, Jochems C, Lamping E, Burmeister A, Marté JL, Cordes LM, Bilusic M, Karzai F, Ojalvo LS, Jehl G, Rolfe PA, Hinrichs CS, Madan RA, Schlom J, Gulley JL. Bintrafusp alfa, a bifunctional fusion protein targeting TGF-β and PD-L1, in patients with human papillomavirus-associated malignancies. J Immunother Cancer. 2020 Dec;8(2). pii: e001395. doi: 10.1136/jitc-2020-001395.

ReferenceCitation: Cho BC, Daste A, Ravaud A, Salas S, Isambert N, McClay E, Awada A, Borel C, Ojalvo LS, Helwig C, Rolfe PA, Gulley JL, Penel N. Bintrafusp alfa, a bifunctional fusion protein targeting TGF-β and PD-L1, in advanced squamous cell carcinoma of the head and neck: results from a phase I cohort. J Immunother Cancer. 2020 Jul;8(2). pii: e000664. doi: 10.1136/jitc-2020-000664. Erratum in: J Immunother Cancer. 2020 Oct;8(2):.

ReferenceCitation: Wilkins JJ, Vugmeyster Y, Dussault I, Girard P, Khandelwal A. Population Pharmacokinetic Analysis of Bintrafusp Alfa in Different Cancer Types. Adv Ther. 2019 Sep;36(9):2414-2433. doi: 10.1007/s12325-019-01018-0. Epub 2019 Jul 5.

ReferenceCitation: Strauss J, Heery CR, Schlom J, Madan RA, Cao L, Kang Z, Lamping E, Marté JL, Donahue RN, Grenga I, Cordes L, Christensen O, Mahnke L, Helwig C, Gulley JL. Phase I Trial of M7824 (MSB0011359C), a Bifunctional Fusion Protein Targeting PD-L1 and TGFβ, in Advanced Solid Tumors. Clin Cancer Res. 2018 Mar 15;24(6):1287-1295. doi: 10.1158/1078-0432.CCR-17-2653. Epub 2018 Jan 3.

ReferenceCitation: Tan B, Khattak A, Felip E, Kelly K, Rich P, Wang D, Helwig C, Dussault I, Ojalvo LS, Isambert N. Bintrafusp Alfa, a Bifunctional Fusion Protein Targeting TGF-β and PD-L1, in Patients with Esophageal Adenocarcinoma: Results from a Phase 1 Cohort. Target Oncol. 2021 Jul;16(4):435-446. doi: 10.1007/s11523-021-00809-2. Epub 2021 May 19.

ReferenceCitation: Vugmeyster Y, Grisic AM, Wilkins JJ, Loos AH, Hallwachs R, Osada M, Venkatakrishnan K, Khandelwal A. Model-informed approach for risk management of bleeding toxicities for bintrafusp alfa, a bifunctional fusion protein targeting TGF-β and PD-L1. Cancer Chemother Pharmacol. 2022 Oct;90(4):369-379. doi: 10.1007/s00280-022-04468-6. Epub 2022 Sep 6.

lead_sponsor: EMD Serono Research & Development Institute, Inc.

location_country:
Taiwan
Spain
Italy
United Kingdom
Australia
Canada
Korea, Republic of
United States
France
Belgium
Japan
Germany

location_facility: University of North Carolina at Chapel Hill

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: Universitaetsklinikum Carl Gustav Carus TU Dresden

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: University of California Davis Health System

location_facility: Institut Curie - Centre de Lutte Contre le Cancer (CLCC) de Paris

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Penn State University Milton S. Hershey Medical Center

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

location_facility: South Texas Accelerated Research Therapeutics, LLC

location_facility: Hospital Universitario Clinico San Carlos

location_facility: GZA Ziekenhuizen - Campus Sint-Augustinus

location_facility: Eastern Connecticut Hematology/Oncology Assoc.

location_facility: University of Texas M. D. Anderson Cancer Center - Investigational Cancer Therapeutics

location_facility: Fondazione del Piemonte per l'Oncologia IRCC Candiolo

location_facility: Hematology - Oncology Associates of Treasure Coast

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Greenville Hospital System University Medical Center (ITOR)

location_facility: Institut Régional du Cancer de Montpellier

location_facility: Seoul National University Bundang Hospital

location_facility: Gallipoli Medical Research Foundation Ltd

location_facility: Charite Universitaetsmedizin Berlin - Campus Charite Mitte

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Peter MacCallum Cancer Centre-East Melbourne


primary_purpose: Prevention

acronym: VOYAGER PAD

title: An International, Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Trial Investigating the Efficacy and Safety of Rivaroxaban to Reduce the Risk of Major Thrombotic Vascular Events in Patients With Symptomatic Peripheral Artery Disease Undergoing Lower Extremity Revascularization Procedures

ReferenceCitation: Hess CN, Baumgartner I, Anand SS, Nehler MR, Patel MR, Debus ES, Szarek M, Capell W, Muehlhofer E, Berkowitz SD, Haskell LP, Bauersachs RM, Bonaca MP, Hsia J. Sex-Based Differences in Outcomes Following Peripheral Artery Revascularization: Insights From VOYAGER PAD. J Am Heart Assoc. 2022 Jun 21;11(12):e024655. doi: 10.1161/JAHA.121.024655. Epub 2022 Jun 14.

ReferenceCitation: Hogan SE, Nehler MR, Anand S, Patel MR, Debus S, Jackson MT, Buchanan C, King RW, Hess C, Muehlhofer E, Haskell LP, Bauersachs RM, Berkowitz SD, Hsia J, Bonaca MP. Improvement in walking impairment following surgical and endovascular revascularization: Insights from VOYAGER PAD. Vasc Med. 2022 Aug;27(4):343-349. doi: 10.1177/1358863X221085606. Epub 2022 Apr 25.

ReferenceCitation: Hess CN, Patel MR, Bauersachs RM, Anand SS, Debus ES, Nehler MR, Fanelli F, Yeh RW, Secemsky EA, Beckman JA, Mauri L, Govsyeyev N, Capell WH, Brackin T, Berkowitz SD, Muehlhofer E, Haskell LP, Hiatt WR, Bonaca MP. Safety and Effectiveness of Paclitaxel Drug-Coated Devices in Peripheral Artery Revascularization: Insights From VOYAGER PAD. J Am Coll Cardiol. 2021 Nov 2;78(18):1768-1778. doi: 10.1016/j.jacc.2021.08.052.

ReferenceCitation: Debus ES, Nehler MR, Govsyeyev N, Bauersachs RM, Anand SS, Patel MR, Fanelli F, Capell WH, Brackin T, Hinterreiter F, Krievins D, Nault P, Piffaretti G, Svetlikov A, Jaeger N, Hess CN, Sillesen HH, Conte M, Mills J, Muehlhofer E, Haskell LP, Berkowitz SD, Hiatt WR, Bonaca MP. Effect of Rivaroxaban and Aspirin in Patients With Peripheral Artery Disease Undergoing Surgical Revascularization: Insights From the VOYAGER PAD Trial. Circulation. 2021 Oct 5;144(14):1104-1116. doi: 10.1161/CIRCULATIONAHA.121.054835. Epub 2021 Aug 12.

ReferenceCitation: Bauersachs RM, Szarek M, Brodmann M, Gudz I, Debus ES, Nehler MR, Anand SS, Patel MR, Hess CN, Capell WH, Rogers K, Muehlhofer E, Haskell LP, Berkowitz SD, Hiatt WR, Bonaca MP; VOYAGER PAD Committees and Investigators. Total Ischemic Event Reduction With Rivaroxaban After Peripheral Arterial Revascularization in the VOYAGER PAD Trial. J Am Coll Cardiol. 2021 Jul 27;78(4):317-326. doi: 10.1016/j.jacc.2021.05.003. Epub 2021 May 16.

ReferenceCitation: Hiatt WR, Bonaca MP, Patel MR, Nehler MR, Debus ES, Anand SS, Capell WH, Brackin T, Jaeger N, Hess CN, Pap AF, Berkowitz SD, Muehlhofer E, Haskell L, Brasil D, Madaric J, Sillesen H, Szalay D, Bauersachs R. Rivaroxaban and Aspirin in Peripheral Artery Disease Lower Extremity Revascularization: Impact of Concomitant Clopidogrel on Efficacy and Safety. Circulation. 2020 Dec 8;142(23):2219-2230. doi: 10.1161/CIRCULATIONAHA.120.050465. Epub 2020 Nov 3.

ReferenceCitation: Bonaca MP, Bauersachs RM, Anand SS, Debus ES, Nehler MR, Patel MR, Fanelli F, Capell WH, Diao L, Jaeger N, Hess CN, Pap AF, Kittelson JM, Gudz I, Mátyás L, Krievins DK, Diaz R, Brodmann M, Muehlhofer E, Haskell LP, Berkowitz SD, Hiatt WR. Rivaroxaban in Peripheral Artery Disease after Revascularization. N Engl J Med. 2020 May 21;382(21):1994-2004. doi: 10.1056/NEJMoa2000052. Epub 2020 Mar 28.

