ReferenceCitation: Montesinos P, Beckermann BM, Catalani O, Esteve J, Gamel K, Konopleva MY, Martinelli G, Monnet A, Papayannidis C, Park A, Récher C, Rodríguez-Veiga R, Röllig C, Vey N, Wei AH, Yoon SS, Fenaux P. MIRROS: a randomized, placebo-controlled, Phase III trial of cytarabine ± idasanutlin in relapsed or refractory acute myeloid leukemia. Future Oncol. 2020 May;16(13):807-815. doi: 10.2217/fon-2020-0044. Epub 2020 Mar 13.

name: Departamento de Hematologia, Hospital Universitari i Politècnic La Fe, València, Spain

name: CIBERONC, Instituto Carlos III, Madrid, Spain

family: Montesinos

full_name: Pau Montesinos

given: Pau

name: F. Hoffmann-La Roche Ltd, Basel, Switzerland

family: Beckermann

full_name: Benjamin M Beckermann

given: Benjamin M

family: Catalani

full_name: Olivier Catalani

given: Olivier

name: Hospital Clinic de Barcelona, IDIBAPS, Barcelona, Spain

family: Esteve

full_name: Jordi Esteve

given: Jordi

family: Gamel

full_name: Katia Gamel

given: Katia

name: Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA

family: Konopleva

full_name: Marina Y Konopleva

given: Marina Y

name: Department of Hematology and Sciences Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy

family: Martinelli

full_name: Giovanni Martinelli

given: Giovanni

family: Monnet

full_name: Annabelle Monnet

given: Annabelle

name: Department of Experimental, Diagnostic and Specialty Medicine Institute of Hematology & Medical Oncology L & A Seràgnoli, Bologna, Italy

family: Papayannidis

full_name: Cristina Papayannidis

given: Cristina

name: Hoffmann-La Roche Ltd, Mississauga, ON, Canada

family: Park

full_name: Aaron Park

given: Aaron

name: Serviced’Hématologie, Institut Universitaire du Cancer Toulouse – Oncopole,Toulouse, France

family: Récher

full_name: Christian Récher

given: Christian

family: Rodríguez-Veiga

full_name: Rebeca Rodríguez-Veiga

given: Rebeca

name: Department of Internal Medicine, Universitätsklinikum Carl Gustav Carus, Dresden, Germany

family: Röllig

full_name: Christoph Röllig

given: Christoph

name: Hematology Department, Aix-Marseille University, Institut Paoli-Calmettes, Marseille, France

family: Vey

full_name: Norbert Vey

given: Norbert

name: Department of Haematology, The Alfred Hospital & Monash University, Melbourne, VIC, Australia

family: Wei

full_name: Andrew H Wei

given: Andrew H

name: Division of Hematology/Medical Oncology, Department of Internal Medicine, Seoul National University Hospital, Seoul, South Korea

family: Yoon

full_name: Sung-Soo Yoon

given: Sung-Soo

name: Service d'Hématologie Séniors Hôpital Saint-Louis, Assistance Publique – Hôpitaux de Paris, Université de Paris, Paris, France

family: Fenaux

full_name: Pierre Fenaux

given: Pierre

journal_name: Future Oncology

publisher: Future Medicine Ltd

publisher_dissemination: Future Science Ltd

publisher_group: Future Science Ltd

publisher_normalized: Future Science Ltd

intervention_type: Other

status: Terminated

location_country:
Italy
Austria
United States
Switzerland
Netherlands
Spain
Germany
Finland
France
Panama
Israel
Norway
Australia
Belgium
New Zealand
Russian Federation
Canada
United Kingdom
Korea, Republic of

acronym: MIRROS

location_facility: IRCCS AOU S.Martino; Clinica Ematologica

location_facility: Institut J Paoli I Calmettes; Onco Hematologie 2

location_facility: Shaare Zedek Medical Center; Hematology Dept.

location_facility: Ospedale Santa Chiara; Unita Operativa Di Ematologia

location_facility: Klinikum Chemnitz gGmbH Krankenhaus Küchwald Klinik f.Innere Medizin III

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST); Onco-Ematologia

location_facility: Ospedale Cardarelli; Divisione Di Ematologia

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

location_facility: Centre Hospitalier Uni Ire; Service Des Maladies Du Sang

location_facility: Oslo Universitetssykehus HF, Rikshospitalet

location_facility: Hopitaux De Brabois; Hematologie Medecine Interne

location_facility: Geelong Hospital; Andrew Love Cancer Centre

location_facility: Az. Osp. S. Maria Delle Croci; U.O. Di Ematologia

location_facility: Alfred Hospital; Clinical Haematology and Bone Marrow Transplantation

location_facility: Hopital Hotel Dieu Et Hme;Hopital De Jour

location_facility: St. Petersburg State Medical University n.a. I.P. Pavlov; Hematology, transfusiology and transplanta

location_facility: Auckland city hospital; Auckland Regional Cancer Centre and Blood Service

location_facility: Az. Osp. S. Orsola Malpighi; Istituto Di Oncologia Seragnoli

location_facility: Uni. der Johannes Gutenberg-Universitaet Mainz; III. Medizinische Klinik und Poliklinik

location_facility: Universitätsspital Zürich; Klinik für Hämatologie

location_facility: Juravinski Cancer Clinic; Clinical Trials Department

location_facility: A.O. Universitaria San Luigi Gonzaga di Orbassano; Ambulatorio per le Malattie Rare del Polmone

location_facility: Hospital Universitario la Fe; Servicio de Hematologia

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

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

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

location_facility: Ichilov Sourasky Medical Center; Heamatology

location_facility: Royal Adelaide Hospital; Haematology Clinical Trials

location_facility: Universitätsklinikum Bonn; Med. Klinik und Poliklinik III; Hämatologie, Onkologie und Rheumatologie

location_facility: Hadassah Ein Karem Hospital; Haematology

location_facility: A.O.U. Citta' Della Salute E Della Scienza-P.O. Molinette;S.C. Ematologia

location_facility: Klinikum Braunschweig; Medizinische Klinik III; Klinik für Hämatologie und Onkologie

location_facility: Rabin Medical Center-Beilinson Campus;Hematology-Oncology

location_facility: Lkh-Univ. Klinikum Graz; Klin. Abt. Für Hämatologie

location_facility: Chonnam National University Hwasun Hospital

location_facility: Helsinki University Central Hospital; Hematology

location_facility: Haukeland Universitetssjukehus; Klinisk forskningspost

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

location_facility: Abramson Cancer Center; Univ of Pennsylvania

location_facility: Az. Osp. Di Careggi; Divisione Di Ematologia

location_facility: Hopital De Haut Leveque; Hematologie Clinique

location_facility: Complejo Hospitalario Arnulfo Arias Madrid; Servicio de Hematología

location_facility: M.D. Anderson Cancer Center; Department of Hematology

location_facility: Universitätsklinikum Marburg Zentrum f. Innere Medizin

location_facility: Concord Repatriation General Hospital; Haematology

location_facility: FGBU "Federal Medical and Research Center named after V.A.Almazov" Russian Ministry of Health

location_facility: HOPITAL SAINT ANTOINE;Hematologie Clinique

location_facility: A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia; Clinica Ematologica

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

location_facility: Canberra Hospital; Haematology Department

location_facility: Az. Osp. Uni Ria Policlinico Tor Vergata; Unita Di Ematologia

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

title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase III Study of Idasanutlin, an MDM2 Antagonist, With Cytarabine Versus Cytarabine Plus Placebo in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)

summary: This is a multicenter, double-blind, randomized, placebo-controlled study designed to compare overall survival in participants with relapsed or refractory AML treated with idasanutlin in combination with cytarabine versus participants treated with placebo and cytarabine. Participants will receive induction treatment with idasanutlin/placebo and cytarabine (Cycle 1). Responding participants may continue to receive a maximum of further two cycles of consolidation (Cycle 2 and Cycle 3). Complete remission (CR), CR with incomplete platelet count recovery (CRp), overall remission rate (ORR), event-free survival (EFS) and percentage of participants with an allogeneic hematopoietic stem cell transplant (HSCT) will also be compared between treatment arms. This study will include participants with and without TP53 wild type (TP53 WT) mutations.

status_simplified: Unknown


type: EudraCT Number

type: Other Identifier

title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of JNJ-63623872 in Combination With Oseltamivir in Adult and Elderly Hospitalized Patients With Influenza A Infection

summary: The purpose of this study is to evaluate the Pharmacokinetic parameters of JNJ-63623872 in combination with oseltamivir in elderly participants (aged 65 to <= 85 years) compared to adults (aged 18 to <= 64 years) with influenza A infection.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Janssen Research & Development, LLC

location_country:
United States
Brazil
Sweden
Hong Kong
Netherlands
Germany
France
Malaysia
Singapore
Belgium
Australia
New Zealand
Spain
Turkey
Canada

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line MEDI4736 (Durvalumab) Monotherapy and MEDI4736 (Durvalumab) in Combination With Tremelimumab Versus Standard of Care Chemotherapy in Patients With Unresectable Stage IV Urothelial Cancer

summary: A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line MEDI4736 (Durvalumab) Monotherapy and MEDI4736 (Durvalumab) in Combination with Tremelimumab Versus Standard of Care Chemotherapy in Patients with Stage IV Urothelial Cancer

status: Active, not recruiting

study_completion_date_type: Anticipated

ReferenceType: derived

ReferenceCitation: Powles T, van der Heijden MS, Castellano D, Galsky MD, Loriot Y, Petrylak DP, Ogawa O, Park SH, Lee JL, De Giorgi U, Bögemann M, Bamias A, Eigl BJ, Gurney H, Mukherjee SD, Fradet Y, Skoneczna I, Tsiatas M, Novikov A, Suárez C, Fay AP, Duran I, Necchi A, Wildsmith S, He P, Angra N, Gupta AK, Levin W, Bellmunt J; DANUBE study investigators. Durvalumab alone and durvalumab plus tremelimumab versus chemotherapy in previously untreated patients with unresectable, locally advanced or metastatic urothelial carcinoma (DANUBE): a randomised, open-label, multicentre, phase 3 trial. Lancet Oncol. 2020 Dec;21(12):1574-1588. doi: 10.1016/S1470-2045(20)30541-6. Epub 2020 Sep 21. Erratum in: Lancet Oncol. 2021 Jan;22(1):e5.

family: Powles

full_name: Thomas Powles

given: Thomas

sequence: first

family: van der Heijden

full_name: Michiel S van der Heijden

given: Michiel S

sequence: additional

family: Castellano

full_name: Daniel Castellano

given: Daniel

family: Galsky

full_name: Matthew D Galsky

given: Matthew D

family: Loriot

full_name: Yohann Loriot

given: Yohann

family: Petrylak

full_name: Daniel P Petrylak

given: Daniel P

family: Ogawa

full_name: Osamu Ogawa

given: Osamu

full_name: Se Hoon Park

given: Se Hoon

family: Lee

full_name: Jae-Lyun Lee

given: Jae-Lyun

family: De Giorgi

full_name: Ugo De Giorgi

given: Ugo

family: Bögemann

full_name: Martin Bögemann

given: Martin

family: Bamias

full_name: Aristotelis Bamias

given: Aristotelis

family: Eigl

full_name: Bernhard J Eigl

given: Bernhard J

family: Gurney

full_name: Howard Gurney

given: Howard

family: Mukherjee

full_name: Som D Mukherjee

given: Som D

family: Fradet

full_name: Yves Fradet

given: Yves

family: Skoneczna

full_name: Iwona Skoneczna

given: Iwona

family: Tsiatas

full_name: Marinos Tsiatas

given: Marinos

family: Novikov

full_name: Andrey Novikov

given: Andrey

family: Suárez

full_name: Cristina Suárez

family: Fay

full_name: André P Fay

given: André P

family: Duran

full_name: Ignacio Duran

given: Ignacio

family: Necchi

full_name: Andrea Necchi

given: Andrea

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:
Greece
Australia
Belgium
Russian Federation
Denmark
Taiwan
France
Japan
Poland
Canada
Korea, Republic of
Netherlands
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Israel
Spain
Turkey


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

acronym: Proxima A

summary: This study seeks to better characterize relationships between visual function and the progression (worsening) of geographic atrophy (GA) due to age-related macular degeneration (AMD). The study is also intended to generate new information on the relationship between genetics and GA progression. This is a global, prospective, multicenter, epidemiologic study enrolling participants with GA secondary to AMD. The study visits are scheduled to occur every 6 months. The anticipated duration of the study is up to 48 months. There is a planned interim analysis around the 2-year time window for the study.

study_type: Observational

lead_sponsor: Hoffmann-La Roche

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

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

location_facility: Hospital Universitario Rio Hortega; Servicio de Oftalmologia

location_facility: Soroka university medical center; Ophtalmology

location_facility: Hospital Universitario Virgen de la Macarena; Servicio de Oftalmologia

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Clinique de la Louviere - Nord retine; Maladie et chirurgie des Yeux

location_facility: Pinderfields Hospital; Clinical Research Team, Rowan House

location_facility: European Interbalkan Medical Center; Ophthalmology Dpt

location_facility: Nuovo Ospedale S. Chiara - A.O.U.P Presidio Ospedaliero di Cisanello; U.O. Oculistica Universitaria

location_facility: Università degli Studi dell'Insubria; Clinica Oculistica

location_facility: Markusovszky Egyetemi Oktatokorhaz ; SZEMESZET

location_facility: CHU Poitiers - CHR La Miletrie; Ophtalmologie

location_facility: Northern Beaches Retina Cataract Glaucoma

location_facility: Duke University Eye Center; Vitreoretinal

location_facility: Hospital Clinico Universitario de Valladolid; Servicio de oftalmologia

location_facility: Azienda Ospedaliero-Universitaria Careggi; S.O.D. Oculistica

location_facility: ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco)

location_facility: Newcastle Eye Hospital Research Foundation

location_facility: University General Hospital of Heraklion; Department of Ophthalmology

location_facility: Klinikum rechts der Isar der TU München; Augenklinik

location_facility: Centres Ophtalmologique St Exupéry; Ophtalmologie

location_facility: Ospedale Classificato Equiparato Sacro Cuore - Don Calabria; Dipartimento Oculistica

location_facility: Università degli Studi di Napoli Federico II; Dipartimento di Scienze Oftalmologiche

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

location_facility: Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie

location_facility: University of North Carolina; Kittner Eye Center

location_facility: Centre ophtalmologique Rabelais; Ophtalmologie

location_facility: Pomorski Uniwersytet Medyczny w Szczecinie, Zaklad Patologii Ogolnej PUM"

location_facility: John Radcliffe Hospital; Oxford Eye Hospital

location_facility: Centre Paradis Monticelli; Ophtalmologie


title: Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Study of AB103 as Compared to Placebo in Patients With Necrotizing Soft Tissue Infections. ACCUTE (AB103 Clinical Composite Endpoint Study in Necrotizing Soft Tissue Infections)

acronym: ACCUTE

summary: The purpose of this study is to determine whether AB103 is safe and effective in the treatment of patients with necrotizing soft tissue infections (NSTI) receiving standard of care therapy.

ReferenceType: result

ReferenceCitation: Bulger EM, May AK, Robinson BRH, Evans DC, Henry S, Green JM, Toschlog E, Sperry JL, Fagenholz P, Martin ND, Dankner WM, Maislin G, Wilfret D, Bernard AC; ACCUTE Study Investigators. A Novel Immune Modulator for Patients With Necrotizing Soft Tissue Infections (NSTI): Results of a Multicenter, Phase 3 Randomized Controlled Trial of Reltecimod (AB 103). Ann Surg. 2020 Sep 1;272(3):469-478. doi: 10.1097/SLA.0000000000004102.

family: Bulger

full_name: Eileen M. Bulger

given: Eileen M.

family: May

full_name: Addison K. May

given: Addison K.

family: Robinson

full_name: Bryce R. H. Robinson

given: Bryce R. H.

family: Evans

full_name: David C. Evans

given: David C.

family: Henry

full_name: Sharon Henry

given: Sharon

family: Green

full_name: John M. Green

given: John M.

family: Toschlog

full_name: Eric Toschlog

given: Eric

family: Sperry

full_name: Jason L. Sperry

given: Jason L.

family: Fagenholz

full_name: Peter Fagenholz

given: Peter

family: Martin

full_name: Niels D. Martin

given: Niels D.

family: Dankner

full_name: Wayne M. Dankner

given: Wayne M.

family: Maislin

full_name: Greg Maislin

given: Greg

family: Wilfret

full_name: David Wilfret

given: David

family: Bernard

full_name: Andrew C. Bernard

given: Andrew C.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Annals of Surgery

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ipd_sharing: No

lead_sponsor: Atox Bio Ltd

location_country:
United States
France

location_facility: Ryder Trauma Center/Jackson Memorial Hospital

location_facility: University of Texas Health Science Center at San Antonio

location_facility: University of California, Davis Medical Center

location_facility: Wayne State University-Sinai Grace Hospital

location_facility: Texas Tech University Health Sciences Center at El Paso

location_facility: Staten Island University Hospital-Northwell Health

location_facility: The Pennsylvania State University and The Milton S. Hershey Medical Center

location_facility: University of Arkansas for Medical Sciences

location_facility: Wright State University & Premier Health Clinical Trials Research Alliance

location_facility: University of Cincinnati Medical Center (UCMC)

location_facility: University of Maryland R Adams Cowley Shock Trauma Center

location_facility: Erie County Medical Center-Affliate of SUNYat Buffalo

location_facility: Wayne State University-Detroit Receiving Hospital

location_facility: Our Lady of the Lake Regional Medical Center

location_facility: Medical College of Wisconsin-Froedtert Hospital

location_facility: Los Angeles Biomedical Research Institute at Harbor UCLA Medical Center

location_facility: Emory University at Grady Memorial Hospital

location_facility: University of Minnesota Medical Center-Fairview

location_facility: Baylor College of Medicine-Ben Taub Hospital


title: An Open-label, 2 x 2 Factorial, Randomized Controlled, Clinical Trial to Evaluate the Safety of Apixaban vs. Vitamin K Antagonist and Aspirin vs. Aspirin Placebo in Patients With Atrial Fibrillation and Acute Coronary Syndrome or Percutaneous Coronary Intervention

summary: The purpose of this study is to determine if Apixaban is safer than a Vitamin K Antagonist given for 6 months in terms of bleeding in patients with an irregular heart beat (atrial fibrillation) and a recent heart attack or a recent procedure to open up a blood vessel in the heart. All patients would also be taking a class of medicines called P2Y12 inhibitors (such as clopidogrel/Plavix) and be treated for up to 6 months. The primary focus will be a comparison of the bleeding risk of Apixaban, with or without aspirin, versus a Vitamin K antagonist, such as warfarin, with or without aspirin.

primary_purpose: Other

ReferenceCitation: Hijazi Z, Alexander JH, Li Z, Wojdyla DM, Mehran R, Granger CB, Parkhomenko A, Bahit MC, Windecker S, Aronson R, Berwanger O, Halvorsen S, de Waha-Thiele S, Sinnaeve P, Darius H, Storey RF, Lopes RD. Apixaban or Vitamin K Antagonists and Aspirin or Placebo According to Kidney Function in Patients With Atrial Fibrillation After Acute Coronary Syndrome or Percutaneous Coronary Intervention: Insights From the AUGUSTUS Trial. Circulation. 2021 Mar 23;143(12):1215-1223. doi: 10.1161/CIRCULATIONAHA.120.051020. Epub 2021 Jan 19.

name: Department of Medical Sciences, Cardiology and Uppsala Clinical Research Center, Uppsala University, Sweden (Z.H.).

family: Hijazi

full_name: Ziad Hijazi

given: Ziad

name: Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (J.H.A., Z.L., D.M.W., C.B.G., R.D.L.).

family: Alexander

full_name: John H. Alexander

given: John H.

family: Li

full_name: Zhuokai Li

given: Zhuokai

family: Wojdyla

full_name: Daniel M. Wojdyla

given: Daniel M.

name: Zena and Michael A. Weiner Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, and Cardiovascular Research Foundation, New York, NY (R.M.).

family: Mehran

full_name: Roxana Mehran

given: Roxana

family: Granger

full_name: Christopher B. Granger

given: Christopher B.

name: NSC Institute of Cardiology, Kyiv, Ukraine (A.P.).

family: Parkhomenko

full_name: Alexander Parkhomenko

given: Alexander

name: Instituto de Neurología Cognitiva (INECO) Neurociencias Oroño, Fundación INECO, Rosario, Argentina (M.C.B.).

family: Bahit

full_name: M. Cecilia Bahit

given: M. Cecilia

name: Bern University Hospital, Inselspital, University of Bern, Switzerland (S.W.).

family: Windecker

full_name: Stephan Windecker

given: Stephan

name: Bristol-Myers Squibb, Lawrenceville, NJ (R.A.).

family: Aronson

full_name: Ronald Aronson

given: Ronald

name: Hospital Israelita Albert Einstein, São Paulo, Brazil (O.B.).

family: Berwanger

full_name: Otavio Berwanger

given: Otavio

name: Oslo University Hospital Ulleval, Norway (S.H.).

family: Halvorsen

full_name: Sigrun Halvorsen

given: Sigrun

name: University Heart Centre Lübeck, University Hospital Schleswig-Holstein, Germany (S.dW.-T.).

name: German Center for Cardiovascular Research (DZHK), Lübeck (S.dW.-T.).

family: de Waha-Thiele

full_name: Suzanne de Waha-Thiele

given: Suzanne

name: University Hospitals Leuven, University of Leuven, Belgium (P.S.).

family: Sinnaeve

full_name: Peter Sinnaeve

name: Vivantes Neukoelln Medical Center, Berlin, Germany (H.D.).

family: Darius

full_name: Harald Darius

given: Harald

name: Department of Infection, Immunity, and Cardiovascular Disease, University of Sheffield, United Kingdom (R.F.S.).

family: Storey

full_name: Robert F. Storey

given: Robert F.

family: Lopes

full_name: Renato D. Lopes

given: Renato D.

journal_name: Circulation

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

ReferenceCitation: Alexander JH, Wojdyla D, Vora AN, Thomas L, Granger CB, Goodman SG, Aronson R, Windecker S, Mehran R, Lopes RD. Risk/Benefit Tradeoff of Antithrombotic Therapy in Patients With Atrial Fibrillation Early and Late After an Acute Coronary Syndrome or Percutaneous Coronary Intervention: Insights From AUGUSTUS. Circulation. 2020 May 19;141(20):1618-1627. doi: 10.1161/CIRCULATIONAHA.120.046534. Epub 2020 Mar 29.

name: Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (J.H.A., D.W., L.T., C.B.G., R.D.L.).

name: Division of Cardiology, Duke Health, Durham, NC (J.H.A., C.B.G., R.D.L.).

full_name: Daniel Wojdyla

given: Daniel

family: Vora

name: Canadian VIGOUR Centre, University of Alberta, Edmonton, Canada (S.G.G.).

name: Terrence Donnelly Heart Centre, St Michael’s Hospital, University of Toronto, Ontario, Canada (S.G.G.).