ReferenceCitation: Capell WH, Bonaca MP, Nehler MR, Chen E, Kittelson JM, Anand SS, Berkowitz SD, Debus ES, Fanelli F, Haskell L, Patel MR, Bauersachs R, Hiatt WR. Rationale and design for the Vascular Outcomes study of ASA along with rivaroxaban in endovascular or surgical limb revascularization for peripheral artery disease (VOYAGER PAD). Am Heart J. 2018 May;199:83-91. doi: 10.1016/j.ahj.2018.01.011. Epub 2018 Feb 3.

location_country:
Serbia
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
Belgium
Japan
Romania
Czechia
Poland
Portugal
Austria
Russian Federation
Argentina
Sweden
Slovakia
Brazil
Canada
Switzerland
Hungary
China
Germany
Bulgaria
Denmark
Taiwan
Latvia
Estonia
Finland
Thailand
Korea, Republic of
France
Netherlands

summary: The purpose of study was to test whether rivaroxaban added to standard of care treatment, when compared to placebo, had the potential to reduce the incidence of the clinical events related to the clots and complications of the heart and brain (CV death, MI, or stroke) or the legs (acute limb ischemia or major amputation) in patients who had undergone recent procedure(s) to improve the blood flow of their legs.


title: An Open-Label, Randomized Phase 3 Trial of Nivolumab, or Nivolumab Plus Ipilimumab, or Nivolumab Plus Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Subjects With Chemotherapy-Naïve Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)

acronym: CheckMate 227

summary: The purpose of this study is to show that Nivolumab, or Nivolumab plus Ipilimumab, or Nivolumab plus Platinum-Doublet Chemotherapy improves progression free survival and/or overall survival compared with chemotherapy in patients with advanced lung cancer.

status: Active, not recruiting

study_completion_date_type: Anticipated

ReferenceCitation: Reck M, Ciuleanu TE, Lee JS, Schenker M, Audigier-Valette C, Zurawski B, Linardou H, Otterson GA, Salman P, Nishio M, de la Mora Jimenez E, Lesniewski-Kmak K, Albert I, Ahmed S, Syrigos K, Penrod JR, Yuan Y, Blum SI, Nathan FE, Sun X, Moreno-Koehler A, Taylor F, O'Byrne KJ. First-Line Nivolumab Plus Ipilimumab Versus Chemotherapy in Advanced NSCLC With 1% or Greater Tumor PD-L1 Expression: Patient-Reported Outcomes From CheckMate 227 Part 1. J Thorac Oncol. 2021 Apr;16(4):665-676. doi: 10.1016/j.jtho.2020.12.019. Epub 2021 Jan 21.

ReferenceCitation: Hellmann MD, Paz-Ares L, Bernabe Caro R, Zurawski B, Kim SW, Carcereny Costa E, Park K, Alexandru A, Lupinacci L, de la Mora Jimenez E, Sakai H, Albert I, Vergnenegre A, Peters S, Syrigos K, Barlesi F, Reck M, Borghaei H, Brahmer JR, O'Byrne KJ, Geese WJ, Bhagavatheeswaran P, Rabindran SK, Kasinathan RS, Nathan FE, Ramalingam SS. Nivolumab plus Ipilimumab in Advanced Non-Small-Cell Lung Cancer. N Engl J Med. 2019 Nov 21;381(21):2020-2031. doi: 10.1056/NEJMoa1910231. Epub 2019 Sep 28.

ReferenceCitation: Reck M, Schenker M, Lee KH, Provencio M, Nishio M, Lesniewski-Kmak K, Sangha R, Ahmed S, Raimbourg J, Feeney K, Corre R, Franke FA, Richardet E, Penrod JR, Yuan Y, Nathan FE, Bhagavatheeswaran P, DeRosa M, Taylor F, Lawrance R, Brahmer J. Nivolumab plus ipilimumab versus chemotherapy as first-line treatment in advanced non-small-cell lung cancer with high tumour mutational burden: patient-reported outcomes results from the randomised, open-label, phase III CheckMate 227 trial. Eur J Cancer. 2019 Jul;116:137-147. doi: 10.1016/j.ejca.2019.05.008. Epub 2019 Jun 11.

ReferenceCitation: Hellmann MD, Ciuleanu TE, Pluzanski A, Lee JS, Otterson GA, Audigier-Valette C, Minenza E, Linardou H, Burgers S, Salman P, Borghaei H, Ramalingam SS, Brahmer J, Reck M, O'Byrne KJ, Geese WJ, Green G, Chang H, Szustakowski J, Bhagavatheeswaran P, Healey D, Fu Y, Nathan F, Paz-Ares L. Nivolumab plus Ipilimumab in Lung Cancer with a High Tumor Mutational Burden. N Engl J Med. 2018 May 31;378(22):2093-2104. doi: 10.1056/NEJMoa1801946. Epub 2018 Apr 16.

lead_sponsor: Bristol-Myers Squibb

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

location_facility: Washington University School Of Medicine

status_simplified: Ongoing


title: A Phase III Randomized Double-blind, Placebo Controlled Study of Alpelisib in Combination With Fulvestrant for Men and Postmenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment

lead_sponsor: Novartis Pharmaceuticals

ReferenceCitation: Ciruelos EM, Rugo HS, Mayer IA, Levy C, Forget F, Delgado Mingorance JI, Safra T, Masuda N, Park YH, Juric D, Conte P, Campone M, Loibl S, Iwata H, Zhou X, Park J, Ridolfi A, Lorenzo I, André F. Patient-Reported Outcomes in Patients With PIK3CA-Mutated Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer From SOLAR-1. J Clin Oncol. 2021 Jun 20;39(18):2005-2015. doi: 10.1200/JCO.20.01139. Epub 2021 Mar 29.

ReferenceCitation: Andre F, Ciruelos EM, Juric D, Loibl S, Campone M, Mayer IA, Rubovszky G, Yamashita T, Kaufman B, Lu YS, Inoue K, Papai Z, Takahashi M, Ghaznawi F, Mills D, Kaper M, Miller M, Conte PF, Iwata H, Rugo HS. Alpelisib plus fulvestrant for PIK3CA-mutated, hormone receptor-positive, human epidermal growth factor receptor-2-negative advanced breast cancer: final overall survival results from SOLAR-1. Ann Oncol. 2021 Feb;32(2):208-217. doi: 10.1016/j.annonc.2020.11.011. Epub 2020 Nov 25.

ReferenceCitation: Rugo HS, André F, Yamashita T, Cerda H, Toledano I, Stemmer SM, Jurado JC, Juric D, Mayer I, Ciruelos EM, Iwata H, Conte P, Campone M, Wilke C, Mills D, Lteif A, Miller M, Gaudenzi F, Loibl S. Time course and management of key adverse events during the randomized phase III SOLAR-1 study of PI3K inhibitor alpelisib plus fulvestrant in patients with HR-positive advanced breast cancer. Ann Oncol. 2020 Aug;31(8):1001-1010. doi: 10.1016/j.annonc.2020.05.001. Epub 2020 May 13.

ReferenceCitation: André F, Ciruelos E, Rubovszky G, Campone M, Loibl S, Rugo HS, Iwata H, Conte P, Mayer IA, Kaufman B, Yamashita T, Lu YS, Inoue K, Takahashi M, Pápai Z, Longin AS, Mills D, Wilke C, Hirawat S, Juric D; SOLAR-1 Study Group. Alpelisib for PIK3CA-Mutated, Hormone Receptor-Positive Advanced Breast Cancer. N Engl J Med. 2019 May 16;380(20):1929-1940. doi: 10.1056/NEJMoa1813904.