ReferenceCitation: Lopes RD, Leonardi S, Wojdyla DM, Vora AN, Thomas L, Storey RF, Vinereanu D, Granger CB, Goodman SG, Aronson R, Windecker S, Thiele H, Valgimigli M, Mehran R, Alexander JH. Stent Thrombosis in Patients With Atrial Fibrillation Undergoing Coronary Stenting in the AUGUSTUS Trial. Circulation. 2020 Mar 3;141(9):781-783. doi: 10.1161/CIRCULATIONAHA.119.044584. Epub 2019 Nov 11.

name: Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L., D.M.W., L.T., C.B.G., J.H.A.).

name: University of Pavia and Fondazione IRCCS Policlinico S. Matteo, Italy (S.L.).

name: University of Medicine and Pharmacy Carol Davila, University and Emergency Hospital of Bucharest, Romania (D.V.).

name: Terrence Donnelly Heart Centre, St Michael’s Hospital, University of Toronto, ON, Canada (S.G.G.).

name: Bern University Hospital, Inselspital, University of Bern, Switzerland (S.W., M.V.).

name: Heart Center Leipzig at the University of Leipzig, Department of Internal Medicine/Cardiology and Leipzig Heart Institute, Germany (H.T.).

name: Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, and Cardiovascular Research Foundation, New York (R.M.).

ReferenceCitation: Windecker S, Lopes RD, Massaro T, Jones-Burton C, Granger CB, Aronson R, Heizer G, Goodman SG, Darius H, Jones WS, Aschermann M, Brieger D, Cura F, Engstrøm T, Fridrich V, Halvorsen S, Huber K, Kang HJ, Leiva-Pons JL, Lewis BS, Malaga G, Meneveau N, Merkely B, Milicic D, Morais J, Potpara TS, Raev D, Sabaté M, de Waha-Thiele S, Welsh RC, Xavier D, Mehran R, Alexander JH; AUGUSTUS Investigators. Antithrombotic Therapy in Patients With Atrial Fibrillation and Acute Coronary Syndrome Treated Medically or With Percutaneous Coronary Intervention or Undergoing Elective Percutaneous Coronary Intervention: Insights From the AUGUSTUS Trial. Circulation. 2019 Dec 3;140(23):1921-1932. doi: 10.1161/CIRCULATIONAHA.119.043308. Epub 2019 Sep 26.

name: Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Switzerland (S.W.).

name: Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L., T.M., C.B.G., G.H., W.S.J., J.H.A.).

name: Bristol-Myers Squibb, Lawrenceville, NJ (C.J.-B., R.A.).

name: Canadian VIGOUR Center, University of Alberta, Edmonton, Canada (S.G.G., R.C.W.).

name: Charles University, Prague, Czech Republic (M.A.).

name: Concord Clinical School, ANZAC Research Institute, University of Sydney, Australia (D.B.).

name: Instituto Cardiovascular de Buenos Aires and Sanatorio Anchorena, Argentina (F.C.).

name: Rigshospital, University of Copenhagen, Denmark (T.E.).

name: National Institute of Cardiovascular Diseases, Bratislava, Slovakia (V.F.).

name: Oslo University Hospital Ulleval, University of Oslo, Norway (S.H.).

name: Wilhelminenhospital and Sigmund Freud University, Medical School, Vienna, Austria (K.H.).

name: Seoul National University Hospital, Seoul National University, Korea (H.-J.K.).

name: Hospital Central Dr Ignacio Morones Prieto, San Luis Potosi, Mexico (J.L.L.-P.).

name: Cardiovascular Clinical Research Institute, Lady Davis Carmel Medical Center, Haifa, Israel (B.S.L.).

name: CONEVID School of Medicine, Universidad Peruana Cayetano Heredia, Lima, Peru (G.M.).

name: University Hospital Jean Minjoz, Besançon, France (N.M.).

name: EA3920, University of Burgundy Franche-Comté, Besançon, France (N.M.).

name: Semmelweis University Heart and Vascular Center, Budapest, Hungary (B.M.).

name: University of Zagreb School of Medicine, University Hospital Centre, Croatia (D.M.).

name: Hospital de Santo André, Leiria, Portugal (J.M.).

name: School of Medicine, Belgrade University, Serbia (T.S.P.).

name: Clinical Centre of Serbia, Belgrade (T.S.P.).

name: University Hospital St Anna, Sofia, Bulgaria (D.R.).

name: University Heart Centre Lübeck, University Hospital Schleswig-Holstein, Germany (S.d.W.-T.).

name: German Center for Cardiovascular Research (DZHK), partner site Hamburg/Kiel/Lübeck, Lübeck (S.d.W.-T.).

name: Mazankowski Alberta Heart Institute, Edmonton, Canada (R.C.W.).

name: St John’s Medical College and Research Institute, Bangalore, India (D.X.).

name: Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, and Cardiovascular Research Foundation, New York, NY (R.M.).

ReferenceCitation: Lopes RD, Heizer G, Aronson R, Vora AN, Massaro T, Mehran R, Goodman SG, Windecker S, Darius H, Li J, Averkov O, Bahit MC, Berwanger O, Budaj A, Hijazi Z, Parkhomenko A, Sinnaeve P, Storey RF, Thiele H, Vinereanu D, Granger CB, Alexander JH; AUGUSTUS Investigators. Antithrombotic Therapy after Acute Coronary Syndrome or PCI in Atrial Fibrillation. N Engl J Med. 2019 Apr 18;380(16):1509-1524. doi: 10.1056/NEJMoa1817083. Epub 2019 Mar 17.

name: From the Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L., G.H., A.N.V., T.M., C.B.G., J.H.A.); Bristol-Myers Squibb, Princeton, NJ (R.A., J.L.); Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, and Cardiovascular Research Foundation, New York (R.M.); Canadian VIGOUR Centre, University of Alberta, Edmonton (S.G.G.), and the Terrence Donnelly Heart Centre, St. Michael’s Hospital, University of Toronto, Toronto (S.G.G.) —...

ReferenceCitation: Lopes RD, Vora AN, Liaw D, Granger CB, Darius H, Goodman SG, Mehran R, Windecker S, Alexander JH. An open-Label, 2 × 2 factorial, randomized controlled trial to evaluate the safety of apixaban vs. vitamin K antagonist and aspirin vs. placebo in patients with atrial fibrillation and acute coronary syndrome and/or percutaneous coronary intervention: Rationale and design of the AUGUSTUS trial. Am Heart J. 2018 Jun;200:17-23. doi: 10.1016/j.ahj.2018.03.001. Epub 2018 Mar 9.

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

location_country:
Peru
Romania
Australia
Belgium
Russian Federation
Denmark
Ukraine
India
Croatia
France
Poland
Slovakia
Norway
Argentina
Canada
Korea, Republic of
Colombia
Chile
Sweden
Switzerland
Netherlands
Bulgaria
Hungary
Puerto Rico
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Serbia
Mexico
Virgin Islands (U.S.)
Czechia
Israel
Spain

location_facility: Clinical Trials of America-NC, LLC - PPDS

location_facility: Clinical Trials of America LA LLC - PPDS

location_facility: Cardiovascular Associates of the Southeast, LLC

location_facility: Duke Cardiology and Cardiovascular Surgery of Lumberton

location_facility: Advocate Medical Group ? Cardiology and Pulmonology

location_facility: University of North Carolina School of Medicine

location_facility: Caprock Cardiac Center Research Institute

location_facility: Knoxville Health Managment Associates Cardiology PPM LLC

location_facility: Clearwater Cardiovascular and Interventional Consultants

location_facility: Carolina Cardiology Clinical Research Institute

location_facility: Hudson Valley Cardiovascular Practice, PC

location_facility: University of Iowa Stead Family Children's Hospital

location_facility: Midwest Cardiovascular Research Foundation

location_facility: New York-Presbyterian Brooklyn Methodist Hospital


ReferenceCitation: Wolf J, Seto T, Han JY, Reguart N, Garon EB, Groen HJM, Tan DSW, Hida T, de Jonge M, Orlov SV, Smit EF, Souquet PJ, Vansteenkiste J, Hochmair M, Felip E, Nishio M, Thomas M, Ohashi K, Toyozawa R, Overbeck TR, de Marinis F, Kim TM, Laack E, Robeva A, Le Mouhaer S, Waldron-Lynch M, Sankaran B, Balbin OA, Cui X, Giovannini M, Akimov M, Heist RS; GEOMETRY mono-1 Investigators. Capmatinib in MET Exon 14-Mutated or MET-Amplified Non-Small-Cell Lung Cancer. N Engl J Med. 2020 Sep 3;383(10):944-957. doi: 10.1056/NEJMoa2002787.

name: From the Department I of Internal Medicine, Center for Integrated Oncology, University Hospital Cologne and University of Cologne, Cologne (J.W.), Internistische Onkologie der Thoraxtumoren, Thoraxklinik im Universitätsklinikum Heidelberg, Translational Lung Research Center Heidelberg, Heidelberg (M.T.), the Department of Hematology and Medical Oncology, University Medical Center Göttingen, Göttingen (T.R.O.), and Hämato-Onkologie Hamburg, Hamburg (E.L.) — all in Germany; the National Hospital...

family: Wolf

full_name: Jürgen Wolf

given: Jürgen

family: Seto

full_name: Takashi Seto

given: Takashi

family: Han

full_name: Ji-Youn Han

given: Ji-Youn

family: Reguart

full_name: Noemi Reguart

given: Noemi

family: Garon

full_name: Edward B. Garon

given: Edward B.

family: Groen

full_name: Harry J.M. Groen

given: Harry J.M.

family: Tan

full_name: Daniel S.W. Tan

given: Daniel S.W.

family: Hida

full_name: Toyoaki Hida

given: Toyoaki

family: de Jonge

full_name: Maja de Jonge

given: Maja

family: Orlov

full_name: Sergey V. Orlov

given: Sergey V.

family: Smit

full_name: Egbert F. Smit

given: Egbert F.

family: Souquet

full_name: Pierre-Jean Souquet

given: Pierre-Jean

family: Vansteenkiste

full_name: Johan Vansteenkiste

given: Johan

family: Hochmair

full_name: Maximilian Hochmair

given: Maximilian

family: Felip

full_name: Enriqueta Felip

given: Enriqueta

family: Nishio

full_name: Makoto Nishio

given: Makoto

family: Thomas

full_name: Michael Thomas

given: Michael

family: Ohashi

full_name: Kadoaki Ohashi

given: Kadoaki

family: Toyozawa

full_name: Ryo Toyozawa

given: Ryo

family: Overbeck

full_name: Tobias R. Overbeck

given: Tobias R.

family: de Marinis

full_name: Filippo de Marinis

given: Filippo

family: Kim

full_name: Tae-Min Kim

given: Tae-Min

family: Laack

full_name: Eckart Laack

given: Eckart

family: Robeva

full_name: Anna Robeva

given: Anna

family: Le Mouhaer

full_name: Sylvie Le Mouhaer

given: Sylvie

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

title: Capmatinib inMETExon 14–Mutated orMET-Amplified Non–Small-Cell Lung Cancer

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:
Italy
Austria
Sweden
Lebanon
Mexico
Germany
Netherlands
France
Japan
Israel
Norway
Singapore
Argentina
Belgium
Russian Federation
Spain
United States
United Kingdom
Korea, Republic of
Taiwan

acronym: Study of oral cMET inhibitor INC280 in patients with EGFR wild-type, advanced NSCLC

location_facility: National Hospital Organization, Yamaguchi-Ube Medical Center

location_facility: Massachusetts General Hospital MGH Cancer Center

location_facility: H Lee Moffitt Cancer Center and Research Institute

location_facility: VA Ann Arbor Health System VA Ann Arbor Health System

location_facility: University of Utah / Huntsman Cancer Institute Oncology

location_facility: University of Iowa Hospitals & Clinics SC-3

location_facility: University of California at Los Angeles Dept of Onc

location_facility: University of California Irvine Medical Center Chao Family Chao Family Comp Cancer Center

location_facility: Cancer Therapy and Research Center UT Health Science Center SC-5

location_facility: NKI-AVL, Department of Thoracic-Oncology

title: A Phase II, Multicenter Study of Oral cMET Inhibitor INC280 in Adult Patients With EGFR Wild-type (wt), Advanced Non-small Cell Lung Cancer (NSCLC)(Geometry Mono-1)

summary: A phase II study to evaluate antitumor activity of oral cMET inhibitor INC280 in adult patients with EGFR wild-type, advanced non-small cell lung cancer (NSCLC) as measured by overall response rate (ORR). The study will also evaluate safety and pharmacokinetics of INC280.


ReferenceCitation: Herbst RS, Giaccone G, de Marinis F, Reinmuth N, Vergnenegre A, Barrios CH, Morise M, Felip E, Andric Z, Geater S, Özgüroğlu M, Zou W, Sandler A, Enquist I, Komatsubara K, Deng Y, Kuriki H, Wen X, McCleland M, Mocci S, Jassem J, Spigel DR. Atezolizumab for First-Line Treatment of PD-L1-Selected Patients with NSCLC. N Engl J Med. 2020 Oct 1;383(14):1328-1339. doi: 10.1056/NEJMoa1917346.

name: From the Yale School of Medicine, New Haven, CT (R.S.H.); Weill Cornell Medical Center, New York (G.G.); the European Institute of Oncology, IRCCS, Milan (F.M.); Asklepios Lung Clinic, Munich-Gauting, Germany (N.R.); University Hospital Limoges, Limoges, France (A.V.); Centro de Pesquisa Clínica, Hospital São Lucas, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil (C.H.B.); Nagoya University Graduate School of Medicine, Aichi, Japan (M. Morise); Vall d’Hebron University...

family: Herbst

full_name: Roy S. Herbst

given: Roy S.

family: Giaccone

full_name: Giuseppe Giaccone

given: Giuseppe

family: Reinmuth

full_name: Niels Reinmuth

given: Niels

family: Vergnenegre

full_name: Alain Vergnenegre

given: Alain

family: Barrios

full_name: Carlos H. Barrios

given: Carlos H.

family: Morise

full_name: Masahiro Morise

given: Masahiro

family: Andric

full_name: Zoran Andric

given: Zoran

family: Geater

full_name: Sarayut Geater

given: Sarayut

family: Özgüroğlu

full_name: Mustafa Özgüroğlu

given: Mustafa

family: Zou

full_name: Wei Zou

given: Wei

family: Sandler

full_name: Alan Sandler

given: Alan

family: Enquist

full_name: Ida Enquist

given: Ida

family: Komatsubara

full_name: Kimberly Komatsubara

given: Kimberly

family: Deng

full_name: Yu Deng

given: Yu

family: Kuriki

full_name: Hiroshi Kuriki

given: Hiroshi

family: Wen

full_name: Xiaohui Wen

given: Xiaohui

family: McCleland

full_name: Mark McCleland

given: Mark

family: Mocci

full_name: Simonetta Mocci

given: Simonetta

family: Jassem

full_name: Jacek Jassem

given: Jacek

family: Spigel

full_name: David R. Spigel

given: David R.

journal_name: New England Journal of Medicine

evidence: open (via free article)

publisher: Massachusetts Medical Society

title: Atezolizumab for First-Line Treatment of PD-L1–Selected Patients with NSCLC

location_country:
Italy
Brazil
Serbia
Spain
Germany
France
Japan
Greece
Poland
Thailand
Romania
Hungary
Russian Federation
China
Turkey
United States
United Kingdom
Korea, Republic of
Ukraine

location_facility: Vanderbilt University Medical Center; Multiple Sclerosis Center

location_facility: Azienda Ospedaliera Universitaria Integrata Verona; UOC Oncologia

location_facility: Kyiv Railway Clinical Hospital #3 of Branch Health Center of the PJSC Ukrainian Railway

location_facility: Centre Hospitalier Regional La Reunion Site Felix Guyon

location_facility: Centro Di Riferimento Oncologico; Struttura Operativa Complessa Di Oncologia Medica B

location_facility: Hematology Oncology Associates of Fredericksburg, Inc.

location_facility: Municipal Noncommercial Institution Regional Center of Oncology

location_facility: University of Maryland Greenebaum Cancer Center

location_facility: Ibaraki Prefectural Central Hospital; Division of respiratory

location_facility: Hospital Universitario Vall d'Hebron - PPDS

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

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: Municipal Noncomercial Enterprise Odessa Regional Oncology Center ofthe Odessa StateAdministration

location_facility: EUROMEDICA General Clinic of Thessaloniki; Gastroenterology Department

location_facility: Prof. Dr. I. Chiricuta Institute of Oncology

location_facility: Teo Health SA - Saint Constantin Hospital

location_facility: National Cancer Center Hospital; Thoracic Medical Oncology

location_facility: Instituto Nacional de Cancer - INCa; Oncologia

location_facility: Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy

location_facility: Prince of Songkla University; Department Of Internal Medicine, Faculty Of Medicine

location_facility: The Municipal Enterprise Volyn Regional Medical Oncology Centre of the Volyn Regional Council

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Arkhangelsk Regional Clinical Oncology Dispensary

location_facility: Nagoya University Hospital; Respiratory Medicine

location_facility: Santa Casa de Misericordia de Porto Alegre

location_facility: Azienda Ospedaliero-Universitaria "PoliclinicoVittorio Emanuele"- P.O. G. Rodolico; Oncologia Medica

location_facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino

location_facility: Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu

location_facility: Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic

location_facility: Izmir Dr. Suat Seren Gogus Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi

location_facility: Azienda Socio Sanitaria Territoriale - ASST di Monza

location_facility: Instituto Joinvilense de Hematologia E Oncologia

location_facility: Municipal non profit enterprise of Sumy Regional Council Sumy Regional Clinical Oncology Disp

location_facility: Osaka International Cancer Institute; Thoracic Oncology

location_facility: Ege Universitesi Tip Fakultesi Hastanesi

location_facility: Chonnam National University Hwasun Hospital

location_facility: St. Petersburg Med Univ; n.a. I.P. Pavlov; Pulmonology Research

location_facility: Hospital Clinico San Carlos; Servicio de Oncologia

location_facility: Inonu University Faculty of Medicine Turgut Ozal Medical Center

location_facility: Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc w Olsztynie

location_facility: Hacettepe Universitesi Tip Fakultesi Hastanesi; Ic Hastaliklari Anabiim Dali

location_facility: Communal Nonprofit Enterprise Podilsky Regional Center Of Oncology OfTheVinnytsia Regional Council

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

location_facility: Papageorgiou General Hospital of Thessaloniki

location_facility: Azienda Ospedaliera Istituti Ospitalieri

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

location_facility: Tokyo Medical University Hospital; Dept of Surgery

location_facility: Volgograd Regional Clinical Oncology Dispensary

location_facility: Associacao Hospital de Caridade Ijui*X; Departamento De Oncologia

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Private Enterprise Private Manufacturing Company Acinus

location_facility: Seoul National University Bundang Hospital

location_facility: Saint Petersburg Clinical Hospital of the Russian Academy of Sciences

location_facility: Centro de Pesquisas Clinicas em Oncologia - CPCO

location_facility: Kansai Medical university Hospital; Thoracic Oncology

location_facility: Instituto Do Câncer Do Estado de São Paulo Octávio Frias de Oliveira

location_facility: Harbin Medical University Tumor Hospital

location_facility: Federal State Institution Medical Radiology Research Center

location_facility: Institutul Regional de Oncologie Iasi; Clinica de Hematologie

location_facility: Okayama University Hospital; Respiratory and Allergy Medicine

location_facility: Communal Non-profit Enterprise City Clinical Hospital #4 of Dnipro City Council - PPDS; Chemotherapy

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

location_facility: Sendai Kousei Hospital; Pulmonary Medicine

location_facility: Aichi Cancer Center Hospital; Respiratory Medicine

location_facility: Hospital d Instructions des Armees Percy

location_facility: Principal Military Clinical Hospital n.a. N.N. Burdenko

location_facility: Sibiu Emergency Clinical County Hospital

location_facility: Saitama Cancer Center; Thoracic Oncology

location_facility: Consorcio Hospitalario Provincial de Castellon

location_facility: Kobe City Medical Center General Hospital; Respiratory Medicine

location_facility: National Hospital Organization Kinki-Chuo Chest Medical Center

location_facility: Asklepios-Fachklinik Muenchen-Gauting; Klinik Für Pneumologie

location_facility: Szabolcs-Szatmar-Bereg Megyei; Korhazak es Egyetemi Oktatokorhaz

location_facility: Hopital d'Instruction des Armees de Begin

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet; Megyei Onkologiai Kozpont

location_facility: Georgios Papanikolaou General Hosp. of Thessaloniki

location_facility: Cukurova University Medical Faculty Balcali Hospital

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

title: A Phase III, Open Label, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) Compared With a Platinum Agent (Cisplatin or Carboplatin) in Combination With Either Pemetrexed or Gemcitabine for PD-L1-Selected, Chemotherapy-Naive Patients With Stage IV Non-Squamous Or Squamous Non-Small Cell Lung Cancer

summary: This randomized, open-label study will evaluate the efficacy and safety of atezolizumab compared with chemotherapy consisting of a platinum agent (cisplatin or carboplatin per investigator discretion) combined with either pemetrexed (non-squamous disease) or gemcitabine (squamous disease) in programmed death-ligand 1 (PD-L1)-selected, chemotherapy-naive participants with Stage IV Non-Squamous or Squamous NSCLC.


ReferenceCitation: Locatelli F, Zugmaier G, Rizzari C, Morris JD, Gruhn B, Klingebiel T, Parasole R, Linderkamp C, Flotho C, Petit A, Micalizzi C, Mergen N, Mohammad A, Kormany WN, Eckert C, Möricke A, Sartor M, Hrusak O, Peters C, Saha V, Vinti L, von Stackelberg A. Effect of Blinatumomab vs Chemotherapy on Event-Free Survival Among Children With High-risk First-Relapse B-Cell Acute Lymphoblastic Leukemia: A Randomized Clinical Trial. JAMA. 2021 Mar 2;325(9):843-854. doi: 10.1001/jama.2021.0987.

name: IRCCS Ospedale Pediatrico Bambino Gesù and Sapienza University of Rome, Rome, Italy

family: Locatelli

full_name: Franco Locatelli

given: Franco

name: Amgen Research (Munich GmbH), Munich, Germany

family: Zugmaier

full_name: Gerhard Zugmaier

given: Gerhard

name: University of Milano–Bicocca, MBBM Foundation, Monza, Italy

family: Rizzari

full_name: Carmelo Rizzari

given: Carmelo

family: Morris

full_name: Joan D. Morris

given: Joan D.

family: Gruhn

full_name: Bernd Gruhn

given: Bernd

name: Universitätsklinikum Frankfurt am Main, Frankfurt, Germany

family: Klingebiel

full_name: Thomas Klingebiel

given: Thomas

name: Azienda Ospedaliera di Rilievo Nazionale Santobono Pausilipon, Naples, Italy

family: Parasole

full_name: Rosanna Parasole

given: Rosanna

name: Medizinische Hochschule Hannover, Hannover, Germany

family: Linderkamp

full_name: Christin Linderkamp

given: Christin

name: Universitätsklinikum Freiburg, Freiburg, Germany

family: Flotho

full_name: Christian Flotho

given: Christian

name: Sorbonne Université, Hôpital Armand Trousseau, AP-HP, Paris, France

family: Petit

full_name: Arnaud Petit

given: Arnaud

name: IRCCS Istituto Giannina Gaslini, Genova, Italy

family: Micalizzi

full_name: Concetta Micalizzi

given: Concetta

family: Mergen

full_name: Noemi Mergen

given: Noemi

family: Mohammad

full_name: Abeera Mohammad

given: Abeera

family: Kormany

full_name: William N. Kormany

given: William N.