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:
Spain
Italy
United Kingdom
United States
Peru
Belgium
Japan
Romania
Czechia
Hong Kong
Austria
Australia
Russian Federation
Argentina
India
Israel
Mexico
Sweden
Brazil
Lebanon
Canada
Hungary
Germany
Bulgaria
Taiwan
Greece
Thailand
Korea, Republic of
France
Chile
Netherlands

location_facility: Cancer Therapy and Research Center UT Health Science Center InstituteForDrugDevelopment(4)

location_facility: Good Samaritan Regional Medical Center Good Samaritan Reg Med Ctr

location_facility: Florida Cancer Specialists FL Cancer Specialists

location_facility: North Shore University Health System NorthShore University

location_facility: Rutgers Cancer Institute of New Jersey SC-2

location_facility: Massachusetts General Hospital Updated Regulatory

location_facility: Rush University Medical Center Rush Uni Medical Center

location_facility: Texas Oncology PA Dallas Presbyterian Hospital SC-1

location_facility: University Hospitals of Cleveland Seidman Cancer Center SC

location_facility: Fort Wayne Medical Oncology/Hematology, Inc. Dept.of Fort Wayne Med Onc/Hem

location_facility: St. Francis Health Comprehensive Cancer Center SC

location_facility: Ironwood Cancer and Research Centers Chandler 2

summary: To determine whether treatment with alpelisib plus fulvestrant prolongs progression-free survival compared to fulvestrant and placebo in men and postmenopausal women with hormone receptor positive (HR+), HER2-negative advanced breast cancer, who received prior treatment with an Aromatase Inhibitor either as (neo)adjuvant or for advanced disease.


title: A Randomized, Double-blind, Multicenter, Active-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Fixed Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Subjects With Treatment-resistant Depression

summary: The purpose of this study is to compare the efficacy and safety of switching treatment-resistant depression (TRD) participants from a prior antidepressant treatment (to which they have not responded) to either intranasal esketamine plus a new oral antidepressant or switching to a new oral antidepressant plus intranasal placebo.

ReferenceCitation: Jha MK, Williamson DJ, Magharehabed G, Turkoz I, Daly EJ, Trivedi MH. Intranasal esketamine effectively treats treatment-resistant depression in adults regardless of baseline irritability. J Affect Disord. 2023 Jan 15;321:153-160. doi: 10.1016/j.jad.2022.10.020. Epub 2022 Oct 20.

ReferenceCitation: Chen G, Chen L, Zhang Y, Li X, Lane R, Lim P, Daly EJ, Furey ML, Fedgchin M, Popova V, Singh JB, Drevets WC. Relationship Between Dissociation and Antidepressant Effects of Esketamine Nasal Spray in Patients With Treatment-Resistant Depression. Int J Neuropsychopharmacol. 2022 Apr 19;25(4):269-279. doi: 10.1093/ijnp/pyab084.

ReferenceCitation: Jones RR, Freeman MP, Kornstein SG, Cooper K, Daly EJ, Canuso CM, Nicholson S. Efficacy and safety of esketamine nasal spray by sex in patients with treatment-resistant depression: findings from short-term randomized, controlled trials. Arch Womens Ment Health. 2022 Apr;25(2):313-326. doi: 10.1007/s00737-021-01185-6. Epub 2022 Jan 1.

ReferenceCitation: Dean RL, Hurducas C, Hawton K, Spyridi S, Cowen PJ, Hollingsworth S, Marquardt T, Barnes A, Smith R, McShane R, Turner EH, Cipriani A. Ketamine and other glutamate receptor modulators for depression in adults with unipolar major depressive disorder. Cochrane Database Syst Rev. 2021 Sep 12;9:CD011612. doi: 10.1002/14651858.CD011612.pub3. Review.

ReferenceCitation: Turkoz I, Daly E, Singh J, Lin X, Tymofyeyev Y, Williamson D, Salvadore G, Nash AI, Macaluso M, Wilkinson ST, Nelson JC. Treatment Response With Esketamine Nasal Spray Plus an Oral Antidepressant in Patients With Treatment-Resistant Depression Without Evidence of Early Response: A Pooled Post Hoc Analysis of the TRANSFORM Studies. J Clin Psychiatry. 2021 Jul 20;82(4). pii: 20m13800. doi: 10.4088/JCP.20m13800.

ReferenceCitation: Doty RL, Popova V, Wylie C, Fedgchin M, Daly E, Janik A, Ochs-Ross R, Lane R, Lim P, Cooper K, Melkote R, Jamieson C, Singh J, Drevets WC. Effect of Esketamine Nasal Spray on Olfactory Function and Nasal Tolerability in Patients with Treatment-Resistant Depression: Results from Four Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Studies. CNS Drugs. 2021 Jul;35(7):781-794. doi: 10.1007/s40263-021-00826-9. Epub 2021 Jul 7.

ReferenceCitation: Perez-Ruixo C, Rossenu S, Zannikos P, Nandy P, Singh J, Drevets WC, Perez-Ruixo JJ. Population Pharmacokinetics of Esketamine Nasal Spray and its Metabolite Noresketamine in Healthy Subjects and Patients with Treatment-Resistant Depression. Clin Pharmacokinet. 2021 Apr;60(4):501-516. doi: 10.1007/s40262-020-00953-4. Epub 2020 Oct 31.

ReferenceCitation: Katz EG, Hough D, Doherty T, Lane R, Singh J, Levitan B. Benefit-Risk Assessment of Esketamine Nasal Spray vs. Placebo in Treatment-Resistant Depression. Clin Pharmacol Ther. 2021 Feb;109(2):536-546. doi: 10.1002/cpt.2024. Epub 2020 Oct 13.

ReferenceCitation: Saad Z, Hibar D, Fedgchin M, Popova V, Furey ML, Singh JB, Kolb H, Drevets WC, Chen G. Effects of Mu-Opiate Receptor Gene Polymorphism rs1799971 (A118G) on the Antidepressant and Dissociation Responses in Esketamine Nasal Spray Clinical Trials. Int J Neuropsychopharmacol. 2020 Dec 3;23(9):549-558. doi: 10.1093/ijnp/pyaa030.

ReferenceCitation: Fedgchin M, Trivedi M, Daly EJ, Melkote R, Lane R, Lim P, Vitagliano D, Blier P, Fava M, Liebowitz M, Ravindran A, Gaillard R, Ameele HVD, Preskorn S, Manji H, Hough D, Drevets WC, Singh JB. Efficacy and Safety of Fixed-Dose Esketamine Nasal Spray Combined With a New Oral Antidepressant in Treatment-Resistant Depression: Results of a Randomized, Double-Blind, Active-Controlled Study (TRANSFORM-1). Int J Neuropsychopharmacol. 2019 Oct 1;22(10):616-630. doi: 10.1093/ijnp/pyz039.

lead_sponsor: Janssen Research & Development, LLC

location_country:
Brazil
Estonia
Mexico
Canada
Hungary
United States
France
Belgium
Slovakia


title: A Phase 3, Randomized, Efficacy and Safety Study of Enzalutamide Plus Leuprolide, Enzalutamide Monotherapy, and Placebo Plus Leuprolide in Men With High-Risk Nonmetastatic Prostate Cancer Progressing After Definitive Therapy

summary: The purpose of this study is to assess enzalutamide plus leuprolide in patients with high-risk nonmetastatic prostate cancer progressing after radical prostatectomy or radiotherapy or both.

ReferenceCitation: Freedland SJ, De Giorgi U, Gleave M, Rosbrook B, Shen Q, Sugg J, Haas GP, Shore ND. A phase 3 randomised study of enzalutamide plus leuprolide and enzalutamide monotherapy in high-risk non-metastatic hormone-sensitive prostate cancer with rising PSA after local therapy: EMBARK study design. BMJ Open. 2021 Aug 12;11(8):e046588. doi: 10.1136/bmjopen-2020-046588.

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

lead_sponsor: Pfizer

location_country:
Denmark
Poland
Taiwan
Brazil
Spain
Italy
Austria
Australia
United Kingdom
Canada
Finland
Sweden
Korea, Republic of
United States
France
Netherlands
Slovakia

location_facility: Hospital das Clinicas da Faculdade de Ciencias Medicas da UNICAMP

location_facility: Department of Radiology, University Hospital Salzburg, Austria

location_facility: Fundacao Pio XII - Hospital de Cancer de Barretos

location_facility: Fakultna nemocnica s poliklinikou F.D.Roosevelta

location_facility: Memorial Sloan Kettering Cancer Center Rockville Centre

location_facility: Farmacia Ospedaliera, Padiglione specialita, A.O.U. San Luigi Gonzaga

location_facility: Chonnam National University Hwasun Hospital

location_facility: University Health Network - Princess Margaret Cancer Centre

location_facility: Alaska Urological Institute dba Alaska Clinical Research Center

location_facility: Sutter Medical Group, Vascular & Varicose Vein Center

location_facility: TriState Urologic Services PSC Inc., dba The Urology Group

location_facility: Hospital Barmherzige Schwestern Linz, Department of Urology

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale/Oncologia Medica A

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

location_facility: Memorial Sloan Kettering Cancer Center Commack

location_facility: GU Research Network, LLC / Urology Cancer Center

location_facility: UO di Radiologia, Azienda Socio Sanitaria Territoriale di Cremona

location_facility: U.O. di Oncologia Medica, Ospedale Santa Chiara

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o., Oddzial Urologiczny

location_facility: The University of Kansas Cancer Center, Investigational Drug Services

location_facility: Pusan National University Yangsan Hospital

location_facility: Lakeland Regional Health Hollis Cancer Center

location_facility: Department of Internal Medicine I, Medical university Vienna

location_facility: Althaia, Xarxa Assistencial Universitària de Manresa

location_facility: Azienda Ospedaliera S, Camillo Forlanini, UOC per il governo clinico in Oncologia Medica,pad,Flajani

location_facility: S.C.D.U. Radiodiagnostica, A.O.U. San Luigi Gonzaga

location_facility: The Sidney Kimmel Cancer Center at Johns Hopkins Hospital- Oncology Investigational Drug Services

location_facility: University of California, Davis, School of Medicine

location_facility: Associated Medical Professionals of New York, PLLC

location_facility: Duke Investigational Chemotherapy Services

location_facility: Farmacia Interna, Ospedale degli Infermi

location_facility: Hospital General Universitario Gregorio Maranon. Servicio de Oncologia.