name: Charité–Universitätsmedizin Berlin, Berlin, Germany

family: Eckert

full_name: Cornelia Eckert

given: Cornelia

name: Universitätsklinikum Schleswig–Holstein, Kiel, Germany

family: Möricke

full_name: Anja Möricke

given: Anja

name: Westmead Hospital, Sydney, New South Wales, Australia

family: Sartor

full_name: Mary Sartor

given: Mary

name: Charles University, Motol University Hospital, Prague, Czech Republic

family: Hrusak

full_name: Ondrej Hrusak

given: Ondrej

name: St Anna Children’s Hospital, Vienna, Austria

family: Peters

full_name: Christina Peters

given: Christina

name: The University of Manchester, Manchester, United Kingdom

name: Tata Translational Cancer Research Center, Tata Medical Center, Kolkata, West Bengal, India

family: Saha

full_name: Vaskar Saha

given: Vaskar

family: Vinti

full_name: Luciana Vinti

given: Luciana

family: von Stackelberg

full_name: Arend von Stackelberg

given: Arend

journal_name: JAMA

oa_colors: green other

oa_host_type: publisher;repository

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

location_country:
Greece
Romania
Australia
Belgium
Russian Federation
Denmark
France
Poland
Norway
Argentina
Sweden
Switzerland
Netherlands
Portugal
Germany
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
Israel
Spain
Turkey

title: Phase 3 Trial to Investigate the Efficacy, Safety, and Tolerability of Blinatumomab as Consolidation Therapy Versus Conventional Consolidation Chemotherapy in Pediatric Subjects With HR First Relapse B-precursor ALL

summary: B-precursor ALL is an aggressive malignant disease. Therapy is usually stratified according to risk characteristics to ensure that appropriate treatment is administered to patients with high-risk of relapse. In general, pediatric treatment regimens are more intense than those employed in adults and include courses of combination chemotherapy. Standard of care chemotherapy is associated with considerable toxicity. There is a lack of novel treatment options for subjects who relapse or are refractory to treatment. Therefore, innovative therapeutic approaches are urgently needed. Blinatumomab is a bispecific single-chain antibody construct designed to link B cells and T cells resulting in T cell activation and a cytotoxic T cell response against CD19 expressing cells. This study will evaluate the event-free survival (EFS) after treatment with blinatumomab when compared to standard of care (SOC) chemotherapy. The effect of blinatumomab on overall survival and reduction of minimal residual disease compared to SOC chemotherapy will also be investigated.


location_country:
Peru
Australia
Belgium
Russian Federation
Taiwan
Ukraine
France
Japan
Lithuania
Slovakia
Argentina
Canada
Chile
Netherlands
Bulgaria
Singapore
Portugal
Germany
United States
Italy
Austria
Brazil
Mexico
Israel
Spain
Latvia

location_facility: Schwarzwald-Baar Klinikum/VS GmbH; Onkologie/Hämatologie/Infektologie

location_facility: Kaohsiung Medical University Hospital; Department of Urology

location_facility: Rambam Health Corporation; Oncology Institute

location_facility: Maryland Oncology Hematology (Lanham) - USOR

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: Klinikum Bogenhausen; Klinik für Pneumologie und Pneumologische Onkologie

location_facility: Hopital de Pontchaillou; Service de Pneumologie

location_facility: Communal Non profit Enterprise Regional Center of Oncology; Oncosurgical dept of thoracic organs

location_facility: Hematology-Oncology; Associates of the Quad Cities

location_facility: Ibaraki Prefectural Central Hospital; Division of respiratory

location_facility: Chaim Sheba Medical Center; Oncology Dept

location_facility: Kaiser Permanente - San Leandro Medical Center

location_facility: Azienda Ospedaliero Universitaria Seconda Università degli Studi di Napoli; Farmacia Centralizzata

location_facility: Centro Hospitalar do Porto - Hospital de Santo António

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Centro Oncologico Riojano Integral (CORI)

location_facility: ME Kryviy Rih Oncology Dispensary of Dnipropetrovs'k Regional Council; Chemotherapy Department

location_facility: Robert Bosch Krankenhaus; Pneumologie und pneumologische Onkologie

location_facility: Changhua Christian Hospital; Hematology-Oncology

location_facility: IRCCS Giovanni Paolo II Istituto Oncologico

location_facility: Kanagawa Cancer Center;Thoracic Oncology

location_facility: National Cancer Center Hospital; Thoracic Medical Oncology

location_facility: Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis

location_facility: Hospital Lucus Augusti; Servicio de Oncologia

location_facility: *X*Fundação Pio XII Hospital de Câncer de Barretos

location_facility: Hematology and Oncology Associates at Bridgepoint

location_facility: Hôpital d'Instruction des Armées de Sainte Anne; Service Pharmacie Essais Cliniques

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Calvary Mater Newcastle; Medical Oncology

location_facility: Nagoya University Hospital; Respiratory Medicine

location_facility: National Hospital Organization Shikoku Cancer Center; Internal Medicine

location_facility: Sociedad de Investigaciones Medicas Ltda (SIM)

location_facility: Russian Oncology Research Center n.a. N.N. Blokhin

location_facility: Ev.Krankenhaus Bielefeld gGmbH; Klinik für Innere Medizin und Geriatrie

location_facility: Osaka City Uni Hospital; Respiratory Medicine

location_facility: Catharina Hospital; Afdeling Longgeneeskunde en Tuberculose

location_facility: Kaiser Permanente; Oncology Clinical Trials

location_facility: Southeastern Regional Medical Center, Inc.

location_facility: Universität Des Saarlandes; Klinik für Innere Medizin V

location_facility: Kaiser Permanente - Sacramento Medical Center and Medical Offices

location_facility: IPCEM; Instituto de Pesquisa de Estudos Multicêntricos

location_facility: Cite de La Sante de Laval; Hemato-Oncologie

location_facility: University Cancer & Blood Center, LLC; Research

location_facility: National Cancer Center Hospital East; Thoracic Oncology

location_facility: Niigata University Medical & Dental Hospital; Respiratory Medicine and Infectious Disease

location_facility: Osaka International Cancer Institute; Thoracic Oncology

location_facility: Pauls Stradins Clinical University Hospital

location_facility: Krankenhaus Martha-Maria; Halle-Dolau gGmbH

location_facility: Complejo Hospitalario Universitario Insular-Materno Infantil

location_facility: Cenantron - Centro Avancado de Tratamento Oncologico

location_facility: Hospital Clinico San Carlos; Servicio de Oncologia

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Instituto Do Cancer Delondrina_X; Unidade De Pesquisa Clinica

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: Hospital Nacional Guillermo Almenara Irigoyen ESSALUD

location_facility: Hospital Pulido Valente; Servico de Pneumologia

location_facility: Municipal Institution City Clinical Hospital #4 of Dnipro City Council - PPDS; Dept of Chemotherapy

location_facility: VU Medisch Centrum; VU University Medical Center

location_facility: Communal Nonprofit Enterprise Podilsky Regional Center Of Oncology OfTheVinnytsia Regional Council

location_facility: Southcoast Health System; Southcoast Centers For Cancer Care

location_facility: SI Institute of Medical Radiology n.a. S.P. Hryhoriev of NAMS of Ukraine

location_facility: Hospital General Universitario de Valencia

location_facility: Tokyo Medical University Hospital; Dept of Surgery

location_facility: Centre Hospitalier Regional Sud Reunion; Service de Pneumologie

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

location_facility: Volgograd Regional Clinical Oncology Dispensary

location_facility: Instituto Regional de Enfermedades Neoplásicas Del Norte

location_facility: Hospital Universitario Marques de Valdecilla; Servicio de Oncologia

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Kansai Medical university Hospital; Thoracic Oncology

location_facility: Fort Wayne Med Oncology & Hematology Inc

location_facility: National Hospital Organization Kyushu Medical Center; Respiratory Internal Medicine

location_facility: Krankenhaus Barmherzige Bruder Regensburg

location_facility: National Hospital Organization Himeji Medical Center

location_facility: Hospital de Sao Joao; Servico de Pneumologia

location_facility: Okayama University Hospital; Respiratory and Allergy Medicine

location_facility: Multiprofile Hospital for Active Treatment Central Onco Hospital OOD

location_facility: Fundación CENIT para la Investigación en Neurociencias

location_facility: Joliet Oncology-Hematology; Associates, Ltd.

location_facility: Instituto Catalan de Oncologia de Hospitalet (ICO); Servicio de Farmacia

location_facility: Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialita San Giuseppe Moscati

location_facility: Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden

location_facility: Poltava Regional Clinical Oncology Dispensary of Poltava Regional Council; Thoracic department

location_facility: Municipal Institution Chernivtsi Regional Clinical Oncology Dispensary; Surgery Department #1

location_facility: Kyoto University Hospital, Respiratory Medicine

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

location_facility: Kaiser Permanente Oakland Medical Center

location_facility: Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe

location_facility: Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes

location_facility: Ctr Jean Bernard Clin V. Hugo; Service d'Oncologie Méd

location_facility: Multiprofile Hospital for Active Treatment Serdika EOOD

location_facility: Shizuoka Cancer Center; Thoracic Oncology

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

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

location_facility: SCRI The Center For Cancer and Blood Disorders

location_facility: Complejo Hospitalario Universitario A Coruña

location_facility: Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building)

location_facility: Riga East Clinical University Hospital Latvian Oncology Centre

location_facility: Centro de Investigacion; Clinica - Clinica Viedma S.A.

location_facility: Hospital de Base de Sao Jose do Rio Preto

location_facility: Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary

location_facility: Hematology Oncology Associates of the Treasure Coast

location_facility: MNPE Zaporizhzhia Regional Antitumor Center ZRC

location_facility: MI of the Lviv Regional Council Lviv Oncology Regional Treatment and Diagnostic Centre; Chemotherapy

source: euctr

title: A Phase III, Open-Label, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Paclitaxel or Atezolizumab in Combination With Carboplatin+Nab-Paclitaxel Versus Carboplatin+Nab-Paclitaxel in Chemotherapy-Naive Patients With Stage IV Squamous Non-Small Cell Lung Cancer

summary: This randomized, open-label study will evaluate the safety and efficacy of atezolizumab (MPDL3280A) in combination with carboplatin + paclitaxel or carboplatin + nab-paclitaxel compared with treatment with carboplatin + nab-paclitaxel in chemotherapy-naive participants with Stage IV squamous NSCLC.