location_facility: Thomas Jefferson University Hospital, Bodine Buiding

location_facility: Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner

location_facility: Gangnam Severance Hospital, Yonsei University Health System

location_facility: University Medical Centrum Groningen, Department Urologie

location_facility: Complejo Hospitalario Universitario de Santiago

location_facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

location_facility: VU Medical Centrum, Department of Urology

location_facility: Department of Nuclear Medicine and Endocrinology, University Hospital Salzburg, Austria

location_facility: Premier Medical Group of the Hudson Valley PC

location_facility: UO Radiologia,IRCCS Istituto Scientifico Romagnolo Per lO Studio e la Cura dei Tumori (IRST)

location_facility: Urology Associates/ Urologic Medical Research

location_facility: Manitoba Prostate Centre CancerCare Manitoba

location_facility: Vychodoslovensky onkologicky ustav, a.s.

location_facility: Farmacia, Azienda Socio Sanitaria Territoriale di Cremona

location_facility: Servizio di Farmacia, Ospedale Santa Maria delle Croci

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: GU Research Network/Wichita Urology Group

location_facility: Centro de Estudos e Pesquisas de Hematologia e Oncologia - Faculdade de Medicina do ABC

location_facility: UO di Radiologia, Ospedale Civile degli Infermi

location_facility: University of Alabama at Birmingham, IDS Pharmacy

location_facility: Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o. o.

location_facility: UO di Oncologia, Ospedale Civile Umberto I

location_facility: Urological Associates of Southern Arizona, PC

location_facility: Severance Hospital. Yonsei University Health System

location_facility: Winship Cancer Institute, Emory University

location_facility: CLINIONCO - Clinica de Oncologia de Porto Alegre Ltda.

location_facility: Memorial Sloan Kettering Cancer Center Westchester

location_facility: Uo di Radiologia, Ospedale Civile Umberto I

location_facility: ICO Girona; Hospital Universitari de Girona Dr. Josep Trueta. Servicio de Oncologia

location_facility: Complejo Hospitalario Universitario de Orense

location_facility: U.O. Medicina Nucleare, Ospedale Santa Chiara

location_facility: University of California, Irvine Medical Center

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

location_facility: Eastern Connecticut Hematology Oncology Associates

location_facility: Centre Hospitalier de l'Universite de Montreal

location_facility: Comprehensive Urology - Royal Oak (Stephenson) office

location_facility: Clinique Pasteur - Lanroze Service Pharmacie

location_facility: Department of Urology,Paracelsus Medical University Salzburg

location_facility: Seoul National University Bundang Hospital

location_facility: The Male/Female Health and Research Centre, Royal Court Medical Centre

location_facility: The University of Kansas Cancer Center and Medical Pavilion

location_facility: Maastricht University Medical Center, Department of Urology

location_facility: University Hospitals Bristol NHS Foundation Trust

location_facility: Servizio di Radiologia, Ospedale Santa Maria Delle Croci

location_facility: Vanderbilt Unversity Medical Center, Dept. of Urologic Surgery

location_facility: CHU de Quebec - L'Hotel-Dieu de Quebec - CRCEO

location_facility: Memorial Sloan Kettering Cancer Center Basking Ridge

location_facility: Oncosite - Centro de Pesquisa Clinica em Oncologia Ltda

location_facility: U.O. Oncologia Medica, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

location_facility: London Health Sciences Centre - Victoria Hospital

location_facility: Fakultna nemocnica s poliklinikou Zilina

location_facility: Centro Oncologico MD Anderson International Espana

location_facility: Sidney Kimmel Center for Prostate and Urologic Cancers

location_facility: University of California Davis Medical Center

location_facility: Uniwersyteckie Centrum Kliniczne Klinika Onkologii i Radioterapii

location_facility: UO di Oncologia Medica, Ospedale Santa Maria delle Croci

location_facility: Memorial Sloan Kettering Cancer Center Nassau

location_facility: Kujawsko-Pomorskie Centrum Urologicznw Sp z o.o

location_facility: Hospital Clinic i Provincial de Barcelona, Dr. Antonio Alcaraz Asensio

location_facility: Vanderbilt Unversity Medical Center, The Urology Clinic

location_facility: S.C.D.U. Oncologia Medica, A.O.U. San Luigi Gonzaga

location_facility: Laboratorio Farmaci Antiblastici, IRCCS Istituto

location_facility: Struttura Complessa di Oncologia, Azienda Socio Sanitaria Territoriale di Cremona

location_facility: Rigshospitalet - Copenhagen University Hospital

location_facility: UO di Oncologia,Ospedale Civile degli Infermi

location_facility: Johns Hopkins Kimmel Cancer Center/ Sibley Infusion

location_facility: CITO - Centro Integrado de Terapia Onco-Hematologica - Hospital de Clinicas de Passo Fundo


title: A Phase II, Randomized, Open-Label, Multi-Center, Global Study of MEDI4736 Monotherapy, Tremelimumab Monotherapy, and MEDI4736 in Combination With Tremelimumab in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

lead_sponsor: AstraZeneca

ReferenceCitation: Siu LL, Even C, Mesía R, Remenar E, Daste A, Delord JP, Krauss J, Saba NF, Nabell L, Ready NE, Braña I, Kotecki N, Zandberg DP, Gilbert J, Mehanna H, Bonomi M, Jarkowski A, Melillo G, Armstrong JM, Wildsmith S, Fayette J. Safety and Efficacy of Durvalumab With or Without Tremelimumab in Patients With PD-L1-Low/Negative Recurrent or Metastatic HNSCC: The Phase 2 CONDOR Randomized Clinical Trial. JAMA Oncol. 2019 Feb 1;5(2):195-203. doi: 10.1001/jamaoncol.2018.4628.

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

location_country:
Taiwan
Spain
United Kingdom
Georgia
Australia
Canada
Hungary
Korea, Republic of
United States
France
Israel
Malaysia
Belgium
Germany
Czechia

summary: The purpose of this study is to determine the efficacy and safety of investigational medical products (MEDI4736 monotherapy, tremelimumab monotherapy, and MEDI4736 + tremelimumab combination therapy) in the treatment of patients with recurrent or metastatic carcinoma of the head and neck who have progressed during or after treatment with a platinum containing regimen for recurrent/metastatic disease.


title: Multicenter, Randomized, Double-blind, Double-dummy, Active-comparator, Event-driven, Superiority Phase III Study of Secondary Prevention of Stroke and Prevention of Systemic Embolism in Patients With a Recent Embolic Stroke of Undetermined Source (ESUS), Comparing Rivaroxaban 15 mg Once Daily With Aspirin 100 mg

acronym: NAVIGATE ESUS

summary: This is a study in patients who recently had a brain attack (stroke) and in whom no clear cause of the stroke could be identified. These strokes are likely due to a blood clot and therefore, can be called embolic stroke of undetermined source. The abbreviation is ESUS. The study will compare 2 blood thinners. Patients will be randomly assigned to either Rivaroxaban 15 mg or Aspirin 100 mg and the study is intended to show, if patients given rivaroxaban have fewer blood clots in the brain (stroke) or in other blood vessels.

ReferenceCitation: Hart RG, Sharma M, Mundl H, Kasner SE, Bangdiwala SI, Berkowitz SD, Swaminathan B, Lavados P, Wang Y, Wang Y, Davalos A, Shamalov N, Mikulik R, Cunha L, Lindgren A, Arauz A, Lang W, Czlonkowska A, Eckstein J, Gagliardi RJ, Amarenco P, Ameriso SF, Tatlisumak T, Veltkamp R, Hankey GJ, Toni D, Bereczki D, Uchiyama S, Ntaios G, Yoon BW, Brouns R, Endres M, Muir KW, Bornstein N, Ozturk S, O'Donnell MJ, De Vries Basson MM, Pare G, Pater C, Kirsch B, Sheridan P, Peters G, Weitz JI, Peacock WF, Shoamanesh A, Benavente OR, Joyner C, Themeles E, Connolly SJ; NAVIGATE ESUS Investigators. Rivaroxaban for Stroke Prevention after Embolic Stroke of Undetermined Source. N Engl J Med. 2018 Jun 7;378(23):2191-2201. doi: 10.1056/NEJMoa1802686. Epub 2018 May 16.

ReferenceCitation: Kasner SE, Lavados P, Sharma M, Wang Y, Wang Y, Dávalos A, Shamalov N, Cunha L, Lindgren A, Mikulik R, Arauz A, Lang W, Czlonkowska A, Eckstein J, Gagliardi R, Amarenco P, Ameriso SF, Tatlisumak T, Veltkamp R, Hankey GJ, Toni DS, Bereczki D, Uchiyama S, Ntaios G, Yoon BW, Brouns R, DeVries Basson MM, Endres M, Muir K, Bornstein N, Ozturk S, O'Donnell M, Mundl H, Pater C, Weitz J, Peacock WF, Swaminathan B, Kirsch B, Berkowitz SD, Peters G, Pare G, Themeles E, Shoamanesh A, Connolly SJ, Hart RG; NAVIGATE ESUS Steering Committee and Investigators. Characterization of Patients with Embolic Strokes of Undetermined Source in the NAVIGATE ESUS Randomized Trial. J Stroke Cerebrovasc Dis. 2018 Jun;27(6):1673-1682. doi: 10.1016/j.jstrokecerebrovasdis.2018.01.027. Epub 2018 Mar 7.

ReferenceCitation: Hart RG, Sharma M, Mundl H, Shoamanesh A, Kasner SE, Berkowitz SD, Pare G, Kirsch B, Pogue J, Pater C, Peters G, Davalos A, Lang W, Wang Y, Wang Y, Cunha L, Eckstein J, Tatlisumak T, Shamalov N, Mikulik R, Lavados P, Hankey GJ, Czlonkowska A, Toni D, Ameriso SF, Gagliardi RJ, Amarenco P, Bereczki D, Uchiyama S, Lindgren A, Endres M, Brouns R, Yoon BW, Ntaios G, Veltkamp R, Muir KW, Ozturk S, Arauz A, Bornstein N, Bryer A, O'Donnell MJ, Weitz J, Peacock F, Themeles E, Connolly SJ. Rivaroxaban for secondary stroke prevention in patients with embolic strokes of undetermined source: Design of the NAVIGATE ESUS randomized trial. Eur Stroke J. 2016 Sep;1(3):146-154. doi: 10.1177/2396987316663049. Epub 2016 Aug 3.

ReferenceCitation: Sharma M, Smith EE, Pearce LA, Perera KS, Kasner SE, Yoon BW, Ameriso SF, Puig J, Damgaard D, Fiebach JB, Muir KW, Veltkamp RC, Toni DS, Shamalov N, Gagliardi RJ, Mikulik R, Engelter ST, Bereczki D, O'Donnell MJ, Saad F, Shoamanesh A, Berkowitz SD, Mundl H, Hart RG; NAVIGATE ESUS MRI Substudy Investigators. Rivaroxaban versus aspirin for prevention of covert brain infarcts in patients with embolic stroke of undetermined source: NAVIGATE ESUS MRI substudy. Int J Stroke. 2022 Aug;17(7):799-805. doi: 10.1177/17474930211058012. Epub 2021 Nov 18.

ReferenceCitation: Merkler AE, Pearce LA, Kasner SE, Shoamanesh A, Birnbaum LA, Kamel H, Sheth KN, Sharma R. Left Ventricular Dysfunction Among Patients With Embolic Stroke of Undetermined Source and the Effect of Rivaroxaban vs Aspirin: A Subgroup Analysis of the NAVIGATE ESUS Randomized Clinical Trial. JAMA Neurol. 2021 Dec 1;78(12):1454-1460. doi: 10.1001/jamaneurol.2021.3828.

ReferenceCitation: Sharma M, Smith EE, Pearce LA, Shoamanesh A, Perera KS, Coutts SB, Damgaard D, Ameriso SF, Rha JH, Modrau B, Yoon BW, Romano M, Messé SR, Barlinn J, Lambeck J, Saad F, Berkowitz SD, Mundl H, Connolly SJ, Hart RG; NAVIGATE ESUS MIND MRI Substudy Investigators. Frequency and Patterns of Brain Infarction in Patients With Embolic Stroke of Undetermined Source: NAVIGATE ESUS Trial. Stroke. 2022 Jan;53(1):45-52. doi: 10.1161/STROKEAHA.120.032976. Epub 2021 Sep 20.

ReferenceCitation: Shoamanesh A, Hart RG, Connolly SJ, Kasner SE, Smith EE, Martí-Fàbregas J, Liu YY, Uchiyama S, Mikulik R, Veltkamp R, O'Donnell MJ, Ntaios G, Muir KW, Field TS, Santo GC, Olavarria V, Mundl H, Lutsep H, Berkowitz SD, Sharma M. Microbleeds and the Effect of Anticoagulation in Patients With Embolic Stroke of Undetermined Source: An Exploratory Analysis of the NAVIGATE ESUS Randomized Clinical Trial. JAMA Neurol. 2021 Jan 1;78(1):11-20. doi: 10.1001/jamaneurol.2020.3836. Erratum in: JAMA Neurol. 2021 Jan 1;78(1):120.

ReferenceCitation: Scheitz JF, Pare G, Pearce LA, Mundl H, Peacock WF, Czlonkowska A, Sharma M, Nolte CH, Shoamanesh A, Berkowitz SD, Krahn T, Endres M; NAVIGATE-ESUS Biomarker Working Group. High-Sensitivity Cardiac Troponin T for Risk Stratification in Patients With Embolic Stroke of Undetermined Source. Stroke. 2020 Aug;51(8):2386-2394. doi: 10.1161/STROKEAHA.120.029628. Epub 2020 Jul 9.

ReferenceCitation: Veltkamp R, Pearce LA, Korompoki E, Sharma M, Kasner SE, Toni D, Ameriso SF, Mundl H, Tatlisumak T, Hankey GJ, Lindgren A, Berkowitz SD, Arauz A, Ozturk S, Muir KW, Chamorro Á, Perera K, Shuaib A, Rudilosso S, Shoamanesh A, Connolly SJ, Hart RG. Characteristics of Recurrent Ischemic Stroke After Embolic Stroke of Undetermined Source: Secondary Analysis of a Randomized Clinical Trial. JAMA Neurol. 2020 Oct 1;77(10):1233-1240. doi: 10.1001/jamaneurol.2020.1995. Erratum in: JAMA Neurol. 2020 Oct 1;77(10):1322.

ReferenceCitation: Mikulík R, Eckstein J, Pearce LA, Mundl H, Rudilosso S, Olavarría VV, Shoamanesh A, Chamorro Á, Martí-Fàbregas J, Veltkamp R, Öztürk Ş, Tatlisumak T, Peacock WF, Berkowitz SD, Connolly SJ, Hart RG. Frequency and Predictors of Major Bleeding in Patients With Embolic Strokes of Undetermined Source: NAVIGATE-ESUS Trial. Stroke. 2020 Jul;51(7):2139-2147. doi: 10.1161/STROKEAHA.119.027995. Epub 2020 Jun 10.

ReferenceCitation: Ntaios G, Pearce LA, Veltkamp R, Sharma M, Kasner SE, Korompoki E, Milionis H, Mundl H, Berkowitz SD, Connolly SJ, Hart RG; NAVIGATE ESUS Investigators. Potential Embolic Sources and Outcomes in Embolic Stroke of Undetermined Source in the NAVIGATE-ESUS Trial. Stroke. 2020 Jun;51(6):1797-1804. doi: 10.1161/STROKEAHA.119.028669. Epub 2020 Apr 16.

ReferenceCitation: Martinez-Majander N, Ntaios G, Liu YY, Ylikotila P, Joensuu H, Saarinen J, Perera KS, Marti-Fabregas J, Chamorro A, Rudilosso S, Prats-Sanchez L, Berkowitz SD, Mundl H, Themeles E, Tiainen M, Demchuk A, Kasner SE, Hart RG, Tatlisumak T; NAVIGATE ESUS investigators. Rivaroxaban versus aspirin for secondary prevention of ischaemic stroke in patients with cancer: a subgroup analysis of the NAVIGATE ESUS randomized trial. Eur J Neurol. 2020 May;27(5):841-848. doi: 10.1111/ene.14172. Epub 2020 Mar 11.

ReferenceCitation: Ntaios G, Pearce LA, Meseguer E, Endres M, Amarenco P, Ozturk S, Lang W, Bornstein NM, Molina CA, Pagola J, Mundl H, Berkowitz SD, Liu YY, Sen S, Connolly SJ, Hart RG. Aortic Arch Atherosclerosis in Patients With Embolic Stroke of Undetermined Source: An Exploratory Analysis of the NAVIGATE ESUS Trial. Stroke. 2019 Nov;50(11):3184-3190. doi: 10.1161/STROKEAHA.119.025813. Epub 2019 Sep 17.