ReferenceCitation: Dent S, Cortés J, Im YH, Diéras V, Harbeck N, Krop IE, Wilson TR, Cui N, Schimmoller F, Hsu JY, He J, De Laurentiis M, Sousa S, Drullinsky P, Jacot W. Phase III randomized study of taselisib or placebo with fulvestrant in estrogen receptor-positive, PIK3CA-mutant, HER2-negative, advanced breast cancer: the SANDPIPER trial. Ann Oncol. 2021 Feb;32(2):197-207. doi: 10.1016/j.annonc.2020.10.596. Epub 2020 Nov 10.

family: Dent

full_name: S. Dent

given: S.

family: Cortés

full_name: J. Cortés

given: J.

family: Im

full_name: Y.-H. Im

family: Diéras

full_name: V. Diéras

given: V.

family: Harbeck

full_name: N. Harbeck

given: N.

family: Krop

full_name: I.E. Krop

family: Wilson

full_name: T.R. Wilson

family: Cui

full_name: N. Cui

family: Schimmoller

full_name: F. Schimmoller

given: F.

family: Hsu

full_name: J.Y. Hsu

family: He

full_name: J. He

family: De Laurentiis

full_name: M. De Laurentiis

given: M.

family: Sousa

full_name: S. Sousa

family: Drullinsky

full_name: P. Drullinsky

given: P.

family: Jacot

full_name: W. Jacot

given: W.

journal_name: Annals of Oncology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

location_country:
Peru
Finland
Greece
Romania
Australia
Russian Federation
Taiwan
France
Poland
Thailand
Canada
Korea, Republic of
Colombia
Sweden
Netherlands
Bulgaria
Portugal
China
Germany
United States
Italy
Austria
Bosnia and Herzegovina
Serbia
Mexico
Czechia
Spain
Turkey

acronym: SANDPIPER

location_facility: Centro Catanese Di Oncologia; Oncologia Medica

location_facility: Department of Surgery, King Chulalongkorn Memorial Hospital

location_facility: Instituto Nacional de Enfermedades Neoplasicas

location_facility: Uni Hospital Linkoeping; Dept. of Oncology

location_facility: Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica

location_facility: St John of God Murdoch Hospital; Oncology West

location_facility: Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology

location_facility: Turku Uni Central Hospital; Oncology Clinics

location_facility: Ch Lyon Sud; Onco Secteur Jules Courmont

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

location_facility: Centro Oncologico MD Anderson Internacional; Servicio de Oncologia

location_facility: Klinikum Mutterhaus der Borromäerinnen, Innere Medizin I

location_facility: University Hospital of Patras Medical Oncology

location_facility: Ordensklinikum Linz Barmherzige Schwestern; Abt. fur Innere Medizin 1

location_facility: Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc

location_facility: Mercy Hospitals East Communities d/b/a Mercy Hospital St. Louis

location_facility: Centre Alexis Vautrin; Oncologie Medicale

location_facility: Alexandras General Hospital of Athens; Oncology Department

location_facility: Mackay Memorial Hospital; Dept of Surgery

location_facility: Centrum Onkologii Ziemi LUBELSKIEJ im. Sw Jana z Dukli, I oddz. Chemioterapii

location_facility: Prof. Dr. I. Chiricuta Institute of Oncology

location_facility: Hospital de Santa Maria; Servico de Oncologia Medica

location_facility: Newcastle Mater Misericordiae Hospital; Oncology

location_facility: Univ General Hosp Heraklion; Medical Oncology

location_facility: Hospital Universitario de Canarias;servicio de Oncologia

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: Instituto Nacional De Cancerologia; Oncology; Tumores Mamarios

location_facility: Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii

location_facility: Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional

location_facility: Hospital Universitario Puerta de Hierro; Servicio de Oncologia

location_facility: Complex Oncological Center - Plovdiv, EOOD

location_facility: A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

location_facility: Pole de Cancerologie Prive Strasbourgeois

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

location_facility: Azienda USL 9 Grosseto; Dipartimento Politiche del Farmaco

location_facility: Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Klinika Nowotworów Piersi i Chirurgii

location_facility: Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie

location_facility: Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia

location_facility: VETERANS GENERAL HOSPITAL; Department of General Surgery

location_facility: Institut of Oncology Al. Trestioreanu Bucharest; Oncology Department

location_facility: Euromedical General Clinic of Thessaloniki; Oncology Department

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Clinic of Oncology, University Clinical Center Sarajevo

location_facility: John Theurer Cancer Ctr at Hackensack Univ Medical Ctr

location_facility: Clinical Oncology Dispensary of Ministry of Health of Tatarstan

location_facility: The Ottawa Hospital Cancer Centre; Oncology

location_facility: University Hospital; Oncology and Radiotherapy

location_facility: AZ. Usll12 Veneziana-Ospedale Dell'angelo;Oncologia Medica

location_facility: Praxisklinik Krebsheilkunde für Frauen / Brustzentrum (Dres. Kittel/Klare)

location_facility: IPO de Lisboa; Servico de Oncologia Medica

location_facility: Memorial Sloan Kettering Cancer Center; Memorial Sloan Kettering; at Westchester

location_facility: Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

location_facility: IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A

location_facility: McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology

location_facility: SHATOD Dr. Marko Antonov Markov-Varna, EOOD

location_facility: Azienda usl 5 Di Pisa-Ospedale Di Pontedera;U.O. Oncologia

location_facility: British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre

location_facility: Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital

location_facility: State Inst. Of Healthcare Orenburg Regional Clinical Oncology Dis

location_facility: Hospital de Cruces; Servicio de Oncologia

location_facility: S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)

location_facility: IPO do Porto; Servico de Oncologia Medica

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

location_facility: Hospital Garcia de Orta; Servico de Oncologia Medica

location_facility: Oregon Health & Science University; Knight Cancer Institute, Community Hematology Oncology

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej

location_facility: Klinikum der Universität München; Frauenklinik - Onkologie II

location_facility: Hospital da Luz; Departamento de Oncologia Medica

location_facility: National Taiwan Uni Hospital; General Surgery

location_facility: Universitätsklinikum Essen; Zentrum Für Frauenheilkunde

location_facility: Hochwaldkrankenhaus; Abt.Gynäkologie Geburtshilfe u.Senologie

location_facility: Centrum Onkologii w Bydgoszczy; Oddzial Kliniczny Onkologii

location_facility: University Clinical Center of the Republic of Srpska

location_facility: Hospital San Jose Del Tec. de Monterrey; Oncology

location_facility: Przychodnia Lekarska KOMED, Roman Karaszewski

location_facility: ARCISPEDALE S. MARIA NUOVA - REGGIO EMILIA; Struttura Semplice Coordinamento Breast Unit Integrata

location_facility: Maharaj Nakorn Chiang Mai Hospital; Department of Surgery/Head Neck and Breast Unit; Clinical Trial

location_facility: Regional Clinical Oncology Dispensary; Surgery Dept, Thoracic

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

location_facility: Centre Georges François Leclerc; Service Pharmacie, Bp 77980

location_facility: KYS Sadesairaala; Syopatautien poliklinikka

location_facility: Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology

location_facility: Woj.Wielospecjalistyczne Centrum Onkologii i Traumatologii; Oddz.Hematologii Pododz.Chemioterapii

location_facility: Lkh-Univ. Klinikum Graz; Klinik Für Innere Medizin I

location_facility: Instituto Regional de Enfermedades Neoplasicas - IREN Norte

location_facility: Zachodniopomorskie Centrum Onkologii, Osrodek Innowacyjnosci, Rozwoju i Badan Klinicznych

location_facility: Papageorgiou General Hospital; Medical Oncology

location_facility: Consultorio de Medicina Especializada; Dentro de Condominio San Francisco

location_facility: Hospital Universitario Miguel Servet; Servicio Oncologia

location_facility: Liverpool Hospital; Cancer Therapy Centre

location_facility: Wojewodzki Szpital Specjalistyczny; Osrodek Badawczo-Rozwojowy, Oddzial Chemioterapii

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

location_facility: Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem

location_facility: Medizinische Universität Wien; Univ.Klinik für Innere Medizin I

title: A Phase III, Double-Blind, Placebo-Controlled, Randomized Study of Taselisib Plus Fulvestrant Versus Placebo Plus Fulvestrant in Postmenopausal Women With Estrogen Receptor-Positive and HER2-Negative Locally Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy

summary: This international, multicenter, randomized, double-blinded, placebo-controlled study is designed to compare the efficacy and safety of taselisib + fulvestrant with that of placebo + fulvestrant in postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative, oncogene that encodes for phosphatidylinositol-4,5-bisphosphate 3-kinase (PIK3CA)-mutant, unresectable, locally advanced or metastatic breast cancer after recurrence or progression during or after an aromatase inhibitor (AI) therapy. There will be a 2:1 randomization to the taselisib arm versus the placebo arm. Enrollment will be enriched for participants with PIK3CA mutant tumors via central testing. The anticipated duration of the study is approximately 3.5 years.


title: A Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre 24-week Study to Evaluate the Efficacy and Safety of Mepolizumab Adjunctive Therapy in Subjects With Severe Eosinophilic Asthma on Markers of Asthma Control

summary:
This is a multi-centre, placebo-controlled, double-blind, parallel-group study to evaluate the efficacy and safety of mepolizumab adjunctive therapy in participants with severe eosinophilic asthma on markers of asthma control. The overall intent of the current study is to more fully explore the impact of mepolizumab on health-related quality of life (HR-QoL) and other measures of asthma control, including lung function.

Participants who meet the predefined criteria will be randomised to receive either mepolizumab or placebo in addition to standard of care asthma treatment. Approximately 780 participants with severe eosinophilic asthma will be screened to ensure the randomisation of 544 participants (272 participants per treatment group) into the study.

ReferenceCitation: Lemiere C, Taillé C, Lee JK, Smith SG, Mallett S, Albers FC, Bradford ES, Yancey SW, Liu MC. Impact of baseline clinical asthma characteristics on the response to mepolizumab: a post hoc meta-analysis of two Phase III trials. Respir Res. 2021 Jun 22;22(1):184. doi: 10.1186/s12931-021-01767-z.

family: Lemiere

full_name: Catherine Lemiere

given: Catherine

family: Taillé

full_name: Camille Taillé

given: Camille

family: Lee

full_name: Jason Kihyuk Lee

given: Jason Kihyuk

family: Smith

full_name: Steven G. Smith

given: Steven G.

family: Mallett

full_name: Stephen Mallett

given: Stephen

family: Albers

full_name: Frank C. Albers

given: Frank C.

family: Bradford

full_name: Eric S. Bradford

given: Eric S.

family: Yancey

full_name: Steven W. Yancey

given: Steven W.

family: Liu

full_name: Mark C. Liu

given: Mark C.

journal_name: Respiratory Research

oa_host_type: repository

evidence: oa repository (via pmcid lookup)

host_type: repository

repository_normalized: PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Gibson PG, Prazma CM, Chupp GL, Bradford ES, Forshag M, Mallett SA, Yancey SW, Smith SG, Bel EH. Mepolizumab improves clinical outcomes in patients with severe asthma and comorbid conditions. Respir Res. 2021 Jun 7;22(1):171. doi: 10.1186/s12931-021-01746-4.

family: Gibson

full_name: Peter G. Gibson

given: Peter G.

family: Prazma

full_name: Charlene M. Prazma

given: Charlene M.

family: Chupp

full_name: Geoffrey L. Chupp

given: Geoffrey L.

family: Forshag

full_name: Mark Forshag

given: Mark

full_name: Stephen A. Mallett

given: Stephen A.

full_name: Steve W. Yancey

given: Steve W.

family: Bel

full_name: Elisabeth H. Bel

given: Elisabeth H.

currency_apc_doaj: GBP

ReferenceCitation: Yancey SW, Ortega HG, Keene ON, Bradford ES. Efficacy of add-on mepolizumab in adolescents with severe eosinophilic asthma. Allergy Asthma Clin Immunol. 2019 Sep 3;15:53. doi: 10.1186/s13223-019-0366-x. eCollection 2019.