ReferenceCitation: Ntaios G, Swaminathan B, Berkowitz SD, Gagliardi RJ, Lang W, Siegler JE, Lavados P, Mundl H, Bornstein N, Meseguer E, Amarenco P, Cucchiara B, Camps-Renom P, Makaritsis K, Korompoki E, Papavasileiou V, Marti-Fabregas J, Milionis H, Vemmos K, Connolly SJ, Hart RG; NAVIGATE ESUS Investigators. Efficacy and Safety of Rivaroxaban Versus Aspirin in Embolic Stroke of Undetermined Source and Carotid Atherosclerosis. Stroke. 2019 Sep;50(9):2477-2485. doi: 10.1161/STROKEAHA.119.025168. Epub 2019 Aug 12.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
South Africa
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
Israel
Turkey
Mexico
Sweden
Brazil
Canada
Switzerland
Hungary
China
Germany
Denmark
Greece
Ireland
Finland
Korea, Republic of
France
Chile


title: Identification and Description of Severe Asthma Patients in a Cross-sectional Study-the IDEAL Study

summary: This will be a non-drug interventional cross-sectional study, where the screening visit and study visit can occur on the same day. Investigational product will not be administered. Approximately 790 subjects with severe asthma will be screened to achieve a total of at least 750 evaluable study subjects. The study will not include a run-in or follow-up period. This study will provide a more reliable description of the severe asthma patient landscape with respect to the potential eligibility for treatment with mepolizumab, omalizumab, and reslizumab. This study aims to estimate the potential overlap of patients eligible for treatment with mepolizumab and those eligible for treatment with omalizumab and/or reslizumab. Additionally, the current study will also ascertain and describe reslizumab eligibility with respect to both mepolizumab and omalizumab, in the severe asthma patient population.

ReferenceCitation: Müllerová H, Cockle SM, Gunsoy NB, Nelsen LM, Albers FC. Clinical characteristics and burden of illness among adolescent and adult patients with severe asthma by asthma control: the IDEAL study. J Asthma. 2021 Apr;58(4):459-470. doi: 10.1080/02770903.2019.1708095. Epub 2020 Jan 9.

ReferenceCitation: Nelsen LM, Cockle SM, Gunsoy NB, Jones P, Albers FC, Bradford ES, Mullerova H. Impact of exacerbations on St George's Respiratory Questionnaire score in patients with severe asthma: post hoc analyses of two clinical trials and an observational study. J Asthma. 2020 Sep;57(9):1006-1016. doi: 10.1080/02770903.2019.1630640. Epub 2019 Jun 28.

ReferenceCitation: Albers FC, Müllerová H, Gunsoy NB, Shin JY, Nelsen LM, Bradford ES, Cockle SM, Suruki RY. Biologic treatment eligibility for real-world patients with severe asthma: The IDEAL study. J Asthma. 2018 Feb;55(2):152-160. doi: 10.1080/02770903.2017.1322611. Epub 2017 Jun 16.

lead_sponsor: GlaxoSmithKline

location_country:
United Kingdom
Australia
Canada
United States
France
Germany


title: A Prospective, Open-Label, Multicenter Randomized Phase III Trial to Compare The Efficacy and Safety of A Combined Regimen of Obinutuzumab and Venetoclax Versus Obinutuzumab and Chlorambucil in Previously Untreated Patients With CLL and Coexisting Medical Conditions

ReferenceCitation: Badawi M, Chen X, Marroum P, Suleiman AA, Mensing S, Koenigsdorfer A, Schiele JT, Palenski T, Samineni D, Hoffman D, Menon R, Salem AH. Bioavailability Evaluation of Venetoclax Lower-Strength Tablets and Oral Powder Formulations to Establish Interchangeability with the 100 mg Tablet. Clin Drug Investig. 2022 Aug;42(8):657-668. doi: 10.1007/s40261-022-01172-4. Epub 2022 Jul 13.

ReferenceCitation: Samineni D, Gibiansky L, Wang B, Vadhavkar S, Rajwanshi R, Tandon M, Sinha A, Al-Sawaf O, Fischer K, Hallek M, Salem AH, Li C, Miles D. Pharmacokinetics and Exposure-Response Analysis of Venetoclax + Obinutuzumab in Chronic Lymphocytic Leukemia: Phase 1b Study and Phase 3 CLL14 Trial. Adv Ther. 2022 Aug;39(8):3635-3653. doi: 10.1007/s12325-022-02170-w. Epub 2022 Jun 16.

ReferenceCitation: Al-Sawaf O, Zhang C, Lu T, Liao MZ, Panchal A, Robrecht S, Ching T, Tandon M, Fink AM, Tausch E, Schneider C, Ritgen M, Böttcher S, Kreuzer KA, Chyla B, Miles D, Wendtner CM, Eichhorst B, Stilgenbauer S, Jiang Y, Hallek M, Fischer K. Minimal Residual Disease Dynamics after Venetoclax-Obinutuzumab Treatment: Extended Off-Treatment Follow-up From the Randomized CLL14 Study. J Clin Oncol. 2021 Dec 20;39(36):4049-4060. doi: 10.1200/JCO.21.01181. Epub 2021 Oct 28.

ReferenceCitation: Al-Sawaf O, Zhang C, Tandon M, Sinha A, Fink AM, Robrecht S, Samoylova O, Liberati AM, Pinilla-Ibarz J, Opat S, Sivcheva L, Le Dû K, Fogliatto LM, Niemann CU, Weinkove R, Robinson S, Kipps TJ, Tausch E, Schary W, Ritgen M, Wendtner CM, Kreuzer KA, Eichhorst B, Stilgenbauer S, Hallek M, Fischer K. Venetoclax plus obinutuzumab versus chlorambucil plus obinutuzumab for previously untreated chronic lymphocytic leukaemia (CLL14): follow-up results from a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2020 Sep;21(9):1188-1200. doi: 10.1016/S1470-2045(20)30443-5.

ReferenceCitation: Fischer K, Al-Sawaf O, Bahlo J, Fink AM, Tandon M, Dixon M, Robrecht S, Warburton S, Humphrey K, Samoylova O, Liberati AM, Pinilla-Ibarz J, Opat S, Sivcheva L, Le Dû K, Fogliatto LM, Niemann CU, Weinkove R, Robinson S, Kipps TJ, Boettcher S, Tausch E, Humerickhouse R, Eichhorst B, Wendtner CM, Langerak AW, Kreuzer KA, Ritgen M, Goede V, Stilgenbauer S, Mobasher M, Hallek M. Venetoclax and Obinutuzumab in Patients with CLL and Coexisting Conditions. N Engl J Med. 2019 Jun 6;380(23):2225-2236. doi: 10.1056/NEJMoa1815281. Epub 2019 Jun 4.

location_country:
Croatia
Spain
Italy
United Kingdom
United States
Romania
Poland
Austria
Australia
Russian Federation
Argentina
Mexico
Brazil
Canada
Switzerland
Germany
Bulgaria
Denmark
Estonia
New Zealand
France

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Chu Estaing; Hematologie Clinique Adultes

location_facility: North Estonia medical Centre; Hematology

location_facility: Stiftung Kathol. Krankenhaus Marienhospital Herne Klinik Mitte

location_facility: Western General Hospital; Department of Haematology

location_facility: Ashford Cancer Centre Research; Internal Medicine/Medical Oncology

location_facility: Tom Baker Cancer Centre; Dept of Medicine

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wrocławiu; Klinika Hematologii

location_facility: Canterbury Health Laboratories; Haematology

location_facility: Republican Clinical Oncologic Dispensary of Republic Of Tatarstan

location_facility: Hospital Universitari Vall d'Hebron; Servicio de Hematologia

location_facility: Instituto de Ensino e Pesquisa Sao Lucas - IEP

location_facility: Institutul Regional de Oncologie Iasi; Clinica de Hematologie

location_facility: Regional Clinical Hospital N.A. Semashko; Hematology

location_facility: Krankenhaus Barmherzige Bruder Regensburg

location_facility: Hopital Saint Louis ; Service d Oncologie Medicale Fougere 6 (Pr Misset)

location_facility: University Hospital Merkur Clinic for Internal Medicine/ Hematology

location_facility: Gemeinschaftspraxis Dr. med. Holger Klaproth

location_facility: Royal Adelaide Hospital; Haematology Clinical Trials

location_facility: Hôpital Saint Eloi; Service d'Hématologie et Oncologie Clinique - Recherche Clinique

location_facility: Hospital Universitario de Canarias;servicio de Hematologia

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

location_facility: Hospital Arnau de Vilanova (Valencia) Servicio de Hematologia

location_facility: Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology

location_facility: MHAT Hristo Botev; First Internal Department

location_facility: Moscow State Budgetary Healthcare Institution

location_facility: Queen Elizabeth II Health Sciences Centre; Oncology

location_facility: Arcispedale S. Anna; Sezione Di Ematologia

location_facility: Tartu Uni Hospital; Hematology - Oncology Clinic

location_facility: Wojewodzki Szpital Specjalistyczny im. J. Korczaka; Oddział Chorób Wewnetrznych/Hematologiczny

location_facility: Hospital Clinico Universitario de Salamanca;Servicio de Hematologia

location_facility: Gesundheitszentrum St. Marien GmbH; Med. II, Hämatologie/Onkologie

location_facility: University Hospital Sv.Georgi Clnic of Hematology; Hematology

location_facility: Fundeni Clinical Inst. ; Hematology Dept

location_facility: Klinikum der Universität München, Campus Großhadern; Medizinische Klinik und Poliklinik III

location_facility: Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Hämatologie & Hämostaseologie

location_facility: Tiroler Landeskrankenanstalten Ges.M.B.H.; Innere Medizin Abt. Für Hämatologie & Onkologie

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

location_facility: Hospital Universitario de la Princesa; Servicio de Hematologia

location_facility: Uniwersytecki Szpital Kliniczny w Białymstoku, Klinika Hematologii z Pododdziałem Chorob Naczyn

location_facility: Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik und Poliklinik I

location_facility: München Klinik Schwabing; Klinik für Hämatologie, Onkologie, Immunologie

location_facility: Klinik Esslingen; Klinik für Allgemeine Innere Medizin, Onkologie/Haematologie

location_facility: Uniklinik RWTH Aachen; Klinik IV; Klinik Hämatologie, Onkologie, Hämostaseologie und Stamm.

location_facility: Kliniken Maria Hilf GmbH; Innere Medizin I; Hämatologie und internistische Onkologie

location_facility: Uni Göttingen, Georg-August-Universität; Klinik für Hämatologie und Medizinische Onkologie

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

location_facility: Klinikum rechts der Isar der Technischen Universität München

location_facility: Institut d'Hématologie de Basse Normandie

location_facility: Az. Osp. S. Maria; Dept. Di Oncologia Medica

location_facility: Hopital Pontchaillou; Hematologie Clinique

location_facility: Praxisklinik für Hämatologie und Onkologie Koblenz

location_facility: Ospedali Riuniti Papardo-Piemonte; Struttura Complessa Di Ematologia

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

location_facility: University Hospital Center Zagreb; Haematology Department

location_facility: University Multiprofile Hospital For Active Treatment "Sveti Ivan Rilski" EAD; clinical hematology

location_facility: Hospital Clínic i Provincial; Servicio de Hematología y Oncología

location_facility: Hanusch-Krankenhaus; Iii. Medizinische Abt.

location_facility: UMHAT " Sveti Georgi" Plovdiv - Clinic of Oncology and Hematology

location_facility: Inselspital Bern; Hämatologie und Hämatologisches Zentrallabor

location_facility: Wojewódzki Szpital Specjalistyczny im.MikołajaKopernika;KlinikaHematologiiUniwersytetuMedycznego

location_facility: Spitalul Clinic Judetean de Urgenta Targu-Mures; compartiment Hematologie

location_facility: Universitätsklinikum Essen; Klinik für Hämatologie

location_facility: Universitätsspital Zürich Medizin Hämatologie; Klinik für Hämatologie

location_facility: Hopital Hotel Dieu Et Hme;Hopital De Jour

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: Universtitätsklinikum Ulm; Klinik für Innere Medizin III

location_facility: Hospital del Mar; Servicio de Hematologia

location_facility: Hospital Univ. 12 de Octubre; Servicio de Hematologia

location_facility: AOU Città della Salute e della Scienza di Torino - Presidio Le Molinette

location_facility: Universitätsklinikum Köln; Innere Medizin I; Onkologie, Hämatologie

summary: This open-label, multicenter, randomized Phase III study is designed to compare the efficacy and safety of a combined regimen of obinutuzumab and venetoclax versus obinutuzumab + chlorambucil in participants with chronic lymphocytic leukemia (CLL) and coexisting medical conditions. The time on study treatment was approximately one year and the follow-up period will be up to 9 years.


acronym: POLO

title: A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Maintenance Olaparib Monotherapy in Patients With gBRCA Mutated Metastatic Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum Based Chemotherapy

ReferenceType: background

ReferenceCitation: Golan T, Hammel P, Reni M, Van Cutsem E, Macarulla T, Hall MJ, Park JO, Hochhauser D, Arnold D, Oh DY, Reinacher-Schick A, Tortora G, Algül H, O'Reilly EM, McGuinness D, Cui KY, Schlienger K, Locker GY, Kindler HL. Maintenance Olaparib for Germline BRCA-Mutated Metastatic Pancreatic Cancer. N Engl J Med. 2019 Jul 25;381(4):317-327. doi: 10.1056/NEJMoa1903387. Epub 2019 Jun 2.

ReferenceCitation: Amin S, Joo S, Nolte S, Yoo HK, Patel N, Byrnes HF, Costa-Cabral S, Johnson CD. Health-related quality of life scores of metastatic pancreatic cancer patients responsive to first line chemotherapy compared to newly derived EORTC QLQ-C30 reference values. BMC Cancer. 2022 May 20;22(1):563. doi: 10.1186/s12885-022-09661-7.

ReferenceCitation: Li N, Zheng H, Huang Y, Zheng B, Cai H, Liu M. Cost-Effectiveness Analysis of Olaparib Maintenance Treatment for Germline BRCA-Mutated Metastatic Pancreatic Cancer. Front Pharmacol. 2021 Apr 20;12:632818. doi: 10.3389/fphar.2021.632818. eCollection 2021.

ReferenceCitation: Zhan M, Zheng H, Yang Y, He Z, Xu T, Li Q. Cost-Effectiveness Analysis of Maintenance Olaparib in Patients with Metastatic Pancreatic Cancer and a Germline BRCA1/2 Mutation Based on the POLO Trial. Cancer Manag Res. 2020 Dec 16;12:12919-12926. doi: 10.2147/CMAR.S283169. eCollection 2020.

ReferenceCitation: Golan T, Kindler HL, Park JO, Reni M, Macarulla T, Hammel P, Van Cutsem E, Arnold D, Hochhauser D, McGuinness D, Locker GY, Goranova T, Schatz P, Liu YZ, Hall MJ. Geographic and Ethnic Heterogeneity of Germline BRCA1 or BRCA2 Mutation Prevalence Among Patients With Metastatic Pancreatic Cancer Screened for Entry Into the POLO Trial. J Clin Oncol. 2020 May 1;38(13):1442-1454. doi: 10.1200/JCO.19.01890. Epub 2020 Feb 19.

ReferenceCitation: Hammel P, Kindler HL, Reni M, Van Cutsem E, Macarulla T, Hall MJ, Park JO, Hochhauser D, Arnold D, Oh DY, Reinacher-Schick A, Tortora G, Algül H, O'Reilly EM, McGuinness D, Cui KY, Joo S, Yoo HK, Patel N, Golan T; POLO Investigators. Health-related quality of life in patients with a germline BRCA mutation and metastatic pancreatic cancer receiving maintenance olaparib. Ann Oncol. 2019 Dec 1;30(12):1959-1968. doi: 10.1093/annonc/mdz406.

ReferenceCitation: Lowery MA, Kelsen DP, Capanu M, Smith SC, Lee JW, Stadler ZK, Moore MJ, Kindler HL, Golan T, Segal A, Maynard H, Hollywood E, Moynahan M, Salo-Mullen EE, Do RKG, Chen AP, Yu KH, Tang LH, O'Reilly EM. Phase II trial of veliparib in patients with previously treated BRCA-mutated pancreas ductal adenocarcinoma. Eur J Cancer. 2018 Jan;89:19-26. doi: 10.1016/j.ejca.2017.11.004. Epub 2017 Dec 8.