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.

name: Patient Centered Outcomes, Value Evidence and Outcomes, GSK, Collegeville, PA, USA;

name: Value Evidence and Outcomes, GSK House, Brentford, UK;

name: Clinical Statistics, GSK, Stockley Park, UK;

name: Respiratory Medical, GSK House, Brentford, UK;

name: Respiratory Medical Franchise, GSK SK, Research Triangle Park, NC, USA;

name: Respiratory Therapeutic Area, GSK, Research Triangle Park, NC, USA;

name: Real World Evidence and Epidemiology, GSK, Stockley Park, Uxbridge, UK

title: 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

ReferenceCitation: Yancey SW, Bradford ES, Keene ON. Disease burden and efficacy of mepolizumab in patients with severe asthma and blood eosinophil counts of ≥150-300 cells/μL. Respir Med. 2019 May;151:139-141. doi: 10.1016/j.rmed.2019.04.008. Epub 2019 Apr 8.

title: Disease burden and efficacy of mepolizumab in patients with severe asthma and blood eosinophil counts of ≥150–300 cells/μL

ReferenceCitation: Ortega H, Menzies-Gow A, Llanos JP, Forshag M, Albers F, Gunsoy N, Bradford ES, Yancey SW, Kraft M. Rapid and Consistent Improvements in Morning PEF in Patients with Severe Eosinophilic Asthma Treated with Mepolizumab. Adv Ther. 2018 Jul;35(7):1059-1068. doi: 10.1007/s12325-018-0727-8. Epub 2018 Jun 15.

ReferenceCitation: Chupp GL, Bradford ES, Albers FC, Bratton DJ, Wang-Jairaj J, Nelsen LM, Trevor JL, Magnan A, Ten Brinke A. Efficacy of mepolizumab add-on therapy on health-related quality of life and markers of asthma control in severe eosinophilic asthma (MUSCA): a randomised, double-blind, placebo-controlled, parallel-group, multicentre, phase 3b trial. Lancet Respir Med. 2017 May;5(5):390-400. doi: 10.1016/S2213-2600(17)30125-X. Epub 2017 Apr 5.

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

location_country:
Italy
United States
Peru
Netherlands
Germany
France
Bulgaria
Czechia
Greece
Slovakia
Norway
Belgium
Argentina
Russian Federation
Spain
Estonia
Canada
United Kingdom
Ukraine


ReferenceCitation: Ackaert O, McDougall D, Pérez-Ruixo C, Pérez-Ruixo JJ, Jezorwski J, Crauwels HM. Population Pharmacokinetic Analysis of Darunavir and Tenofovir Alafenamide in HIV-1-Infected Patients on the Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Single-Tablet Regimen (AMBER and EMERALD Studies). AAPS J. 2021 Jun 7;23(4):82. doi: 10.1208/s12248-021-00607-8.

family: Ackaert

full_name: Oliver Ackaert

given: Oliver

family: McDougall

full_name: David McDougall

given: David

family: Pérez-Ruixo

full_name: Carlos Pérez-Ruixo

given: Carlos

full_name: Juan Jose Pérez-Ruixo

given: Juan Jose

family: Jezorwski

full_name: John Jezorwski

given: John

family: Crauwels

full_name: Herta M. Crauwels

given: Herta M.

bso_classification: Chemistry

journal_name: The AAPS Journal

ReferenceCitation: Huhn GD, Wilkin A, Mussini C, Spinner CD, Jezorwski J, El Ghazi M, Van Landuyt E, Lathouwers E, Brown K, Baugh B; AMBER and EMERALD study groups. Week 96 subgroup analyses of the phase 3, randomized AMBER and EMERALD trials evaluating the efficacy and safety of the once daily darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) single-tablet regimen in antiretroviral treatment (ART)-naïve and -experienced, virologically-suppressed adults living with HIV-1. HIV Res Clin Pract. 2020 Dec;21(6):151-167. doi: 10.1080/25787489.2020.1844520. Epub 2021 Feb 2.

name: Ruth M. Rothstein CORE Center, Chicago, IL, USA

family: Huhn

full_name: Gregory D. Huhn

given: Gregory D.

name: Section on Infectious Diseases, Wake Forest School of Medicine, Winston-Salem, NC, USA

family: Wilkin

full_name: Aimee Wilkin

given: Aimee

name: Department of Infectious Diseases, University of Modena and Reggio Emilia, Modena, Italy

family: Mussini

full_name: Cristina Mussini

given: Cristina

name: School of Medicine, Technical University of Munich, Munich, Germany

family: Spinner

full_name: Christoph D. Spinner

given: Christoph D.

name: Janssen Research and Development LLC, Pennington, NJ, USA

family: El Ghazi

full_name: Mohsine El Ghazi

given: Mohsine

family: Van Landuyt

full_name: Erika Van Landuyt

given: Erika

family: Lathouwers

full_name: Erkki Lathouwers

given: Erkki

family: Brown

full_name: Kimberley Brown

given: Kimberley

name: Janssen Research and Development LLC, Raritan, NJ, USA

family: Baugh

full_name: Bryan Baugh

given: Bryan

name: on behalf of the AMBER and EMERALD study groups

journal_name: HIV Research & Clinical Practice

evidence: open (via crossref license)

license: cc-by

license_normalized: cc-by

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

ReferenceCitation: Lathouwers E, Wong EY, Brown K, Baugh B, Ghys A, Jezorwski J, Mohsine EG, Van Landuyt E, Opsomer M, De Meyer S; AMBER and EMERALD Study Groups. Week 48 Resistance Analyses of the Once-Daily, Single-Tablet Regimen Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) in Adults Living with HIV-1 from the Phase III Randomized AMBER and EMERALD Trials. AIDS Res Hum Retroviruses. 2020 Jan;36(1):48-57. doi: 10.1089/AID.2019.0111. Epub 2019 Oct 21.

name: Janssen Pharmaceutica NV, Beerse, Belgium.

name: Janssen Scientific Affairs, LLC, Titusville, New Jersey.

family: Wong

full_name: Eric Y Wong

given: Eric Y

name: Janssen Research & Development LLC, Raritan, New Jersey.

name: Janssen Research & Development, Pennington, New Jersey.

name: on behalf of the AMBER and EMERALD Study Groups

repository_institution: Ghent University - Ghent University Academic Bibliography

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

repositories:
HAL
LIRIAS (KU Leuven)
PubMed Central
archive.ugent.be

ReferenceCitation: Huhn GD, Eron JJ, Girard PM, Orkin C, Molina JM, DeJesus E, Petrovic R, Luo D, Van Landuyt E, Lathouwers E, Nettles RE, Brown K, Wong EY. Darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-experienced, virologically suppressed patients with HIV-1: subgroup analyses of the phase 3 EMERALD study. AIDS Res Ther. 2019 Aug 29;16(1):23. doi: 10.1186/s12981-019-0235-1.

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

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

ReferenceCitation: Orkin C, Molina JM, Negredo E, Arribas JR, Gathe J, Eron JJ, Van Landuyt E, Lathouwers E, Hufkens V, Petrovic R, Vanveggel S, Opsomer M; EMERALD study group. Efficacy and safety of switching from boosted protease inhibitors plus emtricitabine and tenofovir disoproxil fumarate regimens to single-tablet darunavir, cobicistat, emtricitabine, and tenofovir alafenamide at 48 weeks in adults with virologically suppressed HIV-1 (EMERALD): a phase 3, randomised, non-inferiority trial. Lancet HIV. 2018 Jan;5(1):e23-e34. doi: 10.1016/S2352-3018(17)30179-0. Epub 2017 Oct 6.

location_country:
United States
Sweden
Switzerland
France
Poland
Belgium
Puerto Rico
Spain
Canada
United Kingdom

title: A Phase 3, Randomized, Active-controlled, Open-label Study to Evaluate the Efficacy, Safety and Tolerability of Switching to a Darunavir/ Cobicistat/ Emtricitabine/ Tenofovir Alafenamide (D/C/F/TAF) Once-daily Single-tablet Regimen Versus Continuing the Current Regimen Consisting of a Boosted Protease Inhibitor (bPI) Combined With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) in Virologically-suppressed, Human Immunodeficiency Virus Type 1 (HIV-1) Infected Subjects

summary: The purpose of this study is to demonstrate non-inferiority in efficacy while switching to a once-daily single-tablet regimen containing darunavir (DRV)/ cobicistat (COBI)/ emtricitabine (FTC)/ tenofovir alafenamide (TAF) (D/C/F/TAF tablet) relative to continuing the current regimen consisting of a boosted protease inhibitor (bPI) combined with tenofovir disoproxil fumarate (FTC/TDF) in virologically-suppressed (human immunodeficiency virus type 1 ribonucleic acid [HIV-1 RNA] concentrations less than [<] 50 copies per milliliter [copies/mL]) HIV-1 infected participants.


title: A Phase 1b/3, Multicenter, Trial of Talimogene Laherparepvec in Combination With Pembrolizumab (MK-3475) for Treatment of Unresectable Stage IIIB to IVM1c Melanoma (MASTERKEY-265/KEYNOTE-034)

summary: Phase 1b Subjects will be treated with talimogene laherparepvec until all injectable tumors have disappeared, disease progression per modified Immune-Related Response Criteria (irRC), or intolerance of study treatment, up to a maximum of 24 months of study treatment. Subjects will be treated with MK-3475 (pembrolizumab) until complete response (CR) disease progression per irRC, or intolerance of study treatment, up to a maximum of 24 months of study treatment. In Phase 3, Subjects will be treated with talimogene laherparepvec plus pembrolizumab(arm 1) or placebo plus pembrolizumab (arm 2) until 24 months from the date of the first dose of pembrolizumab or end of treatment due to disappearance of injectable lesions, complete response, disease progression per irRC-RECIST or intolerance of study treatment.

ReferenceType: background

ReferenceCitation: Ribas A, Dummer R, Puzanov I, VanderWalde A, Andtbacka RHI, Michielin O, Olszanski AJ, Malvehy J, Cebon J, Fernandez E, Kirkwood JM, Gajewski TF, Chen L, Gorski KS, Anderson AA, Diede SJ, Lassman ME, Gansert J, Hodi FS, Long GV. Oncolytic Virotherapy Promotes Intratumoral T Cell Infiltration and Improves Anti-PD-1 Immunotherapy. Cell. 2017 Sep 7;170(6):1109-1119.e10. doi: 10.1016/j.cell.2017.08.027. Erratum in: Cell. 2018 Aug 9;174(4):1031-1032.

ReferenceCitation: Dummer R, Hoeller C, Gruter IP, Michielin O. Combining talimogene laherparepvec with immunotherapies in melanoma and other solid tumors. Cancer Immunol Immunother. 2017 Jun;66(6):683-695. doi: 10.1007/s00262-017-1967-1. Epub 2017 Feb 25. Review.

ReferenceCitation: Watanabe D, Goshima F. Oncolytic Virotherapy by HSV. Adv Exp Med Biol. 2018;1045:63-84. doi: 10.1007/978-981-10-7230-7_4. Review.

family: Watanabe

full_name: Daisuke Watanabe

given: Daisuke

family: Goshima

full_name: Fumi Goshima

given: Fumi

genre: book-chapter

genre_raw: book-chapter

journal_name: Human Herpesviruses

publisher: Springer Singapore

title: Oncolytic Virotherapy by HSV

ipd_sharing: Yes

lead_sponsor: Amgen

location_country:
Finland
Greece
Australia
Belgium
Russian Federation
France
Poland
Canada
Korea, Republic of
South Africa
Switzerland
Netherlands
Hungary
Portugal
United States
Germany
United Kingdom
Italy
Austria
Czechia
Spain


title: A Phase 3 Randomized, Placebo-controlled Double-blind Study of JNJ-56021927 in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Subjects With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC)

summary: The purpose of this study is to compare the radiographic progression-free survival (rPFS) of apalutamide in combination with abiraterone acetate (AA) plus prednisone or prednisolone (AAP) and AAP in participants with chemotherapy-naive (participants who did not receive any chemotherapy [treatment of cancer using drugs]) metastatic castration-resistant prostate cancer (mCRPC) (cancer of prostate gland [gland that makes fluid that aids movement of sperm]).