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.

location_country:
Spain
Italy
United Kingdom
Australia
Netherlands
Canada
Korea, Republic of
United States
France
Israel
Belgium
Germany

summary: A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Maintenance Olaparib Monotherapy in Patients with gBRCA Mutated Metastatic Pancreatic Cancer whose Disease Has Not Progressed on First Line Platinum Based Chemotherapy


title: A Phase III Clinical Trial of BBI608 Plus Weekly Paclitaxel vs. Placebo Plus Weekly Paclitaxel in Adult Patients With Advanced, Previously Treated Gastric and Gastro-Esophageal Junction Adenocarcinoma

acronym: BRIGHTER

summary: The purpose of this study is to find out whether it is better to receive a new drug, BBI608, in addition to paclitaxel chemotherapy or better to receive paclitaxel chemotherapy alone as second line treatment for gastric and gastroesophageal junction cancer after prior first line platinum and fluoropyrimidine based chemotherapy.

lead_sponsor: Sumitomo Pharma Oncology, Inc.

location_country:
Spain
Italy
United Kingdom
Lithuania
United States
Romania
Belgium
Japan
Czechia
Poland
Russian Federation
Australia
Israel
Brazil
Canada
Hungary
China
Germany
Bulgaria
Estonia
Korea, Republic of
France

location_facility: Indiana University Health University Hospital

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: State University of New York Upstate Medical University

location_facility: Weill Medical College of Cornell University

location_facility: Magodent sp. z o.o. Szpital Onkologiczny

location_facility: Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onko

location_facility: Europejskie Centrum Zdrowia Otwock, Szpital im. F. Chopina

location_facility: The 307th Hospital of Chinese People's Liberation Army

location_facility: IRCCS Ospedale Oncologico "Giovanni Paolo II"

location_facility: Institut Català d'Oncologia-Hospital Germans Trias i Pujol

location_facility: Rabin Medical Center - Beilinson Hospital

location_facility: Hospital de Base de São José do Rio Preto

location_facility: Radiotherapy Center CJ radioterapie si chimioterapie adulti

location_facility: Klinikum der Johann Wolfgang Goethe-Universität

location_facility: UMHAT ""Dr. Georgi Stranski"" Dept. Medical Oncology

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

location_facility: Northwestern State Medical University n.a. Mechnikov

location_facility: Harbin Medical University Cancer Hospital

location_facility: Kobe City Medical Center General Hospital

location_facility: Azienda Ospedaliera "Istituti Ospitalieri" di Cremona

location_facility: Sunshine Coast Hospital and Health Service

location_facility: Multiprofile hospital for active treatment

location_facility: Ballarat Oncology and Haematology Services

location_facility: First Pavlov State Medical University of Saint-Petersburg

location_facility: Saint Michael's Hospital Li Ka Shing Knowledge Institute

location_facility: Vilniaus Universiteto ligonines Santariskiu Klinikos

location_facility: Instituto do Câncer do Ceará - Instituto do Câncer do Cear

location_facility: Northern Indiana Cancer Research Consortium

location_facility: Uni. Multiprofile Hospital for Active treatment Sveta Marina

location_facility: Hospital of Lithuanian University of Health Sciences

location_facility: New Hampshire Oncology Hematology - Concord

location_facility: General Hospital of Ningxia Medical University

location_facility: Szpital Specjalistyczny im. L. Rydygiera w Krakowie

location_facility: East Tallinn Central Hospital Oncology Center

location_facility: Fujian Medical University Union Hospital

location_facility: Spitalul Clinic Judetean de Urgenta Sibiu

location_facility: Russian Oncological Research Center n.a. N.N. Blokhin RAMS

location_facility: Egyesített Szent István és Szent László Kórház-Rendelőintéze

location_facility: Ospedale Molinette, AO Città della Salute e della Scienza di

location_facility: The E. Wolfson Medical Center [Oncology]

location_facility: New Hampshire Oncology Hematology - Laconia

location_facility: Ospedale Guglielmo da Saliceto, AUSL Piacenza

location_facility: The University of Oklahoma Health Sciences Center (OUHSC)

location_facility: UPCO - Unidade de Pesquisa Clinica em Oncologia LTDA

location_facility: Tianjin Medical University Cancer Institute & Hospital

location_facility: Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház- Rendelőinté

location_facility: District Dispensery with Stationary - Sofia District

location_facility: Indiana University Health Goshen Center For Cancer Care

location_facility: Kliniken Essen-Mitte Evang. Huyssens-Stiftung

location_facility: Peninsula & South Eastern Haematology and Oncology Group

location_facility: Cancer Hospital Chinese Academy of Medical Sciences

location_facility: Azienda Ospedaliera Fatebenefratelli e Oftalmico

location_facility: The Beatson West Of Scotland Cancer Centre

location_facility: Specialised Hospital for Active Treatment in Oncology

location_facility: Xin Jiang Tumor Hospital, Xin Jiang Medical University

location_facility: Saku Central Hospital Advanced Care Center

location_facility: Centre Hospitalier De Mont De Marsan - Hopital Layné

location_facility: NZOZ Centrum Medyczne HCP Lecznictwo Stacjonarne

location_facility: The First Hospital of China Medical University

location_facility: Sp. Jud. de Urg. "Dr. Constantin Opris" Baia Mare

location_facility: Swedish Cancer Institute/ Swedish Health Services

location_facility: Policlinico S.Orsola Malpighi, AOU di Bologna

location_facility: The First Affiliated Hospital of Zhengzhou University

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

location_facility: Wojewodzki Szpital Specjalistyczny im. M.Kopernika

location_facility: Southern Medical University, Nanfang Hospital

location_facility: Seoul National University Bundang Hospital

location_facility: McGill University Health Centre - Montreal General Hospital

location_facility: Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital

location_facility: GBUZ of Stavropol Territory Pyatigorsk Oncology Dispensary

location_facility: The First Bethune Hospital of Jilin University

location_facility: SPb State Budget Institution Oncology Dispansery

location_facility: CHU de Liège - Domaine Universitaire du Sart Tilman

location_facility: Spitalul Clinic Municipal de Urgenta Timisoara

location_facility: Charite - Campus Benjamin Franklin (Cbf)

location_facility: The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital

location_facility: The 81 Hospital of the Chinese People's Liberation Army

location_facility: Osaka Medical Center for Cancer and Cardiovascular Diseases

location_facility: GBUZ Saint Petersburg clinical scientific and practical cent

location_facility: AOU S.Martino, IRCCS, IST-Istituto Nazionale Ricerca Sul Can

location_facility: Ospedale Umberto I, AOU Ospedali Riuniti Umberto I - GM.Lanc

location_facility: Military Medical Academy n.a. S.M. Kirov

location_facility: Tartu University Hospital Clinic of Hematology and Oncology

location_facility: Hospital of Lithuanian University of Health sciences

location_facility: Unità di Biostatistica e Sperimentazioni Cliniche IRST


title: Prospective Observational Study of Febrile Neutropenia (FN) and Pegfilgrastim Primary Prophylaxis in Breast Cancer and Non-Hodgkin's Lymphoma Patients Receiving High (>20%) FN-risk Chemotherapy

summary: To estimate the incidence of febrile neutropenia in patients with breast cancer and non-Hodgkin's lymphoma receiving high (> 20%) FN-risk chemotherapy and pegfilgrastim primary prophylaxis.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Mahtani RL, Belani R, Crawford J, Dale D, DeCosta L, Gawade PL, Huynh C, Lawrence T, Lewis S, MacLaughlin WW, Narang M, Rifkin R. A prospective cohort study to evaluate the incidence of febrile neutropenia in patients receiving pegfilgrastim on-body injector versus other options for prophylaxis of febrile neutropenia: breast cancer subgroup analysis. Support Care Cancer. 2022 Jul;30(7):6135-6144. doi: 10.1007/s00520-022-07025-2. Epub 2022 Apr 14.

lead_sponsor: Amgen

location_country: Poland Romania Greece Austria France Belgium Germany Bulgaria Czechia


title: Clinical Evaluation of the Physiological Diagnosis Function in the PARADYM CRT

acronym: CLEPSYDRA

summary: This clinical investigation is a prospective, non-randomized, multi-center, pivotal trial.This trial is being performed in order to demonstrate the sensivity of the diagnostic feature "Physiological Diagnostic" (PhD).

primary_purpose: Diagnostic

lead_sponsor: LivaNova

location_country:
Spain
Italy
United Kingdom
Netherlands
Canada
Switzerland
United States
France
Germany

location_facility:
Dr. Sperzel
Dr. Defaye
Pr. Eckhardt
Dr. Beiras
Pr. Sadoul
Dr. Fleck - Dr. Goetze
Pr. Kacet
Drs. Jagmeet Singh, Kevin, Hiest
Dr. Delay
Pr. Da Costa
Dr. Bonnemeier
Dr Mantovan
Dr. Morgan
Dr. NG
Drs. Lewis, Garg
Dr. Gold
Drs. Thibualt, Guerra
Dr. Leonardo Calo
Dr Abbey
Pr. Anselme
Dr. Brugada
Pr. Davy
Pr. Mewis - Pr. Fröhlig
Dr. Dupuis
Dr. Burban
Dr. Klein - Dr. Oswald
Dr. Delnoy
Dr. Champagne, Dr. Philippon
Dr. Jauvert
Dr Auricchio
Dr. Leyva
Dr. Bru
Dr. Ritter
Dr. Bowes
Dr. Martinez
Dr. Vogt
Dr. Butter
Dr. Schlegl
Dr. Peinado
Pr. Bauer
Dr. Kolb
Pr. Brachmann
Pr. Mabo
Dr Fluck - Dr. Beeton
Dr. Murgatroyd
Drs. John Fisher, Jay Gross
Pr. Weiss
Dr. Haines
Dr. Wieckhorst
Dr. Pisapia

intervention_type: Device