ReferenceCitation: Saad F, Efstathiou E, Attard G, Flaig TW, Franke F, Goodman OB Jr, Oudard S, Steuber T, Suzuki H, Wu D, Yeruva K, De Porre P, Brookman-May S, Li S, Li J, Thomas S, Bevans KB, Mundle SD, McCarthy SA, Rathkopf DE; ACIS Investigators. Apalutamide plus abiraterone acetate and prednisone versus placebo plus abiraterone and prednisone in metastatic, castration-resistant prostate cancer (ACIS): a randomised, placebo-controlled, double-blind, multinational, phase 3 study. Lancet Oncol. 2021 Nov;22(11):1541-1559. doi: 10.1016/S1470-2045(21)00402-2. Epub 2021 Sep 30.

family: Saad

full_name: Fred Saad

given: Fred

family: Efstathiou

full_name: Eleni Efstathiou

given: Eleni

family: Attard

full_name: Gerhardt Attard

given: Gerhardt

family: Flaig

full_name: Thomas W Flaig

given: Thomas W

family: Franke

full_name: Fabio Franke

given: Fabio

family: Goodman

full_name: Oscar B Goodman

given: Oscar B

suffix: Jr

family: Oudard

full_name: Stéphane Oudard

given: Stéphane

family: Steuber

full_name: Thomas Steuber

given: Thomas

family: Suzuki

full_name: Hiroyoshi Suzuki

given: Hiroyoshi

family: Wu

full_name: Daphne Wu

given: Daphne

family: Yeruva

full_name: Kesav Yeruva

given: Kesav

family: De Porre

full_name: Peter De Porre

given: Peter

family: Brookman-May

full_name: Sabine Brookman-May

given: Sabine

family: Li

full_name: Susan Li

given: Susan

full_name: Jinhui Li

given: Jinhui

family: Thomas

full_name: Shibu Thomas

given: Shibu

family: Bevans

full_name: Katherine B Bevans

given: Katherine B

family: Mundle

full_name: Suneel D Mundle

given: Suneel D

family: McCarthy

full_name: Sharon A McCarthy

given: Sharon A

family: Rathkopf

full_name: Dana E Rathkopf

given: Dana E

journal_name: The Lancet Oncology

location_country:
Brazil
South Africa
Mexico
Netherlands
Germany
Spain
France
Japan
Korea, Republic of
Belgium
Argentina
Australia
Russian Federation
United States
United Kingdom
Canada


title: Trabectedin for Recurrent Grade II or III Meningioma: a Randomized Phase II Study of the EORTC Brain Tumor Group

summary: The aim of this study is to collect data on activity, toxicity and quality of life of trabectedin therapy in patients with recurrent high-grade meningioma.

ReferenceCitation: Hundsberger T, Surbeck W, Hader C, Putora PM, Conen K, Roelcke U. [Meningioma: management of the most common brain tumour]. Praxis (Bern 1994). 2016 Apr 13;105(8):445-51. doi: 10.1024/1661-8157/a002320. Review. German.

name: Klinik für Neurologie, Kantonsspital St. Gallen

name: Klinik für Hämatologie und Onkologie, Kantonsspital St. Gallen

family: Hundsberger

full_name: Thomas Hundsberger

name: Klinik für Neurochirurgie, Kantonsspital St. Gallen

family: Surbeck

full_name: Werner Surbeck

given: Werner

name: Klinik für Radiologie und Nuklearmedizin, Kantonsspital St. Gallen

family: Hader

full_name: Claudia Hader

given: Claudia

name: Klinik für Radioonkologie, Kantonsspital St. Gallen

family: Putora

full_name: Paul Martin Putora

given: Paul Martin

name: Klinik für Onkologie, Universitätsspital Basel

family: Conen

full_name: Katrin Conen

given: Katrin

name: Neurologische Klinik und Hirntumorzentrum, Kantonsspital Aarau

family: Roelcke

full_name: Ulrich Roelcke

given: Ulrich

journal_name: Praxis

publisher: Hogrefe Publishing Group

publisher_dissemination: Hogrefe Publishing Group

publisher_group: Hogrefe Publishing Group

publisher_normalized: Hogrefe Publishing Group

title: Das Meningeom: Management des häufigsten hirneigenen Tumors

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

location_country:
Italy
Austria
Switzerland
Netherlands
France
Norway
Belgium
Spain
Germany
United Kingdom

location_facility: CHU de Lyon - CHU Lyon - Hopital neurologique Pierre Wertheimer

location_facility: Spaarne Gasthuis - Vrije Universiteit Medisch Centrum

location_facility: Universitaetsklinikum Heidelberg - UniversitaetsKlinikum Heidelberg - Head Hospital

location_facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale San Giovanni - Dipartimento Neuroscienze

location_facility: Universitaetsklinikum Freiburg - Klinik fuer Neurochirurgie

location_facility: Ludwig-Maximilians-Universitaet Muenchen - Klinikum der Universitaet Muenchen - Campus Grosshadern

location_facility: Fondazione IRCCS Istituto Neurologico Carlo Besta

location_facility: CHU de Bordeaux - Groupe Hospitalier Saint-André - Hopital Saint-Andre

location_facility: University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre

location_facility: Erasmus MC Cancer Institute - location Daniel den Hoed

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

location_facility: Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia)

location_facility: Istituto Regina Elena / Istituti Fisioterapici Ospitalieri

location_facility: Hospital Clinic Universitari de Barcelona

location_facility: Eberhard Karls Universitaet Tuebingen - Universitaetsklinikum Tuebingen

location_facility: Assistance Publique - Hopitaux de Paris - La Pitie Salpetriere

location_facility: Centre Hospitalier Universitaire Vaudois - Lausanne

location_facility: Newcastle Hospitals NHS Trust - Freeman Hospital, Northern Centre For Cancer Care

location_facility: Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme

location_facility: Medical University Vienna - General Hospital AKH

location_facility: Istituto Oncologico Veneto IRCCS - Ospedale Busonera

location_facility: Oslo University Hospital - Radiumhospitalet

location_facility: Institut Catala d'Oncologia - ICO L'Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia)


title: Plegridy™ (Peginterferon β-1a) Real World Effectiveness and Safety Observational Program

acronym: POP

summary: The primary objectives of the study are to determine the incidence of serious adverse events (SAEs) in participants with relapsing forms of multiple sclerosis (MS) in routine clinical practice and to assess the overall long-term clinical effectiveness of Plegridy in participants with relapsing forms of MS in routine clinical practice. The secondary objectives of this study in this study population are to describe Plegridy prescription and utilization adherence patterns in routine clinical practice; to assess the specific long-term clinical effectiveness of Plegridy in participants with relapsing forms of MS in routine clinical practice; to monitor the safety and tolerability of Plegridy in routine clinical practice by assessing the incidence of adverse events (AEs) of flu-like symptoms (FLS), injection site reactions (ISRs), and AEs (including laboratory abnormalities) leading to treatment discontinuation; to assess the effect of FLS on participant-reported effectiveness of, and satisfaction with, prophylactic management using a FLS-Visual Analog Scale (FLS-VAS); to evaluate the change in health-related quality of life (HRQoL), FLS, FLS-VAS, healthcare resource consumption, and treatment adherence over time.

time_perspective: Prospective

lead_sponsor: Biogen

location_country:
Italy
Austria
United States
Switzerland
Netherlands
Spain
Germany
France
Ireland
Australia
Portugal
Denmark
Canada
United Kingdom

location_facility:
Research site
Research Site

status_simplified: Ongoing


status: Recruiting

enrollment_type: Anticipated

location_country:
Italy
Switzerland
France
Poland
Norway
Ireland
Belgium
Spain
Denmark
Canada
United Kingdom

acronym: PEACE III

location_facility: Hospital Universitario de Gran Canaria Doctor Negrin

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

location_facility: Royal Marsden Hospital - Chelsea, London

location_facility: Assistance Publique - Hopitaux de Paris - CHU Henri Mondor

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

location_facility: The Royal Surrey County Hospital NHS Foundation Trust

location_facility: Nottingham University Hospitals NHS Trust - City Hospital

location_facility: CHUM - Centre Hospitalier de l'Université de Montreal - Pavillon Saint-Luc

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

location_facility: Maria Sklodowska-Curie Memorial Cancer Centre

location_facility: Hopitaux Universitaires de Strasbourg - Hôpitaux Universitaires de Strasbourg - Hôpital civil

location_facility: United Lincolnshire Hospitals NHS Trust - Lincoln County Hospital

title: A Randomized Multicenter Phase III Trial Comparing Enzalutamide vs. a Combination of Ra223 and Enzalutamide in Asymptomatic or Mildly Symptomatic Castration Resistant Prostate Cancer Patients Metastatic to Bone.

summary: The objective of this randomized phase III open label trial is to assess if upfront combination of enzalutamide and Ra223 improves radiological progression-free survival compared to enzalutamide single agent in asymptomatic or mildly symptomatic castration resistant prostate cancer patients metastatic to bone.


title: iNNOVATE Study: A Randomized, Double-Blind, Placebo- Controlled, Phase 3 Study of Ibrutinib or Placebo in Combination With Rituximab in Subjects With Waldenström's Macroglobulinemia

summary: The purpose of this study is to evaluate the safety and efficacy of ibrutinib in combination with rituximab in participants with Waldenström's macroglobulinemia (WM).

ReferenceCitation: Dimopoulos MA, Tedeschi A, Trotman J, García-Sanz R, Macdonald D, Leblond V, Mahe B, Herbaux C, Tam C, Orsucci L, Palomba ML, Matous JV, Shustik C, Kastritis E, Treon SP, Li J, Salman Z, Graef T, Buske C; iNNOVATE Study Group and the European Consortium for Waldenström's Macroglobulinemia. Phase 3 Trial of Ibrutinib plus Rituximab in Waldenström's Macroglobulinemia. N Engl J Med. 2018 Jun 21;378(25):2399-2410. doi: 10.1056/NEJMoa1802917. Epub 2018 Jun 1.

ReferenceCitation: Dimopoulos MA, Trotman J, Tedeschi A, Matous JV, Macdonald D, Tam C, Tournilhac O, Ma S, Oriol A, Heffner LT, Shustik C, García-Sanz R, Cornell RF, de Larrea CF, Castillo JJ, Granell M, Kyrtsonis MC, Leblond V, Symeonidis A, Kastritis E, Singh P, Li J, Graef T, Bilotti E, Treon S, Buske C; iNNOVATE Study Group and the European Consortium for Waldenström's Macroglobulinemia. Ibrutinib for patients with rituximab-refractory Waldenström's macroglobulinaemia (iNNOVATE): an open-label substudy of an international, multicentre, phase 3 trial. Lancet Oncol. 2017 Feb;18(2):241-250. doi: 10.1016/S1470-2045(16)30632-5. Epub 2016 Dec 10.

ipd_sharing_description: Requests for access to individual participant data from clinical studies conducted by Pharmacyclics LLC, an AbbVie Company, can be submitted through Yale Open Data Access (YODA) Project site at the following link.

lead_sponsor: Pharmacyclics LLC.

location_country:
Italy
United States
Germany
France
Greece
Australia
Spain
Canada
United Kingdom

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

location_facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Azienda Ospedaliero Universitaria Santa Maria della Misericordia di Udine

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Centre Hospitalier de Saint Brieuc Hopital Yves le Foll

location_facility: DIAKO Evangelische Diakonie Krankenhaus gGmbH

location_facility: ASST di Pavia - Fondazione IRCCS Policlinico San Matteo di Pavia

location_facility: Queen Elizabeth II Health Sciences Center

location_facility: University General Hospital of Thessaloniki "AHEPA"